The results of a postmarketing study of its cardiovascular safety have led to the removal of the weightloss drug sibutramine (Meridia) from the market in the US and Canada. It has also been withdrawn in Europe and Australia, but remains on the market in many other countries. The study that led the FDA to ask Abbott Laboratories to withdraw the drug randomized 10,744 overweight patients with cardiovascular disease, diabetes or both to sibutramine or placebo for a mean duration of 3.4 years. The primary endpoint (non-fatal myocardial infarction, nonfatal stroke, cardiovascular death or...

A recent article in the New England Journal of Medicine confirms something that others, including The Medical Letter (Treat Guidel Med Lett 2008; 6:23), have been saying for years: no particular combination of protein, carbohydrate and fat in the diet offers any advantage in losing weight. This randomized 2-year trial followed 800 overweight and obese subjects on low fat/average protein, low fat/high protein, high fat/average protein, and high fat/high protein diets. Carbohydrate intake varied from 35% (in the high fat/high protein diet) to 65% (in the low fat/average protein diet). All...

The FDA has approved tirzepatide (Mounjaro – Lilly), a peptide hormone with activity at both glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, to improve glycemic control in adults with type 2 diabetes. Tirzepatide, which is injected subcutaneously once weekly, is the first dual GIP/GLP-1 receptor agonist to become available in the US. Selective GIP receptor agonists are not available in the US; GLP-1 receptor agonists have been available for years.

Metreleptin (Myalept – Amylin), a recombinant leptin analog produced in E. coli, has been approved by the FDA to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. It has not been approved to date for the treatment of partial lipodystrophies, including those associated with the use of protease inhibitors in patients with HIV. Metreleptin is approved in Japan for the treatment of any lipodystrophy disorder.

In the short time since fluoxetine (Prozac - Lilly) first became available in the USA (Medical Letter, 30:45, 1988), it has become the most frequently prescribed of all antidepressants. Some recent reports, however, have questioned its safety.

Modestly elevated C-reactive protein (CRP) concentrations have been associated with an increased risk of coronary heart disease. The recently published and heavily publicized results of the JUPITER trial will lead many patients to ask health care professionals whether they should have a CRP test to see if they should be taking a statin.

Naltrexone (ReVia -DuPont Pharma), a long-acting oral opioid antagonist previously marketed for treatment of opioid dependence under the trade name Trexan, was recently approved by the US Food and Drug Administration (FDA) for treatment of alcohol dependence. The new trade name will now also be used for the old indication.

View the Table: GLP-1 and GIP/GLP-1 Receptor Agonists for Type 2 Diabetes

The oral biguanide metformin (Glucophage, and others) is generally the drug of choice for initial treatment of type 2 diabetes. It has also been used to prevent or at least delay the onset of diabetes in patients considered to be at high risk for the disease. Recent guidelines recommend considering use of metformin in patients with prediabetes (fasting plasma glucose 100-125 mg/dL, 2-hr post-load glucose 140-199 mg/dL, or A1C 5.7-6.4%), especially in those who are <60 years old, have a BMI >35 kg/m2, or have a history of gestational diabetes. Metformin has not been approved...

At a US Senate hearing prompted by the withdrawal of Vioxx, an FDA officer cited 5 drugs as potentially dangerous. It may be useful to revisit Medical Letter reviews of these drugs.