scholarly journals A prospective and open label study of use of cilnidipine and chlorthalidone fixed dose combination in Indian hypertensive patients, intolerant or uncontrolled on amlodipine and hydrochlorothiazide combination

2017 ◽  
Vol 4 (6) ◽  
pp. 1522
Author(s):  
Suresh V. Sagarad ◽  
Hari Prasad S.
Keyword(s):  
Blood Pressure ◽  
Antihypertensive Efficacy ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Hypertensive Patients ◽  
Blood Pressures ◽  
Dose Combination

Background:Primary aim of this study was to evaluate the antihypertensive efficacy of the Cilnidipine and Chlorthalidone fixed dose combination in Indian hypertensive patients who are not controlled on traditionally used amlodipine and hydrochlorothiazide combination and also to evaluate the safety of this combination.Methods: A total of 70 eligible patients were enrolled in this prospective, open label study. The patients were given cilnidipine (10 mg) and chlorthalidone (12.5 mg) who had not achieved target blood pressure (140/90 mmHg) despite on amlodipine (5 mg) and hydrochlorothiazide (12.5mg) combination or are intolerant to the medication. The assessment was done at the end of 4 weeks and 8 weeks.Results: There were significant falls in the SBP (5.43±2.45 mmHg, P<0.05), and DBP (4.11±2.35 mmHg, P<0.05) at the end of 4 weeks as compared to those at the baseline. The trend was sustained at 8 weeks. No further significant fall in the SBP and DBP were noted after 4 weeks (5.43±2.45 and 5.22±2.38 mmHg at 4 weeks vs 4.11±2.35 and 4.01±2.23 mmHg at 8 weeks P=NS). The SBP target (140 mmHg) was achieved in 25 patients (35.71%). The DBP target (90 mmHg) was achieved in 18 patients (25.71%). The combined SBP and DBP target was achieved in 12 patients (17.14%). A similar fall in the SBP was observed in the subgroups which were analysed.Conclusions: The hypertensive patients who do not achieve the target blood pressures on amlodipine and hydrochlorothiazide can be switched to the cilnidipine and chlorthalidone combination. The combination is effective and well tolerated.

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.

scholarly journals MP121THE EFFECT OF CILNIDIPINE ON INTRADIALYTIC BLOOD PRESSURE IN INTRADIALYTIC HYPERTENSIVE PATIENTS: A MULTICENTER, PROSPECTIVE, RANDOMIZED, OPEN-LABEL STUDY

2017 ◽  
Vol 32 (suppl_3) ◽  
pp. iii472-iii472 ◽  
Author(s):  
Takayasu Ito ◽  
Naoki Fujimoto ◽  
Eiji Ishikawa ◽  
Kaoru Dohi ◽  
Michiyo Kiyohara ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Hypertensive Patients

Abstract 178: Byvalson Fixed-Dose Combination for the Treatment of Hypertension: A Comprehensive Review

2017 ◽  
Vol 10 (suppl_3) ◽  
Author(s):  
Charles E Wight ◽  
Nicole Jara ◽  
Chelsea Harlan ◽  
Paul Petrillo ◽  
Mara N Poulakos
Keyword(s):  
Blood Pressure ◽  
Phase I ◽  
Phase I Study ◽  
Fixed Dose Combination ◽  
Phase Iii ◽  
Fixed Dose ◽  
Open Label ◽  
Phase Iii Trial ◽  
Treatment Of Hypertension ◽  
Dose Combination

Purpose: Byvalson (nebivolol and valsartan), FDA approved in June 2016 for the treatment of hypertension, is the first combination beta blocker and ARB fixed-dose combination medication available. Two-thirds of patients with hypertension require more than one drug to achieve BP control. The combination of two antihypertensive medications has been associated with greater BP control, compliance, and reduced adverse effects. Nebivolol is a highly selective β1-adrenergic receptor antagonist with vasodilator properties and valsartan is an ARB. The objective of this study is to evaluate clinical efficacy and safety of this combination of BP-lowering medications in the treatment of hypertension. Methods: A comprehensive literature search was conducted to date utilizing MEDLINE and PUBMED with the following search terms: “nebivolol”, “valsartan”, and “hypertension” to retrieve clinical trials. The following three studies were found: a phase I randomized, open-label study investigating pharmacokinetic and pharmacodynamic interactions between nebivolol and valsartan; and two phase III studies evaluating the safety and efficacy of combination treatment: one is an open-label, single-arm study over 52 weeks and the other is a phase III randomized, placebo-controlled study comparing fixed-dose combination to nebivolol and valsartan alone over 8 weeks. Analysis of the study designs, methods, results, statistical analyses, and conclusions were properly conducted for appropriateness and validity. Results: The pharmacokinetic and pharmacodynamics parameters in the phase I study involving 30 patients had statistically significant steady-state PK interactions deemed not clinically significant, significant reductions in blood pressure (p≤0.005) and other PD interactions. A phase III trial (n=4161) showed significantly greater reductions from baseline at 8 weeks in DBP in the fixed-dose combination group than both nebivolol 40 mg (mean difference –1.2 mm Hg [95% CI, –2.3 to –0.1; p=0.030] and valsartan 320 mg (–4.4 mm Hg [95% CI, –5.4 to –3.3]; p<0.0001). SBP reductions were also significant (p<0.01). Another phase III trial (n=810) showed significant reductions from baseline at 52 weeks for SBP (-25.5±15.9 mm Hg) and for DBP (-19.0±8.7 mm Hg). 75.7% of nebivolol/valsartan and 57.8% of nebivolol/valsartan/HCTZ patients achieved a BP goal of <140/90. Conclusion: Both phase III trials evaluating the combination treatment of nebivolol and valsartan demonstrated long term safety, efficacy, and tolerability with significant reductions in systolic and diastolic blood pressure compared with monotherapy. The phase I study showed limited PK interactions, additive PD effects, and tolerability in healthy volunteers. As an initial therapy in patients with inadequately controlled blood pressure, Byvalson 5/80 mg taken orally once daily is a safe and effective treatment for the hypertension.

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