Miller M A, Texter M, Gmerek A, Robbins J, Shurzinske L, Canter D
Parke-Davis Pharmaceutical Research, Division of Warner-Lambert Company, Ann Arbor, Michigan 48105.
Cardiovasc Drugs Ther. 1994 Apr;8(2):271-5. doi: 10.1007/BF00877336.
Patients with mild to moderate hypertension (diastolic blood pressure > or = 95 and < or = 115 mmHg) and renal dysfunction entered one of two studies to assess the safety of efficacious daily doses of quinapril on renal function and blood pressure. Twenty-four patients with moderate renal impairment (MRI) (creatinine clearance > 30 and < or = 60 ml/min) entered 24 weeks of open-label quinapril treatment; 31 patients with chronic renal failure (CRF) (creatinine clearance < 30 ml/min) entered 16 weeks of open-label quinapril treatment. Patients with MRI initially received quinapril 5 mg once daily (qd) followed by titration to a maximum dosage of 40 mg/day (furosemide optional at 40 mg only). Patients with CRF initially received quinapril 2.5 mg qd and were titrated up to 20 mg/day (furosemide optional). Open-label quinapril treatment resulted in significant decreases in mean systolic (SBP) and diastolic (DBP) blood pressure. The 20 patients with MRI and the 28 with CRF who completed the open-label phase were then randomly assigned to continue active drug or to receive placebo in a 4-week, double-blind, drug-withdrawal phase. During the double-blind withdrawal phase, placebo-treated patients had significant increases in mean SBP and DBP from the end of open label. Creatinine clearance was essentially unchanged following open-label quinapril treatment or quinapril withdrawal. In conclusion, in patients with mild to moderate hypertension and renal dysfunction, quinapril in dosages of 5-40 mg qd for patients with MRI and 2.5 to 20 mg qd for patients with CRF significantly reduces blood pressure without adversely affecting renal function.
轻度至中度高血压(舒张压≥95且≤115 mmHg)及肾功能不全患者进入两项研究之一,以评估每日有效剂量喹那普利对肾功能和血压的安全性。24例中度肾功能损害(MRI)(肌酐清除率>30且≤60 ml/min)患者进入24周的喹那普利开放标签治疗;31例慢性肾衰竭(CRF)(肌酐清除率<30 ml/min)患者进入16周的喹那普利开放标签治疗。MRI患者最初每日一次服用喹那普利5 mg(qd),随后滴定至最大剂量40 mg/天(仅在40 mg时可选用速尿)。CRF患者最初每日服用喹那普利2.5 mg qd,并滴定至20 mg/天(可选用速尿)。开放标签的喹那普利治疗导致平均收缩压(SBP)和舒张压(DBP)显著降低。然后,完成开放标签阶段的20例MRI患者和28例CRF患者被随机分配继续接受活性药物或在为期4周的双盲撤药阶段接受安慰剂。在双盲撤药阶段,接受安慰剂治疗的患者的平均SBP和DBP自开放标签结束后显著升高。开放标签的喹那普利治疗或撤药后肌酐清除率基本未变。总之,对于轻度至中度高血压及肾功能不全患者,MRI患者每日服用5 - 40 mg的喹那普利,CRF患者每日服用2.5至20 mg的喹那普利,可显著降低血压且不影响肾功能。