Switching from a Free Association of Perindopril/Amlodipine to a Fixed-Dose Combination: Increased Antihypertensive Efficacy and Tolerability.
OBJECTIVE
Although single-pill, fixed-dose combinations (FDCs) are widely endorsed for the reduction of blood pressure and cardiovascular risk, studies to date have not evaluated the differences between FDCs and free associations using matched drugs and doses. The objective of this study was to determine whether switching from a free association of perindopril/amlodipine to the FDC formulation led to significant improvements in efficacy and tolerability.


METHODS
In this subanalysis of the previously published SYMBIO study, we looked at the effect of switching patients from a free association of perindopril/amlodipine to an equivalent dose of FDC (N = 335). In the SYMBIO study, concomitant antihypertensive medications were allowed; however, they remained unchanged till the end of the study. Blood pressure was measured at baseline, 1, and 3 months. Targets were defined as blood pressure <140/90 mmHg or <130/80 mmHg for patients with type 2 diabetes mellitus or at high cardiovascular risk.


RESULTS
Compared to baseline, mean blood pressure decreased significantly after 1 and 3 months of treatment with FDC perindopril/amlodipine. Mean changes from baseline were -15.6 ± 14.3/-7.7 ± 9.1 mmHg at 1 month (p < 0.0001) and -23.3 ± 16.4/-11.3 ± 9.8 mmHg at 3 months (p < 0.0001). The percentage of patients who reached their blood pressure target increased from 16.0 % at baseline to 50.6 % at 1 month, to 75.9 % at 3 months. The incidence of ankle edema decreased from 14.9 % at baseline, to 9.9 % at 1 month, to 5.4 % at 3 months. The relative risk reduction for ankle edema was -37.5 % at 1 month (vs. baseline; p < 0.001) and -57.2 % at 3 months (vs. baseline; p < 0.001).


CONCLUSIONS
These data suggest that switching from a free association of perindopril/amlodipine to the same dose of the FDC formulation led to significant improvements in efficacy and tolerability.
P.J. Safarik University School of Medicine, Kosice, Slovakia. hatalova@cardioconsult.sk.|Cardioconsult-Cardiology Clinics, Cajkovskeho 5, 81104, Bratislava, Slovakia. hatalova@cardioconsult.sk.
Katarina
K
Hatalova
P.J. Safarik University School of Medicine, Kosice, Slovakia.|First Department of Internal Medicine, Louis Pasteur Hospital, Kosice, Slovakia.
Daniel
D
Pella
Department of Statistics, Faculty of Economic Informatics, Economic University, Bratislava, Slovakia.
Rastislav
R
Sidlo
National Cardiovascular Institute and Slovak Medical University, Bratislava, Slovakia.
Robert
R
Hatala
D000328:Adult; D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure; D015331:Cohort Studies; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D004338:Drug Combinations; D004487:Edema / Q000453:epidemiology / Q000209:etiology; D005260:Female; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000188:drug therapy*; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D020913:Perindopril / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D012307:Risk Factors
D000959:Antihypertensive Agents; D004338:Drug Combinations; C542336:amlodipine, perindopril drug combination; D017311:Amlodipine; D020913:Perindopril