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Gynecomastiaan enlargement of the gland tissue in the male breast is the caused by an imbalance of hormonesCertain medical.
In contrasthoweverthe rate of fatal stroke is stated to have been higher in the raloxifene group than in the placebo group2.2 per 1000 women using raloxifene per year v1.5 per 1000 women using placebo per yearp0.0499no confidence intervals were stated1 This means that about 1 in 455 women in the trial taking raloxifene would have had a stroke in a yearas compared with only 1 in 667 women in the trial taking placeboIn terms of the number needed to harm1428 postmenopausal women at risk of a cardiovascular event would have to be treated with the drug before 1 woman would have a treatment-related fatal strokeThe reasons for this effectif it is realare unclear.
WarfarinIn vitroraloxifene did not interact with the binding of warfarinThe concomitant administration of EVISTA and warfarina coumarin derivativehas been assessed in a single-dose studyIn this studyraloxifene had no effect on the pharmacokinetics of warfarinHowevera 10decrease in prothrombin time was observed in the single-dose studyIn the osteoporosis treatment trialthere were no clinically relevant effects of warfarin co-administration on plasma concentrations of raloxifenesee DRUG INTERACTIONS
GenderTotal extent of exposure and oral clearancenormalized for lean body weightare not significantly different between age-matched female and male volunteers.
Endometrial thickness was evaluated annually in a subset of the study population1781 patientsfor 3 yearsPlacebo-treated women had a 0.27 mm mean decrease from baseline in endometrial thickness over 3 yearswhereas the EVISTA-treated women had a 0.06 mm mean increasePatients in the osteoporosis treatment study were not screened at baseline or excluded for pre-existing endometrial or uterine diseaseThis study was not specifically designed to detect endometrial polypsOver the 36 months of the studyclinically or histologically benign endometrial polyps were reported in 17 of 1999 placebo-treated women37 of 1948 EVISTA-treated womenand in 31 of 2010 women treated with raloxifene HCl 120 mg/dayThere was no difference between EVISTAand placebo-treated women in the incidences of endometrial carcinomavaginal bleedingor vaginal discharge.
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