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PARAMETER: HF therapy superior to olmesartan for systolic hypertension in some elderly patients
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LONDON — Elderly patients with systolic hypertension and suspected arterial stiffness had lower central systolic BP and pulse pressure when assigned a therapy recently approved for treatment of HF than when assigned olmesartan, according to results from the PARAMETER study.
Researchers assigned 454 patients aged 60 years or older with systolic BP ≥ 150 mm Hg and pulse pressure > 60 mm Hg, a surrogate for arterial stiffness, to receive sacubitril/valsartan (Entresto, Novartis) 400 mg/day or olmesartan 40 mg/day for 12 weeks, and then to be supplemented with other BP-lowering therapies for up to 52 weeks if systolic BP was not controlled at 12 weeks.
According to the study background, systolic hypertension and elevated pulse pressure are markers of arterial aging and stiffening and predictors for incident CVD and HF; and stiffness of the large artery raises central aortic systolic pressure and central aortic pulse pressure compared with brachial BP, which can trigger HF.
Bryan Williams
Bryan Williams, MD, FRCP, FESC, FAHA, chair of medicine at University College London, and colleagues hypothesized that sacubitril/valsartan, recently approved by the FDA for treatment of HF, would reduce central aortic systolic pressure and pulse pressure more effectively than olmesartan, an angiotensin receptor blocker. Williams presented their findings at the European Society of Cardiology Congress here.
At 12 weeks, the sacubitril/valsartan group had a mean reduction in central aortic systolic pressure of –12.6 mm Hg, compared with –8.9 mm Hg for the olmesartan group (mean difference, –3.7 mm Hg; P = .01), Williams reported.
The researchers also found that 12-week mean reduction in pulse pressure was –6.4 mm Hg in the sacubitril/valsartan group and –4 mm Hg in the olmesartan group (mean difference, –2.4 mm Hg; P = .012).
The sacubitril/valsartan group also had a greater reduction at 12 weeks than the olmesartan group in brachial systolic BP (P = .016) and in brachial pulse pressure (P = .013), as well as in 24-hour ambulatory BP, they found.
The difference was most pronounced at nighttime, which is a period where people with high BP are at elevated risk for CV events, Williams said at a press conference.
“We’ve never seen a drug before that has such a powerful effect on nighttime [BP] relative to its overall [BP] effect,” he said. “If it really is doing that, than this could have significant advantages in those very high-risk patients who are characterized by an abnormally high nighttime pressure.”
At 52 weeks, the differences between the groups in central and brachial aortic systolic pressure and pulse pressure were no longer statistically significant because other medications (amiloride, hydrochlorothiazide or both) were added to the regimens of those whose BP was not under control at 12 weeks, Williams said.
However, those in the sacubitril/valsartan group were less likely than those in the olmesartan group to need add-on therapies to control BP (P = .002), he said. Sixty-eight percent of the sacubitril/valsartan group achieved BP control with monotherapy compared with 53% of the olmesartan group.
There were no significant differences between the groups in adverse events or serious adverse events, Williams said.
“These results suggest that [sacubitril/valsartan], an angiotensin receptor neprilysin inhibitor, has beneficial effects on central aortic hemodynamics and function that could provide a therapeutic advantage beyond those observed with conventional renin-angiotensin system agents,” Williams said. – by Erik Swain
Reference:
Williams B, et al. Hot Line IV: Hypertension. Presented at: European Society of Cardiology Congress 2015.
Disclosures: The study was funded by Novartis. Williams reports receiving honoraria from Novartis for lectures.
Perspective
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José Ramón González-Juanatey, MD, PhD, FESC, FACC
The effects of this new drug (LCZ-696) on HF were already well-demonstrated, but now we see its superior effect compared with a very well-known agent (olmesartan) not only in BP control but particularly in central aortic pressure reduction. But we need more information, particularly a head-to-head comparison with other antihypernsive drugs and after the PATHWAY results with a two-diuretic regimen, a thiazide and amiloride, not only for efficacy in BP reduction but in terms of CV and renal protection.
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