Abstract
Background
Inadequate blood pressure (BP) control remains a serious concern worldwide. Recent evidence suggests that the combination of a calcium channel blocker (CCB) with an angiotensin-converting enzyme inhibitor (ACEi) in patients with essential hypertension provides effective BP control with decreased adverse cardiac and renal events.
Objectives
This study was designed to quantitatively evaluate the efficacy and tolerability of a fixed dose combination of perindopril and amlodipine in the Kingdom of Saudi Arabia on a population of patients with essential hypertension, as well as to identify the predictors of BP control in this population.
Methods
This was an observational, multicenter, open-label cohort study of patients with essential hypertension with or without diabetes mellitus, treated with a fixed dose combination of perindopril and amlodipine. Patients were followed up in four-week intervals for a total of 12 weeks. They were initially started on the lowest dose of the ACEi/CCB combination and up-titrated at each follow-up according to their response to treatment. The primary end-point of the study was the percentage of patients with controlled BP at study termination (week 12).
Results
A total of 1996 patients completed the study. Both systolic blood pressure (SBP) and diastolic blood pressure (DBP) control was observed in 93.3 % of patients at week 12. As for the predictors of BP control, it was found that female gender was associated with more BP control [odds ratio (OR) = 1.76, 95 % CI: 1.14–2.70, p value = 0.01], whereas older age was associated with less BP control (OR = 0.98, 95 % CI: 0.96–1.00, p value = 0.02). Similarly, having type I and type II diabetes mellitus was also associated with less BP control (OR = 0.19, 95 % CI: 0.08–0.45, p < 0.0001 and OR = 0.33, 95 % CI: 0.22–0.48, p < 0.0001, respectively). In a qualitative assessment, both investigators and patients perceived efficacy and tolerability of perindopril/amlodipine to be excellent.
Conclusion
We found that a fixed combination of perindopril/amlodipine is effective in controlling BP in patients with essential hypertension, with older age, male gender, and diabetes mellitus being independent risk factors for less BP control.
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Acknowledgment
The authors acknowledge the contribution of all 200 participating medical centers in Saudi Arabia, as well as the recruiting physicians.
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Funding
This study was funded by Les Laboratoires Servier, Saudi Arabia.
Conflict of interest
A. Abdelhady and S. Khader received lecturing and consulting honorarium from Les Laboratoires Servier, Saudi Arabia. A. Albow and S. Sinnuqrut are employees of Les Laboratoires Servier. A. Abdelhady received grant for clinical work, travelled to ESH, Milano 2013 to present the poster, received payment for reviewing the data, received payment for reviewing the manuscript, as well as received payment for lectures from Servier.
Ethical approval
The study was descriptive in nature, and no intervention was carried out. Management of patients was based on the physicians’ discretion. Due to the inclusion of a number of physicians in private practice, the study didn’t undergo an Institutional Review Board review. Nevertheless, the conduct of the study was in accordance with the 1964 Helsinki Declaration. Data collected were secured in password protected computers, and access to these files was limited to the investigators conducting the study. Physicians included in this study consented on being part of this study, and their patients provided oral consent as well.
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Abdelhady, A., Khader, S., Sinnuqrut, S. et al. The Efficacy of Perindopril/Amlodipine in Reaching Blood Pressure Targets: Results of the CONTROL Study. Clin Drug Investig 36, 357–366 (2016). https://doi.org/10.1007/s40261-015-0370-y
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DOI: https://doi.org/10.1007/s40261-015-0370-y