PRECIOUS TRIAL CONFIRMS SAFETY AND EFFICACY OF GUIDELINE'S SINGLE-PILL COMBINATION STRATEGY. (April 2021)

• Record Type: Journal Article
• Authors: Brguljan, Jana; Chazova, Irina E.; Gaciong, Zbignew; Simic, Dragan; Vajer, Peter; Zelveian, Parounak; Jelakovic, Bojan
• Is Part Of: Journal of hypertension. Volume 39(2021)e-Supplement 1
• Publication Date: 2021-04
• Subjects: Hypertension -- Periodicals; Hypertension -- Periodicals; 616.132005
• DOI: 10.1097/01.hjh.0000749432.56014.0c
• Languages: English
• ISSNs: 1473-5598

Abstract

Abstract : Objective: To assess the efficacy and safety of guideline's SPC strategy with perindopril/amlodipine (dual SPC arm) and perindopril/amlodipine/indapamide (triple SPC arm) with the goal of reaching blood pressure (BP) control in newly diagnosed and uncontrolled hypertensive patients. Design and method: 450 adults with essential hypertension were assessed in the interventional, open-label, prospective, international, multicentre PRECIOUS trial. Treatment duration was 16 weeks, divided into four treatment periods. Office BP was measured with a validated automated BP-measuring device by a qualified health professional following guidelines protocol. At the inclusion naïve or patients uncontrolled on previous mono or dual therapy (other than perindopril/amlodipine (P/A)) were assigned to dual SPC arm with initial dose of 4/5 mg P/A. Those uncontrolled on previous dual or triple therapy were assigned to triple SPC arm with initial dose of 4/5/1.25 mg perindopril/amlodipine/indapamide (P/A/I). If BP control was not reached, the initial dose was up-titrated in 4-week intervals to 8/5 mg, 8/10 mg P/A or 8/10/2.5 mg P/A/I in dual SPC arm and to 8/5/2.5 mg, or 8/10/2.5 mg P/A/I in triple SPC arm. Results: After 4 months of treatment mean office BP lowered from 159.5 ± 11.6/ 99.6 ± 8.6 mmHg to 128.6 ± 9.4/81.7 ± 7.2 mmHg and from 162.4 ± 14.3/ 99.5 ± 9, 6 mmHg to 127.8 ± 11.3/80.2 ± 7.5 mmHg in dual and triple SPC arm (all p < 0.001), respectively. Significant decrease by -17.1/-10.9 mmHg in dual and -14.4/-9.0 mmHg in triple SPC arm was achieved after one month of treatment (both p < 0.001). Target BP of <140/90 mmHg was achieved in 77.7% of patients in dual and in 83.0% of patients in triple SPC arm. The majority of the effect was observed within 3 months. Approximately 1/3 of patients remained on initial dose, and 1/3 needed one up-titration of the therapy. 85% of patients experienced no adverse events, recorded ones were clinically irrelevant. Conclusions: Guideline's SPC strategy with perindopril/amlodipine and perindopril/amlodipine/indapamide resulted in fast achievement of guideline's recommended target BP with no or just 1 up-titration therapy step in approximately 2/3 of patients, accompanied by good tolerability.