Atherosclerosis · 2014
Berberis aristata combined with Silybum marianum on lipid profile in patients not tolerating statins at high doses.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Derosa Giuseppe, Romano Davide, D'Angelo Angela, Maffioli Pamela
Аннотация
AIM: To evaluate the effects of Berberis aristata combined with Silybum marianum in dyslipidemic patients intolerant to statins at high doses.
METHODS: 137 euglycemic, dyslipidemic subjects, with previous adverse events to statins at high doses, were enrolled. Statins were stopped for 1 month (run-in), then they were re-introduced at the half of the previously taken dose. At randomization, patients tolerating the half dose of statin, were assigned to add placebo or B. aristata/S. marianum 588/105 mg, 1 tablet during the lunch and 1 tablet during the dinner, for six months. We evaluated lipid profile and safety parameters variation at randomization, and after 3, and 6 months.
RESULTS: B. aristata/S. marianum reduced fasting plasma glucose (-9 mg/dl), insulin (-0.7 μU/ml), and HOMA-index (-0.35) levels compared to baseline and also to placebo. Lipid profile did not significantly change after 6 months since the reduction of statin dosage and the introduction of B. aristata/S. marianum, while it worsened in the placebo group both compared to placebo and with active treatment (+23.4 mg/dl for total cholesterol, +19.6 mg/dl for LDL-cholesterol, +23.1 mg/dl for triglycerides with placebo compared to B. aristata/S. marianum). We did not record any variations of safety parameters in nether of groups.
CONCLUSIONS: B. aristata/S. marianum can be considered as addition to statins in patients not tolerating high dose of these drugs.
METHODS: 137 euglycemic, dyslipidemic subjects, with previous adverse events to statins at high doses, were enrolled. Statins were stopped for 1 month (run-in), then they were re-introduced at the half of the previously taken dose. At randomization, patients tolerating the half dose of statin, were assigned to add placebo or B. aristata/S. marianum 588/105 mg, 1 tablet during the lunch and 1 tablet during the dinner, for six months. We evaluated lipid profile and safety parameters variation at randomization, and after 3, and 6 months.
RESULTS: B. aristata/S. marianum reduced fasting plasma glucose (-9 mg/dl), insulin (-0.7 μU/ml), and HOMA-index (-0.35) levels compared to baseline and also to placebo. Lipid profile did not significantly change after 6 months since the reduction of statin dosage and the introduction of B. aristata/S. marianum, while it worsened in the placebo group both compared to placebo and with active treatment (+23.4 mg/dl for total cholesterol, +19.6 mg/dl for LDL-cholesterol, +23.1 mg/dl for triglycerides with placebo compared to B. aristata/S. marianum). We did not record any variations of safety parameters in nether of groups.
CONCLUSIONS: B. aristata/S. marianum can be considered as addition to statins in patients not tolerating high dose of these drugs.