METHODS: Twenty-three studies including 5794 hypertensive patients and three studies including 1455 postmyocardial
infarction patients exposed for a median follow-up time of 3 months to
zofenopril at doses of 7.5-60 mg once-daily were analyzed. The incidence of
zofenopril-induced
cough was 2.6% (range 0%-4.2%): 2.4% in the
hypertension trials (2.4% in the double-blind randomized studies and 2.4% in the open-label postmarketing studies) and 3.6% in the doubleblind randomized postmyocardial
infarction trials.
Zofenopril-induced
cough was generally of a mild to moderate intensity, occurred significantly (P < 0.001) more frequently in the first 3-6 months of treatment (3.0% vs 0.2% 9-12 months), and always resolved or improved upon
therapy discontinuation.
Zofenopril doses of 30 mg and 60 mg resulted in significantly (P = 0.042) greater rate of
cough (2.1% and 2.6%, respectively) than doses of 7.5 mg and 15 mg (0.4% and 0.7%, respectively). In direct comparison trials (
enalapril and
lisinopril), incidence of
cough was not significantly different between
zofenopril and other
ACE inhibitors (2.4% vs 2.7%).
CONCLUSION: Evidence from a limited number of studies indicates a relatively low incidence of
zofenopril-induced
cough. Large head-to-head comparison studies versus different
ACE inhibitors are needed to highlight possible differences between
zofenopril and other
ACE inhibitors in the incidence of
cough.