THE CARE STUDY - A POSTMARKETING EVALUATION OF RAMIPRIL IN 11,100 PATIENTS

A postmarketing surveillance study was undertaken to confirm the effic acy and safety of the angiotensin-converting enzyme inhibitor ramipril and to extend the findings of controlled clinical trials into real-wo rld conditions. A total of 11,100 patients with mild-to-moderate hyper tension treated by primary care physicians were enrolled in this 8-wee k, 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 recor ded 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 less than or equal to 90 mm Hg or a greater than or equal to 10 mm Hg decrease from baseline; t he highest response was seen in elderly patients (87.2%), and the lowe st response was seen in black patients (81.2%). Of patients with isola ted systolic hypertension, 70.4% achieved a final systolic blood press ure of less than or equal to 140 mm Hg or a greater than or equal to 2 0 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 whit e patients (71.8%), and the lowest response was seen in black patients (64.4%). Adverse events were generally mild; cough (3.0%) was the mos t frequent. Once-daily ramipril was effective and well tolerated durin g an 8-week period in a large, diverse population of patients who had mild-to-moderate hypertension and who were treated by primary care phy sicians.