Abstract
Introduction
In everyday medical practice, physicians often need to manage patients whose blood pressure is not well controlled. Those with a history of cerebrovascular disease are a high-risk group in need of rapid blood pressure control.
Methods
The PICASSO study was a real-life, observational trial involving 9257 inadequately treated hypertensive patients who were switched from previous therapy to the fixed-dose combination of perindopril 10 mg/indapamide 2.5 mg (PI) for 3 months. A subanalysis of data of 1117 hypertensive patients who met the clinical criteria of previous stroke or transient ischemic attack was performed. Twenty-four hour ambulatory blood pressure measurements (ABPMs) were also done in a small group of patients (n:38).
Results
At baseline, mean systolic/diastolic blood pressure (SBP/DBP) was 161.5 ± 15.2/93.1 ± 9.9 mmHg. After 1 month with the fixed dose of PI, average office SBP/DBP decreased to 140.0 ± 11.9/83.5 ± 7.7 mmHg. After 3 months, SBP/DBP had dropped to 132.9 ± 9.8/80.0 ± 6.2 mmHg, by 28.6 ± 15.5/13.1 ± 10.0 mmHg (p < 0.001). Blood pressure control rate (< 140/90 mmHg) was 67.3% after 3 months. When data were stratified by baseline blood pressure, decreases in SBP/DBP were statistically significant in patients with all grades (1–3) of hypertension. In patients previously treated with an angiotensin-converting enzyme inhibitor ± hydrochlorothiazide (n = 677), blood pressure decreased by 29.8 ± 15.5/13.3 ± 10.2 mmHg (p < 0.001). Decreases in 24-h ABPM values were also significant (n = 38). Treatment was well tolerated; only a few adverse events were recorded.
Conclusion
This study suggests that fixed combination perindopril 10 mg/indapamide 2.5 mg is an effective and well-tolerated treatment for patients with a history of stroke or transient ischemic attack.
Funding
EGIS Pharmaceuticals Plc.
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Acknowledgements
The authors acknowledge the contribution of all members of the PICASSO investigator group and would like to acknowledge the assistance of Bela Malomvölgyi, MD (medical advisor), and Norbert Habony, MD (coordinator).
Funding
PICASSO study was funded by EGIS Pharmaceuticals Plc. (Budapest, Hungary). The article processing charges were funded by Szívkatéterezés Győr Alapítvány. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis.
Authorship
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. The authors take responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.
Disclosures
Csaba András Dézsi and Csaba Farsang have nothing to disclose.
Compliance with Ethics Guidelines
All patients signed informed consent prior to enrollment in the study. The Ethics Committee of the Hungarian Medical Research Council (TUKEB no. 8-34812009-1018EKU (866/PII09.) approved the protocol. This article is based on previously conducted studies and does not contain any studies with human participants or animals performed by any of the authors.
Data Availability
The data sets during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Dézsi, C.A., Farsang, C. & on behalf of The PICASSO Investigators. Efficacy and Tolerability of Fixed-Dose Combination Perindopril/Indapamide in Hypertensive Patients with a History of Stroke or Transient Ischemic Attack: PICASSO Trial. Adv Ther 35, 644–654 (2018). https://doi.org/10.1007/s12325-018-0705-1
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DOI: https://doi.org/10.1007/s12325-018-0705-1