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Nutraceutical combination lowered LDL in patients with dyslipidemia, CHD, statin intolerance
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A combination of nutraceuticals alone or in conjunction with ezetimibe lowered LDL and were well-tolerated in statin-intolerant patients with dyslipidemia and CHD, according to new findings.
Researchers conducted a single blind, single-center, randomized, prospective, parallel-group trial to compare the efficacy and tolerability of a combination of red yeast rice, policosanol, berberine, folic acid, coenzyme Q10 and astaxanthin (Armolipid Plus, Rottapharm Srl) vs. ezetimibe (Zetia, Merck) in 100 patients with dyslipidemia, ischemic heart disease and statin intolerance who underwent PCI. The mean age of the nutraceutical group was 64 years, 52% were men and mean LDL at baseline was 149 mg/dL; the mean age of the ezetimibe group was 63 years, 56% were men and mean LDL at baseline was 150 mg/dL.
After 3 months, patients assigned the nutraceutical combination who did not achieve an LDL target goal of less than 100 mg/dL were allowed to add ezetimibe, and vice versa. The outcomes of interest were lipid profile, adverse events, transaminases and creatine kinase at 3 months and 12 months.
At 3 months, 14 patients (28%) from the nutraceutical group reached the target of LDL less than 100 mg/dL vs. none from the ezetimibe group, and the nutraceutical group had lower levels of LDL, total cholesterol and triglycerides (P < .0001 for all) and higher levels of HDL (P = .02) than the ezetimibe group, Giuseppe Marazzi, MD, PhD, from Istituto Ricerca a Carattere Scientifico San Raffaele Pisana, Rome, and colleagues wrote.
After 3 months, those who did not achieve the LDL target (36 from the nutraceutical group and 50 from the ezetimibe group) added the other therapy to their regimen.
At 12 months, 73% of those on both therapies and 100% of those who had achieved the target on the nutraceutical combination alone had LDL less than 100 mg/dL, Marazzi and colleagues wrote. They noted that LDL, total cholesterol and triglyceride levels progressively decreased and HDL levels progressively increased from baseline (P < .001 for all).
During the study period, researchers observed no discontinuations, no important adverse events and no significant increases in transaminases or creatine kinase.
“Nutraceuticals alone or in combination with ezetimibe are well-tolerated and improve the lipid profile in statin-intolerant patients with [CHD],” Marazzi and colleagues wrote. “Further studies are needed to assess long-term effects of nutraceuticals or mortality.”
The nutraceutical combination is not yet available in the United States. – by Erik Swain
Disclosure: The researchers report no relevant financial disclosures.
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