scholarly journals Beneficial Effects of Fixed-Dose Combination of Amlodipine and Atorvastatin in Patients with Concomitant Hypertension and Hypercholesterolemia: A Multi-Institutional Cohort Study

2021 ◽  
Author(s):  
Chia-Pin Lin ◽  
Fu-Chih Hsiao ◽  
Chia-Tung Wu ◽  
Yu-Sheng Lin ◽  
Shao-Wei Chen ◽  
...  
Keyword(s):  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Clinical Results ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Beneficial Effects ◽  
Significant Difference ◽  
Dose Combination ◽  
Concomitant Hypertension

Abstract Background Blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) are important risk factors for cardiovascular (CV) diseases and treating these factors simultaneously is recommended by current guidelines but only short-term clinical results were available. The objective of this study was to examine the longer-term efficacy and safety of fixed-dose combination (FDC) versus free combination of amlodipine and atorvastatin in patients with concomitant hypertension and hypercholesterolemia. Methods Patients with hypertension and hypercholesterolemia were stratified into three groups (FDC of amlodipine 5 mg/atorvastatin 10 mg [Fixed 5/10], FDC of amlodipine 5 mg/atorvastatin 20 mg [Fixed 5/20], and free combination of amlodipine 5 mg/atorvastatin 10 mg [Free 5/10]). After inverse probability of treatment weighting, the composite CV outcome, liver function, BP, LDL-C and glycated hemoglobin (HbA1c) changes were compared. Results A total of 1,788 patients were eligible for analysis and the mean follow-up period was 1.7 year. There was no significant difference in the composite CV outcome among the three groups during the 30-month follow-up period (Fixed 5/10 6.1%, Fixed 5/20 6.3% and Free 5/10 6.0%). The LDL-C level was significantly reduced in the Fixed 5/20 group (-35.7 mg/dL) compared to the Fixed 5/10 (-23.6 mg/dL) and Free 5/10 (-10.3 mg/dL) groups (P=0.001 and <0.001, respectively). The changes in HbA1c were similar among the three groups. Conclusions FDC of amlodipine and atorvastatin, especially the regimen with higher dosage of statin, significantly reduced the mid-term LDL-C level compared to free combination in patients with concomitant hypertension and hypercholesterolemia. Blood sugar level during the follow-up period was not significantly changed by this aggressive treatment strategy.

scholarly journals Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy

2019 ◽  
Vol 27 (6) ◽  
pp. 593-603 ◽  
Author(s):  
Christie M Ballantyne ◽  
Ulrich Laufs ◽  
Kausik K Ray ◽  
Lawrence A Leiter ◽  
Harold E Bays ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Statin Therapy ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Lipoprotein Cholesterol ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Low Density ◽  
Low Density Lipoprotein Cholesterol ◽  
Dose Combination

Aims The aim of this study was to evaluate the low-density lipoprotein cholesterol lowering efficacy and safety of a bempedoic acid 180 mg and ezetimibe 10 mg fixed-dose combination in patients with hypercholesterolemia and a high risk of cardiovascular disease receiving maximally tolerated statin therapy. Methods This phase 3, double-blind clinical trial enrolled adult patients at high risk of cardiovascular disease due to atherosclerotic cardiovascular disease, heterozygous familial hypercholesterolemia, or multiple cardiovascular disease risk factors. Patients were randomly assigned (2:2:2:1) to treatment with the fixed-dose combination, bempedoic acid 180 mg, ezetimibe 10 mg or placebo added to stable background statin therapy for 12 weeks. The primary efficacy endpoint was the percentage change from baseline to week 12 in low-density lipoprotein cholesterol. Results Among the 301 patients included in the primary analysis, the mean baseline low-density lipoprotein cholesterol level was 3.87 mmol/L (149.8 mg/dL). At week 12, the fixed-dose combination lowered low-density lipoprotein cholesterol (–36.2%) significantly more than placebo (1.8% (placebo-corrected difference –38.0%); P < 0.001), ezetimibe alone (–23.2%; P < 0.001) or bempedoic acid alone (–17.2%; P < 0.001). The fixed-dose combination lowered low-density lipoprotein cholesterol levels similarly across subgroups, including patients receiving high-intensity, other-intensity or no statin therapy. Improvements with the fixed-dose combination were also observed in secondary efficacy endpoints, including high-sensitivity C-reactive protein. In this trial, fixed-dose combination treatment had a generally similar safety profile compared with bempedoic acid, ezetimibe or placebo. Conclusion The bempedoic acid and ezetimibe fixed-dose combination significantly lowered low-density lipoprotein cholesterol versus placebo or other oral monotherapies and had a favourable safety profile when added to maximally tolerated statin therapy in patients with hypercholesterolemia and high cardiovascular disease risk. Trial Registration ClinicalTrials.gov identifier: NCT03337308.

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 The novel bronchodilator navafenterol: a phase 2a, multi-centre, randomised, double-blind, placebo-controlled crossover trial in COPD

2021 ◽  
pp. 2100972
Author(s):  
Dave Singh ◽  
Jutta Beier ◽  
Carol Astbury ◽  
Maria G. Belvisi ◽  
Carla A. Da Silva ◽  
...  
Keyword(s):  
Adverse Events ◽  
Mean Difference ◽  
Beta Agonist ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Double Blind ◽  
Once Daily ◽  
Significant Difference ◽  
Dose Combination ◽  
Severe Copd

BackgroundNavafenterol (AZD8871) belongs to a new class of bronchodilator, the single-molecule muscarinic antagonist and beta agonist (MABA), being developed for the treatment of chronic obstructive pulmonary disease (COPD). This study aimed to evaluate the efficacy, pharmacokinetics and safety of navafenterol versus placebo and an active comparator treatment for moderate-to-severe COPD.MethodsThis phase 2a, randomised, multicentre (Germany and UK), double-blind, double-dummy, three-way complete crossover study (ClinicalTrials.gov identifier: NCT03645434) compared 2 weeks’ treatment of once-daily navafenterol 600 µg via inhalation with placebo and a fixed-dose combination bronchodilator (umeclidinium/vilanterol [UMEC/VI]; 62.5 µg/25 µg) in participants with moderate-to-severe COPD. The primary outcome was change from baseline in trough FEV1 on day 15. Secondary endpoints included: change from baseline in peak FEV1; change from baseline in breathlessness, cough and sputum scale (BCSS); change from baseline in COPD assessment tool (CAT); adverse events; and pharmacokinetics.ResultsSeventy-three participants were randomised. After 14 days, trough FEV1 was significantly improved with navafenterol compared with placebo (least-squares [LS] mean difference 0.202 L; p<0.0001). There was no significant difference in FEV1 between navafenterol and UMEC/VI (LS mean difference −0.046 L; p=0.075). COPD symptoms (CAT and BCSS) showed significantly greater improvements with both active treatments versus placebo (all p<0.005). Novel objective monitoring (VitaloJAK) showed that cough was reduced with both active treatments compared with placebo. Safety profiles were similar across the treatment groups and no serious adverse events were reported in the navafenterol treatment period.ConclusionOnce-daily navafenterol was well tolerated, improved lung function and reduced COPD-related symptoms, similar to an established once-daily fixed-dose combination bronchodilator.

scholarly journals Effect of a fixed-dose combination of perindopril arginine/amlodipine on the level and variability of blood pressure according to its office visit-to-visit measurements and self-measurements at home: A subanalysis of the PREVOSHODSTVO (SUPERIORITY) program

2017 ◽  
Vol 89 (8) ◽  
pp. 29-36
Author(s):  
O D Ostroumova
Keyword(s):  
Blood Pressure ◽  
Combination Therapy ◽  
Patient Group ◽  
Antihypertensive Drugs ◽  
Office Visit ◽  
Fixed Dose Combination ◽  
Uncontrolled Hypertension ◽  
Fixed Dose ◽  
Dose Combination

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

scholarly journals A comparison of treatment outcomes among HIV positive tuberculosis patients receiving DOTS and fixed dose combination in Visakhapatnam

2019 ◽  
Vol 6 (4) ◽  
pp. 1780
Author(s):  
Sai Sushma Kuppli ◽  
Devi Madhavi Bhimarasetty ◽  
Siva Kumar Lotheti
Keyword(s):  
Treatment Outcomes ◽  
Communicable Disease ◽  
Treatment Success ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Hiv Positive ◽  
Hiv Patients ◽  
Chi Square ◽  
Significant Difference ◽  
Dose Combination

Background: Tuberculosis is a communicable disease which requires special attention in HIV patients. According to newer guidelines, the treatment regimen for tuberculosis has been changed from intermittent DOTS to daily FDC. This study was taken up to explore effectiveness of fixed dose combination in comparison to intermittent DOTS. Objective was to compare the treatment outcomes for tuberculosis among HIV positive TB patients receiving intermittent DOTS with those receiving daily fixed dose combination (FDC).Methods: A retrospective cohort study was done during November 2017. The data was collected from patient records in an ART centre, attached to King George Hospital, Visakhapatnam. All the HIV patients newly registered for anti-tubercular treatment at the ART center, during 1st quarter of 2016(intermittent DOTS) were compared with those registered during 1st quarter of 2017(FDC). The treatment outcomes include (1) treatment success (completed/ cured), and (2) other treatment outcomes (lost to follow up (LFU), Death). Data was analysed using MS Excel. Association of factors affecting treatment outcomes was tested using chi-square test.Results: Out of a total 83 patients, 34 were on intermittent DOTS and 49 on FDC. The percentage of treatment success in intermittent DOTS was higher than FDC (p=0.06, chi-square value=3.42). The percentage of deaths in FDC is high when compared to intermittent DOTS (P=0.74, chi-square=3.1762). In subject receiving FDC, it was observed that more females had treatment success as compared to males (p=0.28, chi square=1.13).Conclusions: There is no statistically significant difference in the TB treatment outcomes of intermittent DOTS and FDC.

scholarly journals Az atorvastatin/amlodipin fix kombináció versus az atorvastatinterápia a terápiahűség tükrében

2016 ◽  
Vol 157 (11) ◽  
pp. 425-429 ◽  
Author(s):  
Gábor Simonyi ◽  
Tamás Ferenci
Keyword(s):  
Survival Analysis ◽  
Fixed Dose Combination ◽  
Combination Method ◽  
Fixed Dose ◽  
Pharmacy Claims ◽  
Significant Difference ◽  
Atorvastatin Therapy ◽  
Dose Combination ◽  
One Year ◽  
The One

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.

scholarly journals Cefixime and Ofloxacin fixed dose combination induced petechial rash: a case report

2016 ◽  
Vol 6 (1) ◽  
pp. 211
Author(s):  
Sudhir Kumar ◽  
Kirti Nirmal ◽  
Amit Kumar Nirmal ◽  
S. K. Bhattacharya
Keyword(s):  
Case Report ◽  
Male Patient ◽  
Fixed Dose Combination ◽  
Local Application ◽  
Fixed Dose ◽  
Petechial Rash ◽  
Patient Reported ◽  
Dose Combination

Petechial rash is a type of rash which is associated with many infectious and non-infectious conditions. We present a case of Petechial rash induced by administration of cefixime with ofloxacin tablet. A eighteen year old male patient reported to us with a presentation of rash with itching for three days on administration of the fixed dose combination of cefixime + ofloxacin along with paracetamol for the previous symptoms of fever with chills, headache and bodyache. Patient describes itching in the rash which is increasing. The duty doctor attended the patient and immediately stopped the further administration of the offending medication. The patient was prescribed tablet cetirizine orally along with calamine lotion for local application. The patient reported back in for follow-up and was without any residual rashes or other such complaints. He was advised to remember and cautious from the use of drugs in the offending category.

scholarly journals Triple fixed-dose combination in the treatment of hypertension: the results of the Russian observational study TRICOLOR

2020 ◽  
Vol 25 (10) ◽  
pp. 4130
Author(s):  
Yu. A. Karpov ◽  
V. M. Gorbunov ◽  
N. A. Logunova
Keyword(s):  
Clinical Practice ◽  
Antihypertensive Efficacy ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Medical Adherence ◽  
Open Label ◽  
Actual Clinical Practice ◽  
Treatment Of Hypertension ◽  
Dose Combination

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.

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