ArticleDrugs - real world outcomes2017
The Impact of US FDA and Health Canada Warnings Related to the Safety of High-dose Simvastatin.
Article in Drugs - real world outcomes, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
3 citing papers in PubMed.
- SLCO1B1*5 Allele Is Associated With Atorvastatin Discontinuation and Adverse Muscle Symptoms in the Context of Routine Care.Clinical pharmacology and therapeutics · 2022Article
- Simvastatin decreases the silver resistance of E. faecalis through compromising the entrapping function of extracellular polymeric substances against silver.World journal of microbiology & biotechnology · 2020Article
- Diagnoses of Cardiovascular Disease or Substance Addiction/Abuse in US Adults Treated for ADHD with Stimulants or Atomoxetine: Is Use Consistent with Product Labeling?Drugs - real world outcomes · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
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 (< 40 mg), medium dose (40 mg to < 80 mg), or high dose (≥ 80 mg) of simvastatin over time.
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.
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Registered trials
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