I-ADD Study: Assessment of Efficacy and Safety Profile of Irbesartan/Amlodipine Fixed-Dose Combination Therapy Compared With Irbesartan Monotherapy in Hypertensive Patients Uncontrolled With Irbesartan 150 mg Monotherapy: A Multicenter, Phase III, Prospective, Randomized, Open-Label With Blinded–End Point Evaluation Study

2012 ◽  
Vol 34 (8) ◽  
pp. 1720-1734.e3 ◽  
Author(s):  
Guillaume Bobrie
Keyword(s):  
Combination Therapy ◽  
Evaluation Study ◽  
Phase Iii ◽  
Fixed Dose ◽  
Efficacy And Safety ◽  
Open Label ◽  
Hypertensive Patients ◽  
Point Evaluation ◽  
Multicenter Phase ◽  
Dose Combination

scholarly journals Practical efficacy and safety of Konsilar D24 in patients with hypertension: data from the KONSONANS program

2021 ◽  
Vol 26 (9) ◽  
pp. 4651
Author(s):  
A. O. Konradi ◽  
A. S. Galyavich ◽  
V. V. Kashtalap ◽  
Yu. M. Lopatin ◽  
N. P. Lyamina ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Antihypertensive Therapy ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Baseline Body Mass Index ◽  
Efficacy And Safety ◽  
Open Label ◽  
Hypertensive Patients ◽  
Dose Combination

Aim. In practice, to evaluate the efficacy, safety and long-term adherence to therapy with a fixed-dose combination of ramipril/indapamide (Konsilar-D24) in patients with grade 1-2 hypertension (HTN) who have not achieved blood pressure (BP) control with prior therapy or have not taken antihypertensive therapy.Material and methods. This multicenter open-label observational program included 524 patients with grade 1-2 HTN who did not take antihypertensive therapy or did not reach the target BP level with mono or dual antihypertensive therapy, as well as patients shifted to Konsilar-D24 therapy no later than two weeks before the start of the program. All patients signed a written informed consent to participate in the program. The safety analysis set includes all patients who have taken at least one dose of a fixed-dose combination of ramipril/indapamide and have visited physician at least once during the program. The effectiveness analysis set included all patients in the safety population who completed the study in accordance with protocol (n=511). Clinical systolic blood pressure (SBP), diastolic BP (DBP) and heart rate were assessed at baseline, as well as at 0,5, 1, 3 and 6 months of treatment. A post hoc subgroup analysis of changes in BP and heart rate was performed depending on age, sex and baseline body mass index.Results. The fixed-dose combination of ramipril with indapamide significantly reduced SBP and DBP after 2-week treatment (-20,9±10,1 mm Hg; pConclusion. Despite the limitations inherent in observational studies, the KONSONANS program has demonstrated high efficacy and safety of fixed-dose combination of ramipril/indapamide taken once a day in hypertensive patients. Ramipril/indapamide fixed-dose combination therapy significantly improved BP control and achieved even lower individual target BP levels in the majority of hypertensive patients.

scholarly journals A ramipril versus ramipril/amlodipin fix kombináció egyéves perzisztenciája hypertoniás betegekben

2017 ◽  
Vol 158 (42) ◽  
pp. 1669-1673 ◽  
Author(s):  
Gábor Simonyi ◽  
Tamás Ferenci
Keyword(s):  
Blood Pressure ◽  
Survival Analysis ◽  
Combination Therapy ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Hypertensive Patients ◽  
Persistence Rate ◽  
Dose Combination ◽  
One Year ◽  
The One

Abstract: Introduction: In the treatment of hypertension avoiding adverse cardiovascular complications to achieve target blood pressure is essential. The appropriate drug selection, and if necessary to change to combination therapy, patients adherence is important which may help fixed dose combination. Aim: The aim of the authors was to investigate the one year adherence of the ramipril and ramipril/amlodipine fixed dose combination in hypertensive patients. Method: Prescriptions database of the National Health Insurance Fund in Hungary on pharmacy-claims was analysed between October 1, 2012 and September 30, 2013. The authors identified patients who filled prescriptions for ramipril monotherapy and fixed dose combinations of ramipril/amlodipine prescribed for the first time in hypertensive patients who have not received similar drugs in the previous year. To model the adherence, the apparatus of survival analysis was used, where “survival” was the time to abandon the medication. As it was available to month precision, discrete time survival analysis was applied: a generalized linear model was estimated with complementary log-log link function with the kind of drug being the only explanatory variable. Results: 92,546 patients met the inclusion criteria. During the trial period, ramipril therapy or ramipril/amlodipine fixed dose combination was started in 82,251 and 10,295 patients, respectively. One year persistence rate in patients with ramipril was 30% and 54% in patients with ramipril/amlodipine fixed dose combination therapy. Considering only the 360-day study period, the mean duration of persistence was 189.9 days in patients on ramipril and 270.6 days on ramipril/amlodipine fixed dose combination therapy. The hazard of discontinuation was more than twofold higher during treatment with ramipril compared with the use of the ramipril/amlodipine fixed dose combination therapy (HR = 2.11 [95% CI: 2.05–2.17], p<0,001). Conclusions: There is a significant difference between the one year persistence of ramipril and ramipril/amlodipine fixed dose combination therapy in hypertension. The result demonstrated that ramipril/amlodipine fixed dose combination therapy has a better one year persistence rate. When the next step is necessary to achieve target blood pressure, ramipril/amlodipine fixed dose combination therapy is preferable. Orv Hetil. 2017; 158(42): 1668–1673.

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