Giuseppe Derosa1, Davide Romano2, Angela D'Angelo2, Pamela Maffioli3. 1. Department of Internal Medicine and Therapeutics, University of Pavia, Fondazione IRCCS, Policlinico S. Matteo, Pavia, Italy; Center for the Study of Endocrine-Metabolic Pathophysiology and Clinical Research, University of Pavia, Pavia, Italy. Electronic address: giuseppe.derosa@unipv.it. 2. Department of Internal Medicine and Therapeutics, University of Pavia, Fondazione IRCCS, Policlinico S. Matteo, Pavia, Italy. 3. Department of Internal Medicine and Therapeutics, University of Pavia, Fondazione IRCCS, Policlinico S. Matteo, Pavia, Italy; PhD School in Experimental Medicine, University of Pavia, Pavia, Italy.
Abstract
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.
RCT Entities:
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.
Authors: Valentina Trimarco; Raffaele Izzo; Eugenio Stabile; Francesco Rozza; Mario Santoro; Maria Virginia Manzi; Federica Serino; Gabriele Giacomo Schiattarella; Giovanni Esposito; Bruno Trimarco Journal: High Blood Press Cardiovasc Prev Date: 2015-04-14
Authors: Bahare Salehi; Zeliha Selamoglu; Bilge Sener; Mehtap Kilic; Arun Kumar Jugran; Nunziatina de Tommasi; Chiara Sinisgalli; Luigi Milella; Jovana Rajkovic; Maria Flaviana B Morais-Braga; Camila F Bezerra; Janaína E Rocha; Henrique D M Coutinho; Adedayo Oluwaseun Ademiluyi; Zabta Khan Shinwari; Sohail Ahmad Jan; Ebru Erol; Zulfiqar Ali; Elise Adrian Ostrander; Javad Sharifi-Rad; María de la Luz Cádiz-Gurrea; Yasaman Taheri; Miquel Martorell; Antonio Segura-Carretero; William C Cho Journal: Foods Date: 2019-10-22