Does abiraterone added to prednisone increase the rate of cardiac events in chemotherapy-naïve patients with asymptomatic or mildly symptomatic metastatic castration resistant prostate cancer?

Objective: To test whether selection bias has affected the reported effect estimate for abiraterone plus prednisone in comparison to prednisone plus placebo (RD 0.06. 95%CI: 0.00 to 0.11), regarding the increase of cardiac events in chemotherapy-naïve patients with asymptomatic or mildly symptomatic metastatic castration resistant prostate cancer. Method: Trial adjusted, simulated comparator trial (SCT) based I2 test for single randomised controlled trials Result: The estimated selection bias level (B%) of 30% suggests that 21-30% (66 – 94 of 313) of the total trial subjects were non-randomly allocated in favour of one treatment group above the other. This level appears not to be high enough in order to have affected the reported effect estimate. Conclusion: The effect estimate reported by the tested trial suggests a borderline significantly higher cardiac event rate in the abiraterone plus prednisone intervention group in comparison to the treatment with prednisone plus placebo. The selection bias level, estimated by use of the trial adjusted, simulated comparator trial (SCT) based I2 test for single RCTs, B% = 30%, appears not to be high enough in order to have affected the reported estimate.