Dataset Information

Efficacy and Safety of Valsartan or Chlorthalidone vs. Combined Valsartan and Chlorthalidone in Patients With Mild to Moderate Hypertension: The VACLOR Study.

ABSTRACT: Objective:To evaluate the efficacy and safety of valsartan (V) or chlorthalidone (C) monotherapy in comparison with a fixed combination of valsartan and chlorthalidone (V + C). Methods:This 12-week multicenter randomized three-arm open-label study randomly allocated 72 patients to V or C as monotherapy or a combination of V + C. The aim was to measure changes in office systolic blood pressure (SBP) and diastolic blood pressure (DBP) and in 24-hour ambulatory blood pressure monitoring (ABPM) from baseline to week 12, in addition to medication tolerability. Results:The proportion of patients achieving target BP in office at week 12 was not statistically different for the three groups. However, comparisons of daytime and nighttime 24-hour ABPM values from baseline to week 12 revealed significant differences in nighttime mean SBP for the three groups, due to a significantly greater reduction in the values in patients assigned to the V + C group (-14.7 vs. -8.7 vs. -10.7, P = .042, V+C; V; C, respectively). Although patients assigned to the V + C group also had greater nighttime reduction in mean DBP values compared with those in the other groups, this difference was not statistically significant. The incidence of adverse events did not differ significantly. Conclusion:In patients with hypertension treated with V, C, and both medications combined, the fixed combination of V + C provided a significantly greater reduction of late night to early morning BP values when interventions were assessed with 24-hour ABPM. Trial registration:clinicaltrials.gov Identifier: NCT.01850160, https://clinicaltrials.gov/ct2/show/NCT01850160.

SUBMITTER: Manzur F

PROVIDER: S-EPMC6122245 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Efficacy and Safety of Valsartan or Chlorthalidone vs. Combined Valsartan and Chlorthalidone in Patients With Mild to Moderate Hypertension: The VACLOR Study.

Manzur Fernando F Rico Andrés A Romero Juan Diego JD Rodriguez-Martinez Carlos E CE

Clinical Medicine Insights. Cardiology 20180903

<h4>Objective</h4>To evaluate the efficacy and safety of valsartan (V) or chlorthalidone (C) monotherapy in comparison with a fixed combination of valsartan and chlorthalidone (V + C).<h4>Methods</h4>This 12-week multicenter randomized three-arm open-label study randomly allocated 72 patients to V or C as monotherapy or a combination of V + C. The aim was to measure changes in office systolic blood pressure (SBP) and diastolic blood pressure (DBP) and in 24-hour ambulatory blood pressure monitor ...[more]

PMID: 30202211

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Project description:ImportanceChlorthalidone is currently recommended as the preferred thiazide diuretic to treat hypertension, but no trials have directly compared risks and benefits.ObjectiveTo compare the effectiveness and safety of chlorthalidone and hydrochlorothiazide as first-line therapies for hypertension in real-world practice.Design, setting, and participantsThis is a Large-Scale Evidence Generation and Evaluation in a Network of Databases (LEGEND) observational comparative cohort study with large-scale propensity score stratification and negative-control and synthetic positive-control calibration on databases spanning January 2001 through December 2018. Outpatient and inpatient care episodes of first-time users of antihypertensive monotherapy in the United States based on 2 administrative claims databases and 1 collection of electronic health records were analyzed. Analysis began June 2018.ExposuresChlorthalidone and hydrochlorothiazide.Main outcomes and measuresThe primary outcomes were acute myocardial infarction, hospitalization for heart failure, ischemic or hemorrhagic stroke, and a composite cardiovascular disease outcome including the first 3 outcomes and sudden cardiac death. Fifty-one safety outcomes were measured.ResultsOf 730 225 individuals (mean [SD] age, 51.5 [13.3] years; 450 100 women [61.6%]), 36 918 were dispensed or prescribed chlorthalidone and had 149 composite outcome events, and 693 337 were dispensed or prescribed hydrochlorothiazide and had 3089 composite outcome events. No significant difference was found in the associated risk of myocardial infarction, hospitalized heart failure, or stroke, with a calibrated hazard ratio for the composite cardiovascular outcome of 1.00 for chlorthalidone compared with hydrochlorothiazide (95% CI, 0.85-1.17). Chlorthalidone was associated with a significantly higher risk of hypokalemia (hazard ratio [HR], 2.72; 95% CI, 2.38-3.12), hyponatremia (HR, 1.31; 95% CI, 1.16-1.47), acute renal failure (HR, 1.37; 95% CI, 1.15-1.63), chronic kidney disease (HR, 1.24; 95% CI, 1.09-1.42), and type 2 diabetes mellitus (HR, 1.21; 95% CI, 1.12-1.30). Chlorthalidone was associated with a significantly lower risk of diagnosed abnormal weight gain (HR, 0.73; 95% CI, 0.61-0.86).Conclusions and relevanceThis study found that chlorthalidone use was not associated with significant cardiovascular benefits when compared with hydrochlorothiazide, while its use was associated with greater risk of renal and electrolyte abnormalities. These findings do not support current recommendations to prefer chlorthalidone vs hydrochlorothiazide for hypertension treatment in first-time users was found. We used advanced methods, sensitivity analyses, and diagnostics, but given the possibility of residual confounding and the limited length of observation periods, further study is warranted.

Project description:Microvascular rarefaction influences peripheral vascular resistance, perfusion and metabolism by affecting blood pressure and flow pattern. In hypertension microvascular rarefaction has been described in experimental animal studies as well as in capillaroscopy of skin and biopsies of muscle tissue in patients. Retinal circulation mirrors cerebral microcirculation and allows non-invasive investigations. We compared capillary rarefaction of retinal vessels in hypertensive versus normotensive subjects.In this study retinal capillary rarefaction in 70 patients with long time (more than 67 month of disease duration) and 64 patients with short time hypertension stage 1 or 2 has been compared to 55 healthy control subjects, who participated in clinical trials in our Clinical Research Center ( www.clinicaltrials.gov : NCT01318395, NCT00627952, NCT00152698, NCT01319344). Retinal vascular parameters have been measured non-invasively and in vivo in perfusion image by scanning laser Doppler flowmetry (Heidelberg Engineering, Germany). Capillary rarefaction was assessed by capillary area (CapA) (in pixel-number) and intercapillary distance (ICD) (in ?m). Additionally retinal capillary flow (RCF) was measured.ICD was greater in the long time hypertensive group compared to healthy individuals (24.2?±?6.3 ?m vs 20.1?±?4.2 ?m, p?=?0.001) and compared to short time hypertensive patients (22.2?±?5.2 ?m, p?=?0.020). Long time hypertensive patients showed less CapA compared to healthy people (1462?±?690 vs 1821?±?652, p?=?0.005). Accordingly, RCF was significantly lower in the long time hypertensive group compared to the healthy control group (282?±?70 AU vs 314?±?60 AU, p?=?0.032). Our data indicate a lower level of retinal capillary density in hypertensive patients, especially in those with long time hypertension.Patients with hypertension stage 1 or 2 showed retinal capillary rarefaction in comparison to healthy normotensive subjects. Retinal capillary rarefaction was intensified with duration of disease.

Dataset Information

Efficacy and Safety of Valsartan or Chlorthalidone vs. Combined Valsartan and Chlorthalidone in Patients With Mild to Moderate Hypertension: The VACLOR Study.

Publications

Efficacy and Safety of Valsartan or Chlorthalidone vs. Combined Valsartan and Chlorthalidone in Patients With Mild to Moderate Hypertension: The VACLOR Study.

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