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Serious Adverse Events Among SPRINT Trial Participants Taking Statins at Baseline
BACKGROUND: Real-world evidence of statin side effects is potentially biased because statin use is neither randomized nor unblinded. An innovative study design can mitigate these biases. For example, in the recent ASCOT-LLA trial, patient-reported adverse events such as muscle pain and weakness were...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer International Publishing
2017
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5694426/ https://www.ncbi.nlm.nih.gov/pubmed/29058304 http://dx.doi.org/10.1007/s40268-017-0213-9 |
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author | Huesch, Marco D. |
author_facet | Huesch, Marco D. |
author_sort | Huesch, Marco D. |
collection | PubMed |
description | BACKGROUND: Real-world evidence of statin side effects is potentially biased because statin use is neither randomized nor unblinded. An innovative study design can mitigate these biases. For example, in the recent ASCOT-LLA trial, patient-reported adverse events such as muscle pain and weakness were higher in the non-randomized and non-blinded setting than in the randomized, blinded setting. Less optimally, secondary re-analysis of clinical trials in which statin use is recorded and in which serious adverse events (SAEs) are adjudicated may be conducted. OBJECTIVE: The objective of this study was to evaluate SAEs by statin use at baseline among participants in the SPRINT blood pressure (BP) management trial. METHODS: Unadjusted overall SAE and treatment-related SAE rates by statin use as well as adjusted hazard ratios for statin use were computed in four cohorts [by baseline clinical cardiovascular disease (CVD), by intervention arm]. RESULTS: Statin use at baseline was not associated with higher overall or treatment-related SAE rates among (1) those without pre-existing CVD, regardless of BP arm, nor among (2) those randomized to standard BP management, regardless of pre-existing CVD. Among higher risk patients with existing clinical CVD randomized to intensive BP management, a small but significant increase in overall SAE rate was found among those taking statin at baseline. CONCLUSIONS: In SPRINT, generally statin use was not associated with increased risk of reporting SAEs. Only statin use by higher risk patients was associated with more overall SAEs. Confounding by clinical CVD and the polytherapy of intensive BP management may explain this. |
format | Online Article Text |
id | pubmed-5694426 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-56944262017-11-29 Serious Adverse Events Among SPRINT Trial Participants Taking Statins at Baseline Huesch, Marco D. Drugs R D Original Research Article BACKGROUND: Real-world evidence of statin side effects is potentially biased because statin use is neither randomized nor unblinded. An innovative study design can mitigate these biases. For example, in the recent ASCOT-LLA trial, patient-reported adverse events such as muscle pain and weakness were higher in the non-randomized and non-blinded setting than in the randomized, blinded setting. Less optimally, secondary re-analysis of clinical trials in which statin use is recorded and in which serious adverse events (SAEs) are adjudicated may be conducted. OBJECTIVE: The objective of this study was to evaluate SAEs by statin use at baseline among participants in the SPRINT blood pressure (BP) management trial. METHODS: Unadjusted overall SAE and treatment-related SAE rates by statin use as well as adjusted hazard ratios for statin use were computed in four cohorts [by baseline clinical cardiovascular disease (CVD), by intervention arm]. RESULTS: Statin use at baseline was not associated with higher overall or treatment-related SAE rates among (1) those without pre-existing CVD, regardless of BP arm, nor among (2) those randomized to standard BP management, regardless of pre-existing CVD. Among higher risk patients with existing clinical CVD randomized to intensive BP management, a small but significant increase in overall SAE rate was found among those taking statin at baseline. CONCLUSIONS: In SPRINT, generally statin use was not associated with increased risk of reporting SAEs. Only statin use by higher risk patients was associated with more overall SAEs. Confounding by clinical CVD and the polytherapy of intensive BP management may explain this. Springer International Publishing 2017-10-22 2017-12 /pmc/articles/PMC5694426/ /pubmed/29058304 http://dx.doi.org/10.1007/s40268-017-0213-9 Text en © The Author(s) 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Original Research Article Huesch, Marco D. Serious Adverse Events Among SPRINT Trial Participants Taking Statins at Baseline |
title | Serious Adverse Events Among SPRINT Trial Participants Taking Statins at Baseline |
title_full | Serious Adverse Events Among SPRINT Trial Participants Taking Statins at Baseline |
title_fullStr | Serious Adverse Events Among SPRINT Trial Participants Taking Statins at Baseline |
title_full_unstemmed | Serious Adverse Events Among SPRINT Trial Participants Taking Statins at Baseline |
title_short | Serious Adverse Events Among SPRINT Trial Participants Taking Statins at Baseline |
title_sort | serious adverse events among sprint trial participants taking statins at baseline |
topic | Original Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5694426/ https://www.ncbi.nlm.nih.gov/pubmed/29058304 http://dx.doi.org/10.1007/s40268-017-0213-9 |
work_keys_str_mv | AT hueschmarcod seriousadverseeventsamongsprinttrialparticipantstakingstatinsatbaseline |