Prempro
Prempro has been linked to invasive breast cancer, coronary heart disease, stroke and pulmonary embolism.
Coronary heart disease, stroke, invasive breast cancer, and pulmonary embolism have all been linked to Prempro, an estrogen and progestin combination drug. On July 9, 2002, the National Heart, Lung and Blood Institute (NHLBI), a part of the National Institutes of Health, announced it has discontinued a clinical study of the benefits and risks associated with combining estrogen and progestin. The study should have lasted until 2005, but data divulged that after an average follow-up period of 5.2 years, there were documented increases in coronary heart disease, stroke, invasive breast cancer, and pulmonary embolism in patients undergoing combination therapy compared to women taking a placebo.
16,608 women ages 50 to 79 who had never undergone a hysterectomy were the subjects of the NHLBI study. Prempro was the only estrogen and progestin combination drug tested in the study. Women participating in the study were not administered other brands of HRT drugs with lower doses of estrogen or estrogen skin patches. The decision to postpone the study was issued on May 31, 2002 when the Data and Safety Monitoring Board (DSMB) held its biannual meeting to assess the results of the study. Prior DSMB evaluations showed rising rates of coronary heart disease, stroke, and blood clots. However, at the May 31st meeting, the DSMB analyzed data gathered through February 2002 that exhibited a realized increase in breast cancer in women taking Prempro compared to women in the control group.