Bariatric and metabolic surgery.

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Authors: Martin RF
PMID: 22054160 [PubMed – in process] (Source: The Surgical Clinics of North America)

Treat Obese Diabetics With Surgery, IDF Says

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Obese patients with type 2 diabetes should have bariatric surgery to treat their disease, according to a new position statement from the International Diabetes Federation.

Patients with diabetes and a body mass index (BMI) of 35 or more should be treated with any of the various forms of bariatric surgery, including gastric bypass and gastric banding, the IDF said.

Surgery should also be used in patients with a BMI of 30 to 35 whose diabetes is not adequately controlled by medications — especially among those with other major risk factors for heart disease, including hyperlipidemia, hypertension, and a history of myocardial infarction, according to the statement.

That latter recommendation conflicts with that of the American Diabetes Association, which recommends that surgery be used only for diabetic patients with a BMI of 35 or above, especially if they have other heart disease risk factors.

There’s not enough evidence to recommend surgery for patients with a BMI under 35, according to the ADA.

The IDF said it took the position in light of increasing rates of both obesity and diabetes, sparked by an “obesogenic” environment in developed countries. Research has shown that the surgery normalizes blood glucose levels and reduces the need for medications, according to the organization.

The IDF guideline writers noted that physicians should use a lower BMI reference for Asian patients and some other ethnicities — as much as 2.5 BMI points lower.

The statement was released Monday at the organization’s 2nd World Congress on Interventional Therapies for Diabetes in New York City.

The paper calls for the establishment of a national registry of patients who’ve had bariatric surgery “in order to ensure quality patient care and to monitor both short- and long-term outcomes.”

It also highlights the need for studies to establish criteria that help determine which patients will benefit most from surgery, and which ones will benefit most from which surgical procedures.

The new recommendations coincide with an FDA ruling last month that expanded the indication for Allergan’s Lap-Band device to include patients with a lower BMI — of 30 and up.

FDA Expands Gastric Band Indication

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WASHINGTON — The FDA has sanctioned use of gastric banding for weight-loss surgery in a wider range of patients — those with BMIs of 30 or more, rather than a minimum BMI of 35.

The FDA approved Allergan’s Lap-Band System for adults with a BMI of 30 to 40 and at least one obesity-related comorbidity, such as diabetes.

Patients also must have tried and failed more conservative weight-loss therapies such as diet, exercise, and weight-loss medications.

According to a company press release, some 37 million Americans will be covered by the expanded indication. The product was previously approved for a narrower range of individuals: those with BMI of 40 or more, BMI of 35 or more with at least one comorbid condition, or at least 100 pounds of excess weight irrespective of BMI.

The approval to reduce the BMI threshold was based on the FDA review of 12- and 24-month data from a prospective, single-arm, multicenter study with five years of follow-up.

The company said it planned to follow study participants for an additional five years as part of its postmarketing surveillance.

Additionally, “there will be an analysis of the outcomes of patients with BMI of 30 to 40 recorded in the Bariatric Outcomes Longitudinal Database,” the company said.

The lap-band study, which was initiated and supported by Allergan, recruited 149 patients who had a mean excess weight of 62.8 lbs and had been obese on average for 17 years. All 149 underwent the LAP-BAND System procedure.

The primary endpoint was clinically meaningful weight loss at one year. The trial stipulated that at least 40% of the patients needed to achieve that endpoint.

Clinically meaningful weight loss “was defined as at least 30% Excess Weight Loss (EWL)” meaning a weight loss equal to at least 30% of the difference between the patient’s normal weight and his or her baseline weight.

Allergan said that “83.9% of the patients lost at least 30% of their excess weight at the one-year time point, 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.”

The secondary endpoints for the trial were improvement in obesity-related conditions including dyslipidemia, type 2 diabetes, and hypertension, as well as improved quality of life.

About a third of patients with the comorbid conditions “saw their conditions resolved after one year,” according to the company.

An FDA advisory panel determined by a vote of 8-2 in December that the product was adequately safe for the indication sought by Allergan. It also voted 8-1 that it was effective.