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瑞舒伐他汀:新制剂。选择对临床结局有疗效证据的他汀类药物。

Rosuvastatin: new preparation. Opt for statins with evidence of efficacy on clinical outcome.

出版信息

Prescrire Int. 2004 Aug;13(72):132-4.

Abstract

(1) Simvastatin and pravastatin are the two reference statins for type IIA and type IIB hypercholesterolaemia because they have the best-documented protective effect against cardiovascular events. Simvastatin and pravastatin are also the reference statins for familial heterozygous hypercholesterolaemia, though there is no evidence that they prevent cardiovascular events in this group. Statins are not very effective in familial homozygous hypercholesterolaemia. (2) Rosuvastatin is the sixth statin to arrive on the French market. The fifth, cerivastatin, was withdrawn from the market in 2001 because of serious adverse effects. (3) Rosuvastatin has not been assessed in terms of morbidity or mortality. The results of comparative trials in type IIA and type IIB hypercholesterolaemia suggest that rosuvastatin is slightly more active than simvastatin, pravastatin and atorvastatin on some lipid parameters after a few weeks of treatment. (4) Rosuvastatin has not been compared with simvastatin or pravastatin in familial heterozygous hypercholesterolaemia. One trial showed it to be slightly more effective than atorvastatin on cholesterol levels. According to one trial, rosuvastatin does not appear to be more effective than atorvastatin in homozygous forms. (5) In clinical trials the adverse effects of rosuvastatin were similar to those of other statins, with the exception of renal adverse effects. We don't know whether rosuvastatin is more or less likely than other statins to cause rhabdomyolysis. (6) Clinical trials reported some cases of proteinuria and renal failure suggesting there is a need for more thorough assessment in long-term trials. (7) In practice, statins with the best-documented benefits (simvastatin and pravastatin) should be used first for cardiovascular prevention in patients with hypercholesterolaemia.

摘要

(1) 辛伐他汀和普伐他汀是治疗IIA型和IIB型高胆固醇血症的两种参考他汀类药物,因为它们对心血管事件具有记录最充分的保护作用。辛伐他汀和普伐他汀也是家族性杂合子高胆固醇血症的参考他汀类药物,尽管没有证据表明它们能预防该群体的心血管事件。他汀类药物对家族性纯合子高胆固醇血症疗效不佳。(2) 瑞舒伐他汀是第六种进入法国市场的他汀类药物。第五种,西立伐他汀,因严重不良反应于2001年退市。(3) 瑞舒伐他汀尚未在发病率或死亡率方面进行评估。IIA型和IIB型高胆固醇血症的对比试验结果表明,治疗几周后,瑞舒伐他汀在某些血脂参数上比辛伐他汀、普伐他汀和阿托伐他汀活性略高。(4) 瑞舒伐他汀尚未在家族性杂合子高胆固醇血症中与辛伐他汀或普伐他汀进行比较。一项试验表明,它在降低胆固醇水平方面比阿托伐他汀略有效。根据一项试验,瑞舒伐他汀在纯合子形式中似乎并不比阿托伐他汀更有效。(5) 在临床试验中,瑞舒伐他汀的不良反应与其他他汀类药物相似,但肾脏不良反应除外。我们不知道瑞舒伐他汀导致横纹肌溶解的可能性比其他他汀类药物高还是低。(6) 临床试验报告了一些蛋白尿和肾衰竭病例,这表明有必要在长期试验中进行更全面的评估。(7) 在实际应用中,对于高胆固醇血症患者的心血管预防,应首先使用记录最充分的有益他汀类药物(辛伐他汀和普伐他汀)。

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