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

التفاصيل البيبلوغرافية
العنوان: Effect of Febuxostat on Ambulatory Blood Pressure in Subjects With Hyperuricemia and Hypertension: A Phase 2 Randomized Placebo-Controlled Study
المؤلفون: Lachy McLean, Barbara Hunt, Lhanoo Gunawardhana, Daniel I. Feig, Robert N. Palmer, Andrew Whelton, Henry A. Punzi
المصدر: Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
سنة النشر: 2017
مصطلحات موضوعية: Male, Time Factors, Placebo-controlled study, Blood Pressure, hyperuricemia, 030204 cardiovascular system & hematology, chemistry.chemical_compound, 0302 clinical medicine, serum urate, Clinical Studies, 030212 general & internal medicine, Hyperuricemia, Prospective Studies, Enzyme Inhibitors, Xanthine oxidase inhibitor, Original Research, Cardiovascular Surgery, Blood Pressure Monitoring, Ambulatory, Middle Aged, Treatment Outcome, Ambulatory, Cardiology, Female, Febuxostat, Cardiology and Cardiovascular Medicine, medicine.drug, Adult, medicine.medical_specialty, Xanthine Oxidase, Ambulatory blood pressure, hypertension, medicine.drug_class, Placebo, Proof of Concept Study, 03 medical and health sciences, Double-Blind Method, uric acid, Internal medicine, medicine, Humans, Antihypertensive Agents, Aged, business.industry, medicine.disease, ambulatory blood pressure monitoring, chemistry, North America, Uric acid, business, Biomarkers
الوصف: Background 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]). Methods and Results 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. Conclusions 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. Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT 01496469.
تدمد: 2047-9980
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8fb7113a164f996e61305664738f16a1
https://pubmed.ncbi.nlm.nih.gov/29102979
Rights: OPEN
رقم الانضمام: edsair.doi.dedup.....8fb7113a164f996e61305664738f16a1
قاعدة البيانات: OpenAIRE