Effects of a lipid lowering fibrate and hormone replacement therapy on serum lipids and lipoproteins in overweight postmenopausal women with elevated triglycerides.
BACKGROUND
Cardiovascular disease (CVD) is the leading cause of death in women after menopause. In essence major risk factors for CVD are similar in women as for men inclusive of serum lipid perturbations. The effects of estrogens and hormone replacement therapy on lipid metabolism is widely discussed and warrant further evaluation especially when combined with other lipid lowering drugs.


METHODS
Postmenopausal women were studied by an open randomised study during 9 months. Subjects were recruited from outpatient clinics in a rural area of Sweden. Major inclusive criteria comprised body mass index (BMI) >28, serum triglycerides >1.5 mmol/l. Participants were at least 12 months postmenopause with a concomitant serum Follicle Stimulating Hormone (FSH) above 28 IU/l. After inclusion in the study patients were instructed to adhere to a low-fat and caloric diet for 3 months and after this period randomised into two groups of intervention; a lipidlowering fibrate (LLF) group and one hormone replacement therapy group (HRT). The LLF group was given gemfibrozil 600 mg orally twice daily and HRT group received 2 mg oestradiol in combination with 1 mg norethisterone acetate as a continuous combined therapy once daily. After 3 months, the LLF group added the HRT regimen and patients in the HRT group added gemfibrozil. Hence, all participants received the regimens combined for the last 6 months of the study.


RESULTS
Serum s-cholesterol was markedly decreased in both groups during the first 3 months of single treatment (P<0.0001). This decrease reflected a reduction especially of calculated low density lipoprotein (LDL) s-cholesterol (P<0.001). High density lipoprotein (HDL) s-cholesterol was reduced in the HRT group (P<0.005) but increased (P<0.004) in the LLF group. Triglycerides were also decreased by both treatments but more marked in the LLF group (P<0.0001) than in the HRT group (P<0.02). After 9 months the reduction remained in both groups but no additive effects were encountered in any of the groups.


CONCLUSIONS
The effects by gemfibrozil on s-cholesterol and triglycerides levels seem to be superior to continuous combined HRT in overweight women with elevated triglycerides. The combination of the two drugs did not seem to offer any additional benefit concerning the routine serum lipid or lipoprotein profile.
Nerbrand
Christina
C
Department of Medicine, Division of Family Medicine, University of Lund, Lund, Sweden.
Nyberg
Per
P
Nordström
Lennart
L
Samsioe
Göran
G
D000284:Administration, Oral; D002318:Cardiovascular Diseases / Q000517:prevention & control; D002784:Cholesterol / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood / Q000187:drug effects; D008078:Cholesterol, LDL / Q000097:blood / Q000187:drug effects; D004958:Estradiol / Q000008:administration & dosage / Q000627:therapeutic use*; D015914:Estrogen Replacement Therapy; D005260:Female; D015248:Gemfibrozil / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D006949:Hyperlipidemias / Q000150:complications / Q000517:prevention & control*; D000960:Hypolipidemic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D008074:Lipoproteins / Q000097:blood / Q000187:drug effects*; D008875:Middle Aged; D009640:Norethindrone / Q000008:administration & dosage / Q000627:therapeutic use*; D009765:Obesity / Q000150:complications*; D017698:Postmenopause; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood
D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D000960:Hypolipidemic Agents; D008074:Lipoproteins; D014280:Triglycerides; D004958:Estradiol; D002784:Cholesterol; D015248:Gemfibrozil; D009640:Norethindrone