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Pharmacologic Weight-Loss Therapy for Patients With Type 2 Diabetes (9-1999)

• Drug therapy is recommended for diabetic individuals with a BMI >= 27 kg/m2 who have been unable to lose weight via other means.[82]  Older agents such as diethylpropion, phentermine, and mazindol are approved for short-term (few weeks) use and therefore offer limited usefulness for patients who are significantly overweight. However, two recently approved drugs, orlistat and sibutramine, show promise in the treatment of obesity in patients with type 2 diabetes.
  
• Orlistat (Xenical capsule) 120 mg tid during (or up to 1 hour after) each main meal
  Orlistat, a pancreatic lipase inhibitor, was approved in April 1999.[84] It inhibits dietary fat absorption by approximately one-third and is minimally absorbed (>1%) from the gastrointestinal tract. At 52 weeks, weight loss in the orlistat-treated group was associated with a 9% reduction in total cholesterol, a 13% reduction in LDL cholesterol, and an 11% decrease in triglycerides.  Fasting insulin levels declined nearly 5% in the orlistat-treated group in comparison to a 4.3% increase in the placebo group.[85]  Because the drug somewhat limits absorption of fat-soluble vitamins (especially vitamin D) and beta-carotene, multivitamin supplementation is recommended, although not within 2 hours of orlistat use. Adverse effects of orlistat are primarily gastrointestinal and include rectal incontinence and oily stools, the occurrence of which is intensified with consumption of high-fat foods.
  Weight Control & Risk Factor Reduction in Obese Subjects Treated for 2 Years With Orlistat (Xenical)
  JAMA Jan.20, 1999:235 - MH Davidson, etc.  ( Editorial )
  
• Sibutramine (Meridia capsule) 5-10-15 mg/day
  Sibutramine is a satiety-enhancing agent . It produces its therapeutic effect by inhibiting the reuptake of norepinephrine, serotonin, and dopamine.[87]
  Sibutramine has been approved for treating obesity for up to 1 year as part of a basic weight-loss program.[87] In a 24-week, double-blind, placebo-controlled, multicenter trial, sibutramine treatment of obese patients with poorly controlled type 2 diabetes was associated with significant improvements in glycemic control, fasting insulin, and serum lipids.[88] The improvements were tightly correlated with the amount of weight loss. Sibutramine produced significantly more weight loss (4.3 ± 3.5%) than did placebo (0.3 ± 0.4%), and this difference was maintained when the participants were divided among those treated with diet or diet plus an oral antidiabetic agent. .  The most sizeable improvements in glycemic control were, predictably, seen among those who lost the most weight (eg, <10% of baseline)-- in this group, HbA1c declined 1.65%.[88]  A recently-completed, multicenter Finnish study examined the effect of 1-year sibutramine treatment of obese patients with type 2 diabetes.[89] The sibutramine-treated group experienced a 7.3% average weight loss from baseline that was significantly greater than that achieved with diet and placebo (2.4%).
  Generally, the initial dose of sibutramine is 10 mg once daily, by mouth, with or without food.[87] If adequate weight loss is not achieved after 1 month, the dose may be increased to 15 mg once daily. Patients who cannot tolerate the 10-mg dose may be given a 5-mg dose. The most common adverse events associated with sibutramine are dry mouth, anorexia, insomnia, and constipation. A daily dose of 10 to 15 mg sibutramine has been shown to cause a mean increase in heart rate of 3 to 6 beats per minute and an average elevation in diastolic blood pressure of >4 mm Hg. Fewer than 1% of patients discontinued the use of sibutramine because of hypertension, which usually resolved after the drug was discontinued. It is recommended that blood pressure and heart rate be assessed before increasing sibutramine to the maximum dose of 15 mg daily. The centrally acting weight-loss agents fenfluramine and dexfenfluramine, which act by increasing the release of serotonin from nerve terminals, have been associated with an increased incidence of cardiac valve dysfunction.[90] However, the incidence of left-sided cardiac valve dysfunction was not higher in obese patients treated with sibutramine compared with placebo.[91] At present, the use of sibutramine is contraindicated in patients with severe renal impairment or severe hepatic dysfunction, pending further study of the drug in these patients.
• Leptin (the protein hormone) subcutaneously.
  Recombinant methionyl human leptin self-administered by daily morning subcutaneous injection (0 [placebo], 0.01, 0.03, 0.10, or 0.30 mg/kg
  Conclusions: A dose-response relationship with weight and fat loss was observed with subcutaneous recombinant leptin injections in both lean and obese subjects. Based on this study, administration of exogenous leptin appears to induce weight loss in some obese subjects with elevated endogenous serum leptin concentrations. JAMA. Oct.27,1999;282:1568-1575 - Steven B. Heymsfield  

Valvular Abnormalities and Cardiovascular Status Following Exposure to Dexfenfluramine or Phentermine/Fenfluramine - Julius M. Gardin , etc. (JAMA. April 5, 2000;283:1703-1709)      Editorials
Prevalence rates and relative risk (RR) of Aortic Regurgitation were significantly increased in anorexigen-treated patients and were 8.9% in the dexfenfluramine group (RR, 2.18), 13.7% in the phentermine/fenfluramine group (RR, 3.34), and 4.1% in the untreated group (P<.001). No statistically significant differences in prevalence were observed for Mital Regurgitaion, thickening or decreased mobility of any valve leaflet, calculated pulmonary artery systolic pressure, or left ventricular ejection fraction. Serious cardiac events (including myocardial infarction, congestive heart failure, or ventricular arrhythmia) occurring at any time were not statistically different in treated and untreated subjects (dexfenfluramine, 9.0%; phentermine/fenfluramine, 4.0%; and untreated, 8.4%);

American Society for Bariatric Surgery (ASBS)

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2008