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

NCT ID: NCT01701622

Last Updated: 2018-01-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-10-31

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.

Detailed Description

Screening and Recruitment

• Identify and recruit 20 participants from the University of Mississippi Medical Center General Internal Medicine/Hypertension and Family Medicine Clinics.
• Participants must be currently taking allopurinol for the treatment of gout and be on a stable dose of allopurinol for at least 2 months.
• Any antihypertensive medications must be at stable doses for at least 2 months.
• The identified patients will be invited to participate in the study.

Provide Consent

• IRB approved comprehension survey will be administered to participants in determination of competency to provide consent.
• The "Consent to Participate in Research" information will be discussed with each participant and consent acquired.
• Materials can be taken by the potential participant to review and consent provided at a later date.

Data collection

• After consent is provided, study personnel will evaluate blood pressure (BP).
• Participants will undergo 24-hour Ambulatory Blood Pressure Monitor (ABPM). The normal fee for ABPM will be waived.
• Participants will then discontinue allopurinol and initiate febuxostat at a comparable dose. Febuxostat will be provided to all participants at no cost.

• If receiving < 300 mg allopurinol daily, will provide febuxostat 40 mg daily.
• If receiving > 300 mg allopurinol daily, will provide febuxostat 80 mg daily.
• After at least 4 weeks of febuxostat, the participant will repeat 24-hour ABPM. The normal fee for ABPM will be waived.
• After completion of the febuxostat portion of the study, participants will receive a compensation of $50 at the end of the study. Compensation will only be provided to those who complete the entire study.

Results

• Data collection will be added to participant's permanent medical records.
• Results for individual participants will be discussed with the participant as well as their primary care provider.
• The decision to remain on febuxostat or resume allopurinol will lie with the primary care provider.

Conditions

Blood Pressure; Gout

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Allopurinol, febuxostat

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

Group Type: EXPERIMENTAL

febuxostat

Intervention Type: 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.

Interventions

febuxostat

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.

Intervention Type: DRUG

Other Intervention Names

Uloric

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Mississippi Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Deborah Minor

Pharm D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amber S Holdiness, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Locations

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

Jackson, Mississippi, United States

Countries

United States

Other Identifiers

2009-0186

Identifier Type: -

Identifier Source: org_study_id