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UPJ INSIGHT Adverse Events of Abiraterone Acetate vs Enzalutamide

By: Leandro Blas, MD, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan; Masaki Shiota, MD, PhD, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan; Shigehiro Tsukahara, MD, PhD, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan; Shohei Nagakawa, MD, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan; Takashi Matsumoto, MD, PhD, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan; Masatoshi Eto, MD, PhD, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan | Posted on: 20 Jul 2023

Blas L, Shiota M, Tsukahara S, Nagakawa S, Matsumoto T, Eto M. Adverse events of abiraterone acetate vs enzalutamide. Urol Pract. 2023;10(4):360-370.

Study Need and Importance

Monitoring adverse events is a key aspect of pharmacovigilance. Profiling and comparing adverse events caused by abiraterone and enzalutamide can improve the safety profile and help identify the best candidate for each therapy.

What We Found

Both drugs presented different toxicity profiles in most System Organ Classes. Overall, abiraterone presented a higher rate of serious adverse events than enzalutamide. The Figure shows the disproportionate distribution of adverse events between abiraterone and enzalutamide. Moreover, patients ≥70 years using enzalutamide presented a higher rate of toxicity in ear and labyrinth disorders, endocrine disorders, and metabolism and nutrition disorders. On the contrary, patients ≥70 years receiving abiraterone presented a higher vascular disorders toxicity rate. Additionally, men <70 years had a higher incidence rate of toxicity due to abiraterone than enzalutamide in blood and lymphatic system.

Figure. Red and green colors indicate significantly high reporting odds ratio (ROR) for abiraterone and enzalutamide, respectively. CI indicates confidence interval. Asterisk indicates statistically significant difference.

Limitations

Our data cannot account for unbiased data as reporting is mandatory for manufacturers but voluntary for patients and physicians. Additionally, there is variability in data completeness, and information in reports is not verified. We cannot differentiate between tumor stages and grades of adverse events. In addition, there was no information about patients’ backgrounds, such as previous diseases and the evolution of the clinical state.

Interpretation for Patient Care

Our findings suggest that both drugs present a discrete and nonoverlapping toxicity profile that varies by System Organ Class and patient age. This study confirms, for the most part, what has been reported in clinical trials as well as true real-world reports. Additionally, this information can help identify the best candidate for each therapy, considering patient comorbidities and desires.

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