Benazepril (Lotensin - Ciba-Geigy), fosinopril (Monopril - Mead Johnson), and - Hoechst, Upjohn) are new angiotensin-converting enzyme (ACE) inhibitors recently approved by the US Food and Drug Administration (FDA) for once-a-day treatment of hypertension. Three other ACE inhibitors, captopril (Capoten), enalapril (Vasotec), and lisinopril (Prinivil, Zestril) were previously available in the USA for this indication. Captopril and enalapril have also been approved by the FDA for treatment of congestive heart failure.

Captopril (Capoten - Bristol-Myers Squibb), an angiotensin-converting enzyme (ACE) inhibitor previously available for treatment of hypertension, has now been approved by the US Food and Drug Administration (FDA) for treatment of diabetic nephropathy in patients with insulin-dependent diabetes mellitus (IDDM). Diabetic nephropathy is the most common cause of end-stage renal disease in the United States.

The FDA has approved a lingual aerosol formulation of nitroglycerin (NitroMist – Akrimax) for acute relief of an attack or acute prophylaxis of angina pectoris. It is the second nitroglycerin lingual spray to become available in the US; Nitrolingual Pumpspray was approved in 1985. Most patients with angina use sublingual nitroglycerin tablets.

Recent guidelines from the American Heart Association and American Stroke Association reviewed antithrombotic therapy options for secondary prevention of stroke in patients who have had a stroke or transient ischemic attack (TIA).

Myfembree (Myovant/Pfizer), an oral fixed-dose combination of the gonadotropin-releasing hormone (GnRH) receptor antagonist relugolix, the estrogen estradiol, and the progestin norethindrone acetate, has been approved by the FDA for management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. It is the second product to be approved in the US for this indication; Oriahnn, which contains the GnRH receptor antagonist elagolix in combination with estradiol and norethindrone acetate, was approved earlier. Relugolix was approved for...

Trandolapril (tran doe la pril; Mavik - Knoll) has become the ninth angiotensin-converting- enzyme (ACE) inhibitor to be approved by the US Food and Drug Administration (FDA) for treatment of hypertension.

The FDA has approved Aurlumyn (Eicos Sciences), an IV formulation of the prostacyclin analog iloprost, to reduce the risk of digit amputation in adults with severe frostbite. Iloprost is the first drug to be approved by the FDA for treatment of severe frostbite; it has been used off-label for this indication in the EU and elsewhere for decades. In the US, iloprost is also available as an inhaled formulation (Ventavis) for treatment of pulmonary arterial hypertension.

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When the use of aspirin for primary prevention of cardiovascular diseases was last reviewed in The Medical Letter, only one placebo-controlled prospective trial was available: the (male) Physicians' Health Study. Last year, a second large, randomized, placebo-controlled study was reported as part of the Women's Health Study. Recently a sex-specific meta-analysis of 6 trials, including these two, was published.

Tegaserod maleate (Zelnorm), a 5-HT4 receptor partial agonist that increases gastrointestinal (GI) motility, was approved by the FDA in 2002 for short-term treatment of irritable bowel syndrome with constipation (IBS-C) in women and in 2004 for treatment of chronic idiopathic constipation (CIC) in adults <65 years old.In 2007, the manufacturer (Novartis) complied with an FDA request to stop marketing the drug based on an unpublished retrospective analysis of clinical trials in IBS-C and other GI motility disorders that showed a higher rate of ischemic cardiovascular events (including...