Additional therapy for cholesterol lowering in ezetimibe-treated, statin-intolerant patients in clinical practice: results from an internal audit of a university lipid clinic
Abstract
OBJECTIVE: The aim of our study was to evaluate the tolerability and efficacy of alternative approaches to improve cholesterolemia control in patients with statin-related myalgia treated with ezetimibe. RESEARCH DESIGN AND METHODS: We retrospectively evaluated 3534 Clinical Report Forms (CRFs) filled in the period June 2012-June 2015 for first visits to the lipid clinic of the University of Bologna. For this study, we selected 252 CRFs based on the following criteria: statin-related myalgia, previous failed treatment with at least two low-dosed statins, well tolerated treatment with ezetimibe. Then, the following lipid-lowering treatments were added in order to improve the ezetimibe low density lipoprotein cholesterol (LDL-C) lowering efficacy, based on clinical judgment: fenofibrate 145 mg, rosuvastatin 5 mg 1 tablet/week, rosuvastatin 5 mg 2 tablets/week, red yeast rice (standardized in monacolin K 3 mg) + berberine 500 mg, berberine 500 mg b.i.d., phytosterols 900 mg + psyllium fiber 3.5 g b.i.d. Patients continuing to claim a tolerable myalgia were then treated with coenzyme Q10 nanoemulsions 200 mg/day. RESULTS: The treatment with standard lipid-lowering diet plus ezetimibe alone was associated with a mean LDL-C reduction of 17 ± 2%. The additive LDL-lowering effect with the various tested treatment was: -16 ± 2% with fenofibrate 145 mg/day, -13 ± 1% with rosuvastatin 5 mg 1 tablet/week, -17 ± 3% with rosuvastatin 5 mg 2 tablets/week, -19 ± 4% with red yeast rice + berberine, -17 ± 4% with berberine b.i.d. and -10 ± 3% with phytosterols + psyllium b.i.d.; 11% of the patients treated with fenofibrate required treatment modification because of myalgia recurrence, while the percentage was negligible for the other tested treatments. In patients with residual tolerable myalgia, treatment with coenzyme Q10 for 8 weeks was associated with a mean improvement of the graduated myalgia score from 4.8 ± 1.9 to 2.9 ± 1.3 (p = 0.013). CONCLUSIONS: Some alternative treatments seems to be effective and well tolerated, thus improving the ezetimibe effect on cholesterolemia.
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23 studies were included for data extraction, with 9 RCTs analyzed quantitatively.
“23 studies were included for data extraction [20–26,35–50], with 9 RCTs analyzed quantitatively.”
All 8 identified retrospective studies were of low quality, mainly due to concerns regarding residual confounding because of lack of adjustment.
“Notably all 8 identified retrospective studies were of low quality, mainly due to concerns regarding residual confounding because of lack of adjustment (S2 File) [35,36,38,41,42,44,45,50].”
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).”
Many nutraceutical options are available either alone or in combination with statins to help reach recommended goals in a safe and tolerable way for most patients.
“Many nutraceutical options are available either alone or in combination with statins to help to reach recommended goals in a safe and tolerable way for most patients [105]”
From Nutraceuticals in the Management of Dyslipidemia: Which, When, and for Whom? Could Nutraceuticals Help Low-Risk Individuals with Non-optimal Lipid Levels? (2021) · cites this paper as [105]
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- Authors
- Cicero, A. F. G., Morbini, M., Bove, M., D’Addato, S., Fogacci, F., Rosticci, M., & Borghi, C.
- Affiliations
- IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola (IT)
- Corresponding author
- Cicero, Arrigo F.G.
- Venue
- Current Medical Research and Opinion
- Publisher
- Informa UK Limited
- Published
- 2016-06-08
- Volume
- 32
- Issue
- 10
- Pages
- 1633-1638
- ISSN
- 0300-7995 (ISSN-L)
- 1473-4877
- OpenAlex
- W2378046189
- Cited by
- 23
- References
- 46
- Citations by year
- 2025: 2 · 2023: 2 · 2022: 2 · 2021: 3 · 2020: 2 · 2019: 2 · 2018: 3 · 2017: 4 · 2016: 3
- FWCI
- 4.44
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Current Medical Research and Opinion (publishedVersion)
- PubMed (publishedVersion)
- Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion)
- 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
- ezetimibe, statin intolerance, LDL cholesterol lowering, fenofibrate, rosuvastatin, red yeast rice, berberine, phytosterols, psyllium fiber, lipid-lowering therapy, hypercholesterolemia, tolerability, lipid clinic
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