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每日和间断性使用 5 毫克瑞舒伐他汀治疗不耐受他汀类药物的患者:一项观察性研究。

Daily and intermittent rosuvastatin 5 mg therapy in statin intolerant patients: an observational study.

机构信息

East & North Hertfordshire NHS Trust, Lister Hospital, Stevenage, Hertfordshire, UK.

出版信息

Curr Med Res Opin. 2012 Mar;28(3):371-8. doi: 10.1185/03007995.2012.657302. Epub 2012 Feb 7.

DOI:10.1185/03007995.2012.657302
PMID:22256801
Abstract

OBJECTIVE

To examine the efficacy and tolerability of rosuvastatin 5 mg at daily and non-daily dosing regimens.

RESEARCH DESIGN AND METHODS

A retrospective survey was conducted at nine primary, secondary and tertiary healthcare centres in the United Kingdom.

MAIN OUTCOME MEASURES

Changes in lipid fractions from baseline values after more than 3 months' treatment.

RESULTS

A total of 325 patients were identified. These patients were aged 63 ± 10 years, 50% male and prescription was mostly for primary prevention of cardiovascular disease (CVD) (59%). Co-morbidities included: established CVD present in 41%, type 2 diabetes mellitus (15%), hypertension (74%) and smoking (9%). Adverse effects had been documented to simvastatin (75%) or atorvastatin (63%). A total of 289 patients (89%) tolerated rosuvastatin well and were still adherent after a median follow-up of 14.9 (3-79) months. The remainder (n = 36; 11%) discontinued the medication after median 5 months' treatment due to adverse effects. Efficacy was assessed in 224 patients who had adequate data. Baseline lipids were total cholesterol (TC) 7.41 ± 1.50 mmol/L, triglycerides (TG) 2.26 (range 0.36-18.4) mmol/L; high density lipoprotein cholesterol (HDL-C) 1.43 ± 0.47 mmol/L and low density lipoprotein cholesterol (LDL-C) 4.76 ± 1.38 mmol/L. Daily rosuvastatin (n = 134) reduced mean TC by 31%, TG 15% and LDL-C 43% (p < 0.001). Rosuvastatin 5 mg 2-3 times weekly (n = 79) reduced TC 26%, TG 16% and LDL-C 32% (p < 0.001). Weekly rosuvastatin (n = 11) reduced TC 17%, LDL-C by 23% (p < 0.001) but had no effect on TGs. Targets were attained in 17% of CHD-risk equivalent patients and 41% of primary prevention patients by National Cholesterol Education Program criteria and 27% and 68% using UK targets. No myositis or rhabdomyolysis was observed and alanine aminotransferase (ALT) and creatine kinase (CK) were similar to baseline.

CONCLUSIONS

In this retrospective observational multicentre study, rosuvastatin 5 mg was found to be safe and biochemically effective either as daily or intermittent therapy in patients intolerant to other conventional statin regimens.

摘要

目的

研究瑞舒伐他汀 5 毫克每日和非每日剂量方案的疗效和耐受性。

研究设计和方法

在英国的九个初级、二级和三级医疗中心进行了回顾性调查。

主要观察指标

治疗 3 个月以上后,基线值的脂质分数变化。

结果

共确定了 325 名患者。这些患者的年龄为 63±10 岁,50%为男性,处方主要用于心血管疾病(CVD)的一级预防(59%)。合并症包括:已确诊的 CVD 占 41%,2 型糖尿病占 15%,高血压占 74%,吸烟占 9%。记录了不良反应,包括辛伐他汀(75%)或阿托伐他汀(63%)。共有 289 名(89%)患者对瑞舒伐他汀耐受良好,在中位随访 14.9(3-79)个月后仍坚持用药。其余 36 名(11%)患者因不良反应在中位治疗 5 个月后停止用药。在有足够数据的 224 名患者中评估了疗效。基线血脂为总胆固醇(TC)7.41±1.50mmol/L,甘油三酯(TG)2.26(范围 0.36-18.4)mmol/L;高密度脂蛋白胆固醇(HDL-C)1.43±0.47mmol/L 和低密度脂蛋白胆固醇(LDL-C)4.76±1.38mmol/L。每日瑞舒伐他汀(n=134)降低平均 TC 31%、TG 15%和 LDL-C 43%(p<0.001)。瑞舒伐他汀 5 毫克每周 2-3 次(n=79)降低 TC 26%、TG 16%和 LDL-C 32%(p<0.001)。每周瑞舒伐他汀(n=11)降低 TC 17%,LDL-C 23%(p<0.001),但对 TGs 没有影响。根据国家胆固醇教育计划标准,17%的冠心病风险等效患者和 41%的一级预防患者达到目标,而英国目标分别为 27%和 68%。未观察到肌炎或横纹肌溶解,丙氨酸氨基转移酶(ALT)和肌酸激酶(CK)与基线相似。

结论

在这项回顾性观察性多中心研究中,瑞舒伐他汀 5 毫克每日或间断治疗不耐受其他常规他汀类药物治疗的患者,安全性和生化疗效良好。

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