scholarly journals A ramipril/amlodipin és a lisinopril/amlodipin fix kombinációk a terápiahűség tükrében

2016 ◽  
Vol 157 (1) ◽  
pp. 30-34
Author(s):  
Gábor Simonyi ◽  
Tamás Ferenci

Introduction: Patient’s adherence has a great significance to reach target blood pressure values. The risk of cardiovascular adverse events decreases when patients are on target blood pressure. Aim: The aim of the authors was to investigate the one-year persistence of the ramipril/amlodipine and lisinopril/amlodipine fixed dose combination in hypertensive patients. Method: National Health Insurance Found prescriptions database of Hungary on pharmacy-claims between October 1, 2012 and September 30, 2013 was analyzed. The authors identified patients who filled prescriptions for fixed dose combinations of ramipril and amlodipine, and lisinopril and amlodipine prescribed for the first time, for the therapeutic indication of hypertension. Patients have not received antihypertensive therapy with similar active substances during one year before the study. To model the persistence, 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: During the study period, fixed dose combination antihypertensive therapy with ramipril plus amlodipine and lisinopril plus amlodipine was started in 10,449 and 20,276 patients, respectively. One-year persistence rate in patients taking ramipril and amlodipine as a fixed dose combination was 54%, whereas 36% in those on the fixed lisinopril and amlodipine combination. Considering only the 360-day study period, the mean duration of persistence was 271 days in patients on the ramipril based and 211 days on lisinopril based fixed dose combination. Analyzing persistence on treatment with these combinations showed that the actual rate of discontinuation was about twice higher during treatment with the lisinopril and amlodipine fixed dose combination compared with the use of the ramipril and amlodipine fixed dose combination (hazard ratio = 1.79, p<0.001). Conclusions: There is a significant difference between the one-year persistence of ramipril plus amlodipine and lisinopril plus amlodipine fixed dose combination in patients with hypertension. The result demonstrated that ramipril and amlodipine fixed dose combination has a favourable patients’ adherence as compared to lisinopril and amlodipine fixed dose combination. Orv. Hetil., 2016, 157(1), 30–34.

2017 ◽  
Vol 158 (42) ◽  
pp. 1669-1673 ◽  
Author(s):  
Gábor Simonyi ◽  
Tamás Ferenci

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.


2017 ◽  
Vol 158 (36) ◽  
pp. 1421-1425
Author(s):  
Gábor Simonyi ◽  
Tamás Ferenci ◽  
Mihály Medvegy ◽  
Roland Gasparics ◽  
Ervin Finta

Abstract: Introduction: In management of hypertension patient adherence is one of the most important factors. In hypertension the cardiovascular risk reduction can be reached only by prolonged and effective pharmacotherapy. Aim: To evaluate the persistence of one-year treatment of free and fixed-dose combination of perindopril/amlodipine in hypertension. Method: Information from the National Health Insurance of Hungary prescriptions database on pharmacy claims between October 1, 2012 and September 30, 2013 was analysed. Authors identified patients who filled prescriptions for free and fixed-dose combination of perindopril/amlodipine, prescribed for the first time for hypertension. Patients have not received antihypertensive therapy with similar active substances during the one year before. 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. Results: 109,248 patients met the inclusion criteria. Combination antihypertensive therapy with perindopril/amlodipine was started with a free or a fixed-dose combination of these agents in 19,365 and 89,883 patients, respectively. One year persistence rate in patients taking perindopril/amlodipine as a free combination was 27.15%, whereas it was 46.89% in those on the fixed-dose combination. Mean duration of persistence was 177.6 days in patients on the perindopril/amlodipine free, whereas 245.7 days on fixed-dose combination. Actual rate of discontinuation was approximately twice higher with the treatment of free, compared with the use of the fixed-dose combination (hazard ratio =1.94 [95% CI: 1.91–1.98], p<0.001). Orv Hetil. 2017; 158(36): 1421–1425.


2016 ◽  
Vol 157 (11) ◽  
pp. 425-429 ◽  
Author(s):  
Gábor Simonyi ◽  
Tamás Ferenci

Introduction: Hypertension and dyslipidemia are modifiable cardiovascular risk factors. In Hungary hypertension and dyslipidemia are quite frequent conditions. The patients’ adherence is very important factor to reach the targets. Aim: The aim of the authors was to investigate the one-year persistence of the atorvastatin therapy and atorvastatin and amlodipine fixed dose combination. Method: National Health Insurance Found prescriptions database of Hungary on pharmacy claims between October 1, 2012 and September 30, 2013 was analyzed. The authors identified patients who filled prescriptions for atorvastatin and amlodipine fixed dose combination and atorvastatin prescribed for the first time. Patients did not receive similar drugs for one year before the study. To model the persistence, 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: During the trial period, atorvastatin and atorvastatin plus amlodipine fixed dose combination was started in 192,579 and 24,433 patients, respectively. One year persistence rate in patients with atorvastatin and amlodipine fixed dose combination was 43%, and 21% in patients with atorvastatin therapy. The 360-days-restricted study period, the mean duration of persistence was 221.4 (SE: 0.894) days in patients on atorvastatin and amlodipine fixed dose combination and 153.0 days (SE: 0.297) in those on atorvastatin regimen. The hazard of discontinuation was almost twofold higher during treatment with atorvastatin therapy compared with the use of the atorvastatin and amlodipine fixed dose combination (hazard ratio = 1.85, p<0.0001). Conclusions: There is a significant difference between the one-year persistence of atorvastatin therapy and atorvastatin plus amlodipine fixed dose combination. The result demonstrate that atorvastatin and amlodipine fixed dose combination is favourable to reach double goals on blood pressure and LDL-cholesterol. Orv. Hetil., 2016, 157(11), 425–429.


2021 ◽  
Vol 26 (5) ◽  
pp. 4498
Author(s):  
V. M. Gorbunov ◽  
Yu. A. Karpov ◽  
E. V. Platonova ◽  
Ya. N. Koshelyaevskaya

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.


2016 ◽  
Vol 157 (16) ◽  
pp. 618-622
Author(s):  
Gábor Simonyi ◽  
Tamás Ferenci

Introduction: In treatment of type 2 diabetes mellitus it is important to reach glycaemic targets. The elements of this are the adequate diet and the patient’s adherence to medication. Aim: The aim of the authors was to investigate the one year persistence of the metformin monotherapy and sitagliptin/metformin fixed dose combination in type 2 diabetic patients. Method: National Health Insurance Found prescriptions database of Hungary on pharmacy-claims between October 1, 2012 and September 30, 2013 was analyzed. The authors identified patients who filled prescriptions for metformin monotherapy and fixed dose combinations of sitagliptin/metformin prescribed for the first time. Patients have not received similar drugs one year previous to study. To model the persistence, 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: During the trial period, metformin monotherapy or sitagliptin/metformin fixed dose combination was started in 63,386 and 10,039 patients, respectively. One year persistence rate in patients with metformin monotherapy was 30%, and 58% in patients with sitagliptin/metformin fixed dose combination. Considering only the 360-day study period, the mean duration of persistence was 173.4 days in patients on metformin monotherapy and 261.9 days on sitagliptin/metformin fixed dose combination. The hazard of discontinuation was more than twofold higher during treatment with metformin monotherapy compared with the use of the sitagliptin/metformin fixed dose combination (hazard ratio = 2.267, p<0.001). Conclusions: There is a significant difference between the one year persistence of metformin monotherapy and sitagliptin/metformin fixed dose combination in type 2 diabetic patients. The result demonstrated sitagliptin/metformin fixed dose combination has a favourable patients’ adherence as compared to metformin monotherapy. Orv. Hetil., 2016, 157(16), 618–622.


2021 ◽  
Vol 26 (9) ◽  
pp. 4651
Author(s):  
A. O. Konradi ◽  
A. S. Galyavich ◽  
V. V. Kashtalap ◽  
Yu. M. Lopatin ◽  
N. P. Lyamina ◽  
...  

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.


2019 ◽  
Vol 15 (4) ◽  
pp. 510-517 ◽  
Author(s):  
M. P. Savenkov ◽  
S. N. Ivanov ◽  
M. P. Mikhaylusova ◽  
M. V. Borschevskaya ◽  
A. M. Savenkova ◽  
...  

Аim. To study the efficacy, tolerability and safety of using a fixed dose combination of an ACE inhibitor lisinopril with a prolonged-action diuretic indapamide in patients with degree 1-2 hypertension.Material and methods. Patients (n = 32) with uncontrolled 1-2 degrees hypertension, moderate or high cardiovascular risk, without severe comorbid diseases, who were prescribed a fixed dose combination of lisinopril (5, 10 or 20 mg) and indapamide (1.5 mg) were included in the observational study. All patients had home monitoring of blood pressure and diuresis, as well as assessment of subjective tolerance of treatment and registration of adverse events within 3 months of observation. Assessment of changes in circadian fluctuations in blood pressure and diuresis, the frequency of achieving the target blood pressure at the outpatient stage, as well as the subjective tolerance of treatment and adverse events during a three-month follow-up.Results. Target blood pressure was achieved in 44.5% of patients taking the fixed dose combination of lisinopril 5 mg + prolonged-acting indapamide1.5 mg; 76.9% – in patients taking the combination of lisinopril 10 mg + indapamide 1.5 mg; 78,6% – in patients taking the combination of lisinopril 20 mg + indapamide 1.5 mg. The achieved antihypertensive effect was characterized by daily circadian stability, accompanied by an improvement in the initially impaired day and night diuretic profile (increase in the share of daytime diuresis by 29.6% and 22.3% with a decrease in the share of nighttime diuresis by 35% and 49% when using a combination with lisinopril 5 and 10 mg, respectively). The treatment was well tolerated by patients and did not cause the development of serious adverse events. Reported adverse events (non-intense dry cough, headache, general weakness) were transient and did not require correction or withdrawal of treatment.Conclusion. The fixed dose combination of the ACE inhibitor lisinopril (5, 10 or 20 mg) and the long-acting thiazide-like diuretic indapamide (1.5 mg) had good antihypertensive efficacy with improved circadian blood pressure and diuresis profiles, acceptable tolerance and safety of treatment, as well as a simple choice of doses of the drug components.


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