A call for improved reporting on serious adverse events in clinical trials

Abstract

Following SPRINT (Systolic Blood Pressure Intervention Trial) [1], several investigations including systematic reviews and meta-analyses confirmed that reducing SBP to levels below 140 mmHg markedly reduces the risk of cardiovascular disease and all-cause mortality. In a recent systematic review, Bundy et al. [2] included 42 trials (including 144 220 patients) and showed that randomized groups with a mean achieved SBP of 120–124 mmHg had a hazard ratio for major cardiovascular disease of 0.71 (95% confidence interval 0.60–0.83) compared with groups with a mean achieved SBP of 130–134 mmHg; a hazard ratio of 0.58 compared with those with an achieved SBP of 140–144 mmHg; and a hazard ratio of 0.36 compared with those with a mean achieved SBP of at least 160 mmHg. Similar findings were reported for all-cause mortality. These and other reports call for more intensive control of SBP among adults with hypertension