GAITHERSBURG, Maryland (EGMN) – The majority of a U.S. Food and Drug Administration panel on Dec. 3 voted in favor of expanding the approval of the Lap-Band system for weight loss to include people with lower body mass index measurements and no comorbidities.

The device’s manufacturer, Allergan Inc., proposed that the Lap-Band adjustable gastric banding system be approved for weight reduction in people aged 18 years and over with no comorbidities and a body mass index (BMI) of at least 35 kg/m², or a BMI of at least 30 kg/m² and one or more comorbid conditions.

The Lap-Band is a permanent implant that is placed around the upper portion of the stomach to reduce the amount of food that can be ingested; the device is usually placed during a laparoscopic procedure.

Approved in the United States in 2001, the Lap-Band is indicated for a population with stricter criteria: adults with or without comorbid conditions and a BMI of at least 40 kg/m², or adults with one or more comorbid conditions and a BMI of at least 35 kg/m². (Both the approved and the proposed indications include a statement also describing the intended population as obese adults “who have failed for conservative weight reduction alternatives, such as supervised diet, exercise, and behavior modification programs.”)

At the meeting, 8 of the 10 voting members of the FDA’s Gastroenterology and Urology Devices Panel agreed that there was “reasonable assurance” that the device was safe and effective for the proposed population, based on the results of the pivotal study of 149 patients and previous experience with the device. But they strongly recommended that Allergan conduct a postmarketing study of the device in such patients to collect more data on safety and efficacy, which should include more men and more people from nonwhite ethnic groups, who were underrepresented in the study. Several panelists recommended that the company also start a registry of all patients who receive the Lap-Band to obtain long-term, real-world data on safety and efficacy, which is not available now.

In the study, the device was implanted in 149 patients, most of whom were female (91%), white (77%), and aged 18 to 55 years. The patients were either with or without comorbidities, with a BMI ranging from 30 kg/m² to 40 kg/m², who had failed more conservative weight-reduction strategies.

After 1 year, 84% of the patients had lost at least 30% of their excess weight, which was the primary effectiveness end point in the study. Patients steadily lost weight over 12 months, at which time most patients had lost a significant amount of weight (80% had lost at least 10% of their baseline weight and 66% were no longer classified as obese). Weight loss was sustained among those who were followed through 24 months.

At 12 months, there were seven re-operations in both women and men, raising some concerns about the safety in men, whom the panel recommended should be studied in postmarketing trials. Of the seven re-operations four were done for explants, in three men and one woman.

Most of the panel members said that weight loss, as a stand-alone measure of the device’s effectiveness, was sufficient and was a good surrogate for improvement in comorbidities.

The FDA usually follows the recommendations of its advisory panels, which in most cases have been cleared of potential conflicts of interest related to the product being reviewed and only in rare cases, are granted a waiver. At this meeting, the panel chair, Dr. Karen Woods, a gastroenterologist at the Methodist Hospital, Houston, who holds stock in Allergan, was granted a waiver because of her past experience as a panel chair and because of her expertise in therapeutic endoscopy, according to the FDA. Chairs of device advisory panel meetings only vote in cases of ties, and Dr. Woods did not make any comments about the data during the meeting.

The Lap-Band system is approved for use in severely obese and obese people in Europe and Australia.

Copyright (c) 2010 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

马里兰州盖瑟斯堡(EGMN)——12月3日，美国食品药品管理局(FDA)的胃肠道与泌尿外科器械专家组以8比2的投票结果支持将Lap-Band可调节胃束带的适用范围扩大至体重指数(BMI)更低且无合并症的对象。

此次拟新增的适用对象为年龄≥18岁、无合并症且BMI≥35 kg/m²以及具有一种或多种合并症且BMI≥30 kg/m²的保守减肥治疗(如饮食、运动和行为调节)失败者。而此前2001年批准通过的适用对象为有或无合并症且BMI≥40 kg/m²以及有一种或多种合并症且BMI≥35 kg/m²的保守减肥治疗失败者。

专家组此次的决定是基于以往应用该装置的经验和一项关键研究的结果。该研究共入选149例年龄为18~55岁、有或无合并症且BMI为30 kg/m² ~ 40 kg/m²的保守减肥治疗失败者，大部分为女性(91%)和白人(77%)，所有患者均接受Lap-Band胃束带手术。1年后，84%的患者减掉了至少30%的多余体重(主要疗效终点)。术后12月内，患者的体重稳步降低，大部分患者的体重降幅显著，80%的患者较手术前减掉了至少10%的体重，66%的患者不再被归为肥胖者。随访24个月的结果显示，体重降低的效果具有持续性。术后12个月，共进行7例二次手术，其中4例(3例男性，1例女性)的目的是为了取出胃束带。

基于该研究结果，专家组认为该胃束带在拟新增的适用人群中安全有效，但强烈建议生产商Allergan公司在更多的男性及非白人肥胖患者中进行上市后研究，以收集更多的安全性和疗效数据，并建议其对所有接受Lap-Band胃束带手术的患者进行登记，以收集目前在现实世界中尚缺乏的长期安全性和疗效数据。

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