Beggs P W, Clark D W, Williams S M, Coulter D M
Dunedin School of Medicine, University of Otago, New Zealand.
Br J Clin Pharmacol. 1999 Jan;47(1):99-104. doi: 10.1046/j.1365-2125.1999.00846.x.
Because of the importance of treating dyslipidaemia in the prevention of ischaemic heart disease and because patient selection criteria and outcomes in clinical trials do not necessarily reflect what happens in normal clinical practice, we compared outcomes from bezafibrate, gemfibrozil and simvastatin therapy under conditions of normal use.
A random sample of 200 patients was selected from the New Zealand Intensive Medicines Monitoring Programme's (IMMP) patient cohorts for each drug. Questionnaires sent to prescribers requested information on indications, risk factors for ischaemic heart disease, lipid profiles with changes during treatment and reasons for stopping therapy.
80% of prescribers replied and 83% of these contained useful information. The three groups were similar for age, sex and geographical region, but significantly more patients on bezafibrate had diabetes and/or hypertension than those on gemfibrozil or simvastatin. After treatment and taking the initial measure into account, the changes in serum lipid values were consistent with those generally observed, but with gemfibrozil being significantly less effective than expected. More patients (15.8%S) stopped gemfibrozil because of an inadequate response compared with bezafibrate (5.4%) and simvastatin (1.6%). Gemfibrozil treatment was also withdrawn significantly more frequently due to a possible adverse reaction compared with the other two drugs.
In normal clinical practice in New Zealand gemfibrozil appears less effective and more frequently causes adverse effects leading to withdrawal of treatment than either bezafibrate or simvastatin.
鉴于治疗血脂异常在预防缺血性心脏病中的重要性，且临床试验中的患者选择标准和结果不一定反映正常临床实践中的情况，我们比较了在正常使用条件下苯扎贝特、吉非贝齐和辛伐他汀治疗的结果。
从新西兰强化药物监测计划（IMMP）中每种药物的患者队列中随机抽取200名患者作为样本。向开处方者发送问卷，询问有关适应症、缺血性心脏病危险因素、治疗期间血脂谱变化以及停药原因的信息。
80%的开处方者回复，其中83%包含有用信息。三组在年龄、性别和地理区域方面相似，但服用苯扎贝特的患者患糖尿病和/或高血压的比例明显高于服用吉非贝齐或辛伐他汀的患者。治疗后并考虑初始测量值，血脂值的变化与通常观察到的一致，但吉非贝齐的效果明显低于预期。与苯扎贝特（5.4%）和辛伐他汀（1.6%）相比，更多患者（15.8%）因反应不足而停用吉非贝齐。与其他两种药物相比，吉非贝齐治疗也因可能的不良反应而更频繁地停药。
在新西兰的正常临床实践中，与苯扎贝特或辛伐他汀相比，吉非贝齐似乎效果较差，且更频繁地导致不良反应而停药。
