@article {Wu:2002:1173-2563:771, author = "Wu N.", author = "Zhu J.R.", author = "Chen K.A.", title = "Tolerability of Ramipril 10 mg/day in High-Risk Cardiovascular Chinese Patients", journal = "Clinical Drug Investigation", volume = "22", year = "2002", abstract = "

Objective: The aim of this study was to investigate the tolerability of ramipril 10 mg/day in high-risk cardiovascular Chinese patients, following similar criteria to those used for patient selection in the Heart Outcomes Prevention Evaluation (HOPE) study and through the collection of adverse event data by Chinese cardiologists.

Design and subjects: This was a non-comparative study with single-group non-blind assessment carried out in 76 nationwide investigational sites. The target population was around 1000 patients. Men and women aged ge55 years were eligible for the study if they had one of the following risk factors for developing major cardiovascular events: a history of coronary artery disease , stroke, peripheral vascular disease or diabetes plus at least one other cardiovascular risk factor. Patients initially received ramipril 2.5mg tablets orally once daily, and were then titrated up to 5 mg/day and 10 mg/day at 2-week intervals. The maintenance dosage was 10 mg/day for 1 month. For patients with stable heart failure, the starting dosage was 1.25 mg/day, titrating up to the same maintenance dosage (10 mg/day). Adverse events were closely followed up and recorded. 981 patients were eligible for the intention-to-treat (ITT) analysis. Twenty-three patients dropped out at their own request or because of protocol violation. 958 patients (97.7%) completed the study per protocol.

Main results: 880 of 958 (91.8%) patients reached and remained at the 10 mg/day dosage level; 78 of 958 (8.1%) stayed at 5mg/day or 2.5 mg/day. 168 patients (17.5%) had at least one adverse event. Fifty-eight patients (6.0%) stopped the treatment because of an adverse event; 110 (11.5%) completed the study in spite of adverse events. Altogether, 185 instances of adverse events were observed, mainly consisting of cough, dizziness, hypotension, rash and serum creatinine elevation. Most adverse events were possibly or probably related to ramipril. Three patients experienced serious adverse events, including one death, but investigation failed to show any evidence of a relationship to ramipril treatment.

Conclusion: Ramipril was well tolerated in Chinese patients with high-risk cardiovascular diseases. Patients were able to tolerate the full effective dosage level of 10 mg/day.

", pages = "771-781(11)", url = "http://www.ingentaconnect.com/content/adis/cdi/2002/00000022/00000011/art00005" }