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Greg Guthrie, (Neil Poulter, Thomas Macdonald, Ian Ford, Isla Mackenzie, Evelyn Findlay, Bryan Williams, Morris Brown, Chim Lang, David Webb, Chronotherapy in hypertension: the devil is in the details, European Heart Journal, Volume 41, Issue 16, 21 April 2020, Pages 1606–1607, https://doi.org/10.1093/eurheartj/ehaa265
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This commentary refers to ‘Bedtime hypertension treatment improves cardiovascular risk reduction: the Hygia Chronotherapy Trial’, by R.C. Hermida et al., doi:10.1093/eurheartj/ehz754.
We read with great interest the recent article by Professor Hermida et al. in the European Heart Journal,1 which appears to show a striking reduction in cardiovascular events in patients assigned to taking their antihypertensive medications in the evening.
We would be interested in how the safe and ethical conduct of the Hygia trial was overseen. A 45% relative risk reduction in cardiovascular disease outcome would have been apparent before the median follow-up duration of 6.3 years. This begs the question, why was the trial allowed to continue for more than 6 years despite a significant difference in event rates that must have been evident earlier in the study?
Only adjusted hazard ratios were reported for the primary outcome, with adjustment made for various baseline characteristics that were not pre-specified. What was the reason for not pre-specifying factors for adjustment?