Women's Health

Hellwig K, Magyari M, MacDonald TM, Cesta CE, Wergeland S, Leinonen MK, Ornoy A, Vukusic S, Lauer A, Zhou X, Kawai A, Weinrib R, Arana A, Boumenna T. A multi-country cohort database study to assess pregnancy and infant outcomes after potential maternal or paternal exposure to cladribine tablets in the treatment of multiple sclerosis: the CLEAR study methods and status update1. Ther Adv Neurol Disord. 2025 Jan 27;18:175628642. doi: 10.1177/17562864241310996


BACKGROUND: Cladribine tablets are contraindicated during pregnancy; therefore, safety data on pregnancies exposed to this treatment are limited. CLEAR collects and describes pregnancy outcomes in this understudied population.

Margulis AV, Riera-Guardia N, Calingaert B, Armstrong R, Fletcher M, Patki K, Weiner E, Rivero-Ferrer E. Fetal and neonatal alloimmune thrombocytopenia: a systematic literature review and meta-analysis of adverse pregnancy-related outcomes to support the development of a novel prophylactic therapeutic. Poster presented at the AMCP Annual Meeting 2024; April 15, 2024. New Orleans, LA. [abstract] J Manag Care Spec Pharm. 2024 Apr; 30(4-a):S96-7. doi: 10.18553/jmcp.2024.30.4-a.s1


Morga A, Zimmermann L, Valluri U, Siddiqui E, McLeod L, Bender RH. Validation and application of thresholds to define meaningful change in vasomotor symptoms frequency: analysis of pooled SKYLIGHT 1 and 2 data. Adv Ther. 2024 Jul;41(7):2845-58. doi: 10.1007/s12325-024-02849-2


Djibo DA, Margulis AV, McMahill-Walraven CN, Saltus CW, Shuminski P, Kaye JA, Johannes CB, Libertin M, Graham S. Validation of an ICD-10 case-finding algorithm for endometrial cancer in US insurance claims. Pharmacoepidemiol Drug Saf. 2024 Jan;33(1):E5690. doi: 10.1002/pds.5690


PURPOSE: To evaluate the positive predictive value (PPV) of an endometrial cancer case finding algorithm using International Classification of Disease 10th revision Clinical Modification (ICD-10-CM) diagnosis codes from US insurance claims for implementation in a planned post-marketing safety study. Two algorithm variants were evaluated.

Sweeney C, Gilsenan A, Calingaert B, Moeller C, Schomakers G, Sok A, Holzmann R, Pisa F. Physician awareness of the safe use of cyproterone acetate in Europe: a survey on the effectiveness of additional risk minimization measures. Pharmaceut Med. 2024 Mar;38(2):145-56. doi: 10.1007/s40290-023-00510-x.


Fassett MJ, Reed SD, Rothman KJ, Pisa F, Schoendorf J, Wahdan Y, Peipert JF, Gatz J, Ritchey ME, Armstrong MA, Raine-Bennett T, Postlethwaite D, Getahun D, Shi JM, Xie F, Chiu VY, Im TM, Takhar HS, Wang J, Anthony MS. Risks of uterine perforation and expulsion associated with intrauterine devices. Obstet Gynecol. 2023 Sep 1;142(3):641-51. doi: 10.1097/AOG.0000000000005299


Saltus C, Djibo DA, Peetluk L, Kaye J, McMahill-Walraven C, Johannes C, Bernick B, Calingaert B, Franklin J, Graham S, Pigoga J, Shuminski P, Margulis AV. Use of very low-dose vaginal estrogens among postmenopausal women in the US. Poster presented at the 39th ICPE Annual Conference; August 26, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):352-3. doi: 10.1002/pds.5687


Sweeney C, Calingaert B, Holzmann R, Moeller C, Schomakers G, Sok A, Pisa F, Gilsenan A. Physician knowledge of safe use of cyproterone acetate monotherapies and meningioma. Poster presented at the 39th ICPE Annual Conference; August 26, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):300. doi: 10.1002/pds.5687


Hagino H, Yoshinaga Y, Hamaya E, Lin TC, Ajmera M, Meyers J. A real-world study of treatment patterns among patients with osteoporotic fracture: analysis of a Japanese hospital database. Arch Osteoporosis. 2023 Jan 23;18(1):23. doi: 10.1007/s11657-022-01201-x


Health records of patients hospitalized for osteoporotic fracture were analyzed. Prior to the index hospital admission, most patients were not receiving any antiosteoporotic treatment. During the index hospitalization visit, 25.5% of patients received antiosteoporotic treatment. The most common treatment regimens were active vitamin D3, bisphosphonates, and teriparatide.

DePree B, Houghton K, DiBenedetti DB, Shiozawa A, King DD, Kim J, Mancuso S. Practice patterns and perspectives regarding treatment for symptoms of menopause: qualitative interviews with US health care providers. Menopause. 2023 Feb;30(2):128-35. doi: 10.1097/GME.0000000000002096


OBJECTIVE: To document health care providers' views regarding treatments for symptoms associated with menopause and discussions with patients about symptoms and treatment decisions. Results informed development of a data collection form for a retrospective medical record review (reported separately).

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