A single-pill mixture of 4 blood-pressure (BP)-lowering medicines was considerably simpler than a mix of three medicines, in response to late-breaking analysis offered in a Scorching Line session in the present day at ESC Congress 2024.
Explaining why new therapy methods are wanted for hypertension, Principal Investigator, Professor Stefano Taddei from the College of Pisa, Italy, mentioned: “Sufferers with resistant hypertension on three BP medicines, specifically a diuretic, a renin-angiotensin system inhibitor and a calcium channel blocker, require the addition of a fourth medicine. Nonetheless, adherence decreases with the variety of tablets prescribed.2 Within the QUADRO trial, we investigated including bisoprolol, as a part of a single-pill mixture of 4 totally different BP-lowering medicines, and located this was simpler than receiving three BP-lowering medicines.”
Within the double-blind randomized managed QUADRO trial, sufferers with resistant hypertension initially entered an 8-week run-in interval the place they obtained the triple mixture of perindopril, indapamide and amlodipine at optimum doses (both 10/2.5/5 mg or 10/2.5/10 mg every day, if tolerated). Those that nonetheless had uncontrolled BP after 8 weeks (workplace systolic BP ≥140 mmHg and 24-hour ambulatory systolic BP ≥130 mmHg), whereas being adherent to the remedy, had been randomized 1:1 to both proceed the identical triple remedy or to obtain a single-pill mixture containing perindopril, indapamide, amlodipine and bisoprolol (at both 10/2.5/5/5 mg or 10/2.5/10/5 mg every day) for 8 weeks. To protect the blinding, sufferers within the two teams obtained the identical variety of tablets day by day: two capsules and one pill. The first endpoint was the change in workplace systolic BP. Secondary endpoints included 24-hour ambulatory BP monitoring, workplace diastolic BP, dwelling BP and BP management.
In whole, 183 sufferers had been randomized from 49 facilities in 13 international locations. The imply age was 57 years and 47% had been feminine. Imply workplace BP at baseline was 150.3 mmHg for systolic BP and 90.0 mmHg for diastolic BP.
After 8 weeks, imply workplace sitting systolic BP had diminished by 20.67 mmHg (normal deviation [SD] 15.37) within the quadruple single-pill group and diminished by 11.32 mmHg (SD 14.77) within the triple group. The adjusted distinction between the teams was vital in favour of the quadruple single tablet (−8.04 mmHg; 95% confidence interval [CI] −11.99 to −4.09; p<0.0001).
A major distinction was additionally seen for the primary secondary endpoint of imply 24-hour ambulatory systolic BP within the quadruple single-pill group vs. the triple group (−7.53 mmHg; 95% CI −10.95 to −4.11; p<0.0001). As well as, a big distinction was seen for imply workplace sitting diastolic BP within the quadruple single-pill group vs. the triple group (−6.14 mmHg; 95% CI −9.00 to −3.27; p<0.0001).
General, BP management (workplace sitting BP <140/90 mmHg) was achieved by 66.3% of sufferers on the quadruple single tablet vs. 42.7% on triple remedy (p=0.001). Ambulatory BP normalization (imply BP over 24 hour <130/80 mmHg) was 51.2% vs. 20.7% in favor of quadruple single tablet (p<0.0001). Residence BP normalization (<135/85 mmHg) was achieved by 60.7% of sufferers on quadruple single-pill remedy vs. 25.4% on triple remedy (p<0.0001).
There have been no main variations between the 2 teams by way of antagonistic occasions, and no severe antagonistic occasions had been reported.
We had been in a position to exhibit the prevalence of the quadruple single-pill mixture, whichever BP measurement technique was used. The supply of a quadruple single-pill mixture that features bisoprolol may assist with non-adherence and supply much-needed efficient BP management in sufferers with resistant or difficult-to-treat hypertension.”
Stefano Taddei, Principal Investigator, Professor from the College of Pisa, Italy
