Rosuvastatin 5 and 10 mg/d: A pilot study of the effects in hypercholesterolemic adults unable to tolerate other statins and reach ldl cholesterol goals with nonstatin lipid-lowering therapies
Abstract
Background Patients with high levels of low-density lipoprotein cholesterol (LDL-C) might not tolerate 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors ("statins") because of adverse effects (AEs) and might not respond well enough to nonstatin lipid-lowering therapies (LLTs) to meet LDL-C goals. Objective The purpose of this study was to assess the acceptability, effectiveness, and safety profile of rosuvastatin 5 and 10 mg/d in consecutively referred patients with primary high LDL-C who were unable to tolerate other statins because of myalgia and, subsequently in some cases, unable to reach LDL-C goals with nonstatin LLT. Methods This prospective, open-label pilot study was conducted in consecutively referred male and female patients aged 38 to 80 years with primary high LDL-C (mean, 177 mg/dL) at The Cholesterol Center, Jewish Hospital, Cincinnati, Ohio. Patients were instructed in the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) therapeutic lifestyle changes diet. Rosuvastatin 5 mg/d was administered to patients categorized by NCEP ATP III risk stratification as moderately high risk, and rosuvastatin 10 mg/d was administered to patients categorized as high or very high risk. End points included acceptability (assessed using patient-initiated discontinuation of rosuvastatin), effectiveness (absolute and percentage reductions in LDL-C and triglycerides), and safety profile (aspartate and alanine aminotransferases [AST and ALT, res…
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The two prospective cohort studies were both of low quality, mainly due to concerns regarding residual confounding and ascertainment of outcomes.
“The two prospective cohort studies were both of low quality, mainly due to concerns regarding residual confounding and ascertainment of outcomes (S2 File) [37,39].”
Three studies reported the incidence of muscle symptoms, five studies provided data on treatment discontinuation due to muscle symptoms, and eight studies reported on effectiveness.
“Three studies reported the incidence of muscle symptoms [36–38], five studies provided data on treatment discontinuation due to muscle symptoms [36,37,39,42,45], and eight studies reported on effectiveness [35–37,39,41,44,45,50].”
We included eight retrospective cohort studies and two prospective cohort studies.
“We included eight retrospective cohort studies [35,38,39,41,42,44,45,50] and two cohort prospective studies [36,37] (S4 File, Table 2).”
The first prospective cohort study compared 5 mg rosuvastatin to 10 mg rosuvastatin and found similar muscle symptoms, discontinuation rate and effectiveness.
“The first prospective cohort study compared 5 mg rosuvastatin to 10 mg rosuvastatin and found similar muscle symptoms, discontinuation rate and effectiveness [39].”
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].”
Cites
Thompson, P. D., Clarkson, P., & Karas, R. H. (2003) · JAMA · doi:10.1001/jama.289.13.1681 · Cited by 1,463 · see citing works
Rosuvastatin safety: lessons from the FDA review and post-approval surveillance
Davidson, M. H. (2004) · Expert Opinion on Drug Safety · doi:10.1517/14740338.3.6.547 · Cited by 80 · see citing works
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Discontinuation of Statins in Routine Care Settings: A Cohort Study
Zhang, H., Plutzky, J., Skentzos, S., Morrison, F., Mar, P., Shubina, M., & Turchin, A. (2013) · Annals of Internal Medicine · doi:10.7326/0003-4819-158-7-201304020-00004 · Cited by 548 · see citing works
An assessment by the statin muscle safety task force: 2014 update
Rosenson, R. S., Baker, S. K., Jacobson, T. A., Kopecky, S. L., & Parker, B. A. (2014) · Journal of Clinical Lipidology · doi:10.1016/j.jacl.2014.03.004 · Cited by 485 · see citing works
Acid-suppressive medication use and the risk for hospital-acquired pneumonia
Herzig, S. J. (2009) · JAMA · doi:10.1001/jama.2009.722 · Cited by 486 · see citing works
Narrative review: statin-related myopathy
Joy, T. R., & Hegele, R. A. (2009) · Annals of Internal Medicine · doi:10.7326/0003-4819-150-12-200906160-00009 · Cited by 453 · see citing works
Red Yeast Rice for Dyslipidemia in Statin-Intolerant Patients: A Randomized Trial
Becker, D. J., Gordon, R. Y., Halbert, S. C., French, B., Morris, P. B., & Rader, D. J. (2009) · Annals of Internal Medicine · doi:10.7326/0003-4819-150-12-200906160-00006 · Cited by 275 · see citing works
Treatment strategies in patients with statin intolerance: the Cleveland Clinic experience
Mampuya, W. M., Frid, D., Rocco, M., Huang, J., Brennan, D. M., Hazen, S. L., & Cho, L. (2013) · American Heart Journal · doi:10.1016/j.ahj.2013.06.004 · Cited by 173 · see citing works
Ahmad, Z. (2014) · The American Journal of Cardiology · doi:10.1016/j.amjcard.2014.02.033 · Cited by 110 · see citing works
Aebi, P. S., Villoz, F., Bührer, J., Lyko, C., Abolhassani, N., Del Giovane, C., Gencer, B., Rodondi, N., & Blum, M. R. (2025) · PLOS One · doi:10.1371/journal.pone.0338575
“…studies reported the incidence of muscle symptoms [36–38], five studies provided data on treatment discontinuation due to muscle symptoms [36,37,39,42,45], and eight studies reported on effectiveness [35–37, The first prospective cohort study compared 5 mg rosuvastatin to 10 mg rosuvastatin…”
Influential
- Authors
- Glueck, C. J., Aregawi, D., Agloria, M., Khalil, Q., Winiarska, M., Munjal, J., Gogineni, S., & Wang, P.
- Affiliations
- Jewish Hospital (US)
- Venue
- Clinical Therapeutics
- Publisher
- Elsevier BV
- Published
- 2006-06
- Volume
- 28
- Issue
- 6
- Pages
- 933-942
- ISSN
- 0149-2918 (ISSN-L)
- OpenAlex
- W2104952039
- Cited by
- 73
- References
- 2
- Citations by year
- 2025: 1 · 2024: 4 · 2021: 3 · 2020: 3 · 2018: 2 · 2017: 1 · 2016: 5 · 2015: 9 · 2014: 8 · 2013: 7 · 2012: 4
- FWCI
- 2.71
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Clinical Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Surgery › Cholesterol and Lipid Metabolism
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer, Lipids, and Metabolism
- Keywords
- rosuvastatin, hypercholesterolemia, LDL cholesterol lowering, statin intolerance, atorvastatin, simvastatin, pravastatin, fluvastatin, ezetimibe, non-statin lipid-lowering therapy, triglycerides, liver enzymes, creatine kinase
- MeSH terms
- Rosuvastatin Calcium, Adult, Aged, Aged, 80 and over, Dose-Response Relationship, Drug, Female, Fluorobenzenes, Humans, Hypercholesterolemia, Cholesterol, LDL, Male, Middle Aged, Pilot Projects, Prospective Studies, Pyrimidines, Sulfonamides, Triglycerides, Cholinergic Antagonists, Hydroxymethylglutaryl-CoA Reductase Inhibitors
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