J Lefebvre1, L Poirier, Y Lacourcière. 1. Hypertension Research Unit, Research Center, Centre Hospitalier de l'Université Laval, Ste-Foy, Québec, Canada.
Abstract
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.
RCT Entities:
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.
Authors: V Charlon; S Dollow; J Fidel; C Hoglund; T Honkanen; I Kobrin; J McEwan; G McInnes; J R Viskoper; K S Woo Journal: Br J Clin Pharmacol Date: 1995-02 Impact factor: 4.335