Why the study?
What is the incidence and characterization of cough as an adverse reaction secondary to captopril in patients with mild to moderate hypertension?
What is the incidence and characterization of cough as an adverse reaction secondary to captopril in patients with mild to moderate hypertension?
Captopril induces a generally mild to moderate cough in approximately 7.1% of treated patients, with only 1.0% requiring drug withdrawal.
Informs expected cough rates with captopril in hypertension; extends initial reports but leaves open need for randomized tolerability data.
OBJECTIVE: Quantify and characterize cough as an adverse reaction secondary to captopril. DESIGN: Cohort analytic study: six-month prospective trial including two-week, placebo, run-in period; five-month, single-blind, active treatment; and two-week, dechallenge period. SETTING: Outpatient clinic. PATIENTS: 199 previously treated or newly diagnosed untreated patients with mild to moderate hypertension. INTERVENTIONS: Captopril 50 mg/d during five months. OUTCOME MEASURES: Self-questionnaires, interviews, dechallenge, and rechallenge periods. Naranjo's algorithm. RESULTS AND CONCLUSIONS: (1) Cumulative incidence of captopril-induced cough over a five-month period was 7.1 percent (95 percent C.I., 6.8-7.4 percent). Incidence of drug withdrawal secondary to severe cough was 1.0 percent; this figure is somewhat similar to first reports about the reaction. (2) Cough was a generally mild to moderate symptom, present day and night in 71.4 percent of patients and resistant to antitussive agents. Cough was not statistically related to sex, age, or smoking habit; however, the female gender and the development of a common cold may be predisposing factors.
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Lefèbvre et al. (1992) studied this question.
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