Efficacy of the fixed-dose combination of amlodipine/perindopril/atorvastatin in patients with hypertension and dyslipidemia in real-world practice. Results of the TARGET study

Objectives. The primary objective was to describe antihypertensive and lipid lowering effectiveness of a polypill of amlodipine, atorvastatin, and perindopril at week 12 in patients with arterial hypertension (HTN) and hypercholesterolemia in daily clinical practice. Design and method. The TARGET study (NCT05764317) was a 12-week ambispective observational study. Adult out-patients with HTN and hypercholesterolemia had initiated treatment with the polypill in dosage strengths of 5/10/5 mg; 5/20/5 mg or 5/20/10 mg within 1 month before enrollment. The primary outcome was mean change from baseline in office systolic and diastolic blood pressure (SBP, DBP) and low-density lipoprotein cholesterol (LDL-C) at week 12. Main secondary outcomes were changes of quality of life as assessed by SF-36 questionnaire and adherence to therapy measured by a Russian questionnaire at week 12 compared to baseline. Effectiveness and safety analyses were performed in modified intention-to-treat population. Uni and multivariate regression models were used to define significant predictors for the achievement of target parameters. Results. Four hundred nine outpatients who had already initiated the polypill of amlodipine/atorvastatin/perindopril were included in the study. Very high or extreme cardiovascular (CV) risk initially had 160 (39.1%) of patients, 166 (40.6%) had high CV risk, 71 (17.4%) had moderate and 12 (2.9%) had low CV risk. Mean baseline blood pressure (BP, SD) was 157.3 (15.6)/ 92.3 (9.1) mmHg and mean LDL-C at baseline was 3.7 (1.0) mmol/L. Mean SBP decreased by 32.4 (15.3) mmHg and DBP by 15.0 (10.0) mmHg by week 12 (both р<0.0001). Mean LDL-C value decreased by 1.6 (0.9) mmol/L (р<0.0001). Changes in physical and psychological components of SF-36 were 5.7 (8.2) and 7.7 (9.9) points by week 12 compared to baseline. Proportion of patients with low/moderate adherence decreased from 17.4% (71/409) to 1.5% (6/409) by week 12, whereas a proportion of patients with a high adherence at the end of the observation period increased up to 97.5%. Older age (OR (odds ratio) 0.97, 95% confidence interval (CI) 0.94 to 0.99) and peripheral artery disease (PAD) (OR 0.44, 95% CI 0.22 to 0.91) were significant negative predictors for achieving target BP. Presence of T2D (OR 0.50, 95% CI 0.28 to 0.89) and LDL-C level increase by week 12 compared to baseline (OR 0.28, 95% CI 0.21 to 0.39) were negative predictors for LDL-C target value achievement. One non-serious adverse event (dry cough) and one special situation (insufficient lipid-lowering effectiveness) were reported. Conclusion. Treatment with a polypill amlodipine/atorvastatin/perindopril demonstrated significant BP and lipid-lowering effectiveness and was well tolerated. These changes were accompanied by improvement of adherence to treatment and quality of life.