scholarly journals Real-world evidence on the strategy of olmesartan-based triple single-pill combination in Korean hypertensive patients: a prospective, multicenter, observational study (RESOLVE-PRO)

2021 ◽  
Vol 27 (1) ◽  
Author(s):  
Il Suk Sohn ◽  
Sang-Hyun Ihm ◽  
Gee Hee Kim ◽  
Sang Min Park ◽  
Bum-Kee Hong ◽  
...  

Abstract Background In this prospective, multicenter, non-comparative observational study, the effectiveness and safety of the triple single-pill combination (SPC) of olmesartan/amlodipine/hydrochlorothiazide (OM/AML/HCTZ) were evaluated in a real clinical practice setting in Korean patients with essential hypertension. Methods A total of 3752 patients were enrolled and followed for 12 months after administration of OM/AML/HCTZ. Primary endpoint was change from baseline to month 6 in the mean systolic blood pressure (SBP). Secondary endpoints included changes from baseline in the mean SBP at month 3, 9, 12 and the mean diastolic blood pressure (DBP) at month 3, 6, 9, 12; changes in the mean SBP/DBP according to age and underlying risk factors; and blood pressure control rate (%) at different time points. Adherence to and satisfaction with OM/AML/HCTZ treatment among patients and physicians were assessed by medication possession ratio (MPR) and numeric rating scale, respectively, as exploratory endpoints. Safety was evaluated by the incidence and severity of adverse events (AEs) as well as the discontinuation rate due to AEs. Results OM/AML/HCTZ administration led to significant reductions in the mean SBP/DBP by 11.5/6.6, 12.3/7.0, 12.3/7.2, and 12.8/7.4 mmHg from baseline to month 3, 6, 9 and 12, respectively (P < 0.0001). The BP reductions were maintained throughout the 1-year observation period in all patients with different age groups and risk factors (diabetes mellitus, cardiovascular disease, and renal disease). The BP control rate (%) of < 140/90 mmHg was 65.9, 67.9, 68.9, and 70.6% at month 3, 6, 9, and 12, respectively. The mean MPR during the observation period was 0.96. The safety results were consistent with the previously reported safety profile of OM/AML/HCTZ. Conclusions Treatment with the triple SPC of OM/AML/HCTZ demonstrated significant effectiveness in reducing SBP/DBP and achieving target BP control with high adherence over the 1-year observation period in Korean hypertensive patients and was well-tolerated. Trial registration CRIS, KCT0002196, Registered 3 May 2016.

2014 ◽  
Vol 6 (2) ◽  
pp. 112-115
Author(s):  
MAK Akanda ◽  
KN Choudhury ◽  
MZ Ali ◽  
LA Sayami ◽  
RM Huda

Back ground: Hypertension is one of the most important modifiable risk factors for cardiovascular disease (CVD) and stroke. Dyslipidemia is closely associated with hypertension. Dyslipidemia and hypertension are the commonest risk factors for CVD. The aim of the present study was to compare different lipid parameters among newly diagnosed hypertensive patients with normotensive subjects in Bangladesh and find out the relationship. Methods: This study was a cross sectional study in which 42 newly diagnosed hypertensive patients who were on no antihypertensive medication and 42 subjects with normal blood pressure (normotensive) were enrolled for compare. Lipid parameters total cholesterol (TC), triglyceride (TG), low density lipoprotein ( LDLc) and high density lipoprotein (HDLc) were estimated by Enzymatic colorimetric test. Results: The mean systolic blood pressure of hypertensive and normotensive were 154.6±22.5 vs111.50±3.42 mmof.Hg and mean diastolic blood pressure were 93.2±5.20 vs 71.44± 3.21mm of Hg. The mean of SBP and DBP of hypertensive patients was found to be higher than normotensive (p< 0.05). There was significant increase in different lipid levels namely TC 199.4±44.5 vs188.7±37.9 mg/dl, TG155.9±88.8 vs 121.9±73.2 mg/dl and LDLc 119.8±35.6 vs112.7±28.6 mg/dl in hypertensive patients as compared to normotensive (p<0.05). However there was no significant difference in HDLc level. BMI and waist circumference showed significant association in hypertensive patients (p<0.001). Conclusion: Analytical results of the study revealed that hypertensive patients have been found to have close association with dyslipidemia, BMI and waist circumference. Hypertension and dyslipidemia can be modified either by proper life style changes or medical management or by the combination of the both. This study suggests that hypertensive patients need measurement of blood pressure and lipid profile at regular interval to prevent heart diseases and stroke. DOI: http://dx.doi.org/10.3329/cardio.v6i2.18350 Cardiovasc. j. 2014; 6(2): 112-115


2020 ◽  
Vol 12 (2) ◽  
Author(s):  
Siti Suhaila MY ◽  
Juwita S ◽  
Harmy MY ◽  
Tengku Alina T

Introduction: Ambulatory blood pressure accurately reflects a patient's actual blood pressure than casual or office blood pressure. This study aims to describe the circadian blood pressure profile of hypertensive patients and to identify the associated cardiovascular risk factors in non-dippers. Methods: A cross-sectional study was conducted from 1st January 2008 to 30th June 2008 among hypertensive patients attending Family Medicine Clinic HUSM. Schiller BR-102 plus was used to get 24 hours blood pressure (BP) reading. Mean of two offices BP were also taken. Non-dippers are defined as a systolic or diastolic nocturnal drop of less than 10%. Analysis was done using SPSS Version 12. Results: 105 patients were recruited with mean (SD) age of 51.8 (9.34) year old. The mean (SD) 24-hour systolic and diastolic BP was 128.4 (12.7) mmHg and 79.7 (8.74) mmHg respectively. Mean (SD) daytime systolic and diastolic BP was 132.1 (11.72) mmHg and 82.4 (9.41) mmHg while for the night time were 123.3 (12.78) mmHg and 76.2 (9.01) mmHg. Mean (SD) systolic and diastolic office BP was 144.2(15.16) mmHg and 90.2(9.71) mmHg. Percentage of non dippers were 68.6% for systolic and 61.9% for diastolic. Conclusion: Mean 24 hours and daytime ambulatory BP was normal but the mean night time diastolic and office BP was above-normal value. Majority of the patients were categorized as non dippers. Therefore, using ambulatory BP is clinically important to get a better understanding of blood pressure fluctuations over 24-hour periods compared to simple clinical measurements.


2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Enver Atalar ◽  
Fatih Eskin ◽  
Haci Bayram Tugtekin ◽  
Alpaslan Karabulut ◽  
Suleyman Kanyilmaz ◽  
...  

Maintaining regular blood pressure control usually requires multidrug regimens rather than monotherapy. The objective of this study was to describe the effectiveness and safety of an angiotensin-converting enzyme inhibitor and a nondihydropyridine calcium channel blocker in a single-tablet combination in patients with hypertension, a heart rate higher than 70 beats/min, and type 2 diabetes mellitus (T2DM). This study was conducted in Turkey as a prospective, noninterventional, observational study. At 22 clinical sites, the data of 200 patients with hypertension were used for efficacy analysis; however, 262 patients received at least one dose of trandolapril/verapamil fixed-dose combination at two dose strengths. Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate, PR interval, glycated haemoglobin (HbA1c), and albumin/creatinine ratios were recorded during 8 weeks of treatment. With treatment, the mean (±SD) SBP that was recorded as 162.8 (±14.642) mm Hg at baseline was reduced to 131.7±11.1 mm Hg at week 8 (p<0.05). Similarly, the mean DBP was reduced from 93.76±9.16 mm Hg to 77.6±7.6 mm Hg (p<0.001). Following 8 weeks of treatment, SBP and DBP values were reduced below 140 mm Hg and 90 mm Hg in most patients (81.5%), respectively. The mean heart rate as evaluated using electrocardiography measurements was reduced to 78.25 beats/min at week 8 as compared with baseline during trandolapril/verapamil single-pill combination treatment (p<0.001). Treatment with trandolapril and verapamil was well tolerated over 8 weeks with no unexpected safety signals. In conclusion, the single-pill combination of trandolapril and verapamil was considered effective in reducing and controlling blood pressure in patients with hypertension and T2DM. There was a significant improvement in HbA1c and ACR levels in a smaller subgroup of the patient cohort. The trandolapril/verapamil combination was evaluated as being safe and well-tolerated following a treatment period of 8 weeks. This trial was registered with NCT02298556.


2021 ◽  
Vol 17 (4) ◽  
pp. 528-536
Author(s):  
M. P. Savenkov ◽  
S. N. Ivanov ◽  
M. V. Borschevskaya ◽  
I. N. Okuneva ◽  
S. V. Ivanova ◽  
...  

Aim. To study the prevalence of comorbidity affecting the choice of antihypertensive treatment, as well as the efficacy and safety of the application of a single pill combination of lysinopril, amlodipine and rosuvastatin (SPC LAR) in hypertensive patients.Material and methods. Observational epidemiological study with the participation of 626 doctors and 13037 hypertensive patients with high cardiovascular risk and dyslipidemia treated with SPC LAR were held in 24 cities of Russia from November 2020 to March 2021. Prevalence and types of comorbidity, changes of blood pressure (BP), of total cholesterol (TC) and blood glucose levels and adverse events were studied during observation. Patients had 3 visits – initially, after 4 and 12 weeks. The obtained data was recorded by doctors through a web portal.Results. Concominant cardiovascular diseases found in all patients (in 38.7% of cases – from 2 to 5 diseases). The most commonly diseases were coronary artery disease (43.1%), metabolic syndrome (36.6%), diabetes (25.2%), chronic heart failure (24.9%), cerebrovascular diseases (12.3%) and chronic obstructive pulmonary disease (0.5%). SPC LAR with minimal doses of components (in 41.1% of patients) or with reinforced antihypertensive or hypocholesterolemic effects, based on the experience of treatment, the patient was prescribed as starting treatment with doctors. Reducing the level of systolic and diastolic BP, as well as the level Tc, respectively, by 20.9%, 16.9% and 29.7% found during the study. Target levels of systolic BP were achieved in 97.6% of patients, diastolic BP – in 99.6%, and target levels TC ≤5 mmol/l, ≤4 mmol/l and ≤3 mmol/l were achieved, respectively, in 94.5%, 68.6% and 23.5% patients. No significant dynamics of the level of glycemia were not found. The treatment was well tolerated by patients. Side effects found in 0.53% of patients (more often there was a dry cough, feet edema and headache). Commitment to treatment was 92.7%.Conclusion. The modern hypertension phenotype has cardiovascular atherosclerosis-associated diseases, which justifies the need to combine antihypertensive and hypolipidemic therapy. Triple SPC LAR, which effectively controlled the blood pressure and improved the violation of lipid metabolism was prescribed to patients in this observational study. The low frequency of side effects and good tolerance of treatment was accompanied by a high adherence of patients to treatment. 


Hypertension ◽  
2012 ◽  
Vol 60 (suppl_1) ◽  
Author(s):  
Dayi Hu ◽  
Lisheng Liu ◽  
Weimin Li

BACKGROUND Single-pill combination (SPC) in hypertension treatment has been recommended in guidelines for its benefits on improving blood pressure (BP) control and reducing adverse events (AEs) by simplifying treatment. OBJECTIVE To evaluate efficacy and safety of valsartan/amlodipine SPC on BP control in Chinese hypertensive patients in a real-life practice setting. METHODS This is a multicenter, open-label, observational study in Chinese hypertensive patients. Adults (18 and older) who were not at BP goal (<140/90 mmHg for uncomplicated patients, and <130/80 mmHg for patients with diabetes and chronic kidney disease) on monotherapy were eligible to the study. Patients were treated with valsartan/amlodipine 80/5 mg SPC and were followed over 8 weeks with approximately monthly intervals between clinic visits. For patients not achieving BP goal at week 4, other antihypertensives might be added. RESULTS A total of 11,879 patients were recruited into the study. In this interim analysis (from October 12, 2010 to October 11, 2011), a total of 4,609 patients were included. Among them, 39 were excluded due to violation of inclusion criteria, 20 discontinued (9 due to AEs). In total, 4,562 were included in the analysis. Mean age was 57.6 years, 7.1% (324 of 4562) of patients aged ≥80. Overall, mean BP was reduced from 159.7/95.6 mmHg at baseline to 132.0/80.3 mmHg at week 8 (-27.7/-15.3 mmHg, P<0.0001). The magnitude of BP reduction increased by severity of baseline BP. Blood pressure goal was achieved in 67.4% (3076 of 4562) of patients. In patients aged 80 or over, 65.1% (211 of 324) achieved BP goal. Add-on antihypertensives were prescribed in 6.2% (283 of 4562) of patients with diuretics the most often used. Adverse events were reported in 2.2% (99 of 4604) of patients. Edema was reported in 12 patients (0.3%). Three patients experienced serious AEs, of which none were trial drug related. In patients aged ≥80, AEs were reported in 1.2% (4 of 327) of patients, with 2 trial drug related AEs (0.61%), 1 of hypotension and 1 of flush. CONCLUSION In this 1 st largest observational study in Chinese hypertensive patients, the interim analysis results showed that valsartan/amlodipine SPC was effective and safe on BP control in Chinese patients, as well as in patients aged 80 and over.


2012 ◽  
Vol 32 (S 01) ◽  
pp. S39-S42 ◽  
Author(s):  
S. Kocher ◽  
G. Asmelash ◽  
V. Makki ◽  
S. Müller ◽  
S. Krekeler ◽  
...  

SummaryThe retrospective observational study surveys the relationship between development of inhibitors in the treatment of haemophilia patients and risk factors such as changing FVIII products. A total of 119 patients were included in this study, 198 changes of FVIII products were evaluated. Results: During the observation period of 12 months none of the patients developed an inhibitor, which was temporally associated with a change of FVIII products. A frequent change of FVIII products didn’t lead to an increase in inhibitor risk. The change between plasmatic and recombinant preparations could not be confirmed as a risk factor. Furthermore, no correlation between treatment regimens, severity, patient age and comorbidities of the patients could be found.


2021 ◽  
Vol 8 (4) ◽  
pp. 12-17
Author(s):  
Basavaraj PG ◽  
Ashok P Yenkanchi ◽  
Chidanand Galagali

Background: Risk factors can lead to clinical conditions, like metabolic syndrome, that predisposes the development of cardiovascular diseases. Objective: The goal of this population-based, prospective and non-randomised cohort study was to study the association between patients with metabolic syndrome and other various factors defining metabolic syndrome. Methods: All the patients referred to the department of Medicine, Al-Ameen Medical college hospital and District Hospital, Vijayapur, Karnataka, India over a period of twenty-two months extending from December 2013 to September 2015 were considered in this study. Results: In the current study, out of 100 patients, 62.9% patients had metabolic syndrome with positive family history of hypertension, diabetes mellitus. 70.8% patients had metabolic syndrome with positive history of smoking. 64.3% patients had metabolic syndrome with positive history of alcohol .73.9% patients had metabolic syndrome with positive history of IHD. 87% of the patients with metabolic syndrome had SBP> 130 mmHg, and 78.85% patients had DBP>85 mmHg. And metabolic syndrome was observed in 71.8% patients on anti hypertensive drugs. The mean level of total cholesterol, LDL cholesterol, triglyceride is increased whereas the mean level of anti-atherogenic HDL cholesterol is low in subjects with MS. At least one lipid abnormality was present in > 95 % of cases. Around 81% subjects with BMI <25 (out of 38) had metabolic syndrome and 58% subjects with BMI>25(out of 62) had metabolic syndrome. Conclusion: All the components defining the metabolic syndrome correlated positively with the abdominal obesity. Systolic blood pressure values were significantly higher than diastolic blood pressure in subjects with abdominal obesity. Metabolic syndrome has multiple risk factors determined by various aspects like the race, the life style, geographical factors larger study is needed to understand the correlation between various components defining it. A healthy lifestyle, that includes avoiding tobacco exposure and proper weight control, must be encouraged in this high-risk population. Keywords: Cardiovascular diseases; Overweight; Risk factors; Smoking.


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