Use of menopausal hormones in the United States, 1992 through June, 2003.
OBJECTIVE
The Women's Health Initiative (WHI) study that documented an unfavorable benefit to risk ratio of Prempro and subsequently an increased risk of stroke with menopausal estrogen prompted us to investigate the use during 1992 through June 2003 of menopausal hormones in the United States.


METHODS
Two pharmaceutical research databases from IMS Health, the National Prescription Audit Plus and the National Disease and Therapeutic Index, were accessed and analyzed.


RESULTS
The number of dispensed outpatient prescriptions for oral menopausal estrogens and oral combination estrogen-progestins increased 2.5-fold (153%) from 34.5 million dispensed in 1992 to a high of 87.3 million in 2000. For July 2002 through June 2003, the year following the publication of the results of the WHI trial, prescriptions for these products declined to 59.6 million, a 32% decrease from their peak in 2000. Prescriptions for transdermal estrogen and transdermal combination estrogen-progestin products increased from 5.2 million dispensed in 1992 to their peak of 8.3 million in 2000, and declined 10% to 7.5 million during July 2002 through June 2003. By contrast, prescriptions for oral menopausal progestins rose to 17.5 million in 1995 and then steadily declined. In the year after the WHI, prescriptions for oral progestins decreased 49% to 8.9 million from their peak in 1995. The earlier decline in oral progestin prescriptions was primarily due to the marketing in 1995 of the popular oral combination estrogen-progestin drugs.


CONCLUSIONS
Prescriptions dispensed for menopausal hormones increased substantially between 1992 and peaked in 2000. By June 2003, prescriptions for oral menopausal estrogens and oral combination estrogen-progestins had declined by about one-third from their peak year.
Wysowski
Diane K
DK
Division of Drug Risk Evaluation, Office of Drug Safety, Food and Drug Administration, Rockville, MD 20857, USA. wysowski@cder.fda.gov
Governale
Laura A
LA
D000279:Administration, Cutaneous; D000284:Administration, Oral; D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D003627:Data Interpretation, Statistical; D004338:Drug Combinations; D011307:Drug Prescriptions / Q000706:statistics & numerical data; D017723:Drug Utilization Review / Q000379:methods / Q000706:statistics & numerical data / Q000639:trends; D015914:Estrogen Replacement Therapy; D004967:Estrogens / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008593:Menopause / Q000187:drug effects*; D008875:Middle Aged; D011372:Progestins / Q000008:administration & dosage / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D013997:Time Factors; D014481:United States
D004338:Drug Combinations; D004967:Estrogens; D011372:Progestins