Optum Epidemiology, Boston, MA, USA.
Clinical Pharmacology, Pharmacy and Environmental Medicine, University of Southern Denmark, Odense, Denmark.
Curr Med Res Opin. 2021 May;37(5):867-877. doi: 10.1080/03007995.2021.1891035. Epub 2021 Mar 8.
This post-authorization safety study (EU PAS Register Number: EUPAS16088) was designed to compare the incidence of cancer outcomes in patients treated with mirabegron versus antimuscarinic medications.
Cohorts of mirabegron initiators during 2012-2018 were propensity-score matched to antimuscarinic medication initiators within real-world data sources (Danish National Registers, Swedish National Registers, Clinical Practice Research Datalink [UK], Optum [US], and Humana [US]). Incident cancer cases were identified during follow-up from direct linkage to cancer registers or validated through medical record review or through physician questionnaires. Comparisons of sex-specific composite cancer outcomes (cancer of the lung/bronchus, colon/rectum, melanoma of skin, urinary bladder, non-Hodgkin lymphoma, kidney/renal pelvis, pancreas, prostate in men and breast and uterus in women) were made overall and for person-time in the first year and after the first year following start of treatment, for all ages and for the subgroup ≥65 years.
Among the 80,637 mirabegron initiators matched to 169,885 antimuscarinic medication initiators, 68% were at least 65 years of age and 66% were women. Over 5000 incident cancer cases were observed overall. Incidence rates were higher for men than women for composite and individual cancer outcomes. The pooled fixed effects hazard ratios for composite cancer outcomes (all ages) were 1.05 (95% confidence interval [CI]: 0.98-1.14) for women and 1.06 (95% CI: 0.98-1.14) for men. Results were similar in persons ≥65 years.
The results suggest no association between mirabegron use and risk of cancer, compared with antimuscarinic medications, in either men or women. EU PAS Register Number: EUPAS16088.
本事后授权安全性研究（欧盟事后授权登记号：EUPAS16088）旨在比较米拉贝隆治疗与抗毒蕈碱药物治疗的患者癌症结局的发生率。
2012 年至 2018 年期间，米拉贝隆使用者队列通过倾向评分匹配法与真实世界数据源（丹麦国家登记处、瑞典国家登记处、临床实践研究数据链接[英国]、Optum[美国]和 Humana[美国]）中的抗毒蕈碱药物使用者队列相匹配。在随访期间，通过直接链接癌症登记处或通过医疗记录审查或通过医生问卷确认癌症病例。总体比较了男性和女性特定的复合癌症结局（肺癌/支气管、结肠/直肠、皮肤黑色素瘤、膀胱癌、非霍奇金淋巴瘤、肾/肾盂、胰腺、前列腺和乳腺癌、子宫），并比较了所有人的年龄和起始治疗后第一年和第一年以后的人时癌症发生率，比较了≥65 岁的亚组。
在 80637 名米拉贝隆使用者与 169885 名抗毒蕈碱药物使用者相匹配的队列中，68%的患者年龄至少为 65 岁，66%为女性。总体观察到超过 5000 例癌症发病例。复合癌症结局和个别癌症结局的男性发病率均高于女性。所有年龄组的复合癌症结局（所有年龄组）的合并固定效应风险比为 1.05（95%置信区间[CI]：0.98-1.14），女性为 1.05（95%CI：0.98-1.14），男性为 1.06（95%CI：0.98-1.14）。≥65 岁患者的结果相似。
与抗毒蕈碱药物相比，无论男性还是女性，使用米拉贝隆与癌症风险之间无关联。欧盟事后授权登记号：EUPAS16088。
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