Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 8, 2024
Open Peer Review Period: Sep 10, 2024 - Nov 5, 2024
Date Accepted: Feb 27, 2025
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Development of the Double-blind, Randomised trials of Effects of Antihypertensive Medicines (DREAM) database: Overview of Methods, Characteristics of Included trials, and Planned Meta-analyses.
ABSTRACT
Background:
A comprehensive evaluation of short-term effects of antihypertensive medicines is important for informing guidelines and clinical practice.
Objective:
We aimed to develop a database of Double-blind Randomised trials of Effects of Antihypertensive Medicines (DREAM) to facilitate a series of meta-analyses evaluating the short-term effects of antihypertensive medicines.
Methods:
We searched the Cochrane Central Register of Controlled Trials, MEDLINE, and Epistemonikos from inception until December 2022 to identify relevant randomized clinical trials (RCTs). We included RCTs in the DREAM database if they were double-blind, enrolled adult participants, evaluated the five major classes of antihypertensive medicines over a duration of 2 to 26 weeks, and were published in the English language. Screening of records for inclusion and data collection were both conducted in duplicate.
Results:
A total of 1,659 RCTs (3,997 eligible groups) were included: 44% were placebo-controlled, 71% had parallel-group allocation, and 37% had three or more randomized groups. A total of 277,749 participants were included: the mean age was about 54 years, about 40% were female, 86% RCTs had participants with hypertension, and 11% RCTs had participants with cardiovascular disease at baseline. RCTs with at least one group randomized to monotherapy accounted for 78%, at least one group randomized to combination therapy accounted for 23%, and at least one group randomized to calcium channel blockers (as the most evaluated class) were 35%. The median duration of treatment was 8 weeks. Most, 91%, RCTs reported data on effects on blood pressure. Meta-analyses planned in the first round of outputs include effects of antihypertensive medicines on blood pressure, safety, headache, cardiovascular events, and blood pressure variability.
Conclusions:
The planned meta-analyses from the DREAM database will produce important evidence to inform clinical practice guidelines and practice. Clinical Trial: Not applicable
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