Prescrire Int. 2003 Aug;12(66):143-8.
The efficacy of pravastatin and simvastatin was first shown several years ago in patients with coronary heart disease. Other trials have since been published. In the HPS trial, which studied patients with coronary heart disease, other cardiovascular conditions, or diabetes, simvastatin significantly reduced the risk of death, coronary events and stroke when compared with placebo. In the ALLHAT-LLT trial, in patients with treated hypertension, pravastatin did not reduce overall mortality. In the PROSPER trial, in patients aged over 70 with cardiovascular disease or cardiovascular risk factors, pravastatin reduced the incidence of coronary events relative to placebo, but did not reduce overall mortality. Pharmacovigilance studies suggest there is no difference between these four statins in terms of their potential to cause rhabdomyolysis. Taken together, these trials show that statin use can be extended to patients with levels of LDL-cholesterol over 2.4 mmol/l (0.9 g/l) if they have coronary heart disease (and no hypercholesterolaemia), a history of ischaemic stroke, or lower-limb arterial disease. Statins can also be prescribed for diabetic patients with no signs of cardiovascular disease but whose LDL-cholesterol exceeds 3.4 mmol/l (1.3 g/l). Clinical trial data support the use of pravastatin or simvastatin in these situations, at a dose of 20 or 40 mg daily. Plasma creatine phosphokinase assay should be done if muscle symptoms occur or if the patient has a particular risk of rhabdomyolysis.
普伐他汀和辛伐他汀的疗效早在数年前就在冠心病患者中得到了证实。此后又发表了其他一些试验。在研究冠心病、其他心血管疾病或糖尿病患者的HPS试验中,与安慰剂相比,辛伐他汀显著降低了死亡、冠心病事件和中风的风险。在ALLHAT - LLT试验中,在接受治疗的高血压患者中,普伐他汀并未降低总体死亡率。在PROSPER试验中,在70岁以上患有心血管疾病或心血管危险因素的患者中,与安慰剂相比,普伐他汀降低了冠心病事件的发生率,但并未降低总体死亡率。药物警戒研究表明,这四种他汀类药物在引起横纹肌溶解的可能性方面没有差异。综合来看,这些试验表明,如果患有冠心病(且无高胆固醇血症)、有缺血性中风病史或下肢动脉疾病,他汀类药物可用于低密度脂蛋白胆固醇水平超过2.4 mmol/l(0.9 g/l)的患者。对于没有心血管疾病迹象但低密度脂蛋白胆固醇超过3.4 mmol/l(1.3 g/l)的糖尿病患者,也可以开具他汀类药物。临床试验数据支持在这些情况下使用普伐他汀或辛伐他汀,剂量为每日20或40毫克。如果出现肌肉症状或患者有横纹肌溶解的特殊风险,应进行血浆肌酸磷酸激酶检测。