Postmenopause hormone treatment in women with NIDDM or impaired glucose tolerance: the MEDIA randomized clinical trial.
OBJECTIVE
To assess the biological safety of four hormone replacement treatment (HRT) combinations in women with non insulin dependent diabetes mellitus (NIDDM) or impaired glucose tolerance (IGT).


METHODS
Randomized, double-blind, placebo-controlled trial to analyze the variation of fibrinogen, factor VII, PAI1, and TG blood levels in women (n=99), with NIDDM or IGT, receiving a 3-month course of either oral oestradiol (1 or 2 mg) combined with Chlormadinone Acetate 5 mg, or transdermal oestradiol 50 microg/24 h in association with Norethisterone Acetate (11.2 or 22.4 mg), or placebo. Follow-up lasted 3 months.


RESULTS
Ninety nine patients, mean age 56 years (SD 5), mean diabetes duration 7 years (S.D. 7), mean glycated hemoglobin (7.3%) were enrolled. There was no significant difference between the groups for any of the primary hemostasis criteria (n=77). Triglycerides (TG) variation significantly differed between groups, P=0.01, from -21% in the large patch group, to +22% in the placebo group (n=82). Treatment administration routes did not significantly differ for any of the criteria. There was a significant difference in the total cholesterol variation between groups, from +8.7% in the placebo group to -10.8% in the oral 1 mg group (P=0.001).


CONCLUSIONS
The treatments had no highly deleterious effect in these patients with NIDDM or with IGT. Long-term trials can be performed with such patients, and an hormone treatment can be prescribed to relieve symptoms. Since these patients had a well-controlled NIDDM, results might be different in less well-controlled diabetes. The data do not support the hypothesis of an impaired oestrogen effect in patients with NIDDM.
Cornu
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C
Service de Pharmacologie Clinique, EA643, Lyon University Hospital, Faculté RTH Laennec, BP 8071, 69376 Cedex 08, Lyon, France. catherine.cornu@upcl.univ-lyon1.fr
Mercier
C
C
Ffrench
P
P
Bully
C
C
Pugeat
M
M
Cousin
P
P
Riou
J P
JP
Bajart
L
L
Orgiazzi
J
J
Pommet-Nicot
C
C
Darsy
P
P
Boissel
J P
JP
Berthezène
F
F
D015415:Biomarkers / Q000097:blood; D002715:Chlormadinone Acetate / Q000008:administration & dosage; D003924:Diabetes Mellitus, Type 2 / Q000097:blood*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004967:Estrogens / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D018149:Glucose Intolerance / Q000097:blood*; D020249:Hormone Replacement Therapy / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D007258:Informed Consent; D008875:Middle Aged; D009640:Norethindrone / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077563:Norethindrone Acetate; D017698:Postmenopause / Q000097:blood
D015415:Biomarkers; D004967:Estrogens; D002715:Chlormadinone Acetate; D000077563:Norethindrone Acetate; D009640:Norethindrone