Announcement Date: March 19, 2015
Participants in five prophylaxis randomized controlled trials with high baseline creatinine level (154μmol/L or more) were significantly less reported in the oseltamivir group than in the placebo group: pooled odds ratio was 0.29 (P = 0.005).
Hama R, Jones M and Jefferson T. Concerns about the randomization in the prophylaxis trials of oseltamivir. Rapid response to Oseltamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments. BMJ 2014;348:g2545
In our Cochrane review , we reported a non-significant increase in renal events in oseltamivir prophylaxis trials on-treatment (RR 3.17, 95% CI 0.96 to 10.49) by random effect model. However there was a statistically significant increase (P=0.02) in sensitivity analysis using Peto’s method. We also noticed two patients in oseltamivir groups who experienced renal failure prior to death : one in trial WV15825 and on in trial WV15708. While assessing the evidence in individual patient data in prophylaxis trials, we found imbalance of baseline renal disorders between the oseltamivir and placebo groups. We independently extracted the data on baseline creatinine level and concomitant renal and urinary tract diseases (renal/UTD) for five studies in total: two in adults (WV15673/WV15697), two in the elderly (WV15708; WV15825) and one in households (WV15799) .