Our library of drug research abstracts drawn from the medical literature is updated on a regular schedule, and you can be assured that new prempro research articles will be listed here shortly after becoming available to us.
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Medical research on prempro
So far, victories are few as breast cancer patients sue Wyeth over hormone therapy.
J Natl Cancer Inst. 2007 Dec 19; 99(24): 1828-9, 1835
Twombly R
Breast. 2008 Apr; 17(2): 172-9
Dai J, Jian J, Bosland M, Frenkel K, Bernhardt G, Huang X
Estrogen and iron play critical roles in a female body development and were investigated in the present study in relation to in vitro cell proliferation. Prempro, a hormone replacement therapy drug, and 17beta-estradiol (E2) were shown to increase cell proliferations in estrogen receptor positive (ER+) cells independent of progesterone receptor (PR) status. For example, increased cell proliferation was observed in ER+/PR+ human breast cancer MCF-7, its matching non-cancerous human breast epithelial MCF-12A, and ER+/PR+ murine mammary cancer MXT+ cells, but not in ER-/PR- MDA-MB-231, its matching non-cancerous MCF-10A, and MXT- (ER-/PR+) cells. By mimicking post-menopausal conditions of high estrogen in local breast tissue and increased iron levels due to cessation of menstrual periods, E2 and iron were shown to exert synergistic effects on proliferation of MCF-7 cells and significantly increased Ki67 and proliferating cell nuclear antigen. Western blotting of E2-treated ER+ but not ER- cells showed that E2 also increased transferrin receptor (TfR). Further studies are needed to assess the mitogenic effects of iron and estrogen in normal post-menopausal breast.
Progesterone: review of safety for clinical studies.
Exp Clin Psychopharmacol. 2007 Oct; 15(5): 427-44
Goletiani NV, Keith DR, Gorsky SJ
Progesterone is a steroid hormone that is important for reproductive function. Progesterone is used in a number of clinical applications and has been investigated as a possible novel approach for treatment of stimulant drug abuse. Extensive clinical studies have been conducted to examine the subjective and physiological effects of exogenous progesterone administration and to evaluate its side effects. This review summarizes the safety and side effects of acute and chronic administration of 3 progesterone formulations (synthetic, natural, and micronized natural), several routes of administration (oral, intramuscular, intravenous, intravaginal, intranasal, transdermal, and rectal), and dosing regimens. Synthetic progestins marketed as Provera, PremPro, and Cycrin are widely used but may produce a number of significant side effects, such as fatigue, fluid retention, lipid level alterations, dysphoria, hypercoagulant states, and increased androgenicity. Natural progesterones are reported to have milder adverse effects, depending on the route of administration. Micronized natural progesterone is available for oral administration, has better bioavailability and fewer side effects than natural progesterone, and is convenient to administer. Therefore, micronized natural progesterone appears to be a safe and effective alternative to synthetic and natural progesterone formulations for variety of clinical and research applications.
New information about hormone therapy and cardiovascular disease prevention in women.
Int J Dent Hyg. 2007 Aug; 5(3): 190-3
Goldie MP
A critique of Women's Health Initiative Studies (2002-2006).
Nucl Recept Signal. 2006; 4: e023
Clark JH
The Women's Health Initiative Studies (WHI) were designed to examine the effects of estrogen and progestin (E+P; Prempro) and estrogen alone (Premarin) in post-menopausal women. The authors of the WHI studies and the National Heart Lung and Blood Institute (NHLBI) concluded that E+P treatment increased the risks of coronary heart disease, invasive breast cancer, stroke and venous thromboembolism. The following paper contains a reevaluation of these studies based on the graphic analysis of their tabulated data. In contrast to the conclusions reached by the WHI and the NHLBI, I conclude that treatment of post-menopausal women with estrogen and progestin (Prempro) does not increase the risks of cardiovascular disease, invasive breast cancer, stroke or venous thromboembolism. I also disagree with the claim that an increased risk of stroke existed in women treated with estrogen alone.
Epilepsia. 2006 Sep; 47(9): 1447-51
Harden CL, Herzog AG, Nikolov BG, Koppel BS, Christos PJ, Fowler K, Labar DR, Hauser WA
PURPOSE: Previous reports have suggested that hormone replacement therapy (HRT) could increase seizure activity in women with epilepsy. We sought to determine whether adding HRT to the medication regimen of postmenopausal women with epilepsy was associated with an increase in seizure frequency. METHODS: This was a randomized, double-blind, placebo-controlled trial of the effect of HRT on seizure frequency in postmenopausal women with epilepsy, taking stable doses of antiepileptic drugs (AEDs), and within 10 years of their last menses. After a 3-month prospective baseline, subjects were randomized to placebo, Prempro (0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxyprogesterone acetate or CEE/MPA) daily, or double-dose CEE/MPA daily for a 3-month treatment period. RESULTS: Twenty-one subjects were randomized after completing baseline. The subjects' ages ranged from 45 to 62 years (mean, 53 years; SD, +/-5), and the number of AEDs used ranged from none to three (median, one). Five (71%) of seven subjects taking double-dose CEE/MPA had a worsening seizure frequency of at least one seizure type, compared with four (50%) of eight taking single-dose CEE/MPA and one (17%) of six taking placebo (p = 0.05). An increase in seizure frequency of the subject's most severe seizure type was associated with increasing CEE/MPA dose (p = 0.008). An increase in complex partial seizure frequency also was associated with increasing CEE/MPA dose (p = 0.05). Two subjects taking lamotrigine had a decrease in lamotrigine levels of 25-30% while taking CEE/MPA. CONCLUSIONS: CEE/MPA is associated with a dose-related increase in seizure frequency in postmenopausal women with epilepsy. CEE/MPA may decrease lamotrigine levels.
J Womens Health (Larchmt). 2006 May; 15(4): 369-78
Wegienka G, Havstad S, Kelsey JL
BACKGROUND: In July 2002, the Women's Health Initiative (WHI) published results that led to early termination of the randomized controlled trial of estrogen plus progestin in postmenopausal women with an intact uterus. Subsequently, the trial of estrogen only also was terminated early, and the results were published in April 2004. The present study examines the impact of both sets of results on menopausal hormone therapy (MHT) prescription patterns, as well as the characteristics of women who did and did not change their MHT behavior after publication of results. METHODS: We examined the number of MHT prescriptions filled in the months before and after each set of results was published, using claims data from 24,446 women aged 50-79 years continuously enrolled in a health maintenance organization (HMO) at Henry Ford Health System from January 2000 through December 2004. RESULTS: After July 2002, a statistically significant (p < 0.05) drop occurred in the rate of MHT prescriptions filled; 29% of the women stopped MHT for at least 4 months, but 24% of these women resumed use by December 2004. Successful stoppers tended to be older. Twenty-one percent of users in April 2004 stopped in May 2004 for at least 4 months; 25% of these had restarted by December. Women continued to initiate MHT after July 2002, but at lower rates in 2003 and 2004 (73% and 77% decreases, respectively, compared with 2001). The types of MHT prescriptions obtained by new users changed after 2001: fewer initiated MHT with oral Premarin (Wyeth, St. David's, PA) and Prempro or Premphase (Wyeth-Ayerst, Philadelphia, PA), and more initiated MHT with Premarin and Estrace (Warner Chilcott, Rockaway, NJ) creams. CONCLUSIONS: Regardless of the goals of the WHI study, the publication of results on estrogen plus progestin in July 2002 impacted overall rates of MHT use, as did, to a lesser extent, the estrogen only results published in May 2004. Although women continued to initiate MHT after the results were published, they were less likely to use the formulations from the WHI and instead used formulations for which there is less information about effectiveness and long-term health consequences.
Harv Womens Health Watch. 2006 May; 13(9): 1-4
Fertil Steril. 2006 Mar; 85(3): 667-73
Carr BR, Khan N, Adams-Huet B, Kakarla N, Havelock JC, Gell J
OBJECTIVE: To investigate the effect of vitamin E with and without estrogen replacement therapy or hormone therapy (HT) on inflammatory markers in postmenopausal women. DESIGN: Prospective, observational study, followed by a randomized, prospective, double-blind study. SETTING: Healthy volunteers in an academic medical referral center in Dallas, Texas. PATIENT(S): Seventy-five postmenopausal healthy women, ages 40 to 65 years, with follicle-stimulating hormone (FSH) levels greater > or =30 mIU/mL and a serum estradiol level < or =30 pg/mL. INTERVENTION(S): After enrollment, all women were studied at baseline and received vitamin E for 4 weeks. They were then randomized from week 4 to week 12 to receive vitamin E in conjunction with conjugated equine estrogen (CEE) (0.625 mg), CEE (0.625 mg) plus medroxyprogesterone acetate (MPA) (2.5 mg), or placebo. MAIN OUTCOME MEASURE(S): Change from baseline and between groups effects of vitamin E with and without estrogen or hormone therapy on seven circulatory inflammatory markers in postmenopausal women. RESULT(S): Vitamin E levels increased to a similar extent in all three groups compared with baseline at weeks 4 and 12. Vitamin E increased serum interleukin-6 levels. Combination CEE plus MPA significantly increased C-reactive protein levels. However, there were no consistent statistically significant effects on six other inflammatory markers. CONCLUSION(S): Vitamin E attenuated C-reactive protein increases in postmenopausal women treated with estrogen replacement therapy but not with HT. Because there was no other persistent effect on six additional inflammatory markers, it can be concluded that vitamin E and HT do not play a major role in promoting a change in cardiovascular inflammatory markers.
Transdermal progesterone cream as an alternative progestin in hormone therapy.
Altern Ther Health Med. 2005 Nov-Dec; 11(6): 36-8
Leonetti HB, Landes J, Steinberg D, Anasti JN
OBJECTIVE: To evaluate the endometrial effects and determine patients' acceptance of transdermal progresterone cream compared to standard hormone therapy. METHODS: Healthy menopausal women were recruited and received a pretreatment endometrial biopsy (EMB). They were randomized to 0.625 mg conjugated equine estrogen (CEE) daily and 2.5 mg medroxyprogesterone acetate (MPA) (Prempro, Wyeth USA) or daily 0.625 mg CEE and twice daily 20 mg transdermal PC (Pro-gest, Transitions for Health USA). At the end of 6 months, a repeat EMB was obtained, and the women were crossed over to other treatment. A final EMB was performed after the final 6 months. RESULTS: Twenty-six women completed both arms of the study. Seventy-seven percent of women preferred the CEE/PC to the CEE/MPA (P