Tolerability of Red Yeast Rice (2,400 mg Twice Daily) Versus Pravastatin (20 mg Twice Daily) in Patients With Previous Statin Intolerance
Open accessAbstract
Currently, no consensus has been reached regarding the management of hyperlipidemia in patients who develop statin-associated myalgia (SAM). Many statin-intolerant patients use alternative lipid-lowering therapies, including red yeast rice. The present trial evaluated the tolerability of red yeast rice versus pravastatin in patients unable to tolerate other statins because of myalgia. The study was conducted in a community-based setting in Philadelphia, Pennsylvania. A total of 43 adults with dyslipidemia and a history of statin discontinuation because of myalgia were randomly assigned to red yeast rice 2,400 mg twice daily or pravastatin 20 mg twice daily for 12 weeks. All subjects were concomitantly enrolled in a 12-week therapeutic lifestyle change program. The primary outcomes included the incidence of treatment discontinuation because of myalgia and a daily pain severity score. The secondary outcomes were muscle strength and plasma lipids. The incidence of withdrawal from medication owing to myalgia was 5% (1 of 21) in the red yeast rice group and 9% (2 of 22) in the pravastatin group (p = 0.99). The mean pain severity did not differ significantly between the 2 groups. No difference was found in muscle strength between the 2 groups at week 4 (p = 0.61), week 8 (p = 0.81), or week 12 (p = 0.82). The low-density lipoprotein cholesterol level decreased 30% in the red yeast rice group and 27% in the pravastatin group. In conclusion, red yeast rice was tolerated as well as pravastatin and achieved a comparable reduction of low-density lipoprotein cholesterol in a population previously intolerant to statins.
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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].”
From Safety outcomes of statin vs non-statin lipid-lowering interventions in patients with prior statin-associated muscle symptoms: A systematic review and meta-analysis (2025) · cites this paper as [40]
The Methods passage (page unavailable) identifies incidence of withdrawal for intolerable muscle symptoms as the primary outcome and a daily pain-severity score as a co-primary outcome. It says the score came from a 0–10 question adapted from the Brief Pain Inventory, not a visual analogue scale (VAS). The Results passage (page unavailable) reports both incidence and pain scores, so the claim is supported except for its identification of the scale as VAS. (LLM, conf=0.87)
Experimental — accuracy not yet measured8 out of 13 RCTs were judged at low risk of bias.
“We judged 8 [20,22,23,25,26,40,48,49] out of 13 RCTs at low risk of bias (S2 File).”
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).”
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]”
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”
One trial assessed statin against red yeast rice.
“one trial statin against red yeast rice [40]”
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].”
Seven trials reported data on effectiveness.
“seven trials [40,43,46–49] reported data on effectiveness”
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”
Most trials used a mean difference in pain intensity between statin and comparator group.
“most trials [22,23,25,40,49] used a mean difference in pain intensity between statin and comparator group”
The effectiveness of red-yeast rice in LDL-C reduction was similar compared to pravastatin.
“However, the effectiveness of red-yeast rice in LDL-C reduction was similar compared to pravastatin [40].”
One trial compared statin-based therapy with red-yeast rice and found no difference in muscle symptoms or therapy discontinuation.
“One trial compared a statin-based therapy with red-yeast rice and found no difference in muscle symptoms or therapy discontinuation.”
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].”
We were not able to pool the data for effectiveness because only three parallel-group RCTs reported effectiveness with standard deviations, each using a different comparator.
“We were not able to pool the data for effectiveness, as only three parallel-group RCTs [40,47,49] reported effectiveness with standard deviations, with each trial using a different comparator.”
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].”
The studies we analyzed utilized different definitions for SAMS, different comparators ranging from placebo to phytotherapeutics and newer lipid-lowering therapies such as PCSK-9 inhibitors.
“This variability is reflected in the studies we analyzed, which utilized different definitions for SAMS, different comparators ranging from placebo to phytotherapeutics and newer lipid-lowering therapies such as PCSK-9 inhibitors [20,40,46].”
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“However, the effectiveness of red-yeast rice in LDL-C reduction was similar compared to pravastatin [40].”
Influential
- Authors
- Halbert, S. C., French, B., Gordon, R. Y., Farrar, J. T., Schmitz, K., Morris, P. B., Thompson, P. D., Rader, D. J., & Becker, D. J.
- Affiliations
- University of Pennsylvania (US)
- Chestnut Hill Hospital (US)
- Hartford Hospital (US)
- Corresponding author
- Becker, David J.
- ORCID
- Venue
- The American Journal of Cardiology
- Publisher
- Elsevier BV
- Published
- 2010-01
- Volume
- 105
- Issue
- 2
- Pages
- 198-204
- ISSN
- 0002-9149 (ISSN-L)
- OpenAlex
- W2029876428
- Cited by
- 154
- References
- 4
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 7 · 2023: 8 · 2022: 3 · 2021: 3 · 2020: 5 · 2019: 9 · 2018: 8 · 2017: 13 · 2016: 16 · 2015: 15 · 2014: 16 · 2013: 14 · 2012: 15
- FWCI
- 11.05
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- The American Journal of Cardiology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute on Aging
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Surgery › Natural Products and Biological Research
- Health Sciences › Medicine › Complementary and alternative medicine › Complementary and Alternative Medicine Studies
- Keywords
- red yeast rice, pravastatin, statin intolerance, hyperlipidemia, dyslipidemia, lipid-lowering therapy, treatment tolerability, LDL cholesterol lowering, myalgia, muscle strength, lifestyle modification
- MeSH terms
- Aged, Biological Products, Drug Administration Schedule, Female, Humans, Hyperlipidemias, Life Style, Cholesterol, LDL, Male, Middle Aged, Muscular Diseases, Recurrence, Incidence, Treatment Outcome, Pravastatin, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Muscle Strength
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