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Guideline on Management of Obesity
(The National Heart, Lung, and Blood Institute)
Pharmacologic Weight-Loss Therapy for Patients With Type 2 Diabetes
Drug therapy is recommended for diabetic individuals with a BMI >= 27
kg/m2 who have been unable to lose weight via other means. 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.
(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.
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.
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)
Jan.20, 1999:235 - MH Davidson, etc.
Sibutramine (Meridia capsule) 5-10-15
Sibutramine is a satiety-enhancing agent . It produces its
therapeutic effect by inhibiting the reuptake of norepinephrine, serotonin,
Sibutramine has been approved for treating obesity for up to 1 year as part
of a basic weight-loss program. 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.
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%. A
recently-completed, multicenter Finnish study examined the effect of 1-year
sibutramine treatment of obese patients with type 2 diabetes. 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. 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. However, the
incidence of left-sided cardiac valve dysfunction was not higher in obese
patients treated with sibutramine compared with placebo.
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)
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.
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.
April 5, 2000;283:1703-1709)
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