February 17th, 2011
There was very important news that broke yesterday with respect to the availability of the lap-band as a treatment option for the obese. The FDA voted to expand the use of the Lap-Band for people with a Body Mass Index of 30 or greater with at least one obesity related medical condition. Until now the minimum BMI necessary to qualify for surgery has been 35. There are now 26 million American who are obese that can potentially benefit by this decision. The following is a press release by Allergan that explains the importance of this decision.
FDA APPROVES EXPANDED USE OF LAP-BAND® ADJUSTABLE GASTRIC BANDING SYSTEM FOR OBESE ADULTS
Obese Adults with a BMI of 30-40 with at Least One Obesity Related Comorbid Condition Now Qualify for LAP-BAND® System Procedure When All Other Conservative Weight-loss Therapies Have Failed
(IRVINE, Calif., February 16, 2011) – Allergan, Inc. (NYSE: AGN) today announced the U.S. Food and Drug Administration (FDA) approved the expanded use of the LAP-BAND® System, Allergan’s gastric band, for adults with obesity who have failed more conservative weight reduction alternatives, such as diet and exercise and pharmacotherapy, and have a Body Mass Index (BMI) of 30-40 and at least one obesity related comorbid condition. Currently, approximately 37 million Americans have a BMI of 30-40 and at least one comorbid condition,1,2 underscoring obesity as a growing health epidemic in the United States and the need for additional effective treatment options.
“Given the proven and significant health ramifications of obesity, we are pleased with the FDA’s decision to expand the use of the LAP-BAND® System,” said Frederick Beddingfield, M.D., Allergan’s Vice President of Clinical Research and Development. “Although this label expansion represents a significant advancement in obesity treatment, the LAP-BAND® System is not intended for everyone. The LAP-BAND® System does represent a potential treatment option for those patients with obesity and a related health condition, who have failed more conservative weight-loss therapies, such as diet and exercise and pharmacotherapy, and under consultation with their physician, have determined that weight-loss surgery is the next best treatment option.”
Obesity is the second-leading cause of preventable death in the United States, second only to smoking.3 Given its known correlation to life-threatening comorbid conditions, such as heart disease, stroke, Type 2 diabetes, high blood pressure, sleep apnea and even premature death, obesity is a disease that requires medical treatment. Medical research has found that, if left untreated, those individuals who are currently obese will likely remain obese.4 However, not all weight-loss treatments are effective over the long term – as a preponderance of data, published literature and scientific research have found that diet and exercise is unsuccessful in 80-85% of patients at one year.5,6
“As a surgeon, I see patients every day who have been obese for years and have tried several diet and exercise programs without success,” said Robert Michaelson, M.D., Ph.D., Northwest Surgical Weight Loss Surgery, Everett, Washington, and Clinical Trial Investigator. “These patients frequently feel judged by their weight, as obesity is often viewed as a lack of will power, which it is not. Obesity is a disease, which requires medical treatment, but unfortunately diet and exercise alone do not work for everyone. The LAP-BAND® System meets an unmet clinical need, as it provides an effective treatment option, which is used in combination with diet and exercise, to enable sustained weight loss.”
The approval to expand the use of the LAP-BAND® Adjustable Gastric Banding System is based on a review of full 12-month data and available 24-month data from a prospective, single-arm, non-randomized, multi-center five year-study and the more than 17-year safety and effectiveness record of the LAP-BAND® System. Following approval, the patients in the trial will continue to be followed for a total of five years. In addition, there will be an analysis of the outcomes of patients with BMI of 30 to 40 recorded in the Bariatric Outcomes Longitudinal DatabaseSM (BOLDSM). Established in 2007 by the Surgical Review Corporation, BOLD is now the world’s largest and most comprehensive repository of clinical bariatric surgery patient information. The database currently contains more than 300,000 patients and 12,000 new patients are added monthly. The BOLD analysis will consist of examining the explant rates, adverse events, weight loss, and changes in the status of obesity related comorbid conditions observed in LAP-BAND® System patients over the course of 10 years.
About the LBMI-001 Clinical Study
The LAP-BAND® System study, initiated by Allergan, Inc., is a prospective, single-arm, non-randomized, multi-center five year-study conducted under an FDA-approved Investigational Device Exemption (IDE G070039; registered at www.clinicaltrials.gov, registration # NCT00570505). The study was conducted to determine the safety and effectiveness of the LAP-BAND® System as a treatment for obesity in adult patients with a BMI of ≥ 30 and < 40, with and without comorbid conditions. The study was initiated in 2007, and included 149 patients, who had a mean excess weight of 62.8 lbs and had been obese on average for 17 years and who underwent the LAP-BAND® System procedure.
The criterion for success was at least 40% of patients achieving clinically meaningful weight loss at the 12-month timepoint, where clinically meaningful weight loss was defined as at least 30% Excess Weight Loss (EWL). Percent excess weight loss (%EWL) is defined as the percent of “excess weight” – i.e., the weight above ideal weight – that is lost. Results from the 12-month dataset demonstrate clinically significant weight loss in this patient group with a low risk of serious complications. Specifically, 83.9% of the patients lost at least 30% of their excess weight at the one-year timepoint, more than twice the percentage required for success. More
than 65% of the patients in the trial were no longer obese after one year. Weight loss was maintained in the second year of the study. This level of weight loss exceeds what is typically seen with more conservative treatment, such as diet and exercise.
The secondary endpoints for the trial were improvement in obesity related comorbid conditions of dyslipidemia, Type 2 diabetes, and hypertension and improvement in Quality of Life (QoL). Eighty five percent of subjects in the trial had at least one comorbid condition. In terms of improvement in comorbid conditions of dyslipidemia, Type 2 diabetes, and hypertension, 22-33% of patients with those conditions, saw their conditions resolved after one year. In addition, approximately 60% of patients, who had a comorbidity at baseline, had improvement of at least one comorbid condition by month 12. Also, there was a statistically significant improvement in QoL at months six and 12.
During the 12-month study period, the types of Adverse Events (AEs) reported by patients were as expected for the surgical procedure, such as vomiting, dysphagia, and gastroesophageal reflux disease (GERD). Most AEs were mild to moderate in severity and resolved in less than four weeks.
About the LAP-BAND® System
The LAP-BAND® System was originally approved by the FDA in 2001 for use in severely obese adults, individuals with a BMI of 35 with at least one severe comorbid condition or a BMI of 40, or those who are at least 100 pounds or more overweight. In addition, the LAP-BAND® System has been approved internationally since 1993. The LAP-BAND® System is now the first and only FDA-approved device for bariatric surgery in patients with a BMI of 30-35. Over the past 18 years, more than 650,000 procedures have been performed, leading to over two million patient years of exposure for the device.
Important LAP-BAND® Safety Information
Indications: The LAP-BAND® System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions.
It is indicated for use in adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives.
Contraindications: The LAP-BAND® System is not recommended for non-adult patients, patients with conditions that may make them poor surgical candidates or increase the risk of poor results (e.g., inflammatory or cardiopulmonary diseases, GI conditions, symptoms or family history of autoimmune disease, cirrhosis) who are unwilling or unable to comply with the
required dietary restrictions, who have alcohol or drug addictions or who currently are or may be pregnant.
Warnings: The LAP-BAND® System is a long-term implant. Explant and replacement surgery may be required. Patients who become pregnant or severely ill, or who require more extensive nutrition, may require deflation of their bands. Anti-inflammatory agents, such as aspirin, should be used with caution and may contribute to an increased risk of band erosion.
Adverse Events: Placement of the LAP-BAND® System is major surgery and, as with any surgery, death can occur. Possible complications include the risks associated with the medications and methods used during surgery, the risks associated with any surgical procedure and the patient’s ability to tolerate a foreign object implanted in the body.
Band slippage, erosion and deflation, reflux, obstruction of the stomach, dilation of the esophagus, infection or nausea and vomiting may occur. Reoperation may be required.
Rapid weight loss may result in complications that may require additional surgery. Deflation of the band may alleviate excessively rapid weight loss or esophageal dilation.
Tags: body mass index, FDA approval, Lap Band, weight loss surgery
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February 9th, 2011
A recent study concluded that successful weight loss through bariatric surgery can extend one’s lifespan. The two most commonly performed weight loss surgeries are Lap-Band and gastric bypass. The following is a press release of these exciting results.
NEW YORK (Reuters Health) Jan 31 - Obese individuals may add years to their lives by drastically cutting pounds with bariatric surgery, according to a new review of clinical trials.
Italian researchers found that undergoing one of the two operations reduced a patient’s odds of dying by nearly half over an average study period of seven to eight years.
Bariatric surgery can produce a sustained reduction in body weight, at a level that is very difficult to achieve with other common obesity-management strategies, Dr. Luca Busetto of the University of Padova, in Italy, told Reuters Health in an e-mail.
This can be life-saving, as people who are morbidly obese carry a two-to-three fold higher risk of death compared to normal-weight people, due in large part to obesity-related conditions such as diabetes and hypertension, added Dr. Busetto, who was not involved in the review but led one of the included studies.
About 220,000 Americans underwent some form of weight-loss surgery in 2009, most often gastric bypass, according to the American Society for Metabolic and Bariatric Surgery. The procedures cost between $14,000 and $26,000, with the price tag for bypass usually slightly higher than for gastric banding.
To help guide doctors and their patients in choosing the best strategy, Dr. Antonio Pontiroli and his colleague Alberto Morabito, both of the University of Milan, looked to the literature on both gastric bypass and banding. They identified eight trials, which included an average of seven-and-a-half years of follow-up on a total of more than 44,000 men and women. About 14,000 of the participants actually underwent bariatric surgery, the rest served as control subjects for comparison.
The researchers tallied about 3,300 deaths across the studies: 2.8% of those who had a bariatric procedure and 9.7% among similar patients who did not have surgery. This translated into 45% lower odds of dying with bariatric surgery.
A similar benefit was found when the team looked specifically at heart-related deaths.
Overall, death rates were comparable for the approximately 10,000 gastric banding and 4,000 gastric bypass surgeries, although the protective effects on heart-related deaths differed: compared to no surgery, banding provided 29% lower odds of heart-related death versus a 52% risk reduction with bypass, according to the researchers’ January 17th online report in the Annals of Surgery.
Dr. Busetto noted that gastric bypass generally provides “more rapid and important weight loss” than banding. On the flip side, bypass is irreversible and introduces a greater chance of severe complications and even surgery-related death. These risks, however, are still very small: about one in a thousand patients dies during a gastric bypass.
Further, while either operation may cost more than other treatments in the short term, said Busetto, “weight loss obtained by bariatric surgery may also save money over time.”
After drastic reductions in pounds, patients tend to find that they need fewer medications for the treatment of obesity-related conditions, and that they take fewer sick days.
But, he added, “Patients should be aware that bariatric surgery is highly effective, but it is not a ‘magic bullet. Failures and complications still exist.”
Ann Surg. Posted January 17, 2011. Abstract
Tags: adjustable gastric banding, bariatric surgery, gastric bypass, Lap Band, weight loss, weight loss surgery
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February 7th, 2011
Confidence in the effectiveness of the Lap-Band was demonstrated when an FDA advisory panel voted to expand the indication for lap-banding to patients with lower body mass inedexes or BMIs.
The following is a copy of the press release for this decision:
December 6, 2010 — A US Food and Drug Administration (FDA) advisory panel has voted 8 to 2 in favor of approving an expanded indication for an implantable adjustable gastric band (Lap-Band Adjustable Gastric Banding System; Allergan) to be used for weight reduction in patients with a body mass index (BMI) of at least 30 kg/m2 and less than 40 kg/m2.
The device is currently indicated for patients with severe obesity (BMI of at least 40 kg/m2 or BMI of at least 35 kg/m2 with 1 or more severe comorbid conditions) or for those who are at least 100 pounds heavier than their estimated ideal body weight.
“Patients with a BMI of less than 35 kg/m2 (even with a comorbid condition) are usually not considered appropriate for bariatric surgery,” note the manufacturers in a report prepared for the FDA. “Expansion of the indication to include lower BMI patients would change the current practice of medicine with respect to bariatric surgery.”
The Gastroenterology and Urology Devices Advisory Committee voted on the expanded indication on December 3.
In a study evaluating the Lap-Band for its original indication, approximately 20% of patients were able to lose at least 50% of their excess weight by 3 years, and 10% lost 75% of their excess weight.
In patients with a BMI of at least 30 kg/m2 and less than 40 kg/m2, a single-group, prospective study was conducted to evaluate the device. A total of 151 patients were enrolled at 7 investigational sites in the United States.
Subjects were primarily female and white, with a median age of 40 years and a mean baseline BMI of 35.4 kg/m2(range, 29.8 - 39.9 kg/m2). Mean weight at surgery was 214.9 pounds (range, 152.6 - 286.2 pounds), and mean excess weight was 62.8 pounds (range, 28.8 - 100.7 pounds).
Almost 66% of all implanted participants lost at least 50% of their excess weight at 1 year. In addition, the primary efficacy endpoint — more than 40% of participants achieving at least 30% excess weight loss at 12 months — was achieved (P < .0001); 83.9% of the intent-to-treat evaluable patients (n = 143) and 80.5% of the intent-to-treat participants (n = 149) achieved this endpoint. The primary endpoint was met in 84.4% of the per protocol patients.
The mean percentage weight loss (total weight loss) was 18.3% (n = 143) at 12 months. Excess weight decreased from a mean of 62.8 pounds at baseline to 22.8 pounds at 12 months (n = 143).
During the 12-month period, 131 patients (87.9%) experienced a total of 524 adverse events. About one third of the adverse events were considered related to treatment. The majority of device-related adverse events were mild (n = 118; 54.9%); 2.3% were severe (5 events in 3 patients).
The most common device-related adverse events were vomiting in 20.0%, dysphagia in 15.3%, postprocedural pain in 13.0%, and gastroesophageal reflux disease in 10.2% of the patients. Reoperations were necessary in less than 5% of patients, and no deaths were reported.
The panel voted on 3 questions regarding the new indication: whether the data supported the efficacy of this device for the new indication, whether the data supported its safety, and whether the benefits appeared to outweigh the risks. The panel voted in favor of each question: 8 to 2 for the first question, 8 to 1 with 1 abstention for question 2, and 8 to 2 for question 3.
“Although the current study is small, I think that there’s reasonable assurance…that this is an acceptable change,” said Jon C. Gould, MD, from the University of Wisconsin School of Medicine and Public Health in Madison.
The committee expressed concerns about the time frame of the study, suggesting that more long-term data are needed to adequately assess the efficacy and safety and that a registry could be set up to collect data on long-term outcomes.
According to the manufacturers, effectiveness of the Lap-Band for “the treatment of severe obesity with respect to long-term weight loss is less than that of other bariatric surgical procedures, but substantially better than traditional behavioral or medical therapy.”
The Lap-Band was first approved for weight reduction in the morbidly obese on June 5, 2001. The device is intended to induce weight loss in obese patients by limiting food consumption.
Tags: adjustable gastric band, Allergan, bariatric surgery, BMI, FDA, Lap Band, percent excess weight loss, severe obesity, weight loss, weight reduction
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December 10th, 2009
Researachers from Harvard and MIchigan have concluded that the health consequences of obesity in our population will offset the health gains made by a significant reduction in smoking in our population. The conclusion in this study was that the increase in life expectancy that our population should experience as a result of decreasing smoking behavior, will be reduced because of the dramatic increase in obesity. Alarmingly, if past trends continue, nearly half of our population-45 percent- will be obese by the year 2020.
Tags: Life expectancy, Obesity, premature death due to obesity
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July 23rd, 2009
A recent study published in the Journal of The American College of Surgeons demonstrated a link between obesity and certain cancers in women. The group from The University of VIrginia concluded that morbidly obese women who had undergone bariatric surgery had less cancers than a similar group of women that had not undergone weight loss surgery. The most common types of cancers found in these morbidly obese women were endometrial (uterine), breast, and ovarian cancers.
Tags: bariatric surgery, breast cancer, cancer, endometrial cancer, Obesity, ovarian cancer, weight loss surgery
Posted in Weight Loss Surgery Outcomes, cancer risk, co-morbidities | No Comments »
May 21st, 2009
The Cochrane Collaboration recently concluded that bariatric surgery is more effective than conventional weight loss management in terms of weight loss, improvement in weight related medical conditions, and in improved quality of life.
The goal of the group’s analysis was to evaluate the effectiveness of various weight loss surgery techniques compared with non-surgical weight loss methods. Included in this comparison were patients who were moderately obese as defined by a body mass index between 30-35. Gastric bypass, adjustable gastric banding (Lap-Band), sleeve gastrectomy and vertical banded gastroplasty procedures were reviewed in this analysis.
The Cochrane Collaboration is an international non-profit organization whose mission is to provide high quality evidence for healthcare decision making around the world.
Tags: adjustable gastric banding, bariatric surgery, body mass index, cochrane collaboration, gastric bypass, Lap Band, moderate obesity, sleeve gastrectomy, vertical banded gastroplasty, weight loss, weight loss management, weight loss surgery
Posted in Weight Loss Surgery Outcomes | No Comments »
May 11th, 2009
Obesity surgery-related complications in the United States fell by 21 percent between 2001 and 2006. These dramatic results were based on an analysis of more than 9,500 patients under age 65 who had bariatric surgery between 2001 and 2002 and between 2005 and 2006. This study was done by the U.S. Agency for Healthcare Research and Quality. The study revealed that complications fell even though there were more older and sicker patients having obesity surgery. During the study period, the proportion of patients over age 50 having obesity surgery increased from 28 percent to 44 percent, and the average number of underlying illnesses — such as diabetes, high blood pressure and sleep apnea — in bariatric surgery patients more than doubled. The three main factors found to be significant causes of the decline in complications among obesity surgery patients include: increased use of laparoscopic approach, which allows surgeons to operate through small incisions; increased use of banding procedures such as lap band; and increased surgeon experience.
Tags: high blood pressure, hypertension, Lap Band, laparoscopic surgery, sleep apnea, type 2 diabetes
Posted in co-morbidities, complications | 2 Comments »
March 3rd, 2009
A dramatic study, published in the British Medical Journal, revealed that teens with obesity had a similar risk of premature death as those who smoked half a pack of cigarretes a day. In this study, nearly 46,000 Swedish men were followed over 38 years. The men who were obese at age 18 were two times more likely to die by age 60 compared to men who were of normal weight. This was about the same risk faced by the normal weight men who smoked half a pack of cigarettes or more a day.
Given that smoking is known to be the most important cause of preventable death, it is quite dramatic that obesity is apparently as lethal.
Tags: premature death due to obesity, risk of obesity, teen obesity
Posted in Life expectancy | 1 Comment »
March 3rd, 2009
There has been a glaring omission in the Clinical Practice Recommendations of the American Diabetes Association (ADA), until now. Despite numerous studies over the past decade that have shown how effective weight loss surgery is in managing diabetes, surgery has not been included in the ADA recommendations. This changed in Jan. 2009 when a section on bariatric surgery was added to the “Standards of Medical Care in Diabetes.” The ADA recommendations were consistent with NIH guidelines that adults with BMI greater than 35 and type 2 diabetes should be considered for weight loss surgery.
This recognition is long overdue and finally brings the ADA in line with well designed studies published in both surgical and medical literature.
Tags: American Diabetes Association, bariatric surgery, diabetes, treatment of diabetes, type 2 diabetes, weight loss surgery
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