A new study questioning the usefulness of arthroscopic surgery for osteoarthritis of the knee should encourage patients to consider physical therapy as an effective non-surgical option, according to the American Physical Therapy Association (APTA). The study was published in the New England Journal of Medicine (NEJM).

The study found that physical therapy, combined with comprehensive medical management, is just as effective at relieving the pain and stiffness of moderate to severe osteoarthritis of the knee as surgery.

“This study offers hope and encouragement to persons with osteoarthritis who would like to avoid the pain and emotional toll of surgery,” said APTA President R Scott Ward, PT, PhD. “Too often, the first line of defense is surgery when it need not always be. Physical therapy can be equally effective and should be considered by not only patients themselves, but also the primary care doctors and orthopedists who are treating them.”

According to physical therapist Christopher M Powers, PhD, PT, director of the Biokinesiology program and co-director of the Musculoskeletal Biomechanics Research Lab at the University of Southern California Division of Biokinesiology & Physical Therapy, “Many times knee pain is associated with abnormal movement patterns that cause increased stress on the joint. Arthroscopic surgery does little to correct the dynamic factors that may be contributing to knee pain and pathology. These findings reinforce the need for a comprehensive treatment approach for such patients.”

The NEJM study adds to a growing body of evidence supporting physical therapy for treatment of osteoarthritis of the knee, including:

• A report published in the January 2008 issue of the journal Physical Therapy that reviewed research on osteoarthritis of the knee from 2000 to 2007 and found “high-quality evidence that exercise and weight reduction reduce pain and improve physical function.”

• A study published in the Feb 1, 2000 issue of the Annals of Internal Medicine that concluded “a combination of manual physical therapy and supervised exercise yields functional benefits for patients with osteoarthritis of the knee and may delay or prevent the need for surgical intervention.”

A physical therapist will perform a thorough examination and design a plan of care that may include:

• A series of exercises designed to help improve motion. Activities in this phase might include water walking, swimming, and flexibility exercises.

• An exercise sequence to restore strength including a functional progression, that is, a gradual return to normal activities using exercises that simulate the knee stresses of your normal activities.

A knee’s tolerance for stressful activities often decreases with age and loss of conditioning. As a result, stresses that would not have caused pain or injury to the knee last year could today. A decrease in levels of activity over a period of time may also contribute to the vulnerability of knees.

But there are steps one can take to help prevent injury in order to continue enjoying sports and exercise. Pursuing an exercise program designed by a physical therapist can be one of the best protections from injury.

The first step in designing your exercise program is an evaluation by your physical therapist. He or she can identify your predisposing factors, those body traits that may make you more or less vulnerable to a knee injury. Based on this evaluation, your physical therapist can design a program that will help you gain your optimum levels of function, strength and conditioning.

Physical therapy plays a key role in treating and rehabilitating the knee, but the patient’s attitude toward recovery plays a big factor in achieving a successful outcome. For more information on taking care of your knees and to find a physical therapist, visit http://www.apta.org/consumer/.

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APTA (http://www.apta.org/) is a national organization representing physical therapists, physical therapist assistants, and students nationwide. Its goal is to foster advancements in physical therapist education, practice, and research. Consumers can visit http://www.findapt.us / to find a physical therapist in their area, as well as http://www.apta.org/consumer/ for physical therapy news and information.

Source: Stephanie Block
American Physical Therapy Association

Nearly 100 of the world’s leading authorities on diabetes, health care policy and finance from public and private sectors will gather in New York City next week to discuss the appropriate role of new interventional therapies for the treatment of Type 2 Diabetes. Currently, the condition is one of the fastest-growing epidemics in the world, affecting an estimated 23.6 million people in the United States in 2007 alone, and is one of the costliest conditions to treat. The 1st World Congress on Interventional Therapies for Type 2 Diabetes will convene on September 15-16, 2008.

The Congress has been endorsed by 26 of the most prestigious diabetes, medical and surgical societies in the world. Attendees and faculty represent 46 countries and six continents.

According to Dr. Jesse Roth, a congress faculty member, researcher and diabetologist at the Feinstein Institute for Medical Research and the Albert Einstein College of Medicine of Yeshiva University in New York City:

“Surgery has arrived like a comet across the firmament of diabetes and obesity — unexpected, brilliant, with great promise for the future. Teams of talented researchers are moving ahead to define the role of surgery in the treatment of both of these scourges.”

Monday, September 15

Session I: Diabetes: Epidemiology, Pathology and Socioeconomic Burden
(7:45 a.m. - 10:00 a.m.)

Dr. Paul Zimmet, professor at the Baker IDI Heart & Diabetes Institute of Monash University in Caulfield South, Australia, will present an update on the incidence and prevalence of diabetes in various countries of the world, analyzing potential implications and future trends.

The social and economic burden of type 2 diabetes will also be discussed amongst diabetes experts, including representatives from the World Health Organization and top health authorities from the United States, including Dr. Richard Daines, New York State Health Commissioner, and from abroad, Dr. José Angel Córdova Villalobos, Minister of Health of Mexico.

Session II: Conventional Diabetes Therapies: Outcomes and Limitations
(10:20 a.m. - 12:00 p.m.)

Dr. Harold Liebowitz, professor of medicine, from the Division of Endocrinology and Metabolism Diabetes at the State University of New York Health Sciences Center, will discuss the current treatments, comparing and contrasting the metabolic advantages and disadvantages of new therapies to the standard of care.

A panel discussion will follow, including surgeons and diabetologists, who will further compare and contrast the various therapies’ risks, benefits and limitations.

Session III: Bariatric Surgery: Diabetic and Metabolic Outcomes
(Part 1: 12:00 p.m. - 1:00 p.m. / Part 2: 2:00 p.m. - 2:45 p.m.)

Dr. Phil Schauer, a bariatric surgeon from the Cleveland Clinic, will chair a session providing an update of the efficacy of bariatric surgery with the hope of controlling diabetes, hyperlipidemia and hypertension. Dr. Schauer will analyze the safety profiles of various operations compared with those of other commonly performed gastrointestinal (GI) surgeries.

Two large, recently published studies will be reviewed — one from United States and one from Sweden — showing that surgery can dramatically reduce mortality of severely obese patients. One such study, published in the New England Journal of Medicine, by Dr. Ted Adams, adjunct associate professor and program director of the Health & Fitness Institute at LDS Hospital, at the University of Utah School of Medicine in Salt Lake City, showed a 90 percent reduction of diabetes-specific mortality after gastric bypass surgery. Dr. Adams will present data from these studies, as well as new, unpublished data concerning the impact of surgery on the typical complications of diabetes. The authors believe that the findings have great significance, because type 2 diabetes has serious cardiovascular complications, which potentially lead to mortality, and remains very difficult to address even by intensive conventional therapy.

The data presented will be critically analyzed by the panel discussion, including leading diabetes experts as well as surgeons and cardiologists.

Session IV: Gastrointestinal Surgery to Treat Diabetes in Patients Who Are Not Severely Obese (BMI <35)
(3:05 p.m. - 4:45 p.m.)

The remarkable control of type 2 diabetes in severely obese patients raises the question of whether surgery may also be a possible therapeutic option for moderately obese or non-obese patients. Dr. Francesco Rubino, chief of Gastrointestinal Metabolic Surgery and director of the Diabetes Surgery Center, at NewYork-Presbyterian Hospital/Weill Cornell Medical Center in New York City, will present a review of published evidence, and an update consisting of data from new clinical studies from around the world investigating the efficacy and safety of surgery for diabetes in overweight or non-obese patients.

The panel discussion, including surgeons, endocrinologists and policy makers, will focus on the appropriate role of surgery in less-obese patients, who do not qualify for bariatric surgery under current measures and standards, and what parameters other than just BMI should be used to determine the need for surgical intervention.

Session V: Gastrointestinal Surgery and Diabetes in Adolescents
(4:45 - 6:00 p.m.)

Dr. Francine Kaufman, one of the world’s foremost childhood-diabetes-researchers, head of the Center for Diabetes, Endocrinology and Metabolism at the Children’s Hospital, and professor of pediatrics and communications, at the Keck School of Medicine at the University of Southern California in Los Angeles, will present data regarding the growing rate of obesity and diabetes epidemic in adolescents. Results examining the efficacy, safety and psychological implications of surgery in this population will be presented and discussed with leading international pediatrician and diabetes experts.

Tuesday, September 16

Session VI: Mechanisms of Surgical Control of Diabetes
(7:30 a.m. - 9:15 a.m.)

Dr. David Cummings, deputy director of the Diabetes Endocrinology Research Unit and associate professor of medicine at the University of Washington in Seattle, will discuss the various mechanisms of diabetes control after GI surgery, including evidence demonstrating diabetic improvement as a result of mechanisms independent of weight-loss and lowered caloric intake. Recent research and ongoing studies will be presented showing important implications of this new information. Dr. Cummings will discuss how this new information improves upon the understanding of diabetes and the significance of surgical intervention for the treatment of type 2 diabetes.

A panel of diabetologists and surgeons will attempt to prioritize future research directions in order to gain a greater understanding of the molecular mechanisms and the effects of GI surgery, independent of weight-loss.

Dr. Jesse Roth will explain the mechanisms of surgical control of diabetes and how such procedures might lead to the identification of new drug targets for pharmaceutical research and development with the hope of potentially mimicking the effects of surgery.

Session VII: Weighing Research Priorities in an Era of Constraint
(9:45 a.m. - 11:00 a.m.)

Drs. Cummings and Roth will present data suggesting that the remarkable anti-diabetic impact of certain GI operations — specifically gastric bypass — cannot be attributed solely to reduced food intake and body weight.

A panel of diabetologists and surgeons will attempt to prioritize future research directions in order to gain a greater understanding of the molecular mechanisms and the effects of GI surgery independent of weight.

Session VIII: Novel Gastrointestinal Interventional Therapies
(11:00 a.m. - 12:15 p.m.)

Speakers and panelists will discuss how a better understanding of GI surgery for diabetes, and recent technological developments, are creating the foundation for novel and revolutionary, minimally invasive interventional therapies that may have the same effects of surgery. New endoscopic and endoluminal therapies for diabetes, as well as gastric and intestinal stimulator devices, will be presented, including early clinical trials from the United States, South America and Europe.

New data from a pilot clinical trial will be presented showing that an endoluminal gastrointestinal device may prevent nutrients from contacting the upper part of the small bowel, achieving immediate and sustained improvement of diabetes - independent of weight loss - suggesting a direct action on the mechanisms of disease.

Findings will be presented by Dr. Lee Kaplan, an associate professor of medicine at Harvard Medical School, and the director of the Weight Center at Massachusetts General Hospital in Cambridge, Massachusetts.

Session IX: Clinical and Research Recommendations for Diabetes Surgery: The Rome Consensus Conference
(1:15 p.m. - 2:45 p.m.)

Outcomes of the First International Consensus Conference (the Rome Diabetes Surgery Summit), which examined the use of surgical intervention for diabetes, will be publicly presented for the first time. This session is held under the auspices of the International Diabetes Surgery Task Force, a group of leading scholars from around the world, including some of the most respected diabetes experts, clinical trials specialists, surgeons and scientists. The Task Force has been created to promote the recommendations established by the voting experts of the Rome Summit worldwide.

The Diabetes Surgery Summit guidelines, which include recommendations for the surgical treatment of diabetes, as well as for future research in this field, will be critically discussed by officially designated experts representing leading scientific societies in the field of endocrinology and surgery, including the AACE, ASMBS, TOS, Diabetes UK, WHO, ADA and IFSO.

X: The Economics of Interventional Therapies and Implications for Public Health
(3:15 p.m. - 4:30 p.m.)

During a specially highlighted portion of the Congress, faculty, including health economists and top health authorities from United States and around the world, will discuss economic and social implications of surgical treatment of diabetes. New data from major medical and economic journals will be presented showing that diabetes surgery can benefit individual patients and actually represent a potential cost-savings.

Social implications and insurance coverage will be among the topics of a lively debate between a panel, including the undersecretary of health of England, the director of the British National Health Service, chief executives of patients’ advocacy groups, scientific societies, managed care organizations, and U.S. public and private insurance plans.

Session XI: Comprehensive Management of Patients with Diabetes: The Role of Interventional Therapies
(4:30 p.m. - 5:45 p.m.)

Dr. Robin Goland, associate professor of medicine and co-director of the Naomi Berrie Diabetes Center at the Columbia University College of Physicians and Surgeons in New York, City, and Dr. Louis Aronne, obesity-diabetes expert from NewYork-Presbyterian Hospital/Weill Cornell Medical Center and clinical professor of medicine at Weill Cornell Medical College in New York City, will have a practical discussion on the role of surgery in the comprehensive management of patients with diabetes. The presentation will touch upon and utilize data and discussions from the previous sessions in an attempt to define acceptable applications of surgery and interventional treatments based on current evidence. There will be a dialogue between patients, who have diabetes, or who have undergone interventional therapies, and their health care providers, including endocrinologists, diabetes educators and surgeons.

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The 1st World Congress on Interventional Therapies for Type 2 Diabetes

The 1st World Congress on Interventional Therapies for Type 2 Diabetes is a comprehensive and multidisciplinary forum where leaders in the global health community will conduct an organized review and discussion of the latest scientific data and theories on the use of bariatric surgery for the treatment of type 2 diabetes. The Congress, hosted by Weill Cornell Medical College and NewYork-Presbyterian Hospital, aims to create a forum for the medical community to work with health policy makers, including top public health authorities and insurers from the U.S. and around the world. The overarching aim is to craft an agenda of health policy initiatives to seize the opportunity offered by gastrointestinal surgery and novel interventional therapies for the understanding and treatment of diabetes. For more information, visit http://www.interventionaldiabetology.org/.

SPONSORS OF THE WORLD CONGRESS

Led by Visionary Sponsor Covidien, the Congress has received support from the medical device, biotechnology, and pharmaceutical industry. Sponsors include: Covidien, Ethicon Endo-Surgery, 3 Peaks Consulting, Allergan, GI Dynamics, GlaxoSmithKline, Metacure, Olympus, On-Q Pain Relief System, Power Medical Interventions, Amylin, Lifescan, Obesity Care News Pfizer, Sanofi-Aventis, Karl Storz Endoscopy, and Synovis.

September 15 - 16, 2008
New York Marriott Marquis
For more information or to register, visit http://www.interventionaldiabetology.org/.

Source: John Rodgers
New York- Presbyterian Hospital/Weill Cornell Medical Center/Weill Cornell

Data released at the European Association for the Study of Diabetes (EASD) Annual Meeting concludes that Levemir® (insulin detemir [rDNA origin] injection) is a once-daily treatment for diabetes patients after demonstrating a 24-hour duration of action in both type 1 and type 2 diabetes.1,2 Results from two other studies announced today reveal that Levemir® can lead to significant weight loss for insulin-na?ve patients with type 2 diabetes3, and provides a similar blood glucose response as glargine with no significant difference in daily average consumption (DACON) or diabetes-related pharmacy costs4.

Once-daily Levemir® demonstrates 24-hour duration of action

The randomised, double-blind study by Bock et al1 demonstrates that once-daily Levemir® is effective over a 24-hour period (mean duration 23.3 hours) in type 1 diabetes patients and has a more consistent duration of action compared to insulin glargine1. This reflects other published research in which patients with type 2 diabetes achieve 24-hour glycaemic control with once-daily Levemir®.5

Weight benefit beyond glycaemic control

In another study presented today, a subset analysis of the PREDICTIVE™ study3, it was shown that insulin-na?ve patients with type 2 diabetes and a BMI >35 kg/m2 experienced an average weight loss of up to -3.46 kg after 52 weeks of Levemir® treatment3.

“This data confirms that Levemir® provides a significant weight benefit for overweight or obese patients who are being initiated into insulin treatment. This weight advantage is important because weight gain is a common barrier to insulin initiation,” said Professor Helene Hanaire, Hospital Rangueil, Toulouse, France. “This weight advantage combined with the efficacy and convenience of Levemir®, which can be taken once daily, makes it a good option for overweight or obese diabetes patients who need to take insulin.”

Levemir® shows similar daily average consumption versus glargine

A retrospective analysis of insulin-na?ve patients with type 2 diabetes enrolled in a major US health plan compared daily average consumption (DACON) of and glycaemic control with the insulins Levemir® and glargine, along with associated medical costs. Results showed that there was no difference in HbA1c values between Levemir® and insulin glargine cohorts, and no significant difference in DACON4.

About Levemir® (insulin detemir [rDNA origin] injection)

Levemir® (insulin detemir [rDNA origin] injection) is a long-acting modern insulin (insulin analogue) indicated for once- or twice-daily subcutaneous administration for the treatment of adults and children with type 1 diabetes mellitus and adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycaemia. Levemir® has a relatively flat action profile with up to 24-hour duration of action. It can be added to oral antidiabetic agents, or used in combination with rapid-acting insulin. Levemir® is available in FlexPen®, a prefilled insulin pen for easy, discreet dosing, and in vials. The dose should be taken in the evening, at dinner or before bedtime. Levemir® has been available for use in Europe since March 2004 and is currently approved in more than 50 countries worldwide.

Prescribing information for Levemir® is available by contacting Novo Nordisk or visiting http://www.novonordisk.com.

Levemir® and FlexPen® are registered trademarks of Novo Nordisk A/S.

Novo Nordisk is a healthcare company and a world leader in diabetes care. In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk employs approximately 26,300 employees in 80 countries, and markets its products in 179 countries. Novo Nordisk’s B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol ‘NVO’. For more information, visit http://www.novonordisk.com.

References

1. Bock, G., et al. Pharmacodynamics and pharmacokinetics of long-acting insulin analogues detemir and glargine after 7 days of use and after its first administration in subjects with type 1 diabetes. Presented at the European Association for the Study for Diabetes, September 2008.

2. King, A B., et al. A randomized, crossover, double-blind comparison of insulin detemir and insulin glargine daily blood glucose profiles in subjects with type 2 diabetes. Presented at the American Diabetes Association’s 68th Annual Scientific Sessions, June 2008 and at the European Association for the Study for Diabetes, September 2008.

3. Hanaire, H., et al. Insulin-na?ve patients with type 2 diabetes and higher BMI experience weight loss when initiated onto insulin detemir: 12-week, 26-week and 52-week follow-up data from PREDICTIVE™. Presented at the European Association for the Study for Diabetes, September 2008.

4. Borah, B., et al. Comparative analysis of treatment outcomes of patients on insulin detemir (Levemir®) and insulin glargine (Lantus®). Presented at the American Diabetes Association’s 68th Annual Scientific Sessions, June 2008 and at the European Association for the Study for Diabetes, September 2008.

5. Heise, T, Pieber, T. Towards peakless, reproducible and long-acting insulins. An assessment of the basal analogues based on isoglycaemic clamp studies. Diabetes, Obesity and Metabolism 2007;9(5):648-659.

http://www.novonordisk.com

View drug information on Lantus.

Community-based exercise organizations, such as the YMCA, are an effective tool in the fight against diabetes, according to a study by Indiana University School of Medicine researchers in the October 2008 issue of the American Journal of Preventive Medicine.

More than 60 million Americans have pre-diabetes, and most of them are unaware. Adults with pre-diabetes are at more than 10 times the normal risk for developing diabetes and at twice the risk for heart attack or stroke. Reaching this growing population is a concern for diabetes educators and physicians.

“Previous studies, such as the highly regarded national Diabetes Prevention Program, have shown that structured diet and physical exercise can significantly reduce the progression of pre-diabetes to diabetes. But these trials involved major lifestyle changes that are difficult to translate into large-scale, community-level programs. In our study we were able to train lay people in the community to deliver the program at the YMCA, an environment accessible to many people with pre-diabetes, to help them sustain lifestyle changes,” said the study’s principal author, Ronald Ackermann, M.D., M.P.H., IU School of Medicine assistant professor of medicine and an affiliated scientist of the Regenstrief Institute.

With more than 2,500 facilities serving more than 10,000 inner-city, suburban and rural communities nationwide and a long history of implementing successful health promotion programs, the YMCA is in a unique position to reach persons with pre-diabetes, according to Dr. Ackermann. In this study, 92 individuals were enrolled in two groups. The intervention group received a core curriculum involving 16 classroom-style meetings focused on building knowledge and skills for goal setting, self-monitoring and problem-solving. The control group was offered standard diabetes-prevention advice.

At the 4-6-month follow-up visit, body weight had decreased by 6 percent in the intervention participants and by 2 percent in the control participants. This was equal to a mean weight loss of 12.5 pounds for intervention participants and 4 pounds for the group that received the standard information. The difference in the amount of weight lost is a clinically meaningful and significant difference, as was the change in total cholesterol concentration, according to Dr. Ackermann. These differences persisted at the 12-14 month follow-up visits.

“This is the first study to demonstrate that the YMCA is a promising vehicle for the dissemination of the DPP lifestyle intervention into the community. In the DPP, a 5 percent weight loss was associated with a 58 percent reduction in risk of developing diabetes. In our pilot study, people at high risk for developing diabetes achieved and maintained a mean 6 percent reduction in baseline body weight and significant reductions in total cholesterol,” he noted.

The study concludes, “By lowering the cost of and expanding the accessibility to diabetes-prevention services, the YMCA may serve not only to increase the number of individuals with pre-diabetes who have access to and can pay for evidence-based diabetes prevention; it may also provide a compelling model for health-plan reimbursement. This provides yet another compelling reason to develop and test novel strategies that link community-based program delivery with existing clinical services that could help to identify and activate more adults with pre-diabetes.”

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Support for this study was provided by the National Institute of Diabetes and Digestive and Kidney Diseases, the IU School of Medicine and the YMCA of Greater Indianapolis.

Dr. Ackermann is the deputy director of the Center for Health Policy and Professionalism Research (CHPPR), an innovative think tank at the IU School of Medicine and Riley Hospital for Children.

In addition to Dr. Ackermann, authors of “Translating the Diabetes Prevention Program into the Community: The DEPLOY Pilot Study” are Emily A. Finch, M.A.; Edward Brizendine, M.S.; Honghong Zhou, Ph.D and David G. Marrero, Ph.D., of the IU School of Medicine.

Source: Cindy Fox Aisen
Indiana University

The physical activity levels of children in the United Kingdom havebeen enormously overestimated, according to an article released onSeptember 9, 2008 in the Archives of Disease in Childhood,one of the BMJ Specialty journals.

UK public health policy and practice is generally informed by annualhealth survey data. However, according to the authors of this article,this survey has not yet been validated. These figures have previouslyindicated that the population was generally very physically active, andthat physical activity in children has increased over the past severalyears. One point of the survey, that could lead to errors, is that theinformation about children relies heavily on parent-supplied reporting.

In maintaining proper health and preventing obesity and other illnesseslater in life, it is recommended that children engage in at least onehour of moderate to vigorous exercise every day. Such physicalactivities might include brisk walking, running, or sports.

To examine the survey’s accuracy and reliability, researchers examined130 children between the ages of 6 and 7 over the course of one week.The actual levels of physical activity were assessed using a portablemonitoring and recording device (an accelerometer) which each carriedon a waist belt. These readings were compared with information suppliedby parents using the annual Health Survey for England.

Parents reported that their children were moderately vigorouslyphysically active for about 146 minutes a day. The accelerometerreadings, however, indicated that this figure was 24 minutes per day.Boys generally had 26 minutes and girls had 22 minutes. According tothe survey reports, 83% of boys and 56% of girls achieved therecommended daily levels of moderate to vigorous exercise. However,according to the accelerometer, showed only 3% of boys and 3% of girlsactually achieved this level.

According to the authors, the accelerometer results are in line withother studies of the population which also indicate an increase in therate of car rides children take and an increase in overweight andobesity levels. They say: “Marked improvements in surveillance ofphysical activity will be necessary in order to meet the major publichealth challenges of the 21 st century, particularly where physicalactivity has been implicated in the aetiology of diseases, such asobesity and related disorders,” they comment.

Surveillance of physical activity in the UK is flawed:validationof the Health Survey for England Physical Activity Questionnaire
OnlineFirst Arch Dis Child 2008
doi 10.1136/adc.2007.135905
Click Here For Journal

Written by Anna Sophia McKenney
Copyright: Medical News Today

Health insurers can offset the cost of laparoscopic or traditional bariatric surgery as a weight-loss treatment for obese patients within two to four years as a result of savings on other medical costs, according to a study published this month in the American Journal of Managed Care, the Wall Street Journal reports.

For the study, Pierre-Yves Crémieux, a health economist and principal at Analysis Group, and colleagues analyzed health insurance claims data for 2003 through 2007 for 3,651 severely obese patients who underwent either laparoscopic or traditional bariatric surgery. The patients in large part were female, with an average age of 44; more than one-third of the patients had high blood pressure, and many of them had high cholesterol, diabetes and other health problems.

Researchers matched each patient based on age, gender, geography, health status and baseline costs with a patient who did not undergo either of the surgeries. Researchers tracked claims data for the patients who underwent either of the surgeries for six months of pre-surgical examination and care, the procedures themselves, and about 18 months of post-surgical care; tracked claims data for post-surgical care for some patients for as long as five years; and tracked claims data for the matched patients over the same period.

According to the study, health insurers that covered patients who underwent laparoscopic surgery, which has an average cost of $17,000, offset the cost in about 25 months. Health insurers that covered patients who underwent traditional bariatric surgery, which has an average cost of $26,000, offset the cost in about 49 months. Crémieux said, “The most cost-effective treatment for obesity is bariatric surgery,” adding, “If you do that, within two to four years, you will get your money back.” In addition, he said, “We have identified the break-even point for insurers.”

Implications
The study could “increase pressure” on health insurers to cover laparoscopic or traditional bariatric surgery, the Journal reports. Many health insurers do not cover the surgeries, although evidence indicates that the procedures are effective as weight-loss treatments, as well as treatments for diabetes, high blood pressure and sleep apnea. Susan Pisano, a spokesperson for America’s Health Insurance Plans, said that health insurers continue to have concerns about the safety and effectiveness of the surgeries. She added, “I don’t know if these results would be replicated in other populations.”

According to the Journal, some lawmakers and health insurance industry observers likely will question the study because Ethicon Endo-Surgery, the weight-loss surgery device and instruments manufacturing division of Johnson & Johnson, funded the research. However, Crémieux said that Ethicon “has been totally hands off” the study. In addition, Michael Chernew, co-editor in chief of the Journal of Managed Care, said that the study underwent a comprehensive examination by independent reviewers who requested a series of revisions. He added, “I won’t deny that I would rather this be funded by some other organization, but there is no bias in the methodology.”

Eric Finkelstein — a health economist who earlier conducted a study that found a 10-year return on investment for bariatric surgery — questioned the study. In the event that the matched patents had “one really bad outcome, such as [a]heart transplant,” it could have significantly changed the results of the study, he said. Finkelstein added that the “return-on-investment” analysis of weight-loss surgery is “misguided,” as such analysis is not used to determine the cost-effectiveness of cancer or heart disease treatments (Rundle, Wall Street Journal, 9/8).

An abstract of the study is available online.

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

New clinical data analysis confirms that the first-in-class direct renin inhibitor Rasilez® (aliskiren), known as Tekturna® in the US, provides significantly greater blood pressure reductions in obese patients with high blood pressure compared to the diuretic hydrochlorothiazide (HCT) alone1.

The post hoc analysis presented at the European Society of Cardiology (ESC) 2008 annual congress showed that Rasilez/Tekturna 300 mg monotherapy provided reductions in mean sitting systolic blood pressure (when the heart is pumping) of -16.7 mmHg compared to -12.2 mmHg for HCT, and diastolic (when the heart is at rest) blood pressure reductions of -12.3 mmHg compared to -9.1 mmHg for HCT (p<0.001) 1.

These findings are significant as 70% of patients with high blood pressure are overweight or obese (body mass index ≥30 kg/m2)4. Obese patients with high blood pressure have an increased risk of cardiovascular and kidney disease6. Approximately 58% of diabetes and 21% of ischemic heart disease is attributable to a body mass index above 217.

“Sixty-five percent of people with high blood pressure worldwide still do not have the condition under control and as the rate of obesity and diabetes continues to rise there is a definite need for new treatments to help bring patients to goal,” said Professor Aldo Maggioni of the Italian Association of Hospital Cardiologists Research Center, Florence, Italy. “In addition to providing effective blood pressure reductions in the general hypertensive population these data further confirm that aliskiren is effective and well tolerated in difficult to treat patients who are obese and in patients with heart failure who also have kidney disease or diabetes.”

Two subgroup analyses of the ALOFT study (ALiskiren Observation of Heart Failure Treatment) were also presented. Rasilez/Tekturna, when added to standard therapy in heart failure patients with or without diabetes, provided a 25% reduction in brain natriuretic peptide (BNP), an indicator of heart failure severity, from baseline compared with placebo2. Rasilez/Tekturna was well tolerated when added to standard therapy in chronic heart failure patients, including those with diabetes and kidney disease (eGFR < 60 mL/min/1.73m2)2,3.

BNP is a substance released from the heart’s lower ventricles in response to increased walltension. The level of BNP in the bloodstream increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable.

Approximately 23 million people worldwide have chronic heart failure for which the leading risk factor is high blood pressure5. If high blood pressure is properly controlled, the incidence of heart failure and stroke can be reduced by almost half, and heart attacks by one quarter8.

“In addition to providing powerful blood pressure reductions that last beyond 24 hours both as monotherapy and in combination, Rasilez continues to demonstrate the potential to protect organs such as the heart and kidneys,” said Trevor Mundel, MD, Head of Global Development Functions at Novartis Pharma AG. “We are pleased to report that studies from the ASPIRE HIGHER program, including data from ALOFT and AVOID, have already paved the way for an enhanced European Union label for Rasilez.”

ASPIRE HIGHER is the largest ongoing cardio-renal outcomes program worldwide and is investigating the potential heart and kidney protection benefit of Rasilez/Tekturna.

Findings from three of the 14 studies in the ASPIRE HIGHER program have already been reported. The AVOID study, published recently in The New England Journal of Medicine, showed that Rasilez/Tekturna reduced albuminuria, a key indicator of kidney disease, by an additional 20% in type 2 diabetic patients with kidney disease and high blood pressure who were already taking the maximum standard treatment9.

The ALOFT study, recently published in the Circulation: Heart Failure, showed that the addition of Rasilez/Tekturna to standard heart failure treatments resulted in nearly five times greater reductions in BNP, a marker of heart failure severity, than the standard therapy alone10. The ALLAY study demonstrated that Rasilez/Tekturna reduced left ventricular hypertrophy (LVH), a marker of cardiac damage associated with an increased risk of cardiovascular events11. In ALLAY, the combination of Rasilez/Tekturna and the angiotensin receptor blocker (ARB) losartan achieved a numerically greater reduction in LVH than losartan alone, but the result was not statistically significant11.

Rasilez/Tekturna is approved in 55 countries. Tekturna was approved in the US in March 2007, and in the European Union in August 2007 under the trade name Rasilez. Tekturna HCT®, the first single-pill combination involving Tekturna, was approved in the US in January 2008. Rasilez/Tekturna was discovered by Novartis and developed in collaboration with Speedel.

Novartis is focused on improving the lives of the hundreds of millions of people with cardiovascular and metabolic diseases. As a global leader in cardiovascular and metabolic health for nearly 50 years, Novartis provides innovative therapies and support programs to treat high blood pressure and diabetes - both major public health issues. The portfolio includes the world’s most-prescribed angiotensin receptor blocker, the first and only approved direct renin inhibitor, a single pill combining two leading high blood pressure medicines, and a novel DPP-4 inhibitor. Novartis is dedicated to helping physicians and patients through effective medicines, programs and an ongoing commitment to research.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as “can”, “potential” or similar expressions, or by express or implied discussions regarding potential new indications or labelling for Rasilez/Tekturna or regarding potential future revenues fromRasilez/Tekturn. Such forward-looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Rasilez/Tekturna to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Rasilez/Tekturna will be approved for any additional indications or labelling in any market. Nor can there be any guarantee that Rasilez/Tekturna will achieve any particular levels of revenue in the future. In particular, management’s expectations regarding Rasilez/Tekturna could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; the effect that the foregoing factors could have on the values attributed to the Group’s assets and liabilities as recorded in the Group’s consolidated balance sheet; and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis

Novartis AG provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. In 2007, the Group’s continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,000 full-time associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

References

1.Schmieder RE, Philipp T, Guerediaga J et al. Aliskiren-Based Therapy Lowers Blood Pressure More Effectively than Hydrochlorothiazide-Based Therapy in Obese Hypertensive Patients: Subgroup Analysis of a 52-week, Randomized, Double-Blind Trial. Oral Presentation at European Society of Cardiology 2008 Annual Congress.

2.Maggioni AP, Latini R, McMurray JJ et al. Efficacy and Tolerability of Aliskiren Added to Optimized Medical Therapy in Diabetic Patients with Heart Failure. Poster Presentation at the European Society of Cardiology 2008 Annual Congress.

3.Maggioni AP, McMurray JJ, Latini R et al. Safety and Tolerability Profile of Aliskiren When Added to Optimized Medical Therapy in Patients with Heart Failure and Renal Dysfunction. Oral Presentation at the European Society of Cardiology 2008 Annual Congress.

4.Davy KP, and Hall JE. Obesity and Hypertension: Two Epidemics or One? Am J Physiol Regul Integr Comp Physiol. 2004 May;286(5):R803-13.

5.American Heart Association. The Prevention of Heart Failure. Accessed August 14, 2008. Available at here.

6.Zhang R and Reisin E. Obesity-Hypertension: The Effects on Cardiovascular and Renal Systems. Am J Hypertens. 2000;13,1308-1314.

7.World Heart Federation: Cardiovascular Disease Risk Factors: Obesity. Available here.

8.Chobanian AV, Bakris GL, Black HR, et al. Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure. Hypertension. 2003;42:1206-1251.

9.Parving H-H et al. Aliskiren Combined with Losartan in Type 2 Diabetes and Nephropathy. N Eng J Med. 2008;358:2433-46.

10.McMurray J, Pitt B, Latini R, et al. Effects of the Oral Direct Renin Inhibitor Aliskiren in Patients with Symptomatic Heart failure. Circulation: Heart Failure. 2008;1:17-24.

11.Solomon S, Appelbaum E, Manning WJ, et al. Effect of the Direct Renin Inhibitor Aliskiren, Either Alone or in Combination with Losartan, Compared to Losartan, on Left Ventricular Mass in Patients With Hypertension and Left Ventricular Hypertrophy: The ALiskiren Left Ventricular Assessment of Hypertrophy (ALLAY) Trial. Oral presentation at American College of Cardiology 57th Scientific Sessions 2008.

Novartis

View drug information on Tekturna.

Obese people who have asthma are nearly five times more likely to be hospitalized for the condition than non-obese people with asthma, according to a Kaiser Permanente study published in the September issue of the Journal of Allergy and Clinical Immunology.

This is the first study to control for the risk factors — smoking, use of oral or inhaled corticosteroid medications, gastroesophageal reflux disorder, and demographics — that might explain the obesity-asthma association. Previous studies have shown that obese people are more likely to suffer asthma than non-obese people, and that obese patients often have more severe asthma than their non-obese counterparts.

More than 20 million Americans have been diagnosed with asthma. Nearly a third of adults with asthma are also obese, according to researchers. The Centers for Disease Control and Prevention defines obesity as having a Body Mass Index of 30 or higher (http://www.cdc.gov/nccdphp/dnpa/obesity/defining.htm)

Researchers at Kaiser Permanente Center for Health Research in Portland, Ore., and the Kaiser Permanente Institute for Health Research in Denver surveyed 1,113 patients in Oregon, Washington, and Colorado, age 35 and older, who have persistent asthma. The researchers asked the patients about their weight, height, smoking habits, other illnesses, treatment and their asthma-specific quality of life, asthma control and asthma-related hospitalizations.

“The big finding here is that even after adjusting for risk factors, obese adults were nearly five times more likely to be hospitalized for their asthma,” said study lead author David M. Mosen, Ph.D., MPH, of the Kaiser Permanente Center for Health Research. “Given that nearly 30 percent of our country is obese, this study is yet another example of the long-term dangers of obesity, along with heart disease, diabetes, stroke and dementia.”

The study uncovered these findings:

— Obese people with asthma had significantly worse asthma control, lower asthma-related quality of life, and had 4.6 times higher risk for asthma-related hospitalizations than non-obese asthmatics

— Obese people with asthma were younger and less educated than non-obese people with asthma

— Obese people with asthma used more oral corticosteroids

— Obese people with asthma had a higher incidence of gastroesophageal reflux disorder

“The take-home message of this study for clinicians is that obese people with asthma need to be followed more carefully because it’s harder to control their asthma, so they are more likely to end up in the hospital,” said study co-author Dr. Michael Schatz, Chief of Allergy at Kaiser Permanente San Diego Medical Center. “My advice for obese asthmatics is: be vigilant to keep your asthma symptoms in check, make sure you know what to do when your symptoms worsen, and do whatever you can to lose weight.”

Funded by the Centers for Disease Control and Prevention, the study was authored by David M. Mosen, Ph.D., MPH of the Kaiser Permanente Center for Health Research; Michael Schatz, MD, MS, of Kaiser Permanente San Diego Medical Center; David J. Magid, MD, of the Kaiser Permanente Institute for Health Research in Denver; and Carlos A. Camargo, Jr., MD, DrPH, of the Department of Emergency Medicine, Massachusetts General Hospital and Harvard Medical School.

About the Kaiser Permanente Center for Health Research

Kaiser Permanente’s Center for Health Research, founded in 1964, is a nonprofit research institution dedicated to advancing knowledge to improve health. It has research sites in Portland, Ore., Honolulu, Hawaii and Atlanta.

About Kaiser Permanente Research

Kaiser Permanente’s eight research centers comprise one of the largest research programs in the United States and engage in work designed to improve the health of individuals everywhere. KP HealthConnect(TM), Kaiser Permanente’s electronic health record, and other resources provide population data for research, and in turn, research findings are fed into KP HealthConnect to arm physicians with research and clinical data. Kaiser Permanente’s research program works with national and local health agencies and community organizations to share and widely disseminate its research data. Kaiser Permanente’s research program is funded in part by Kaiser Permanente’s Community Benefit division, which in 2007 directed an estimated $1 billion in health services, technology, and funding toward total community health.

About Kaiser Permanente

Kaiser Permanente is America’s leading integrated health plan. Founded in 1945, the program is headquartered in Oakland, Calif. Kaiser Permanente serves 8.7 million members in nine states and the District of Columbia. Today it encompasses Kaiser Foundation Health Plan, Inc., Kaiser Foundation Hospitals and their subsidiaries, and the Permanente Medical Groups. Nationwide, Kaiser Permanente includes approximately 159,000 technical, administrative and clerical employees and caregivers, and 14,000 physicians representing all specialties. The organization’s Labor Management Partnership is the largest such health care partnership in the United States. It governs how more than 130,000 workers, managers, physicians and dentists work together to make Kaiser Permanente the best place to receive care, and the best place to work. For more Kaiser Permanente news, visit the KP News Center at: http://xnet.kp.org/newscenter

Kaiser Permanente
http://www.kaiserpermanente.org

A report in the September Cell Metabolism, a publication of Cell Press, offers new evidence to explain why those who undergo gastric bypass surgery often show greater control of their diabetes symptoms within days. It also helps to explain why lap-band surgery doesn’t offer the same instant gratification. By studying mice that have undergone both procedures, the researchers show that changes in the intestine are the key.

In addition to removing about two-thirds of the stomach, gastric bypass in effect produces a “double intestine,” said Gilles Mithieux of Institut National de la Sante et de la Recherche Medicale in France. The portion closest to the stomach is taken out of the loop so that it receives no nutrients. The segment normally farther down is then attached directly to the stomach, where it receives all the nutrients coming in.

In both cases, those positional changes ramp up production of blood sugar by the small intestine, Mithieux said. He noted that fasting normally induces blood sugar production by the upper small intestine. By placing the lower small intestine, which doesn’t normally produce much glucose, in close proximity to the stomach, it starts to act more like the upper portion.

That blood sugar synthesized in the intestine pours into the portal vein (a large vein that carries blood from the digestive tract to the liver) where it sends a signal to the brain, he and his colleagues earlier found. “The walls of the portal vein system detect the glucose and inform the brain,” he said. “It’s an important signal for decreasing hunger.”

They now find an important new element of glucose production by the intestine. It also increases insulin sensitivity and lowers blood sugar, improving the symptoms of diabetes. Mithieux said that’s in part because glucose production by the intestine lowers glucose production by the liver, which accounts for a much greater overall proportion of blood sugar synthesis. These metabolic changes take place within days of surgery, well before any weight loss takes place.

While gastric banding, in which a prosthetic band is placed around the upper stomach, works for weight loss, it doesn’t affect the intestine at all and lacks the immediate metabolic benefits of bypass, they report.

Further evidence for the mechanism involved came from studies of mice lacking GLUT-2, a glucose transporter required for glucose sensing in the portal vein. Gastric bypass lost its insulin-sensitizing benefits in those GLUT-2-deficient mice. Similarly, mice whose portal veins had lost their nerve supply also stopped responding to the surgical procedure.

The bottomline, according to Mithieux: the intestine deserves more respect. “Up to now, the intestine had been considered like a machine to assimilate nutrients. We’ve now begun to realize that it is a complex endocrine organ” with particular importance when it comes to glucose metabolism.

As for what patients weighing gastric bypass versus lap-band surgery should do, Mithieux recommends they talk to their doctors about the possible benefits and risks of both procedures. The new findings do support the notion that gastric bypass may be an effective treatment for diabetes in obese patients. It might even have potential for people who are diabetic, whether they are obese or not, he said.

Notes:

The researchers include Stephanie Troy, Institut National de la Sante et de la Recherche Medicale, Faculte′ de Medecine Xavier Bichat, Universite Paris, Paris, France; Maud Soty, Institut National de la Sante et de la Recherche Medicale, Lyon, France, Universite de Lyon, Lyon, France, Universite Lyon, Villeurbanne, France; Lara Ribeiro, Institut National de la Sante et de la Recherche Medicale, Faculte′ de Medecine Xavier Bichat, Universite Paris, Paris, France; Laure Laval, Institut National de la Sante et de la Recherche Medicale, Lyon, France, Universite de Lyon, Lyon, France, Universite Lyon, Villeurbanne, France; Stephanie Migrenne, Universite′ Paris, Paris, France; Xavier Fioramonti, Universite′ Paris, Paris, France; Bruno Pillot, Institut National de la Sante et de la Recherche Medicale, Lyon, France, Universite de Lyon, Lyon, France, Universite Lyon, Villeurbanne, France; Veronique Fauveau, Institut Cochin, Faculte′ de Medecine Cochin, Paris, France; Roberte Aubert, Institut National de la Sante et de la Recherche Medicale, Faculte′ de Medecine Xavier Bichat, Universite Paris, Paris, France; Benoit Viollet, Institut Cochin, Universite′ Paris Descartes, CNRS, Paris, France, Inserm, U567, Paris, France; Marc Foretz, Institut Cochin, Universite′ Paris Descartes, CNRS, Paris, France, Inserm, U567, Paris, France; Jocelyne Leclerc, Institut Cochin, Universite′ Paris Descartes, CNRS, Paris, France, Inserm, U567, Paris, France; Adeline Duchampt, Institut National de la Sante et de la Recherche Medicale, Lyon, France, Universite de Lyon, Lyon, France, Universite Lyon, Villeurbanne, France; Carine Zitoun, Institut National de la Sante et de la Recherche Medicale, Lyon, France, Universite de Lyon, Lyon, France, Universite Lyon, Villeurbanne, France; Bernard Thorens, University of Lausanne, Lausanne, Switzerland; Christophe Magnan, Universite′ Paris, Paris, France; Gilles Mithieux, Institut National de la Sante et de la Recherche Medicale, Lyon, France, Universite de Lyon, Lyon, France, Universite Lyon, Villeurbanne, France; and Fabrizio Andreelli, Institut National de la Sante et de la Recherche Medicale, Faculte′ de Medecine Xavier Bichat, Universite Paris, Paris, France, CHU Bichat Claude Bernard, Service de Diabetologie-Endocrinologie-Nutrition, Paris, France.

Source:
Cathleen Genova
Cell Press

In advance of a debate on obesity in the Scottish Parliament today [Thursday 4 September], BMA Scotland called on politicians to take tough action to tackle childhood obesity. In a briefing paper sent to MSPs, the BMA outlined its five point plan for tackling chilhood obesity in Scotland. The paper also highlights the long term health consequences of obesity and calls on Ministers to take a cross governmental approach to address soaring levels of obesity in Scotland’s children.

In Scotland in 2007/07, one in five (21.0%) of Primary 1 school children were overweight, including 8.5% who were obese and 4.3% who were severely obese. The highest levels of overweight, obese and severely obese children were found in the most deprived areas.

Dr Dean Marshall, Chairman of the BMA’s Scottish General Practitioners Committee, said:

“Childhood obesity rates in Scotland are worryingly high. The Government’s action plan provides little detail on real actions that will reverse this trend. It is time for the government to take tough action.

“Obesity is a very serious issue that can lead to a number of life-threatening health problems. We are in danger of raising a generation of children burdened with long term chronic health conditions. Doctors have a role to play in supporting overweight patients and talking about the dangers of obesity but there is a limit to what they can do. The BMA has been lobbying the government for some time to take real action on this issue in order to achieve a real improvement in the future health of our children. “

In Scotland, over 40 people a day are diagnosed with diabetes, and most of these cases are Type 2 diabetes, which is closely linked with obesity. Increasing rates in childhood obesity will also lead to more future cases of heart disease, osteoarthritis and some cancers. And UK wide, the health service spends at least ￡2 billion every year on treating ill health caused by poor diet.

Dr Marshall added:

“Prevention is much better than cure. It is better, healthier and safer if children are given the tools to manage their weight, eat healthily and take more exercise. But no-one is saying this is easy. It is crucial that we take the opportunity to halt the rise of obesity, and the host of illnesses that come with it - it is vital that the Scottish Government acts without further delay.”

The report recommends that, as part of the wider strategy to tackle childhood obesity in Scotland, the Scottish Government must focus on the following five areas:

-Nutrition in schools
-Exercise
-The media and advertising
-Food labelling and health claims
-The role of health professionals

BMA Scotland
Public Affairs Office
14 Queen Street
Edinburgh
EH2 1LL
http://www.bma.org.uk/scotland