EXPLORE BAXFENDY / EFFICACY Bax24
- A pivotal trial evaluating the effects of BAXFENDY on SBP, published in NEJM
- A pivotal trial demonstrating SBP reductions, day and night, published in The Lancet
In adults with uncontrolled hypertension taking 3 or more antihypertensives,
ADDING BAXFENDY DELIVERED DOUBLE-DIGIT DROPS IN SBP, DAY AND NIGHT[2b]
*^ Bax24 was a randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability, and the effect of BAXFENDY 2 mg versus placebo, on ambulatory SBP in participants with rHTN. The primary efficacy endpoint was the change from Baseline in 24-hour ambulatory SBP at Week 12. This primary endpoint was analyzed in the modified intention-to-treat population using an analysis of covariance (ANCOVA) model with fixed effects for treatment and baseline 24-hour ambulatory SBP as a covariate.[2c]
†^ Bars on the line graph indicate standard error.[2d]
‡^ Analyzed in patients with valid ABPM at both Baseline and Week 12 using a logistic regression model with treatment as a factor and baseline 24-hour ambulatory SBP as a covariate. Only patients with baseline 24-hour ambulatory SBP ≥130 mm Hg were included.[2e]
Bax24: Phase 3, Randomized, Placebo-Controlled Trial Evaluating the Effects of BAXFENDY on Ambulatory SBP in Patients With Uncontrolled Hypertension Taking 3 or More Antihypertensives[2f]
Bax24: Phase 3, Randomized, Placebo-Controlled Trial Evaluating the Effects of BAXFENDY on Ambulatory SBP in Patients with Uncontrolled Hypertension Taking 3 or More Antihypertensives[2f]
BaxHTN EXPLORATORY ENDPOINT: EFFECT OF BAXFENDY ON 24-HOUR & NIGHTTIME AMBULATORY SBP2
In an exploratory analysis of BaxHTN that evaluated a subgroup of patients who participated in 24-hour ABPM, the antihypertensive treatment effect of BAXFENDY was maintained throughout the 24-hour period, including the nighttime period.
- At Week 12, the reduction vs placebo in ambulatory 24-hour average SBP was -16.9 mm Hg (95% CI: -25.6 to -8.3) in the BAXFENDY 2 mg group and -14.6 mm Hg (95% CI: -23.0 to -6.3) in the BAXFENDY 1 mg group
- The reduction vs placebo in ambulatory nighttime average SBP was -11.7 mm Hg (95% CI: -19.5 to -3.8) in a combined 1 mg and 2 mg group
§^ Patients were on maximum tolerated doses based on investigator judgment for ≥4 weeks prior to screening.[2g]
¶^ Additional inclusion criteria: ≥18 years of age, eGFR ≥45 mL/min/1.73 m2, serum K+ ≥3.5 & <5.0 mmol/L.[2i]
#^ A total of 218 patients were randomized and 217 received treatment.[2j]
**^ Data are mean (standard deviation).[2k]
††^ Data are mean (standard deviation). Patients receiving BAXFENDY (n=107) and patients receiving placebo (n=109) had valid ambulatory blood pressure monitoring at baseline.[2l]
With BAXFENDY By Your Side, prescribe with confidence
FIND SUPPORT RESOURCESAbbreviations: ABPM=ambulatory blood pressure monitoring; ACEi=angiotensin-converting enzyme inhibitor; ARB=angiotensin receptor blocker; BB=beta blocker; CCB=calcium channel blocker; CI=confidence interval; eGFR=estimated glomerular filtration rate; FDA=Food and Drug Administration; K+=potassium; NEJM=The New England Journal of Medicine; QD=once daily; SBP=systolic blood pressure; SOC=standard of care.
References:
- ^ BAXFENDY® (baxdrostat) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2026.
- 2a 2b 2c 2d 2e 2f 2g 2h 2i 2j 2k 2l Azizi M, Brown JM, Dwyer JP, et al; Bax24 investigators. Effect of baxdrostat on ambulatory blood pressure in patients with resistant hypertension (Bax24): a phase 3, randomised, double-blind, placebo-controlled trial [including online supplement]. Lancet. 2026;407(10532):988-999.
- ^ Flack JM, Azizi M, Brown JM, et al; BaxHTN Investigators. Efficacy and safety of baxdrostat in uncontrolled and resistant hypertension [including online supplement]. N Engl J Med. 2025;393(14):1363-1374.
- Data on File, REF-335513. AZPLP.
