Dataset Information

Effect of Febuxostat on Ambulatory Blood Pressure in Subjects With Hyperuricemia and Hypertension: A Phase 2 Randomized Placebo-Controlled Study.

ABSTRACT: Hyperuricemia is associated with hypertension, with elevated serum uric acid levels postulated to have a causal role in the development of hypertension. Consequently, serum uric acid reduction may help lower blood pressure (BP). A Phase 2, double-blind, placebo-controlled trial was conducted to assess the potential BP-lowering effects of the xanthine oxidase inhibitor febuxostat in subjects with hypertension and hyperuricemia (serum uric acid ?0.42 mmol/L [?7.0 mg/dL]).Subjects (n=121) were randomized 1:1 to febuxostat 80 mg once daily or to placebo. The primary end point was change from baseline to Week 6 in 24-hour mean ambulatory systolic BP (SBP). Additional end points included the following: change from baseline to Week 3 in 24-hour mean SBP and changes from baseline to Weeks 3 and 6 in 24-hour mean ambulatory diastolic BP, serum uric acid, mean daytime and nighttime ambulatory SBP/diastolic BP, and clinic SBP/diastolic BP. For the overall study population, there were no significant differences between febuxostat and placebo for changes from baseline to Weeks 3 or 6 in ambulatory, daytime or nighttime, or clinic SBP or diastolic BP. However, in a preplanned subgroup analysis, there was a significant decrease in SBP from baseline to Week 6 in subjects with normal renal function (estimated glomerular filtration rate ?90 mL/min) treated with febuxostat versus placebo; least squares mean difference, -6.7; 95% confidence interval -13.3 to -0.0; P=0.049.This study suggests that febuxostat may lower BP in hyperuricemic patients with hypertension and normal renal function; further studies should be conducted to confirm this finding.URL: http://www.clinicaltrials.gov. Unique identifier: NCT01496469.

SUBMITTER: Gunawardhana L

PROVIDER: S-EPMC5721765 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Effect of Febuxostat on Ambulatory Blood Pressure in Subjects With Hyperuricemia and Hypertension: A Phase 2 Randomized Placebo-Controlled Study.

Gunawardhana Lhanoo L McLean Lachy L Punzi Henry A HA Hunt Barbara B Palmer Robert N RN Whelton Andrew A Feig Daniel I DI

Journal of the American Heart Association 20171104 11

<h4>Background</h4>Hyperuricemia is associated with hypertension, with elevated serum uric acid levels postulated to have a causal role in the development of hypertension. Consequently, serum uric acid reduction may help lower blood pressure (BP). A Phase 2, double-blind, placebo-controlled trial was conducted to assess the potential BP-lowering effects of the xanthine oxidase inhibitor febuxostat in subjects with hypertension and hyperuricemia (serum uric acid ≥0.42 mmol/L [≥7.0 mg/dL]).<h4>Met ...[more]

PMID: 29102979

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Project description:BackgroundEstrogen therapy in early menopausal women decreases the risk of coronary heart disease and parenteral, but not oral, estrogen is reported to reduce blood pressure (BP). Progestogens are typically added to estrogens to prevent unopposed endometrial stimulation. The effects of progestogen on BP have been less well studied to date. This study was conducted to explore the impacts of micronized progesterone (MP4) combined with percutaneous estradiol gel (PEG) on hemodynamics in postmenopausal Korean women with grade 1 hypertension.MethodsFifty-two postmenopausal women (aged 49-75 years) with systolic BP (SBP) of 140-160 mmHg or diastolic BP (DBP) of 90-100 mmHg were randomly assigned for 12 weeks to placebo (n = 16), estrogen therapy (ET) (n = 19) with PEG (0.1 %, 1 g./d), or estrogen + progestogen therapy (EPT, n = 17) with PEG and MP4 (100 mg/d). The primary endpoint was ambulatory BP and the secondary endpoints were arterial stiffness as brachial-ankle pulse-wave velocity (baPWV) and aortic parameters on applanation tonometry.ResultsOne woman in the ET group dropped out, so 51 participants were finally analyzed. Outcome measures for ambulatory BP and arterial stiffness were not different between groups. Within-group comparisons showed that EPT significantly decreased daytime heart rate and baPWV: the changes from baseline (mean ± standard deviation) were - 2.5 ± 5.7 bpm (P = 0.03) and - 0.6 ± 1.4 m/s (P = 0.04), respectively. After adjusting for baseline, linear regression analysis revealed a significant difference in the relationship between baseline and 12-week baPWV among groups (P = 0.02). The relationship was significantly different between placebo and ET (P = 0.03) and EPT (P = 0.01), respectively, but not between ET and EPT. Additionally, pooled results of active treatments disclosed that SBP, DBP, PWV, and augmentation index at the aorta were significantly reduced relative to baseline.ConclusionsThere was no difference in ambulatory BP between ET and EPT in postmenopausal Korean women with grade 1 hypertension. Further, ET and EPT similarly decreased baPWV from baseline as compared with placebo. MP4 might not adversely influence estrogen effects on ambulatory BP and arterial stiffness.Trial registrationClinical Research Information Registry, KCT0005405, Registered 22 September 2020 - Retrospectively registered, https://cris.nih.go.kr/cris/search/detailSearch.do?all_type=Y&search_page=L&pageSize=10&page=1&seq=17608&search_lang=E .

Project description:Background: The epidemic of obesity, along with hypertension (HT) and cardiovascular disease, is a growing contributor to global disease burden. It is postulated that obese children are predisposed to hypertension and subsequent cardiovascular disease in adulthood. Early detection and management of hypertension in these children can significantly modify the course of the disease. However, there is a paucity of studies for the characterization of blood pressure in obese children through ambulatory blood pressure monitoring (ABPM), especially in the developing world. This study aims to characterize ambulatory blood pressure in obese children and to explore feasibility of using office BP that will predict ambulatory hypertension. Methods:In the present study, 55 children with a body mass index (BMI) in the ?95th percentile for age and sex were enrolled in a tertiary care hospital and underwent 24 h of ABPM and detailed biochemical investigations. Results:Ambulatory hypertension was recorded in 14/55 (25.5%; white coat hypertension in 17/29 (58.6%) and masked hypertension in 2/26 (7.69%). For office SBP percentile the area under curve (AUC) was 0.773 (95% CI: 0.619-0.926, p = 0.005) and for office DBP percentile the AUC was 0.802 (95% CI: 0.638-0.966, p = 0.002). The estimated cut offs (Youden's index) for office blood pressure which predicts ambulatory hypertension in obese children were the 93rd percentile for systolic BP (sensitivity-67% and specificity-78%) and the 88th percentile for diastolic BP (sensitivity-83% and specificity-62%). Conclusion:Ambulatory blood pressure abnormalities are highly prevalent among children with obesity. Office blood pressure did not accurately predict ambulatory hypertension. More than half of the children labeled as "hypertension" on office blood pressure measurement in the study were diagnosed to have white coat hypertension (WCH), thus emphasizing the role of ABPM for evaluation of WCH before the child is subjected to detailed investigations or started on pharmacotherapy.

Dataset Information

Effect of Febuxostat on Ambulatory Blood Pressure in Subjects With Hyperuricemia and Hypertension: A Phase 2 Randomized Placebo-Controlled Study.

Publications

Effect of Febuxostat on Ambulatory Blood Pressure in Subjects With Hyperuricemia and Hypertension: A Phase 2 Randomized Placebo-Controlled Study.

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