The Blood Pressure Effects of Febuxostat in Patients Previously Treated With Allopurinol: A Pilot Study

NCT01701622 | Terminated Results

• 1 other identifier: 2009-0186
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Hyperuricemia (high uric acid level) has been correlated to hypertension (high blood pressure) and overall cardiovascular disease risk in several studies. The relationship has even been noted to be independent of metabolic syndrome and kidney function. It has been repeatedly noted that hyperuricemia was an independent risk factor of death in those at high cardiovascular disease risk. A recent review concluded that there is strong evidence that hyperuricemia and gout are coupled with atherosclerosis and cardiovascular events. Although this correlation of hypertension and hyperuricemia is known, there has only been one published study that has evaluated if lowering the uric acid would reduce the blood pressure. The authors concluded that in newly diagnosed hypertensive adolescents, allopurinol decreased the blood pressure. Despite this, further evaluation of this therapeutic approach has not been studied. The hypothesis of this study is that febuxostat, a new xanthine oxidase inhibitor, has blood pressure lowering effects superior to allopurinol in patients diagnosed with gout.

Conditions

Blood Pressure; Gout

Keywords

Blood Pressure; Gout; allopurinol; febuxostat; uric acid

Outcome Measures

Primary Outcomes (1)

• BP Differences While on Allopurinol and Febuxostat by Clinic Blood Pressure Readings and 24-hour Ambulatory Blood Pressure Readings

  The data collected will be analyzed and categorized according to age, race, gender, weight, height, 24-hour ABPM (24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and the mean nighttime SBP/SBP). Clinic systolic and diastolic BP and 24-hour AMBPs will be compared between the two treatments.

  4 to 5 weeks

Secondary Outcomes (1)

• If Patients With Hypertension Receive a Greater Reduction in Blood Pressure (BP) While on Febuxostat (Versus Allopurinol)

  Participants will be followed for an expected average of 4 to 5 weeks.

Study Arms (1)

Allopurinol, febuxostat

EXPERIMENTAL

Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.

Drug: febuxostat

Interventions

febuxostat DRUG

If baseline allopurinol dose \< 300 mg daily, will initiate febuxostat 40 mg daily. If baseline allopurinol dose \> 300 mg daily, will initiate febuxostat 80 mg daily. Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks.

Also known as: Uloric

Allopurinol, febuxostat

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients currently treated at the University of Mississippi Medical Center General Internal Medicine/Hypertension or Family Medicine Clinics.
• Have a diagnosis of gout.
• Taking allopurinol at a stable dose for at least 2 months.

You may not qualify if:

• Less than 18 years old.
• Severe renal impairment defined as CrCl \<30 mL/min.
• Previous diagnosis of severe hepatic impairment.
• Currently taking azathioprine, mercaptopurine, or theophylline.
• Pregnant, breastfeeding, or anticipating pregnancy or breastfeeding.
• Arm circumference greater than 50 cm.
• Change in antihypertensive medication within the previous 2 months.

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center General Medicine/Hypertension and Family Medicine Clinics

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Gout

Interventions

Febuxostat

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Early termination leading to no subjects analyzed

Results Point of Contact

• Title: Debbie Minor
• Organization: University of Mississippi Medical Center

DMinor@umc.edu

601-984-6888

Study Officials

• Amber S Holdiness, PharmD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharm D

Study Record Dates

• First Submitted: January 27, 2010
• First Posted: October 5, 2012
• Study Start: January 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 12, 2018
• Results First Posted: February 11, 2013

Record last verified: 2017-12

Locations

US (1)