Summary of Gynecological AE Data over 8 Years of MORE-CORE (N=4011)
{"Image DocumentName": "Summary of Gynecological AE Data over 8 Years of MORE-CORE (N=4011)", "Image ImageDescription": "Source: Martino S et al. Curr Med Res Opin 21; , %Percentage of participants. who experienced event (n) P-value. Placebo. (N=1286) Raloxifene. (N=2725) Uterine cancer\u2020\u2021 0.39 (4) 0.32 (7) Endometrial hyperplasia\u2021 0.29 (3) 0.37 (8) >0.99. Ovarian cancer (2) 0.11 (3) Postmenopausal bleeding\u2021\u00a7 5.4 (55) 5.5 (120) Uterine polyps\u2021 1.9 (19) 3.2 (70) Vulvovaginal signs and symptoms. 5.8 (75) 5.0 (135) Review: discl #MEPN-6E9SHA appr Reviewer Memo: These 8-year MORE-CORE findings are similar to those reported from MORE and other studies of shorter duration. No increased incidence of ovarian cancer, uterine cancer, endometrial hyperplasia, or postmenopausal bleeding associated with raloxifene treatment. These uterine data support a neutral effect of raloxifene on the uterus. Uterine polyps were more common in the raloxifene treatment group over the 8-year period. They were more frequently reported during the MORE trial period versus the CORE period (79 versus 9 events), presumably as a result of the uterine surveillance plan in place during MORE but not CORE. None of the uterine polyps diagnosed in the raloxifene treatment group were associated with an increase in reported bleeding or diagnosis of endometrial cancer over the 8 years, and most likely would not have been identified in a normal clinical setting, as demonstrated in CORE. The increased incidence of uterine polyps in the raloxifene group versus placebo during MORE may in part be related to an increased sensitivity of ultrasound in the active treatment group due to the presence of endometrial fluid. Raloxifene has previously been associated with an increase in endometrial cavity fluid, and it is feasible that this could have aided detection of these benign endometrial changes. Moreover, it is presumed that the greater incidence of endometrial biopsy in the raloxifene treatment group during the MORE period is at least in part the result of this increase in detection of benign endometrial changes during ultrasound in the raloxifene treatment group. Martino S et al. Curr Med Res Opin 21; , Slide Modified: Memo: SCA: Sherie Dowsett. copyright permission received for graphs", "Image XResolution": "37", "Image YResolution": "37", "Image ResolutionUnit": "Pixels/Centimeter", "Image Software": "SlidePlayer", "Image YCbCrPositioning": "Centered"}