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

BACKGROUND: Cyproterone acetate (CPA) is a synthetic progesterone derivative with antiandrogenic properties indicated as monotherapy for signs of androgenisation in women, reduction of drive in sexual deviations in men, and antiandrogen treatment of prostate cancer that vary based on strength and European country. In 2020, the special warning and precaution about meningioma risk was updated in the summary of product characteristics [SmPC] for CPA monotherapies (CPA-M), and a direct healthcare professional communication (DHPC) was distributed.

OBJECTIVES: To assess physicians’ receipt and knowledge of key safety information pertaining to meningioma risk with the use of CPA-M. Methods: This was an observational, cross-sectional survey among a sample of dermatologists, endocrinologists, gynaecologists, urologists, oncologists, psychiatrists, and general practitioners from country-specific panels in France, Germany, Poland, Spain, and the Netherlands who worked in an office or hospital-based setting and had prescribed CPA-M within the previous 12 months. Physicians completed a web-based knowledge questionnaire about the revised SmPC and the DHPC for CPA-M. The target sample size was 600. Frequencies with percentages for responses were tabulated.

RESULTS: A total of 613 physicians participated. Overall, 43% of physicians correctly identified that information in the special warning and precaution section about meningioma was updated in 2020 for CPA-M, with awareness highest among gynaecologists (62%) and endocrinologists (60%) and lowest among oncologists (30%); 66% of physicians identified all 7 correct responses for the clinical signs and symptoms of meningioma. Knowledge of individual signs and symptoms ranged from 72% to 92%. Overall, 85% of physicians knew that CPA-M should be prescribed with the lowest effective dose, 75% correctly indicated that the risk of meningioma increases with increasing cumulative doses of CPA-M, and 73% correctly indicated that treatment with CPA-containing products must be stopped permanently if a patient is diagnosed with meningioma. Overall, 42% of physicians reported receipt of the revised SmPC, and 69% of those reported that they read it. Similarly, 40% reported that they received the DHPC, and 82% of those reported that they reviewed it.

CONCLUSION: In general, knowledge of the clinical signs and symptoms of meningioma, risk of meningioma, and actions to mitigate risk was high despite only 43% of physicians reporting awareness of the recent changes in the warning and precautions implemented in the label and less than half confirming receipt of the revised SMPC and/or DHPC.

Share on: