Efficacy and tolerability of once-weekly rosuvastatin in patients with previous statin intolerance
Abstract
Background Many patients who could benefit from hydroxymethylglutaryl coenzyme-A reductase inhibitors (statins) are unable to take statins because of myalgias while taking previous statin therapy. Objective The primary objective was to assess the efficacy and tolerability of once-weekly rosuvastatin in patients with documented myalgias on statins who were not currently taking a statin and not at low-density lipoprotein (LDL) goal. Methods In this randomized, double-blind, placebo-controlled crossover study we enrolled a total of 17 Clement J. Zablocki Veterans Affairs (VA) primary care patients with a diagnosis of hyperlipidemia and a history of myalgias on statin therapy who were not currently on a statin and not at LDL goal. Two 8-week treatment phases consisted of rosuvastatin 5 mg once-weekly or matching placebo, with a dose titration to 10 mg once-weekly if not at LDL goal at week 4. The primary efficacy outcome was the difference in the mean percentage change in LDL from baseline between rosuvastatin and placebo. Results A significant difference in the mean percentage change in LDL from baseline for rosuvastatin vs. placebo was identified (12.2% reduction vs. 0.4% reduction, respectively; P = .002). Two of the 17 patients (11.8%) in the placebo treatment phase and three of the 15 patients (20%) in the rosuvastatin treatment phase experienced myalgias requiring cessation of therapy. In addition, three patients (20%) were able to attain LDL goal on rosuvastatin compared w…
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Three trials showed some concern on the randomization process.
“Three trials showed some concern on the randomization process [43,46,47].”
13 RCTs conducted between 2006-2023 were included, of which five were parallel, five crossover, and three n-of-1.
“We included 13 RCTs conducted between 2006–2023, of which five were parallel RCTs [40,46–49], five were crossover RCTs [20,21,23,26,43] and three were n-of-1 RCTs [22,24,25] (S4 File, Table 1).”
Insufficient information was provided regarding the methodology to address carryover effects during the data analysis in two crossover trials.
“Insufficient information was provided regarding the methodology to address carryover effects during the data analysis in two crossover trials [24,43].”
Ten trials provided data on incidence of muscle symptoms.
“Ten trials [20,21,25,26,40,43,46–49] provided data on incidence of muscle symptoms”
Most trials used statins with low to moderate intensity.
“Most trials used statins with low to moderate intensity [20,21,24–26,40,43,46,48,49]”
Nine trials assessed statin against placebo.
“nine trials assessed statin against placebo [20–26,43]”
Data on incidence of muscle symptoms were available in five parallel-group RCTs and three crossover RCTs.
“Data on incidence of muscle symptoms were available in five parallel-group RCTs [40,46–49], and three crossover RCTs [20,21,43].”
Nine trials provided data for treatment discontinuation due to muscle symptoms.
“Nine trials [22,25,26,40,43,46–48] provided data for treatment discontinuation due to muscle symptoms”
Seven trials reported data on effectiveness.
“seven trials [40,43,46–49] reported data on effectiveness”
The trials comparing statin-based therapy to placebo showed similar between-group incidence of muscle symptoms and statin-discontinuation rate.
“The trials comparing statin-based therapy to placebo showed similar between-group incidence of muscle symptoms and statin-discontinuation rate. [20,21,25,26,43,47]”
Data on treatment discontinuation due to muscle symptoms were available in three parallel-group RCTs and two crossover RCTs.
“Data on treatment discontinuation were available in three parallel-group RCTs [40,46,48], and two crossover RCTs [20,43].”
In earlier studies, SAMS were assessed through incidence of SAMS and later quantified with the VAS.
“In earlier studies, SAMS were assessed through incidence of SAMS [17,43,46–48] and later quantified with the VAS (visual analogue scale) [22,23,25,40,49].”
The studies varied in minimum number of previously tried statin or various creatinine kinase thresholds.
“The studies varied in minimum number of previously tried statin [35,39,40,46] or various creatinine kinase thresholds [37,43].”
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“Three trials showed some concern on the randomization process [43,46,47].”
Influential
- Authors
- Kennedy, S. P., Barnas, G. P., Schmidt, M. J., Glisczinski, M. S., & Paniagua, A. C.
- Affiliations
- Milwaukee VA Medical Center (US)
- Corresponding author
- Kennedy, Steven P.
- ORCID
- Kennedy, Steven P.
- Venue
- Journal of Clinical Lipidology
- Publisher
- Elsevier BV
- Published
- 2011-07
- Volume
- 5
- Issue
- 4
- Pages
- 308-315
- ISSN
- 1876-4789 (ISSN-L)
- 1933-2874
- OpenAlex
- W2070116770
- Cited by
- 53
- References
- 1
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 2 · 2023: 2 · 2022: 1 · 2021: 2 · 2020: 3 · 2019: 2 · 2018: 1 · 2017: 1 · 2016: 6 · 2015: 5 · 2014: 8 · 2013: 9 · 2012: 4
- FWCI
- 7.51
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of clinical lipidology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer, Lipids, and Metabolism
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Keywords
- rosuvastatin, weekly dosing, statin intolerance, statin-induced myalgia, LDL cholesterol lowering, hyperlipidemia, lipid-lowering therapy, veterans, tolerability, dose titration
- MeSH terms
- Rosuvastatin Calcium, Aged, Double-Blind Method, Drug Tolerance, Fluorobenzenes, Humans, Hyperlipidemias, Lipoproteins, LDL, Male, Middle Aged, Muscular Diseases, Pyrimidines, Sulfonamides, Treatment Outcome, Cross-Over Studies, Hydroxymethylglutaryl-CoA Reductase Inhibitors
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