The CARE study: A postmarketing evaluation of ramipril in 11,100 patients

A postmarketing surveillance study was undertaken to confirm the efficacy and safety of the angiotensin-converting enzyme inhibitor ramipril and to extend the findings of controlled clinical trials into real-world conditions. A total of 11,100 patients with mild-to-moderate hypertension treated by primary care physicians were enrolled in this 8-week, open-label study. Ramipril was usually initiated at a dosage of 2.5 mg once daily and titrated to achieve target blood pressure. Efficacy was assessed in 8261 patients for whom blood pressure data were recorded after the start of treatment: safety was assessed in all patients. Of patients with combined systolic and diastolic hypertension, 86.0% achieved a final diastolic blood pressure of ≤90 mm Hg or a ≤10 mm Hg decrease from baseline; the highest response was seen in elderly patients (87.2%), and the lowest response was seen in black patients (81.2%). Of patients with isolated systolic hypertension, 70.4% achieved a final systolic blood pressure of ≤140 mm Hg or a ≤20 mm Hg decrease from baseline, including 70.6% of women, 70.3% of men, and 69.1% of elderly patients: the highest response was seen in white patients (71.8%), and the lowest response was seen in black patients (64.4%). Adverse events were generally mild; cough (3.0%) was the most frequent. Once-daily ramipril was effective and well tolerated during an 8-week period in a large, diverse population of patients who had mild-to-moderate hypertension and who were treated by primary care physicians.