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Observational Study
. 2021 Jun;38(6):3299-3313.
doi: 10.1007/s12325-021-01754-2. Epub 2021 May 15.

Effectiveness and Tolerability of the Single-Pill Combination of Bisoprolol and Perindopril in Patients with Arterial Hypertension and Stable Coronary Artery Disease in Daily Clinical Practice: The STYLE Study

Collaborators, Affiliations
Observational Study

Effectiveness and Tolerability of the Single-Pill Combination of Bisoprolol and Perindopril in Patients with Arterial Hypertension and Stable Coronary Artery Disease in Daily Clinical Practice: The STYLE Study

Sergey A Boytsov et al. Adv Ther. 2021 Jun.

Abstract

Introduction: Combination antihypertensive therapy is required by most patients to achieve guideline-recommended blood pressure (BP) goals. This study assessed the effectiveness and tolerability of bisoprolol/perindopril (Bis/Per) single-pill combination (SPC) in Russian patients with hypertension and coronary artery disease (CAD) treated in routine clinical practice.

Methods: STYLE (NCT03730116) was an open-label, uncontrolled, prospective observational study conducted in patients who were already receiving Bis/Per SPC, switched to SPC from Bis or Per monotherapy, or switched from a free combination of Bis and Per. Primary endpoint criteria were assessed at 1 and 3 months and included change in mean office systolic/diastolic blood pressure (SBP/DBP), proportion achieving target BP (< 140/90 mmHg), and measures of antianginal effectiveness.

Results: The full analysis set comprised 1892 subjects. Mean age was 61.9 ± 8.8 years, 53.2% were women, and mean durations of hypertension and CAD were 12.5 ± 7.9 and 7.2 ± 6.4 years, respectively. Mean SBP/DBP decreased by 22.3/11.0 mmHg and 31.5/15.9 mmHg at 1 and 3 months, respectively (P < 0.0001 vs baseline). Target BP was achieved by 49.2% and 86.7% of patients at 1 and 3 months, respectively. Reductions in mean number of angina attacks and nitrate consumption and improvements in heart rate were statistically significant. Treatment was well tolerated.

Conclusion: Treatment of patients with hypertension and CAD with Bis/Per SPC for 3 months was associated with significant decreases in SBP/DBP and a high proportion of patients achieving BP treatment goals. This was accompanied by an improvement in angina symptoms. Treatment was well tolerated in a broad patient population representative of those seen in everyday clinical practice.

Keywords: Angina; Arterial hypertension; Bisoprolol; Blood pressure; Coronary artery disease; Heart rate; Perindopril; Single-pill combination (SPC).

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Figures

Fig. 1
Fig. 1
Change in mean blood pressure at visit 2 (1 month) and visit 3 (3 months) compared with visit 1 (inclusion visit). For both SBP and DBP, changes were statistically significant for visit 2 compared with visit 1 and for visit 3 compared with visit 1 (all P < 0.0001)
Fig. 2
Fig. 2
Proportion of subjects achieving blood pressure targets at visit 2 (1 month) and visit 3 (3 months)
Fig. 3
Fig. 3
Change in mean heart rate (HR) at visit 2 (1 month) and visit 3 (3 months) compared with visit 1 (inclusion visit)
Fig. 4
Fig. 4
Change in quality of life at visit 2 (1 month) and visit 3 (3 months) compared with visit 1 (inclusion visit). VAS visual analog scale

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