After 26 weeks, participants taking baxdrostat had an average systolic blood pressure reduction that was 8.1 mm Hg greater than those taking placebo. That represented a reduction of about 5%.
The researchers also examined urine albumin in an exploratory analysis. Albumin is a protein that, when found in urine at high levels, can signal elevated risk for kidney and cardiovascular disease. Participants taking baxdrostat had urine albumin levels that were 55% lower than those taking placebo. That reduction was comparable to what has been seen with medications known to slow kidney disease progression.
“The reduction in urine albumin gives us hope that baxdrostat may also help delay kidney damage. This potential is now being tested in two large Phase 3 trials to determine if baxdrostat delays the progression of kidney disease,” said Dwyer.
Safety findings showed that high potassium levels in the blood were much more common among people taking baxdrostat. This is a known concern with medications that affect the renin angiotensin aldosterone system. High potassium occurred in 41% of baxdrostat participants and 5% of placebo participants, with most cases described as mild to moderate.
No deaths or unexpected adverse events occurred during the trial. Serious adverse events were reported in 9% of participants taking baxdrostat and 3% of participants taking placebo.
Why the Findings Matter
Jordana B. Cohen, M.D., M.S.C.E., who was not involved in the study, said the results are notable because people with chronic kidney disease have often been left out of drug studies, even though they face high rates of hypertension and elevated renin angiotensin aldosterone activity.
“These new findings are reassuring that this new class of antihypertensive medications are likely to have both kidney- and cardio-protective benefits and to be safe and effective for broad patient populations,” said Cohen, immediate past chair of the American Heart Association’s Hypertension and Kidney Cardiovascular Science Committee. “Patients with chronic kidney disease were historically often excluded from drug studies. It is particularly reassuring to know that patients with chronic kidney disease, who have very high rates of hypertension and elevated renin-angiotensin aldosterone activity, were represented in their own study, tolerated the medication well, and had both blood pressure and albuminuric benefits. This medication class could be a game changer in the management of hypertension in this patient group.”
Cohen is deputy director and associate professor of medicine and epidemiology in the Perelman School of Medicine at the University of Pennsylvania.
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