Issue 174 Item 10 Hormone Therapy Risks in Patients Taking Rosiglitazone

Rosiglitazone, used to control glycemic levels in type 2 diabetics, may not be as effective when administered in conjunction with hormone replacement therapy.

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

For this randomized, double-blind, placebo-controlled 12-week study, investigators compared the effects of rosiglitazone 4 mg/daily or placebo in 23 women. The 15 women randomized to rosiglitazone 4 mg/daily and eight women to placebo were evaluated for glycemic 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), hemoglobin 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 hysterectomized 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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