Toxicity profile characteristics of novel androgen-deprivation therapy agents in patients with prostate cancer: a meta-analysis

<p><b>Background</b>: To investigate the toxicity profile characteristics of abiraterone acetate and enzalutamide to see if they are of critical clinical value.</p> <p><b>Methods</b>: Prospective studies were identified by searching the PubMed, EMBASE, Cochrane Library, and American Society of Clinical Oncology Meeting abstracts. Randomized clinical trials that evaluate abiraterone acetate or enzalutamide in patients with prostate cancer were included. The risk ratio (RR) of adverse events (AEs) was calculated for each trial along with appropriate 95% CI using fixed- or random-effects methods.</p> <p><b>Results</b>: Ten studies (5 abiraterone acetate, and 5 enzalutamide studies) were included in the meta-analysis. Use of abiraterone acetate was associated with an increased risk of all-grade adverse effects (RR = 1.01, 95% CI: 1.01–1.02) and high-grade adverse effects (RR = 1.29, 95% CI: 1.15–1.45). Also, there was a significantly higher incidence of some individual adverse effects (e.g. liver-function test abnormalities, arthralgia, cardiac adverse effects, diarrhea, oedema, hypertension and hypokalemia). Treatment with enzalutamide did not increase the risk of all-grade adverse effects and high-grade adverse effects, but there was a significantly higher incidence of some individual adverse effects (e.g. back pain, fatigue, hot flush and hypertension).</p> <p><b>Conclusions</b>: Both abiraterone acetate and enzalutamide have toxicity profile characteristics that need to be recognized. Understanding the toxicity profile characteristics of both drugs could promote decision making in clinical use.</p

A pharmacovigilance analysis of FDA adverse event reporting system events for romosozumab

Romosozumab is a novel drug for the treatment of osteoporosis. The adverse reactions of romosozumab still need to be explored. The FDA Adverse Event Reporting System (FAERS) provides an enormous dataset for adverse events (AEs) analysis. AEs registered in FAERS between January 2019 and December 2020 were collected for this study. The reporting odds ratio (ROR) method was applied to analyze the AEs of romosozumab. The number of AEs ≥4 cases and ROR value 95% confidence interval (CI) lower limit >1 was considered statistically significant. A total of 4,413,695 AEs were collected for this study. There were 1,948 AEs related with romosozumab reported in FAERS. There are 1851 AEs including 17 system classifications after filtered. Injection site pain (ROR = 6.89, CI = 5.60, 8.48), cardiac failure (ROR = 12.62, CI = 9.85, 16.17), renal impairment (ROR = 9.11, CI = 6.98, 11.89), pneumonia (ROR = 1.53, CI = 1.10, 2.21), blood alkaline phosphatase increased (ROR = 14.60, CI = 9.28, 22.97) were possible AEs after romosozumab application. Our study provides an adverse reaction warning for the clinical application of romosozumab and provides a real-world disproportionality analysis data support for the possible AEs of romosozumab.</p