Our objective was to determine the effectiveness of a perindopril/indapamide (Per/Ind) single-pill combination (SPC) in a broad range of patient profiles, including subgroups with varying hypertension severity, age and cardiovascular risk profiles.
Patient data from four large prospective observational studies (FORTISSIMO, FORSAGE, PICASSO, ACES) were pooled. In each study, patients already treated for hypertension were switched to Per/Ind 10/2.5 mg SPC and systolic and diastolic blood pressure (SBP/DBP) measured at the 1-month (M1) and 3-month (M3) visits. Study endpoints included change in SBP and DBP from baseline to M1 and M3 and the percentage of patients achieving BP control (SBP/DBP < 140/90 mmHg for patients without diabetes or < 140/85 mmHg for patients with diabetes).
A total of 16,763 patients were enrolled and received Per/Ind (94% received the full dose of 10/2.5). Mean patient age was 61.4 years (36% were ≥ 65 years old), 57% were women, and 16% had isolated systolic hypertension (ISH). Mean baseline office SBP/DBP was 162/94 mmHg, and mean duration of hypertension was 11 years. Cardiovascular risk factors and comorbid conditions were common in this population. Significant mean reductions in SBP (− 23 mmHg) and DBP (− 11 mmHg) were observed at M1 compared with baseline (P < 0.001), which were maintained at M3 (− 30 mmHg and − 14 mmHg, respectively). At M3, BP control was achieved by 70% of patients (78% for ISH). In patients with SBP ≥ 180 mmHg at baseline (grade III hypertension), the mean SBP/DBP decrease was − 51/− 20 mmHg and 53% achieved BP control. Per/Ind was well tolerated with an overall rate of adverse events of 1.3%, most frequently cough and dizziness at rates of 0.3% and 0.2%, respectively.
In this hypertensive population including difficult-to-control patient subgroups, switching to Per/Ind 10/2.5 mg SPC led to rapid and important reductions in BP. BP control was achieved in 70% of patients overall in an everyday practice context.
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We thank the participants of the studies involved.
FORTISSIMO was sponsored by Servier, France. FORSAGE was sponsored by Servier, Russia. ACES and PICASSO were sponsored by Egis Pharmaceutical Ltd., Hungary. The hypertensive pooled analysis was sponsored by Servier (I.R.I.S.), France. The Journa’s Rapid Service Fee was funded by Servier, France.
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
Medical Writing and Editorial Assistance
Editorial assistance was provided by Jeremy Grierson, PhD, and Jenny Grice, BSc, and funded by Servier, France.
Data from this study have previously been published as an abstract: Dézsi CA et al., Effectiveness of perindopril/indapamide single-pill combination in uncontrolled hypertensive patients: a combined analysis of FORTISSIMO, FORSAGE, ACES and PICASSO observational studies [Abstract A11531]. Journal of Hypertension Vol 36, e-Supplement 3, October 2018.
Csaba András Dézsi has received fees from EGIS Pharmaceutical Ltd., Hungary, as a speaker. Glezer MG has received fees from Servier as a speaker and an investigator. Karpov YA has received fees from Servier as a speaker and an investigator. Brzozowska-Villatte R is a Servier Global Medical Affairs employee. Farsang C has received fees from Servier as a speaker and an investigator.
Compliance with Ethics Guidelines
All diagnostic procedures were performed based on written informed patient consent. The studies were conducted in accordance with the principles of Good Clinical Practice (GCP) and the Declaration of Helsinki. The study protocols were approved by the ethical committees in all participating clinical sites (full list of IRBs included as Supplementary material).
The datasets generated and/or analysed for this study are not publicly available as they include medical records of patients from a secondary source.
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Dézsi, C.A., Glezer, M., Karpov, Y. et al. Effectiveness of Perindopril/Indapamide Single-Pill Combination in Uncontrolled Patients with Hypertension: A Pooled Analysis of the FORTISSIMO, FORSAGE, ACES and PICASSO Observational Studies. Adv Ther 38, 479–494 (2021). https://doi.org/10.1007/s12325-020-01527-3
- Angiotensin-converting enzyme inhibitor
- Blood pressure control
- Cardiovascular risk
- Single-pill combination
- Thiazide-like diuretic