title: Berberine and monacolin effects on the cardiovascular risk profile of women with oestroprogestin-induced hypercholesterolemia.
abstract: BACKGROUND
  One of the most frequent side effect of oral contraceptives use is a stable alteration of the lipid profile. This could be even more relevant in women affected by polycystic ovary syndrome (PCOS).
  
  
  OBJECTIVE
  Considering the importance of a balanced lipid profile in cardiovascular prevention and that the exposure to the drugs could be many years long, our aim was to investigate the possible beneficial effect of a largely tested low-dosed combined lipid-lowering nutraceutical on dyslipidemias induced by oestroprogestins prescribed to young women for different indications.
  
  
  METHODS
  We prospectively enrolled 84 patients in primary cardiovascular disease prevention, with low estimated cardiovascular disease risk (<5 % according to the ESC/EAS guidelines), and LDL-C increased above normal value (LDL-C >130 mg/dL) after the use of at least two different oral oestroprogestins treatments. Forty-four women were prescribed oral oestroprogestins for PCOS, while 40 for pure contraception. The tested nutraceutical contained berberine 500 mg/tab and monacolins 3 mg/tab was prescribed to all enrolled patients, associated the previously prescribed standard lipid-lowering diet.
  
  
  RESULTS
  After 3 months of nutraceutical treatment, we observed a significant improvement in BMI (-1.5 ± 0.8 %, p < 0.001), FPG (-6.9 ± 5.8 %, p < 0.001), HOMA index (-3.5 ± 5.6 %, p < 0.001), TC (-20.1 ± 6.6 %, p < 0.001), LDL-C (-25.3 ± 8.9 %, p < 0.001), HDL-C (+14.1 ± 2.2 %, p < 0.001), TG (-29.9 ± 25.2 %, p < 0.001) and hsCRP (-2.5 ± 2.4 %, p = 0.019). Similar results have been obtained even repeating the analysis by subgroups, beyond hsCRP that significantly improved in PCOS patients compared to both the baseline and the non-PCOS group.
  
  
  CONCLUSIONS
  It appears that the tested combined lipid-lowering nutraceutical is able to equally improve lipid metabolism in oral contraceptive induced hypercholesterolemia in women affected or not by PCOS.
authors.affiliation: Medical and Surgical Sciences Department, University of Bologna, S. Orsola-Malpighi Hospital, Via Albertoni, 15, 40138, Bologna, Italy, afgcicero@cardionet.it.
authors.forename: Arrigo F G
authors.initials: AF
authors.lastname: Cicero
authors.forename: Alessandra
authors.initials: A
authors.lastname: Reggi
authors.forename: Angelo
authors.initials: A
authors.lastname: Parini
authors.forename: Martino
authors.initials: M
authors.lastname: Morbini
authors.forename: Martina
authors.initials: M
authors.lastname: Rosticci
authors.forename: Elisa
authors.initials: E
authors.lastname: Grandi
authors.forename: Claudio
authors.initials: C
authors.lastname: Borghi
mesh_terms: D000328:Adult; D000924:Anticholesteremic Agents / Q000494:pharmacology / Q000627:therapeutic use; D001599:Berberine / Q000494:pharmacology / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000453:epidemiology* / Q000517:prevention & control; D003267:Contraception / Q000379:methods; D003276:Contraceptives, Oral / Q000009:adverse effects* / Q000627:therapeutic use; D019587:Dietary Supplements; D004338:Drug Combinations; D004997:Ethinyl Estradiol / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000139:chemically induced* / Q000150:complications / Q000378:metabolism; D050356:Lipid Metabolism / Q000187:drug effects; D008148:Lovastatin / Q000494:pharmacology / Q000627:therapeutic use*; D009652:Norpregnenes / Q000009:adverse effects* / Q000627:therapeutic use; D010865:Pilot Projects; D011085:Polycystic Ovary Syndrome / Q000188:drug therapy; D011446:Prospective Studies; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D000924:Anticholesteremic Agents; D003276:Contraceptives, Oral; D004338:Drug Combinations; D009652:Norpregnenes; C494367:estroprogestin; D001599:Berberine; D004997:Ethinyl Estradiol; D008148:Lovastatin
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