Low-density lipoprotein-cholesterol lowering effect of a nutraceutical regimen with or without ezetimibe in hypercholesterolaemic patients with statin intolerance
BackgroundStatins are the most widely prescribed medication to lower low-density lipoprotein cholesterol (LDL-c). However, a significant portion of patients are unable to tolerate them due to side effects, most commonly muscle related. Nutraceuticals, natural plant derivatives with lipid-lowering pr...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-11-01
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| Series: | Frontiers in Cardiovascular Medicine |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fcvm.2022.1060252/full |
| _version_ | 1797986900629258240 |
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| author | Natalie C. Ward Christopher M. Reid Gerald F. Watts Gerald F. Watts |
| author_facet | Natalie C. Ward Christopher M. Reid Gerald F. Watts Gerald F. Watts |
| author_sort | Natalie C. Ward |
| collection | DOAJ |
| description | BackgroundStatins are the most widely prescribed medication to lower low-density lipoprotein cholesterol (LDL-c). However, a significant portion of patients are unable to tolerate them due to side effects, most commonly muscle related. Nutraceuticals, natural plant derivatives with lipid-lowering properties, may provide an alternative to lower LDL-c in these patients.AimsTo investigate whether a nutraceutical regimen, either alone or in combination with ezetimibe, can lower LDL-c in patients with hypercholesterolemia who are intolerant to statins.MethodsParticipants were recruited into a double-blind, randomized, placebo-controlled intervention study. Treatments were (i) placebo, (ii) nutraceutical (500 mg berberine, 200 mg red yeast rice (RYR), 2 g plant sterols)/daily, (iii) ezetimibe (10 mg)/daily, or (iv) the combination of nutraceutical and ezetimibe/daily. At baseline and week 8, all participants provide a fasting blood sample for assessment of lipid profile and safety bloods.ResultsFifty participants were randomized, with 44 completing the treatment period. Following adjustment for baseline levels and compared with placebo, LDL-c was significantly reduced (all p < 0.0001) with ezetimibe (−1.02 mmol/L), nutraceutical (−1.15 mmol/L) and the nutraceutical and ezetimibe combination (−1.92 mmol/L). Non-HDL cholesterol was significantly reduced (all p < 0.0001) with ezetimibe (−1.29 mmol/L), nutraceutical (−1.37 mmol/L) and the nutraceutical and ezetimibe combination (−2.18 mmol/L). Remnant cholesterol and triglycerides was significantly reduced with the nutraceutical and ezetimibe combination (p = 0.018).ConclusionA nutraceutical regimen (berberine, RYR and plant sterols) and ezetimibe independently and additively lower LDL-c in patients with hypercholesterolemia who are intolerant to statins. |
| first_indexed | 2024-04-11T07:40:24Z |
| format | Article |
| id | doaj.art-163952fc89bb4ac9aa7c53d625b66679 |
| institution | Directory Open Access Journal |
| issn | 2297-055X |
| language | English |
| last_indexed | 2024-04-11T07:40:24Z |
| publishDate | 2022-11-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Cardiovascular Medicine |
| spelling | doaj.art-163952fc89bb4ac9aa7c53d625b666792022-12-22T04:36:36ZengFrontiers Media S.A.Frontiers in Cardiovascular Medicine2297-055X2022-11-01910.3389/fcvm.2022.10602521060252Low-density lipoprotein-cholesterol lowering effect of a nutraceutical regimen with or without ezetimibe in hypercholesterolaemic patients with statin intoleranceNatalie C. Ward0Christopher M. Reid1Gerald F. Watts2Gerald F. Watts3Dobney Hypertension Centre, Medical School, University of Western Australia, Perth, WA, AustraliaSchool of Population Health, Curtin University, Perth, WA, AustraliaMedical School, University of Western Australia, Perth, WA, AustraliaLipid Disorders Clinic, Department of Cardiology, Royal Perth Hospital, Perth, WA, AustraliaBackgroundStatins are the most widely prescribed medication to lower low-density lipoprotein cholesterol (LDL-c). However, a significant portion of patients are unable to tolerate them due to side effects, most commonly muscle related. Nutraceuticals, natural plant derivatives with lipid-lowering properties, may provide an alternative to lower LDL-c in these patients.AimsTo investigate whether a nutraceutical regimen, either alone or in combination with ezetimibe, can lower LDL-c in patients with hypercholesterolemia who are intolerant to statins.MethodsParticipants were recruited into a double-blind, randomized, placebo-controlled intervention study. Treatments were (i) placebo, (ii) nutraceutical (500 mg berberine, 200 mg red yeast rice (RYR), 2 g plant sterols)/daily, (iii) ezetimibe (10 mg)/daily, or (iv) the combination of nutraceutical and ezetimibe/daily. At baseline and week 8, all participants provide a fasting blood sample for assessment of lipid profile and safety bloods.ResultsFifty participants were randomized, with 44 completing the treatment period. Following adjustment for baseline levels and compared with placebo, LDL-c was significantly reduced (all p < 0.0001) with ezetimibe (−1.02 mmol/L), nutraceutical (−1.15 mmol/L) and the nutraceutical and ezetimibe combination (−1.92 mmol/L). Non-HDL cholesterol was significantly reduced (all p < 0.0001) with ezetimibe (−1.29 mmol/L), nutraceutical (−1.37 mmol/L) and the nutraceutical and ezetimibe combination (−2.18 mmol/L). Remnant cholesterol and triglycerides was significantly reduced with the nutraceutical and ezetimibe combination (p = 0.018).ConclusionA nutraceutical regimen (berberine, RYR and plant sterols) and ezetimibe independently and additively lower LDL-c in patients with hypercholesterolemia who are intolerant to statins.https://www.frontiersin.org/articles/10.3389/fcvm.2022.1060252/fullstatin intolerancenutraceuticalsezetimibelow-density lipoprotein (LDL)lipids |
| spellingShingle | Natalie C. Ward Christopher M. Reid Gerald F. Watts Gerald F. Watts Low-density lipoprotein-cholesterol lowering effect of a nutraceutical regimen with or without ezetimibe in hypercholesterolaemic patients with statin intolerance Frontiers in Cardiovascular Medicine statin intolerance nutraceuticals ezetimibe low-density lipoprotein (LDL) lipids |
| title | Low-density lipoprotein-cholesterol lowering effect of a nutraceutical regimen with or without ezetimibe in hypercholesterolaemic patients with statin intolerance |
| title_full | Low-density lipoprotein-cholesterol lowering effect of a nutraceutical regimen with or without ezetimibe in hypercholesterolaemic patients with statin intolerance |
| title_fullStr | Low-density lipoprotein-cholesterol lowering effect of a nutraceutical regimen with or without ezetimibe in hypercholesterolaemic patients with statin intolerance |
| title_full_unstemmed | Low-density lipoprotein-cholesterol lowering effect of a nutraceutical regimen with or without ezetimibe in hypercholesterolaemic patients with statin intolerance |
| title_short | Low-density lipoprotein-cholesterol lowering effect of a nutraceutical regimen with or without ezetimibe in hypercholesterolaemic patients with statin intolerance |
| title_sort | low density lipoprotein cholesterol lowering effect of a nutraceutical regimen with or without ezetimibe in hypercholesterolaemic patients with statin intolerance |
| topic | statin intolerance nutraceuticals ezetimibe low-density lipoprotein (LDL) lipids |
| url | https://www.frontiersin.org/articles/10.3389/fcvm.2022.1060252/full |
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