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

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.

2020 ◽  
Vol 25 (10) ◽  
pp. 4130
Author(s):  
Yu. A. Karpov ◽  
V. M. Gorbunov ◽  
N. A. Logunova

The article presents the main results of the Russian post-marketing multicenter open-label program TRICOLOR (Triple fixed-dose combination in the treatment of hypertension).Aim. To evaluate the antihypertensive efficacy and tolerability of the triple amlodipine/indapamide/perindopril fixed-dose combination, as well as the adherence of hypertensive (HTN) patients to this therapy in actual clinical practice.Material and methods. The program enrolled 1247 outpatients aged 18 to 79 of both sexes with essential HTN. All patients included in the study receive amlodipine/ indapamide/perindopril fixed-dose combination. The patient’s condition was assessed according to four visits: visit 1 — at inclusion, visit 2 — after 2 weeks, visit 3 — after 4 weeks, visit 4 — after 12 weeks of follow-up. At each visit, the achievement of the target blood pressure (BP) <140/90 mm Hg and <130/80 mm Hg. At enrollment and visit 4, quality of life was analyzed using the SF-36 questionnaire and adherence to therapy using a validated 6-question questionnaire.Results. After 12 weeks, a significant decrease in systolic and diastolic BP was recorded — by 33,5 and 14,3 mm Hg, respectively (p<0,001). Target BP <140/90 mm Hg after 12-week follow-up was achieved by the overwhelming majority (93,4%) of patients. After 12 weeks, the proportion of patients with good medical adherence increased from 18,8% to 49,0%, while the proportion of patients with low adherence, on the contrary, decreased from 46,3% to 5,1%.Conclusion. The results of the TRICOLOR program demonstrate a high antihypertensive efficacy, good tolerance and medical adherence of triple amlodipine/indapamide/perindopril fixed-dose combination in patients with essential HTN in actual clinical practice in Russia.


2021 ◽  
Vol 26 (9) ◽  
pp. 4657
Author(s):  
A. M. Shimkevich

This article discusses a case of using fixed-dose combination of ivabradine/metoprolol in actual clinical practice.


2017 ◽  
Vol 89 (8) ◽  
pp. 29-36
Author(s):  
O D Ostroumova

Aim. To study the effect of a fixed-dose combination of perindopril arginine/amlodipine (prestans) on the goal levels and variability of blood pressure (BP) according to its office visit-to-visit measurements and self-measurement (OVVM and SM) in a subgroup of 483 people from the population of the Russian observational SUPERIORITY program, most cases of whom are given the combination replacing the previously ineffective mono- and combination antihypertensive therapy (AHT). Subjects and methods. The subanalysis included data on 483 patients (34% men) aged 57.9±10.8 years with uncontrolled hypertension, who were both untreated and treated with antihypertensive mono- or combination therapy using a free or fixed-dose combination of 2—3 antihypertensive drugs and in whom the physicians decided to use prestans to correct AHT. The follow-up period was 24 weeks. Results. At the end of the investigation, the patients received prestans in the following doses: 5/5 mg (34% of the patients), 10/5 mg (39.5%), 5/10 mg (3.9%), and 10/10 mg (22%). In the analyzed patient group, the baseline BP was 160.8±8.8/92.6±7.4 mm Hg and dropped to 125.9±7.9/77.8±5.0 mm Hg at 24 weeks (p


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.


Kardiologiia ◽  
2014 ◽  
Vol 1_2014 ◽  
pp. 34-40
Author(s):  
Zh.D. Kobalava Kobalava ◽  
Y.V. Kotovskaya Kotovskaya ◽  
E.A. Troitskaya Troitskaya ◽  
E.A. Lukyanov Lukyanov ◽  
T.B. Dmitrova on Behalf of Physici Dmitrova ◽  
...  

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.


2018 ◽  
Vol 10 (3) ◽  
pp. 19-28 ◽  
Author(s):  
T. M. Ostroumova ◽  
V. A. Parfenov ◽  
O. D. Ostroumova ◽  
E. V. Borisova

Objective: to investigate the effect of indapamide/perindopril fixed-dose combination (FC) on 24-hour blood pressure (BP) and cognitive functions in antihypertensive treatment-naive middle-aged patients with uncomplicated grade 1–2 essential arterial hypertension (EAH) . Patients and methods. The open prospective study enrolled 25 patients (9 men and 16 women) aged 40–59 years with a diastolic BP of 90–109 mm Hg and/or a systolic BP of 140–179 mm Hg, as evidenced by routine measurements. As starting antihypertensive therapy, the patients received indapamide 1.25/perindopril 5 mg FC once daily in the morning; if necessary, after 2 weeks (if the routine blood pressure was ≥140/90 mm Hg) they took indapamide 2.5/perindopril 10 mg once daily in the morning. The follow-up period was 14–16 weeks. Before and at the end of the follow-up, the patients underwent 24-hour ambulatory BP monitoring (ABPM) and evaluation of cognitive functions using the Montreal Cognitive Assessment (MoCA), ten-words test (immediate and delayed word recall), verbal association test (literal and categorical associations), number connecting test (Trail making test (TMT), part A and numbers and letters connecting test (TMT) part B), and Stroop test. Results. At the end of the follow-up period, treatment with indapamide/perindopril fixed-dose combination showed a statistically significant reduction in BPs, as evidenced by routine measurements and ABPM (during 24-hour, and awake and sleep periods); a statistically significant cognitive improvement: an increase in the number of the so-called words in the ten-words test during both immediate (from 5.5±1.6 6.5±1.5 words; p=0.02 vs baseline) and delayed (from 6.2±1.7 to 7.4±1.4 words; p=vs baseline) recalls, a decrease in the performance time of TMTB (from 112.6±42.5 to 90.4±28.4 sec; p=0.02) and Stroop test Part 3 (from 135.5±50.1 to 112.6±19.6 sec; p=0.02), and a larger number of called words in the categorical associations test (from 6.5±2.4 to 8.1±2.9 words; p=0.02). Conclusion. The results obtained indicate that in treatment-naive middle-aged patients with EAH, indapamide/perindopril fixed-dose combination assures an effective reduction in BPs, as evidenced by routine measurements and ABPM, also improves cognitive functions, particularly attention, information processing speed, semantic memory, cognitive flexibility, and short-term and long-term memory.


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