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
URI
http://hdl.handle.net/10394/33501https://journals.lww.com/jhypertension/Fulltext/2019/11000/A_call_for_improved_reporting_on_serious_adverse.6.aspx
https://doi.org/10.1097/HJH.0000000000002194
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- Faculty of Health Sciences [2386]