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Post Hoc Analysis of the CONFIDENCE II, PROTECT I, SHAKE THE HABIT I and SHAKE THE HABIT II Observational Studies in Mild to Moderate Hypertensive Patients Treated with Perindopril and Atorvastatin Concomitantly.
Drugs in R&D ( IF 3 ) Pub Date : 2018-11-19 , DOI: 10.1007/s40268-018-0255-7 John S Sampalis 1, 2 , Eliofotisti Psaradellis 1 , Melissa Stutz 1 , Jenaya Rickard 1 , Emmanouil Rampakakis 1
Drugs in R&D ( IF 3 ) Pub Date : 2018-11-19 , DOI: 10.1007/s40268-018-0255-7 John S Sampalis 1, 2 , Eliofotisti Psaradellis 1 , Melissa Stutz 1 , Jenaya Rickard 1 , Emmanouil Rampakakis 1
Affiliation
BACKGROUND AND OBJECTIVES
Management of hypertension and dyslipidemia is important when considering cardiovascular disease risk; however, achievement of optimal lipid and blood pressure (BP) targets in clinical practice remains inadequate. This analysis sought to estimate the frequency, effectiveness, and safety of co-administrated atorvastatin and perindopril in routine care.
METHODS
We conducted a post hoc analysis of four Canadian, prospective, multi-center, observational studies assessing real-life effectiveness and safety of perindopril + atorvastatin in mild-to-moderate hypertensive patients with concomitant dyslipidemia over 16 weeks. The safety population comprised patients receiving one or more doses of free combination perindopril + atorvastatin; the full analysis set (FAS) received perindopril + atorvastatin at baseline, with one or more post-baseline systolic BP measurements while on treatment.
RESULTS
A total of 3541 and 3172 patients were included in the safety population and FAS, respectively. At the last observation carried forward, significant reductions in mean systolic BP (- 18.0 mmHg; p < 0.001) and diastolic BP (- 8.9 mmHg; p < 0.001) were observed; target BP was achieved by 73.1% of patients. Emergent adverse events (AEs) were reported in 8.0% of patients, the most common being cough (4.5% of patients), headache (0.9%), and dizziness (0.8%). Four serious AEs were reported among three (0.1%) patients. No differences were observed in effectiveness or safety between studies.
CONCLUSIONS
Concomitant perindopril + atorvastatin therapy demonstrated similar efficacy across all studies, with significant reductions in BP and achievement of target BP levels observed in a real-world setting. Results align with known safety profiles of atorvastatin and perindopril, with no unexpected AEs observed when compared with data from treatment with the individual drugs.
更新日期：2019-11-01
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