scholarly journals A Prospective Noninterventional, Observational Study to Describe the Effectiveness and Safety of Trandolapril and Verapamil Single-Pill Combination in the Management of Patients with Hypertension and Type 2 Diabetes Mellitus: A Harvest TR Study

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.

Author(s):  
Hadi Bazyar ◽  
Seyed Ahmad Hosseini ◽  
Sirous Saradar ◽  
Delsa Mombaini ◽  
Mohammad Allivand ◽  
...  

Abstract Background In patients with type 2 diabetes mellitus (T2DM) the inflammatory and metabolic responses to epigallocatechin-3-gallate (EGCG) are unknown. Objectives Evaluate the impacts of EGCG on metabolic factors and some biomarkers of stress oxidative in patients with T2DM. Methods In this randomized, double-blind, placebo-controlled trial, 50 patients with T2DM consumed either 2 tablets (300 mg) EGCG (n=25) or wheat flour as placebo (n=25) for 2 months. The total antioxidant capacity (TAC), interleukin-6 (IL-6), lipid profile, mean arterial pressure (MAP), atherogenic index of plasma (AIP) were evaluated before and after the intervention. Results The finding of present study exhibited a significant increase in the serum levels of TAC after the EGCG supplementation (p=0.001). Also, in compare with control group, the mean changes of TAC were significantly higher in supplement group (p=0.01). In intervention group, a significant decrease was observed in the mean levels of triglyceride, total cholesterol, diastolic blood pressure (DBP), AIP, and MAP (p<0.05). Taking EGCG resulted in the mean changes of total cholesterol, MAP and DBP were significantly lower in compare with control group (p<0.05). Conclusions This study recommended that EGCG supplementation may be improved blood pressure, lipid profile, AIP, and oxidative status in patients with T2DM.


2018 ◽  
Vol 9 (2) ◽  
pp. 96-101
Author(s):  
Roksana Yeasmin ◽  
MA Muttalib ◽  
Nazneen Sultana ◽  
Md Jamil Hasan Karami ◽  
Ayatunnessa ◽  
...  

Background: The role of uric acid in the progression of prediabetes to diabetes has been known. Serum uric acid has been shown to beassociated with cardiovascular disease, hypertension, and chronic kidney disease. However, conflicting data exist asregards the serum uric acid (UA) levels in type 2 diabetes mellitus, which are associated with risk factors andcomplications.Material & Methods: The present study was designed to look for any association of serum uric acid with hypertension in type 2diabetes mellitus, taking into consideration the relevant clinical, biochemical and the anthropometric data. 110 patientswith type 2 male diabetes mellitus as case and 100 healthy malecontrols were included in this study.Results: This study shows that there were significant differences in mean of age, duration of DM, exercise time, waist hip ratio, systolic blood pressure and diastolic blood pressure within case and control but no significant differences of mean BMI was found between and control. The mean age, duration of DM, exercise time, waist hip ratio, systolic blood pressure and diastolic blood pressure and BMI were (51.83±9.911 years, 6.87±5.54 years, 1.94±.831 hours, .92±.03, 140±6.75 mm of Hg,90±2.41 mm of Hg and 25.43±3.19 Kg/m2 respectively), where as in controls these were (44.81±9.66 yrs, 00 years, 1.12±.327 hours, .91±.03, 130±1.28 mm of Hg, 80±6.18 mm of Hg and 24.96±3.02 Kg/m2 respectively). This table also shows that significant differences in mean of FBS, ABF, HbA1C and S. Uric acid between case and control, but there was no significant differences of mean TG, Cholesterol, HDL and LDL. The mean of FBS, ABF, HbA1C and S. Uric acid among the cases were (8.19±2.48 mmol/L, 11.29±3.47 mmol/L, 7.96±6.04 mg%, 189.72±111.36 mg/dl, 179±43 mg/dl, 38.38±13.77 mg/dl, 102.10±35.79 mg/dl and 8.39±2.61 mg/dl respectively, on the other hand among the control these were 5.91±1.13 mmol/L, 9.19±1.95 mmol/L, 5.93±1.01 mg%, 200±104.49 mg/dl, 183±42.25 mg/dl, 38.14±5.52 mg/dl, 110±33.23 mg/dl and 5.14±.84 mg/dl respectively.Anwer Khan Modern Medical College Journal Vol. 9, No. 2: Jul 2018, P 96-101


Author(s):  
Riyaz Mohammed ◽  
Mohammed Azfar Ali

Background: DPP-4 is widely distributed in endothelial cells, pancreas, uterus, liver, salivary glands, lymph node, spleen, and thymus. DPP-4 regulates glucagon-like peptide (GLP)-1, and glucose-dependent insulin tropic peptide (GIP) which leads to glucose homeostasis via enhancing insulin secretion and suppression of glucagon, which results in control of post-prandial and fasting hyperglycemia.Methods: These 40 patients who were enrolled as per the inclusion criteria of receiving metformin dosage of 2 gram per day in established type 2 diabetes mellitus patients with no comorbidities. these patients were divided randomly into two groups comprising of 20 patients each, group A received linagliptin 5 mg per day in addition to metformin 1gm twice daily whereas group B received linagliptin 5 mg per day in a fixed dose (Linagliptin + metformin) of 2.5/1000 twice daily.Results: In the present observational study, the mean age in group A was 46.7±9.4 compared to 51.65±9.9 in group B, p >0.05, mean BMI in group A was 27.8±1.1 compared to 27.28±0.93 in group B p >0.05, Mean FBS in group A was 157.9±24.1 compared to 146.2±21.8 in group B p >0.05, Mean PPBS in group A was 245.8±32.7 compared to 246.2±39.3 in group B p >0.05 and Mean HbA1c in group A was 7.67±0.58 compared to 7.6±0.5 in group B p >0.05. Group A patients were initiated on once daily linagliptin, there was a significant reduction in FBS, PPBS and HbA1c at the end of 6 months p <0.001. Similarly, Group B patients who were initiated on twice daily linagliptin also showed a significant reduction in FBS, PPBS and HbA1c at the end of 6 months p <0.001.Conclusions: The addition of linagliptin to metformin treatment was effective and well tolerated in patients with type 2 diabetes. Linagliptin add-on to metformin during the early course of treatment helps in delaying the exhaustion of pancreatic islet function. Plasma concentrations of linagliptin decline in at least a biphasic manner with a long terminal half-life (>100 hours), related to the saturable binding of linagliptin to DPP-4. The prolonged elimination phase does not contribute to the accumulation of the drug. Addition of linagliptin to metformin has shown a significant reduction in FBS, PPBS and HbA1c.


Author(s):  
Keerthana Puli ◽  
Nikhil Kumar Vanjari

Background: The main aim of the study is to evaluate the efficacy of empagliflozin 10 mg once daily over 12 weeks as add-on therapy to metformin plus sulfonylurea in patients with type 2 diabetes mellitus with inadequate glycemic control.Methods: It is a prospective, observational, study conducted in patients of Sri Badhrakali Diabetic Center located in Warangal, Telangana, India. The efficacy of empagliflozin 10 mg was assessed by measuring the change in the glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), body mass index (BMI) at the baseline and 12 weeks, systolic blood pressure (SBP) and diastolic blood pressure (DBP) at the baseline and after 24 hours of treatment.Results: In the present study, the addition of empagliflozin to metformin and Sulfonylurea therapy for 12 weeks provided 0.87 % reduction in HbA1c. The mean changes of FPG from baseline to 12-week is -26 mg/dl. At 24 hours empagliflozin significantly reduced blood pressure with mean changes of SBP and DBP -4.147 and -1.526 mmHg respectively. The mean changes in BMI from baseline to week 12 is -0.638 kg/m2.Conclusions: Empagliflozin 10 mg provided ancillary reduction in HbA1c outside of metformin and sulfonylurea. Controlled body weight, HbA1c, blood pressure decreases diabetes progression, decreased risk of diabetic complications and reduced risk for cardiovascular disorders.


Author(s):  
Ganapathi Bantwal ◽  
Vageesh Ayyar ◽  
Rajiv Kovil ◽  
Manoj Chawla ◽  
Tejas Shah ◽  
...  

Introduction: Poor adherence of patients to the polypharmacy approach is a crucial challenge in the management of Type 2 Diabetes Mellitus (T2DM) and use of triple Fixed-Dose Combination (FDC) of metformin, glimepiride, and voglibose is effective in achieving glycaemic control and would aid in improved drug adherence. Aim: To analyse clinical profile and treatment patterns of FDC of glimepiride, metformin, and voglibose with or without other antidiabetic therapy in patients with T2DM. Materials and Methods: A retrospective, observational, multi- centric study conducted during August 2019 to March 2020. Included patients of either sex, ≥18 years of age with T2DM and who had received treatment with FDC of glimepiride, metformin, and voglibose of varying strengths with or without other antidiabetic therapy. Data extracted from medical records included demographic characteristics, duration of disease, co- morbidities, concomitant medications and dosage pattern. Data were analysed using Chi-square test and Mann-Whitney U test. Results: A total of 2650 patients with T2DM were included, of which 1689 (63.7%) were males. The mean (standard deviation {SD}) age was 54.2 (11.4) years. The average Body Mass Index (BMI) was 27.2 (4.3) kg/m2 and hypertension 1656 (62.5%) and dyslipidaemia 1109 (41.9%) were the most common co-morbidities. Dipeptidyl peptidase-4 inhibitors 908 (34.3%) and antihypertensives 1601 (60.4%) were the most common concomitant diabetic and non diabetic medications received, respectively. Glimepiride (2 mg)+metformin (500 mg)+voglibose (0.2 mg) FDC twice-a-day 878 (33.1%) was a common triple FDC. A total of 2449 (92.4%) patients were compliant and 2585 (97.9%) achieved glycaemic goal with triple FDC treatment. During the therapy, the majority of patients had decreased weight 1106 (67.2%). The mean Haemoglobin A1c (HbA1c) levels significantly decreased post-treatment (mean change 1.45%; p-value <0.001). Family history of diabetes mellitus, obesity, sedentary lifestyle were the most common risk factors and smoking being prevalent in males. Conclusion: Overall results demonstrate that triple FDC of glimepiride, metformin, and voglibose was effective in reducing HbA1c and weight and was well tolerated. Also, it improves compliance in Indian patients with T2DM.


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