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Hormone Therapy May Need to be Used Cautiously in Patients Taking Rosiglitazone: Presented at NAMS

By Jerry Ingram

MIAMI, FL -- September 19, 2003 -- Rosiglitazone, a thiazolidinedione used to control glycaemic levels in type 2 diabetics, may not be as effective when administered in conjunction with hormone replacement therapy, researchers said.

The findings were presented by Lily Stojanovska, PhD, researcher and associate professor, Victoria University, Melbourne, Australia, here on September 18^th at the 15^th Annual Meeting of the North American Menopause Society.

For this randomised, double-blind, placebo-controlled 12-week study, investigators compared the effects of rosiglitazone 4 mg/daily or placebo in 23 women. The 15 women randomised to rosiglitazone 4 mg/daily and eight women to placebo were evaluated for glycaemic control, lipids, blood pressure (BP), flow mediated dilation of the brachial artery (FMD) and systemic arterial compliance (SAC).

To assessed whether hormone replacement therapy, consisting of transdermal oestradiol 50 mcg and micronised progesterone 100 mg/daily, offered additional vascular benefits, the 12 women receiving rosiglitazone were randomly assigned in a double blind crossover manner to hormone therapy or placebo for an additional 12 weeks.

Results show that rosiglitazone reduced glucose levels from a mean of 9.15 to 7.5 mM/L; (P=0.013), insulin from 11.7 to 8.8 mU/L (P=0.026), haemoglobin A1c from 8.0% to 6.9% (P=0.001), triglycerides from 2.3 to 1.8 mM/L (P=0.009), systolic BP from 130 to 117 mm Hg (P=0.02), diastolic BP from 72 to 67 mm Hg (P=0.02), and mean arterial pressure from 94 to 86 mm Hg (P=0.001). Rosiglitazone also increased FMD from 7.9% to 15% (P=0.019) and SAC from 0.09 to 0.12 arbitrary compliance units (P=0.015).

There was no noticeable effect with placebo on any variables measured. However, the addition of hormone therapy to the rosiglitazone regimen significantly reduced FMD from 15.3% to 6.6% (P<0.05), with no changes in lipids, blood pressure or SAC, or in any of the variables following placebo.

"If physicians need to use hormone replacement therapy in addition to rosiglitazone, then some judgment needs to be made to use it for a shorter time or to use it only in hysterectomised women. Constant monitoring needs to be done, otherwise they might worsen the benefit effect that rosiglitazone is providing," concluded Dr. Stojanovska.


[Study title: The Effects of Rosiglitazone and HRT on Vascular Function in Postmenopausal Women with Type 2 Diabetes Mellitus. Abstract S4]

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