Does Orteronel Switch Maintenance Therapy increase hypertension in patients with metastatic castration resistant prostate cancer? – An Update

Objective: To test whether selection bias has affected the reported adverse effect estimate for Orteronel Switch Maintenance Therapy in comparison to placebo treatment (RD 0.05. 95%CI: -0.13 to 0.22), for the increase of hypertension in patients with metastatic castration resistant prostate cancer. Method: Trial adjusted, simulated comparator trial (SCT) based I2 test for single randomised controlled trials, using revised I2 threshold limits. Result: A baseline covariate imbalance, either due to chance or due to selection bias was established, being equivalent to selection bias level = B% 40 (Bias category = 2). This level suggests that 31-40% of (15 – 19 of the total 47) subjects were non-randomly allocated in favour of one treatment group above the other. Conclusion: The effect estimate reported by the tested trial suggests a non-significant higher hypertension rate in the Orteronel intervention group. The selection bias level, estimated by use of the trial adjusted, simulated comparator trial (SCT) based I2 test for single RCTs, B% = 40%, appears to be high enough in order to have affected the reported estimate. In line with new findings, this report updates previous report to the same RCT: EBSM Volume 2, Issue 2, 2026 Pages 47-50, DOI: 10.5281/zenodo.18457105.