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.
Background and Aims: The present study aimed to describe characteristics of patients with type 2 diabetes (T2D) initiated on dapagliflozin in routine outpatient clinical care in Turkey, post-dapagliflozin changes in glycated hemoglobin (HbA1c), body weight and blood pressure. Materials and Methods: Descriptive retrospective observational cohort study using data from Turkish patient medical records from 79 different internal medicine or endocrinology clinics. Study cohort will include T2D patients who received at least one prescription for dapagliflozin for the first time between July 2016 and June 2017 and who have been registered in that centre for at least 6 months prior to the first dapagliflozin prescription. Results: In total, 1683 patients were identified. The mean age of the patients (56.6% female) included in the analysis was 54.9 years (Table 1). At baseline, mean HbA1c was 9.1% and the mean weight was 89.2 kg. The mean time since T2D diagnosis was 9.1 years and 26.4% of patients had a history of retinopathy, 11.3% a history of neuropathy and 8.3% a history of nephropathy. HbA1c values were recorded in 815 patients, body weight was recorded in 851 and blood pressure in 799 patients before the first prescription of dapagliflozin and during dapagliflozin treatment, 6 months after starting dapagliflozin. HbA1c declined by mean of-1.33% (95% CI-1.44 to-1.20, p<0.001), weight declined by mean of-4.18 kg (95% CI-4.65 to 3.71, p<0.001), and systolic and diastolic blood pressure decreased by means of-8.68 (95% CI-9.53 to-7.83, p<0.001) and-4.92 (95% CI-5.54 to-4.29, p<0.001) mmHg, respectively from baseline (Table 2). Results were consistent across subgroups. Conclusion: This real world evidence study showed significant and clinically meaningful reductions in HbA1c, body weight and blood pressure after initiation of dapagliflozin in patients with T2D in Turkey, and these results support changes observed with dapagliflozin treatment in randomized clinical trials.
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