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 Efficacy and Safety of Triple Drug Fixed-Dose Combination of Telmisartan, Amlodipine and Hydrochlorthiazide in the Management of Hypertension

2015 ◽  
Vol 16 (1) ◽  
pp. 18-22
Author(s):  
Faruqui A Arif ◽  
A Amlaselvam ◽  
Renuka Sriram
Keyword(s):  
Blood Pressure ◽  
Systolic Blood Pressure ◽  
Fixed Dose Combination ◽  
Antihypertensive Drug Therapy ◽  
Fixed Dose ◽  
Age Group ◽  
Optimal Management ◽  
Efficacy And Safety ◽  
Hypertensive Patients ◽  
Dose Combination

Effective BP control is far away from reality in many patients in spite of advancements in many classes of antihypertensive drug therapy. Use of triple drug combination in the management of hypertension have already been established, however this study was conducted to evaluate the efficacy and safety of triple drug fixed dose combination of Telmisartan 40 mg, Amlodipine 5 mg and Hydrochlorothiazide 12.5mg. 69 hypertensive patients with seating cuff systolic blood pressure e” 160 mmHg and diastolic blood pressure e”100 mmHg were enrolled in the study. Patients were prescribed to take triple drug fixed dose combination for 120 days. Patients were evaluated on 30th, 60th and 120th days of treatment. There was statistically significant (p<0.0001) decrease in systolic blood pressure from baseline to 30th, 60th and 120th day of treatment mean±SD (166±18.6 mmHg vs.147±16.1, 137±14.7 and 130±13.9 mmHg) respectively. Similar to SBP, decrease in DBP was highly significant (p<0.0001) from the baseline to the 30th, 60th and 120th day of treatment (104±11.5 mmHg vs. 93.7±12.3, 89±10.2 and 84.5±8.98 mmHg respectively). Moreover at the end of the study period of 120 days 85.7% and 87.8% patients of age group >60 years and <60 years respectively achieved the JNC VIII recommended goal. This triple drug fixed dose combination of Telmisartan, Amlodipine and hydrochlorothiazide was found to be effective and safe option for the optimal management of hypertension.DOI: http://dx.doi.org/10.3329/jom.v16i1.22383 J MEDICINE 2015; 16 : 18-22

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 An observational comparative study of different doses of azilsartan and with chlorthalidone combination in moderate hypertension

2019 ◽  
Vol 8 (2) ◽  
pp. 259
Author(s):  
Tamoghna Maiti ◽  
Sonai Mandal ◽  
Ratul Banerjee ◽  
Sourav Chakrabarty ◽  
Amrita Panda
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Antihypertensive Agents ◽  
Fixed Dose ◽  
High Dose ◽  
Hypertensive Patients ◽  
Medical College ◽  
Fda Approval ◽  
High Prevalence ◽  
Dose Combination

Background: High blood pressure (BP) is one of the significant non-communicable diseases that are of high prevalence in our country. Hypertension (HTN) is responsible cause of 57% of stroke and 24% of coronary heart disease deaths in India. Eight classes of medications are currently used in the treatment of hypertension. Azilsartan medoxomil is a newly added FDA approved drug to the ARB class of antihypertensive agents. azilsartan and chlorthalidone combination is also got the FDA approval. There is limited study in between these two groups regarding efficacy especially in rural Bengal.Methods: A prospective observational study was done in medicine OPD of Bankura Sammilani Medical College for twelve weeks with two groups that are azilsartan (80mg) and fixed dose combination of azilsartan (40mg) plus chlorthalidone (12.5mg) in the age group of 18 to 55years of moderate hypertensive patients. Change of heart rate was assessed as safety parameter.Results: It was found that both the group of drugs are very much effective in lowering blood pressure constantly in respect of both systolic and diastolic BP but azilsartan monotherapy in high dose reduce systolic blood pressure slightly high. Significant change of heart rate was not seen with both the groups.Conclusions: Both the group was effective as well as safe in hypertensive patients.

scholarly journals Twenty-four-hour and office blood pressure measurement in a comprehensive assessment of the effectiveness of 12-week therapy with a triple fixed-dose combination of amlodipine/indapamide/perindopril in hypertensive patients in actual clinical practice

2021 ◽  
Vol 26 (5) ◽  
pp. 4498
Author(s):  
V. M. Gorbunov ◽  
Yu. A. Karpov ◽  
E. V. Platonova ◽  
Ya. N. Koshelyaevskaya
Keyword(s):  
Blood Pressure ◽  
Clinical Practice ◽  
Antihypertensive Therapy ◽  
Blood Pressure Measurement ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Actual Clinical Practice ◽  
Dose Combination ◽  
The Mean

Aim. To study the efficacy and safety of the triple fixed-dose combination (FDC) of amlodipine/indapamide/perindopril on blood pressure (BP) profile in patients with grade I-II hypertension (HTN) in actual clinical practice.Material and methods. Data from 54 patients with paired 24-hour ambulatory BP monitoring (ABPM) data were included in the TRICOLOR subanalysis (ClinicalTrials. gov study ID — NCT03722524). The mean 24-hour, daytime, and nighttime BP were calculated at baseline and after 12-week follow-up. We determined the proportion of patients with nocturnal HTN (≥120/70 mm Hg) and nocturnal hypotension (<100/60 and <90/50 mm Hg) initially and after 12 weeks of triple FDC therapy. Patients with nocturnal BP decrease included dippers (D; 10-20%), reduced dippers (RD; 0-10%) and extreme dippers (ED; >20%), as well as those without nocturnal BP decrease (>0%, non-dipper (ND)). The smoothness index (SI) was analyzed as the ratio of the mean hourly SBP fall to its mean standard deviation in paired ABPM. To assess the BP phenotypes, two methods were used with reference values of <130/80 and <140/90 mm Hg for ABPM and office BP, respectively. Controlled hypertension (CHT), uncontrolled hypertension (UHT), white coat hypertension (WHT) and masked ineffectiveness of antihypertensive therapy were distinguished.Results. Among 1247 participants of the TRICOLOR study, 54 patients with valid paired ABPM were selected (men, 46%; mean age, 57,7 [12,1] years; mean office BP, 150,4 [16,6]/93,3 [10,7] mm Hg; HTN duration, 8,3 [7,5] years). Initially, the mean 24-hour, daytime and nighttime BP was 141,1 [15,4]/85,9 [9,9], 144,2 [15,5]/88,8 [10,5] and 132,6 [18,0]/78,1 [9,9] mm Hg, respectively. After 12-week follow-up, the mean 24-hour, daytime and nighttime BP was 123,1 [10,5]/75,6 [8,5], 125,7 [10,9]/77,9 [8,7] and 115,4 [10,2]/68,6 [8,8] mm Hg, respectively (p<0,001). After 12-week follow-up, the proportion of patients with nocturnal hypertension decreased from 64,8% to 25,0% (2,6 times) (p<0,001). The proportion of NDs and EDs decreased from 16,7% and 7,4% to 5,8% and 0%, respectively (p=0,048); the proportion of patients with RD and D patterns increased from 42,6% and 33,3 to 57,7% and 36,5%, respectively (p=0,048). With triple FDC therapy, the SI during the day was higher than 0,73 in half of the cases. According to the two methods, the proportion of patients with UHT decreased from 81,6% to 4,4%, WHT from 12,2% to 0%. The prevalence of CHT increased from 4,1% to 57,8%, while masked ineffectiveness of antihypertensive therapy — from 2,0% to 37,8%.Conclusion. Twelve-week FDC therapy of amlodipine/indapamide/perindopril led to a significant fall in the mean 24-hour, daytime and nighttime BP values. Comprehensive analysis of two techniques (24-hour and office BP measurement) identified patients requiring further triple FGC titration.

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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