Clinical Pharmacology and Therapeutics

Immediate gene results did not improve blood pressure overall

At three months, the adjusted difference in systolic blood pressure change was minus 0.3 mm Hg for immediate versus delayed genetic results.

Figure 1. Consort diagram: The primary analysis focused on the change in SBP from baseline to 3 months between treatment groups.
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Figure 1. Consort diagram: The primary analysis focused on the change in SBP from baseline to 3 months between treatment groups.Consort diagram: The primary analysis focused on the change in SBP from baseline to 3 months between treatment groups.Empey et al.
Randomized trial in 1,874 adults with hypertension and self-reported African ancestry, 3 monthsInterventions

Multicenter

Limit: Unmeasured lifestyle changes, dietary changes, and over-the-counter medications could influence blood pressure

Edited by Boris Djordjevic · AgingResearch.News

Follow

The randomized trial enrolled 1,874 adults with hypertension and self-reported African ancestry. Participants were assigned to receive genetic results immediately or at trial completion. The results informed recommendations on choosing thiazide diuretics, a class of blood pressure drugs, and dosing hydralazine, another blood pressure drug.

At three months, immediate results did not improve systolic blood pressure, the top number in a reading, overall. The adjusted difference versus delayed results was -0.3 mm Hg; the range of likely values included no difference. In a prespecified subgroup of 867 people with a gene variant predicting a weaker response to thiazide drugs, immediate results lowered systolic pressure by 2.46 mm Hg more than delayed results. Among 659 participants with uncontrolled blood pressure at baseline, the reduction was 2.9 mm Hg greater.

Why it matters

Hypertension care is relevant to health as people age. The authors called for future studies focused on people with uncontrolled blood pressure and gene variants that could guide prescribing.

Caveats

The reported outcome was blood pressure at three months, and improvements appeared only in prespecified subgroups. Participants all had hypertension and self-reported African ancestry; the abstract did not report harms.

From the paper

Participants

Based on the actual standard deviation of 19.0 and sample size of 1874, the GUARDD-PGx power was greater than 95% to detect a 3.5 mm Hg difference between groups.

Methods, Sample size and power

Who took part

GUARDD-US inclusion criteria comprised individuals with hypertension and self-reported Black race or African ancestry who had (1) neither DM nor CKD or (2) CKD stage 1–4 with or without DM.

Methods, Participants

Ages

Participants had a mean (±SD) age of 55 (±10.7), were majority female (64%), had African ancestry (100%), self-reported their race as Black or African American (88.3%), and had greater than a high school education (64.8%).

Results, Participants

Duration

Sub-study participants were randomized at a 1:1 allocation to immediate PGx RoR (intervention) where testing and RoR are performed immediately or delayed PGx RoR (control) where testing and RoR are conducted at 6 months, stratified by clinical site with random block sizes of four and eight within each site …

Methods, Randomization and blinding

Result

The covariate-adjusted change in SBP similarly did not show a difference between groups (−0.2 ± 0.78 mm Hg, 95% CI: −1.7, 1.4).

Results, Primary and secondary blood pressure outcomes

Systolic blood pressure

(−4.59 mmHg; 95% CI: −6.34 to −2.83) vs. those in the delayed group (−2.13 mmHg; 95% CI: −3.93 to −0.32) with a mean difference in SBP of −2.46 (95% CI: −4.57 to −0.36; P = 0.0048).

Results, Blood pressure outcomes in those with actionable genotypes and uncontrolled hypertension

Quoted word for word from the full text on ascpt.onlinelibrary.wiley.com.