Title
High-density Lipoprotein (HDL) Cholesterol in Women Taking Tibolone
Effects of Tibolone and PPARα-agonist on HDL Metabolism in Postmenopausal Women
Phase
Phase 4Lead Sponsor
Keogh Institute for Medical ResearchStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
HDL CholesterolIntervention/Treatment
tibolone fenofibrate ...Study Participants
20Tibolone (Livial) has been shown in previous studies to lower HDL cholesterol by up to 40%.
This study aims to study the effects of fenofibrate on HDL and subfractions in women taking tibolone.
Tibolone decreases plasma concentrations of HDL cholesterol and HDL-apoA1 and pre-beta HDL, consistent with a pro-atherogenic effect. The mechanism of tibolone on HDL cholesterol has been suggested to result from an acceleration of the catabolism of HDL by stimulation of hepatic lipase with no effect on cellular cholesterol efflux.
PPAR-a agonists, in particular fenofibrate, improve HDL metabolism by increasing the expression and hepatic secretion of HDL apoAI and apoAII.
We hypothesise that fenofibrate will rectify the perturbations on HDL metabolism wrought by tibolone.
fenofibrate 160mg daily 8 weeks tibolone 2.5mg daily 23 weeks
tibolone 2.5 mg daily 23 weeks
Inclusion Criteria: Post-menopausal women More than 6 months of amenorrhoea Raised FSH and low oestradiol level If hysterectomised, raised FSH and low oestradiol level Exclusion Criteria: Diabetes Renal failure Proteinuria High alcohol intake Regular endurance exercise Active weight loss of dieting Smokers Agents known to influence lipid metabolism Major systemic illness Intolerance to tibolone and fenofibrate Cholelithiasis CK and ALT > 2ULN Bleeding disorders Peptic ulcer disease.
