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The Impact of US FDA and Health Canada Warnings Related to the Safety of High-dose Simvastatin

机译：美国FDA和加拿大卫生部警告对大剂量辛伐他汀安全性的影响

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IntroductionBetween 2010 and 2012, the US Food and Drug Administration and Health Canada issued warnings to healthcare professionals emphasizing the increased risk of muscle problems with high-dose simvastatin. ObjectiveTo measure the impact of the Health Canada safety warning regarding dose-dependent adverse effects of simvastatin on prescribing of low, medium, and high doses of simvastatin. MethodsAn interrupted time-series design was used to evaluate the impact of a Health Canada safety warning on 7 November 2012 regarding the safety of high-dose simvastatin. Monthly prescription records were analyzed for beneficiaries of the Nova Scotia Seniors’ Pharmacare Program aged 65?years or older who had received?>?1 prescription of simvastatin between 1 January 1997 and 31 March 2015. Autoregressive Integrated Moving Average models were used to test changes in the proportion of beneficiaries dispensed a low dose ( ResultsThere were 219 monthly periods, of which 29 periods occurred after the Health Canada warning. On average during the pre-warning periods there were 2944 simvastatin users per month, of whom 71% were dispensed a low dose, 26% a medium dose, and 2% a high dose. The proportion of beneficiaries dispensed low-dose simvastatin increased by 0.9% (one-sided p value 0.035; 90% CI 0.07–1.65), the proportion dispensed medium-dose simvastatin decreased by 0.7% (one-sided p value 0.0496; 90% CI ?1.48 to ?0), and there was no significant change in the proportion dispensed high-dose simvastatin (?0.15% change, one-sided p value 0.205; 90% CI ?0.45 to 0.15). ConclusionsThe Health Canada Health Care Professional warning had a small effect on increasing the proportion of beneficiaries dispensed low and medium doses of simvastatin but not high doses of simvastatin. Nevertheless, there remain seniors in Nova Scotia receiving high-dose simvastatin for whom the benefit/risk potential may need to be re-evaluated.
机译：简介在2010年至2012年之间，美国食品药品管理局和加拿大卫生部向医疗保健专业人士发出警告，强调高剂量辛伐他汀会增加肌肉疾病的风险。目的评估加拿大卫生部关于辛伐他汀剂量依赖性不良反应对辛伐他汀低，中，高剂量处方的不良影响的安全警告。方法采用中断时间序列设计来评估2012年11月7日加拿大卫生部关于高剂量辛伐他汀安全性的安全警告的影响。分析了1997年1月1日至2015年3月之间接受了≥1辛伐他汀处方的65岁或65岁以上的新斯科舍省老年人药房计划受益人的每月处方记录。使用自回归综合移动平均模型测试变化结果是每月有219个月，其中29个月是在加拿大卫生部警告之后发生的。在预警期间，平均每月有2944辛伐他汀使用者，其中有71％被分配低剂量，中剂量为26％，高剂量为2％。低剂量辛伐他汀的受益人比例增加了0.9％（单面p值0.035; 90％CI为0.07-1.65），中等剂量辛伐他汀的剂量下降了0.7％（单面p值0.0496; 90％CI≤1.48至？0），大剂量辛伐他汀的分配比例没有明显变化（变化0.15％，单面p值0.205） ; 90％CI？0.45至0.15）。结论加拿大卫生部的《健康护理专业警告》对增加低剂量和中剂量辛伐他汀的受益人比例的影响不大，而增加高剂量辛伐他汀的受益人的比例却影响很小。尽管如此，新斯科舍省仍有一些老年人接受大剂量的辛伐他汀治疗，可能需要对他们的利益/风险潜力进行重新评估。

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