ABSTRACT
BACKGROUND: Angioedema is a rare but potentially serious adverse event of angiotensin-converting enzyme inhibitor therapy. However, no prospective, controlled studies have reported on its incidence and clinical characteristics. METHODS: We studied the occurrence of angioedema in a randomized, double-blind, controlled trial of 12 557 persons with hypertension treated with enalapril maleate, 5 to 40 mg/d, using a prospective ascertainment and adjudication of angioedema by an expert committee. RESULTS: Angioedema occurred in 86 (0.68%) of the subjects. Stepwise logistic regression identified black race (odds ratio [OR], 2.88; 95% confidence interval [CI], 1.72-4.82), history of drug rash (OR, 3.78; 95% CI, 1.80-7.92), age greater than 65 years (OR, 1.60; 95% CI, 1.02-2.53), and seasonal allergies (OR, 1.79; 95% CI, 1.06-3.00) as independent risk factors for angioedema. The incidence of angioedema was higher after initiation of therapy (3.6/1000 patients per month) and declined to 0.4/1000 patients per month. Treatment was not given in 44 (51%) of the cases; antihistamines were administered in 35 (41%); corticosteroids, in 20 (23%); and epinephrine, in 1 (1%). Two patients were hospitalized but none had airway compromise. CONCLUSIONS: Enalapril-related angioedema is uncommon. Although it is most likely to occur early after initiation of therapy, it may occur at any time. It is more likely to occur in black patients, those older than 65 years, and those with a history of drug rash or seasonal allergies. Fatal angioedema or angioedema requiring airway protection did not occur in this study.
Subject(s)
Angioedema/chemically induced , Angioedema/epidemiology , Enalapril/adverse effects , Adult , Aged , Aged, 80 and over , Angiotensin-Converting Enzyme Inhibitors/adverse effects , Antihypertensive Agents/adverse effects , Double-Blind Method , Enalapril/administration & dosage , Female , Humans , Hypertension/drug therapy , Incidence , Logistic Models , Male , Middle Aged , Risk FactorsABSTRACT
Ximelagatran, an emerging new direct, oral, fixed-dose thrombin inhibitor may offer an attractive alternate to warfarin for patients with nonvalvular atrial fibrillation. The lack of drug-to-drug interactions and need for coagulation monitoring parameters such as international normalized ratio and a short half-life make therapeutic control and withdrawal in the event of bleeding easier. The side-effect profile, including elevation of liver enzymes, may temper the clinical utility of long-term use ximelagatran.
