IMPORTANCECumulative exposure to high blood pressure (BP) is an adverse prognostic marker. Assessments of BP control over time, such as time at target, have been developed but assessments of the effects of BP-lowering interventions on such measures are lacking.OBJECTIVE To evaluate whether low-dose triple combination antihypertensive therapy was associated with greater rates of time at target compared with usual care. DESIGN, SETTING, AND PARTICIPANTSThe Triple Pill vs Usual Care Management for Patients With Mild-to-Moderate Hypertension (TRIUMPH) trial was a open-label randomized clinical trial of low-dose triple BP therapy vs usual care conducted in urban hospital clinics in Sri Lanka from February 2016 to May 2017. Adults with hypertension (systolic BP >140 mm Hg and/or diastolic BP >90 mm Hg or in patients with diabetes or chronic kidney disease, systolic BP >130 mm Hg and/or diastolic BP >80 mm Hg) requiring initiation (untreated patients) or escalation (patients receiving monotherapy) of antihypertensive therapy were included. Patients were excluded if they were currently taking 2 or more blood pressure-lowering drugs or had severe or uncontrolled blood pressure, accelerated hypertension or physician-determined need for slower titration of treatment, a contraindication to the triple combination pill therapy, an unstable medical condition, or clinically significant laboratory values deemed by researchers to be unsuitable for the study. All 700 individuals in the original trial were included in the secondary analysis. This post hoc analysis was conducted from December 2020 to December 2021.INTERVENTION Once-daily fixed-dose triple combination pill (telmisartan 20 mg, amlodipine 2.5 mg, and chlorthalidone 12.5 mg) therapy vs usual care.MAIN OUTCOMES AND MEASURES Between-group differences in time at target were compared over 24 weeks of follow-up, with time at target defined as percentage of time at target BP. RESULTS There were a total of 700 randomized patients (mean [SD] age, 56 [11] years; 403 [57.6%] women). Patients allocated to the triple pill group (n = 349) had higher time at target compared with those in the usual care group (n = 351) over 24 weeks' follow-up (64% vs 43%; risk difference, 21%; 95% CI, 16-26; P < .001). Almost twice as many patients receiving triple pill therapy achieved more than 50% time at target during follow-up (64% vs 37%; P < .001). The association of the triple pill with an increase in time at target was seen early, with most patients achieving more than 50% time at target by 12 weeks. Those receiving the triple pill achieved a consistently higher time at target at all follow-up periods compared with those receiving usual care (mean [SD]: 0-6 weeks, 36.3% [30.9%] vs 21.7% [28.9%]; P < .001; 6-12 weeks, 55.2% [31.9%] vs 33.7% [33.0%]; P < .001; 12-24 weeks, 66.0% [31.1%] vs 43.5% [34.3%]; P < .001). CONCLUSIONS AND RELEVANCETo our knowledge, this analysis provides the first estimate of time at target as an outcome assessing longitudinal BP control in a randomized clinical trial...
Introduction: Diabetes mellitus (DM) is a major health problem which increases the risk of cardiovascular diseases (CVDs). Zinc (Zn) has a number of antioxidant functions which neutralize the reactive oxygen species (ROS) generated in patients with diabetes. ROS stimulate oxidation of low density lipoprotein (LDL), cholesterol, cholesterol derived species in atherosclerotic plaques in arteries in dyslipidaemia patients. The oxidized LDL (Ox-LDL) has been identified as a major cause of endothelial dysfunction leading to CVDs. Objective: In this study, the serum Zn levels, anthropometric and clinical parameters of diabetes patients with and without dyslipidaemia and CVDs were investigated. Method: The serum samples of 116 subjects which include 42 patients with Type 2 Diabetes Mellitus (T2DM) alone, 55 patients with T2DM and dyslipidaemia and 19 patients with T2DM, dyslipidaemia and CVD from diabetes and endocrinology clinic were analysed. Results: The serum Zn levels of diabetes patients (944.69±241.53 ppb), diabetes with dyslipidaemia (991.45±265.50 ppb) and diabetes, dyslipidaemia and CVD (1,000.97±295.17 ppb) were not statistically significant {significance value of the ANOVA test was 0.619 (p=0.619 > α =0.05)}. Zinc deficiency was 27.27% among male patients and 16.00% among female patients. Zinc concentration among Type 2 diabetes patients was not affected by, gender, body mass index (BMI) and duration of diabetes. Conclusion: Serum zinc levels were not statistically different among diabetic patients with and without dyslipidaemia and CVD. The role of serum zinc levels in T2DM and CVDs need to be examined further in long term longitudinal trials.
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