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)
Methods of Development Double-blind, Randomised Trials of Effects of Antihypertensive Medicines (DREAM) Database, Characteristics of Included Trials, and Umbrella Protocol for 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. The planned meta-analyses using the DREAM database will follow standard methods as recommended by the Cochrane Handbook for Systematic Reviews. The general methods for these meta-analyses are outlined.
Results:
The DREAM database includes 1,623 RCTs (4359 comparisons): 44% were placebo-controlled, 70% had parallel-group allocation, and 37% had three or more randomized groups. A total of 304,253 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 combination therapy accounted for 23%. The median duration of treatment was 8 weeks. Most, 93%, RCTs reported data on effects on blood pressure (BP).
Conclusions:
The first series of meta-analyses using the DREAM database will assess the effects of antihypertensive medicines on BP and safety outcomes - including effects on headache, and cardiovascular events. The Findings of these meta-analysis will inform clinical practice guidelines and help identify priorities for future research.
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