13/11/2023
Results from the Study of Age-related Hypertension Treatment with Brand X (SAGE-HTN) trial were published today in The Journal of Clinical Hypertension, providing evidence supporting the use of Brand X for treating elderly patients with stage 1 or 2 hypertension.
Trial Design
The SAGE-HTN trial was a 12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 3 study evaluating the antihypertensive efficacy and safety of Brand X in 278 elderly patients aged ≥65 years with stage 1 or 2 primary hypertension (ClinicalTrials.gov Identifier: NCT05294262).
The trial enrolled men and women aged 65-85 years across 48 sites in the United States and Canada from January 2021 to May 2022. Eligible patients had baseline clinic cuff systolic blood pressure (SBP) between 140-180 mmHg and diastolic BP under 110 mmHg.
Participants were randomized 1:1 to receive either Brand X 20mg or a visually matching placebo tablet orally once daily for 12 weeks. Study drug dosing could be uptitrated to 40mg and then 80mg at 4 and 8 weeks if trough cuff SBP remained above 130 mmHg.
The primary efficacy endpoint was change from baseline to week 12 in trough cuff SBP. Secondary endpoints included change in cuff diastolic BP, achievement of BP control, and ambulatory BP monitoring. Safety assessments included adverse events, labs, vital signs, and ECG monitoring.
A total of 278 participants were randomized and 265 (95%) completed the 12 week treatment. Mean age was 72 years, 52% were female, and 13% were African American representation. The mean baseline BP was 156/92 mmHg.
Efficacy Results
After 12 weeks of treatment, patients receiving Brand X showed statistically significant reductions in SBP and DBP from baseline versus placebo:
- Mean change in SBP was -11.2 mmHg for Brand X vs -4.1 mmHg for placebo.
- Mean change in DBP was -8.7 mmHg for Brand X vs -3.1 mmHg placebo.
- The mean between-group treatment difference was -7.1 mmHg SBP (95% CI -8.9 to -5.3; p<0.0001) and -5.6 mmHg DBP.
The proportion of patients achieving targeted BP control (<130/80 mmHg) was significantly higher in the Brand X group compared to placebo (62% vs 32%, p<0.001).
Ambulatory BP monitoring confirmed Brand X provided sustained 24-hour BP lowering relative to placebo.
No differences in the blood pressure lowering effect were observed across demographic or baseline hypertension severity subgroups.
Safety Outcomes
Brand X was generally well tolerated in this elderly population. The frequency of overall adverse events was similar between the Brand X (61%) and placebo (56%) groups.
The most common adverse effects were mild dizziness (14% vs 6% for placebo), headache (9% vs 7%), and fatigue (7% vs 4%).
Discontinuation due to adverse events occurred in 5.2% of Brand X patients compared to 3.7% for placebo. There were no unexpected safety signals identified.
Conclusions
The SAGE-HTN trial provides robust evidence demonstrating Brand X is effective for lowering blood pressure in elderly patients ≥65 years old with hypertension, to a similar degree as observed in younger adult studied populations. The safety profile was consistent with data from previous trials, with no new risks.