Abstract
INTRODUCTION: The aim of the observational SIMPLE study was to assess real-life effectiveness and safety of a single-pill combination (SPC) of perindopril arginine/amlodipine in a broad range of subjects with newly diagnosed mild-to-moderate hypertension treated in Canadian general practice. METHODS: Treatment-naïve participants aged 18-65 years with mild-to-moderate hypertension, whose physicians decided to initiate the perindopril/amlodipine SPC, were recruited from Canadian clinical practice from October 2017 to February 2019. Participants were followed at 3- (M3) and 6-month (M6) visits after treatment initiation. The recommended starting dose of 3.5 mg/2.5 mg once daily was up-titrated, at the discretion of the treating physician, if blood pressure (BP) remained above target at subsequent visits. The primary endpoint was change in mean office systolic BP (SBP) and diastolic BP (DBP) at M6. RESULTS: The full analysis set included 1179 participants with a mean age of 51.5 ± 8.7 years; 61% were male. Mean SBP/DBP at baseline was 153.4 ± 11.5/94.8 ± 7.7 mmHg. Treatment was initiated at 3.5 mg/2.5 mg in 76.0% participants. Over the 6-month treatment period, significant (P < 0.001) decreases from baseline were observed for SBP (- 22.9 ± 14.5 mmHg) and DBP (- 13.4 ± 9.1 mmHg), with 70.2% of participants achieving their BP target. Across all perindopril/amlodipine SPC dose groups, 61.4% of participants achieved BP targets at M3; mean SBP was reduced by 20.8 ± 14.7 mmHg and DBP by 11.7 ± 9.2 mmHg (both P < 0.001). Analysis by baseline subgroup revealed significant BP reductions across age groups, sex, hypertension grades, and diabetes status. Participants with Grade 2 hypertension had a significantly greater decrease than those with Grade 1 (P < 0.001). Treatment with the SPC was well tolerated, and in the 6.1% with treatment-related adverse events, the majority were mild to moderate. High (99%) self-reported adherence (< 20 missed doses) in the 49.4% with available data and high physician satisfaction with treatment (82%) were reported. CONCLUSION: Data from routine Canadian clinical practice indicate that a perindopril/amlodipine SPC is associated with significant BP reductions from baseline in a broad range of participants with different cardiovascular risk factors and may represent an appropriate first-line treatment for subjects with newly diagnosed hypertension.