- 期刊
Tolerability of Ramipril 10 mg Daily in High-Risk Cardiovascular Patients in Taiwan: Experience from Kaohsiung Medical University Chung-Ho Memorial Hospital
Ramipril每日10毫克劑量對於高心血管危險因子病患耐受性研究－高醫的臨床經驗
摘要
在大規模HOPE研究已證實每日10 mg的ramipril用藥可以降低高心血管危險因子病患將來發生腦血管與心血管疾病機會與死亡率，並且遠超過血壓下降程度所能帶來的好處。然而使用每日10 mg的ramipril用藥時，病人的耐受性一直是臨床上重視的課題。本觀察性臨床研究，遵循HOPE臨床研究模式，評估本院高危險群病人使用每日10 mg ramipril之耐受性與副作用情況。總共有92位病人接受本臨床試驗。依據病人耐受性，將ramipril劑量從每日2.5毫克（每錠劑2.5毫克），慢慢每月調高到每日5毫克、每日7.5毫克直到每日10毫克。維持劑量目標保持在每日10毫克。所有病人至少追蹤三個月以上並記錄其副作用報告。結果顯示只有18位病人達到每日10 mg的ramipril的治療劑量。其餘分別有11位(15.5%)、22位(30.9)、以及20位(28.20%)病人達到每日5毫克、每日7.5毫克及每日10毫克ramipril治療劑量。有21位(22.6%)病人至少報告過一種副作用。有12位病人(13.0%)因為副作用而必須停止試驗。總共有23起副作用事件報告，其中乾咳佔15.1%，暈眩佔6.0%，低血壓則佔2.4%。我們的結論是，雖然大多數的病人對於ramipril的耐受性還不錯，但是能順利達到每日10 mg的ramipril的治療劑量的病人數只有大約四分之一。乾咳、暈眩及低血壓等副作用仍是醫師在開立此類處方時最常見的問題。本試驗因為上述副作用而必須停藥的病人比例大約在15%，與過去文獻報告的數據接近。
並列摘要
The Heart Outcomes Prevention Evaluation (HOPE) study demonstrated that the angiotensin-converting enzyme inhibitor, ramipril, significantly reduces mortality, myocardial infarction and stroke in high-risk cardiovascular patients, beyond the benefits from blood pressure lowering. The tolerability of ramipril 10 mg/day has been an important concern when applying these results. Following the same criteria as the HOPE study, we investigated the adverse effects profile and tolerability of 10 mg ramipril in high-risk patients at our institution. In total, 92 patients with high cardiovascular risk were eligible for this study. Initially, ramipril was prescribed 2.5 mg orally once daily, and then titrated up to 5.0, 7.5, and 10.0 mg/day at 1-month intervals. The target maintenance dose was 10 mg/day. All adverse events were recorded during at least 3 months of follow-up. After 4-6 months of the titration protocol, only 18 patients (25.3%) reached and remained on ramipril 10 mg/day; 11(15.5%), 22 (30.9%), and 20 patients (28.2%) remained on 2.5, 5.0, and 7.5 mg/day, respectively. Twenty-one patients (22.6%) had at least one adverse event. Twelve patients (13.0%) stopped treatment because of adverse effects. A total of 23 episodes of adverse events were reported, including cough (15.1%), dizziness (6.0%), and hypotension (2.4%). Ramipril was relatively well tolerated in our study population. However, only one-quarter of our patients reached the target maintenance dose of 10 mg/day. Dry cough, dizziness, and hypotension were the major side effects. About 15% of our patients discontinued ramipril treatment, which is comparable with previous reports.