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普伐他汀-吉非贝齐联合治疗混合性高脂血症的长期安全性。

Long-term safety of pravastatin-gemfibrozil therapy in mixed hyperlipidemia.

作者信息

Iliadis E A, Rosenson R S

机构信息

Preventive Cardiology Center, Rush Presbyterian-St. Luke's Medical Center, Chicago, Illinois 60612, USA.

出版信息

Clin Cardiol. 1999 Jan;22(1):25-8. doi: 10.1002/clc.4960220110.

DOI:10.1002/clc.4960220110
PMID:9929751
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6655916/
Abstract

BACKGROUND

Combined HMG-CoA reductase inhibitor and fibric acid derivative therapy is often necessary for the effective reduction of concentrations of low-density lipoprotein (LDL) cholesterol and triglycerides in patients with mixed hyperlipidemia; however, the potential risk of myopathy has limited the use of these agents.

HYPOTHESIS

This study evaluated long-term safety and efficacy of combined pravastatin and gemfibrozil therapy.

METHODS

Eighty-three patients with hyperlipidemia were treated with combined pravastatin and gemfibrozil therapy for a median of 44 months (range 9-78 months). Plasma lipids, serum liver function tests, creatinine, and creatinine kinase (CK) levels were measured every 3 to 4 months.

RESULTS

One patient developed myalgia with a normal CK level after 4 months of combination therapy. Three patients had transient elevations in CK levels that ranged from 3 to 5 times the upper limits of "normal" and that returned to normal upon repeat testing. Liver function tests did not change significantly from baseline. In a subset of 26 previously untreated patients, combined pravastatin (mean daily dose 22 mg) and gemfibrozil (mean daily dose 1,154 mg) therapy lowered total cholesterol by 25% (p < 0.001), triglycerides by 53% (p = 0.0001), LDL cholesterol by 14% (p = 0.24), and increased high-density lipoprotein (HDL) cholesterol by 20% (p = 0.012).

CONCLUSION

Pravastatin and gemfibrozil therapy is safe and efficacious in patients with mixed hyperlipidemia. The long-term safety results are consistent with other reports on follow-up of shorter duration.

摘要

背景

对于有效降低混合性高脂血症患者的低密度脂蛋白(LDL)胆固醇和甘油三酯浓度,联合使用HMG-CoA还原酶抑制剂和纤维酸衍生物治疗通常是必要的;然而,肌病的潜在风险限制了这些药物的使用。

假设

本研究评估了普伐他汀和吉非贝齐联合治疗的长期安全性和疗效。

方法

83例高脂血症患者接受普伐他汀和吉非贝齐联合治疗,中位治疗时间为44个月(范围9 - 78个月)。每3至4个月测量血脂、血清肝功能、肌酐和肌酸激酶(CK)水平。

结果

1例患者在联合治疗4个月后出现肌痛,CK水平正常。3例患者CK水平短暂升高,为“正常”上限的3至5倍,再次检测时恢复正常。肝功能检查与基线相比无显著变化。在26例先前未接受治疗的患者亚组中,联合使用普伐他汀(平均每日剂量22 mg)和吉非贝齐(平均每日剂量1154 mg)治疗可使总胆固醇降低25%(p < 0.001),甘油三酯降低53%(p = 0.0001),LDL胆固醇降低14%(p = 0.24),高密度脂蛋白(HDL)胆固醇升高20%(p = 0.012)。

结论

普伐他汀和吉非贝齐联合治疗对混合性高脂血症患者安全有效。长期安全性结果与其他较短随访时间的报告一致。

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本文引用的文献

1
Safety and efficacy of long-term statin-fibrate combinations in patients with refractory familial combined hyperlipidemia.长期他汀类药物与贝特类药物联合使用对难治性家族性混合性高脂血症患者的安全性和有效性。
Am J Cardiol. 1997 Sep 1;80(5):608-13. doi: 10.1016/s0002-9149(97)00430-x.
2
Metabolism of cerivastatin by human liver microsomes in vitro. Characterization of primary metabolic pathways and of cytochrome P450 isozymes involved.人肝微粒体体外对西立伐他汀的代谢。主要代谢途径及相关细胞色素P450同工酶的特性研究。
Drug Metab Dispos. 1997 Mar;25(3):321-31.
3
Myositis and rhabdomyolysis associated with concurrent use of simvastatin and nefazodone.与辛伐他汀和奈法唑酮同时使用相关的肌炎和横纹肌溶解症。
JAMA. 1997;277(4):296-7. doi: 10.1001/jama.277.4.296.
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Effect of combination therapy with lipid-reducing drugs in patients with coronary heart disease and "normal" cholesterol levels. A randomized, placebo-controlled trial. Harvard Atherosclerosis Reversibility Project (HARP) Study Group.降脂药物联合治疗对冠心病且胆固醇水平“正常”患者的影响。一项随机、安慰剂对照试验。哈佛动脉粥样硬化逆转项目(HARP)研究组。
Ann Intern Med. 1996 Oct 1;125(7):529-40. doi: 10.7326/0003-4819-125-7-199610010-00001.
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Am J Med. 1993 Jan;94(1):13-20. doi: 10.1016/0002-9343(93)90114-5.