PROMETRIUM® protected 3 times more of estrogen’s beneficial effect than CEE plus continuous MPA and 2.5 times that of CEE + cyclic MPA.[1]

Mean percent high-density lipoprotein changes from baseline*[1]

*Active regimens contained CEE (0.625 mg/d) alone or in combination with continuous MPA (2.5 mg/d), cyclic MPA (10 mg/d for 12 d/cycle), or cyclic PROMETRIUM® (200 mg/d for 12 d/cycle).
†P<0.001 vs placebo.
‡P<0.004 vs regimens containing MPA. Lipid changes were calculated from baseline for each treatment group.

While significant changes in HDL levels were observed, the relevance of this in terms of clinical outcome has yet to be determined.

PROMETRIUM® (progesterone, USP) Capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets, as well as for treatment of secondary amenorrhea.[2]

Progestins and estrogens should not be used for the prevention of cardiovascular disease. The Women’s Health Initiative reported an increased risk of myocardial infarction, stroke, breast cancer, pulmonary emboli, and deep venous thrombosis in postmenopausal women (ages 50–79) receiving oral conjugated equine estrogens (0.625 mg/day) in combination with medroxyprogesterone acetate (2.5 mg/day) compared to placebo.[2] While products marketed by Solvay Pharmaceuticals, Inc. were not studied in the WHI, in the absence of conclusive
data, a conservative view would assume the risks to be similar. Because of these risks, the lowest effective dose should be used and should be given for the shortest duration possible.

The most common adverse events reported in patients receiving varying dosages of PROMETRIUM® (100 mg/day to 400 mg/day) were: dizziness, breast pain, headache, abdominal pain, chest pain, and diarrhea.[2]

PATIENTS WHO ARE ALLERGIC TO PEANUTS SHOULD NOT USE PROMETRIUM® CAPSULES.[2]

Next: Provide safe, tolerable protection

References:
1. The Writing Group for the PEPI Trial. Effects of estrogen or estrogen/progestin regimens on heart disease risk factors in postmenopausal women. JAMA. 1995;273:199-208.
2. PROMETRIUM® [package insert]. Marietta, Ga: Solvay Pharmaceuticals, Inc.; 2004.