News
New HRT Drug Relieves Postmenopausal Symptoms With Less Bleeding
New York — Activella, a new hormone replacement therapy (HRT), relieves postmenopausal symptoms with less bleeding and spotting than Prempro, and with a more beneficial effect on lipid profiles. Results of a multicenter, prospective, randomized, double-blind trial appear in the January/February issue of Menopause.
"The most important factor in the continuation of HRT is uterine bleeding," write Julia V. Johnson, MD, from the University of Vermont College of Medicine in Burlington, and colleagues. "The patient taking [Activella] will receive effective treatment for her menopausal symptoms with less bleeding."
Over a 6-month period, 438 healthy postmenopausal women received Prempro (conjugated equine estrogens 0.625 mg in combination with 2.5 mg medroxyprogesterone acetate), which is the most widely prescribed continuous combined HRT in the United States, or Activella (17beta-estradiol 1 mg combined with 0.5 mg norethindrone acetate).
Women receiving Activella had a better bleeding profile than those on Prempro, especially in the first 3 months of treatment in women who were 1 to 2 years from last menses. In this group, 71.4% on Activella and 40.0% on Prempro had no bleeding (P=.01), and 54.8% vs 17.1% had neither bleeding nor spotting (P=.001).
Triglycerides fell by 8.5% in women on Activella and increased by 11.7% in those on Prempro (P<.001), and total cholesterol declined by 9.1% and 6.9%, respectively.
"To improve continuation rates, the HRT regimen should be individualized for each patient," writes R. Don Gambrell, Jr, MD, from the Medical College of Georgia in Augusta, in an accompanying editorial. "No single regimen is suitable for all postmenopausal women, but with so many different preparations, one should be found to meet [the] goals of therapy."
Novo Nordisk Pharmaceuticals, which markets estradiol/norethindrone acetate in Europe, provided support to participating institutions.