Key result
Lisinopril increased spontaneously reported cough compared to nifedipine (8.5% vs 3.1%), with women on lisinopril reporting cough three times more often than men (12.6% vs 4.4%).
Why the study?
Does lisinopril increase the incidence of cough compared to nifedipine in patients with mild to moderate essential hypertension?
RCT (n=828)
Double-blind, double-dummy
Yes
Does lisinopril increase the incidence of cough compared to nifedipine in patients with mild to moderate essential hypertension?
Absolute Event Rate: 8.5% vs 3.1%
Lisinopril is associated with a significantly higher incidence of cough compared to nifedipine, with a marked female preponderance.
Clinicians should weigh cough risk when selecting lisinopril, especially for women; confirms ACEI class effect with marked sex disparity in hypertension.
In a double-blind double-dummy multicenter study, patients with mild to moderate essential hypertension were randomized to receive either nifedipine (n = 416, 47.6% women) or lisinopril (n = 412, 50% women), and side effects were registered by specific questioning, by spontaneous reports, and by use of visual analog scales. Cough was spontaneously reported to occur in 8.5% with lisinopril compared to 3.1% with nifedipine. Women treated with lisinopril reported cough spontaneously three times more often than men, 12.6% v 4.4%, whereas no differences between the sexes were observed during the placebo period or during nifedipine treatment. Similar gender differences were observed during specific questioning. Furthermore, nonsmokers reported an increase in cough more often than did smokers.
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Os et al. (1994) conducted an RCT in Mild to moderate essential hypertension (n=828). Lisinopril vs. Nifedipine was evaluated on Spontaneously reported cough. Lisinopril increased spontaneously reported cough compared to nifedipine (8.5% vs 3.1%), with women on lisinopril reporting cough three times more often than men (12.6% vs 4.4%).
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