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

This study has been terminated.
(unable to enroll participants)
Sponsor:
Information provided by (Responsible Party):
Deborah Minor, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT01701622
First received: January 27, 2010
Last updated: February 8, 2013
Last verified: December 2012
  Purpose

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.


Condition Intervention
Blood Pressure
Gout
Drug: febuxostat

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Blood Pressure Effects of Febuxostat in Patients Previously Treated With Allopurinol: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Mississippi Medical Center:

Primary Outcome Measures:
  • BP Differences While on Allopurinol and Febuxostat by Clinic and Pressure Readings and 24-hour Ambulatory Blood Pressure Readings. [ Time Frame: Participants will be followed for an expected average of 4 to 5 weeks. ] [ Designated as safety issue: No ]
    The following data will be collected: general demographic information, uric acid, casual blood pressure readings, 24-hour ambulatory blood pressure readings, including mean 24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and mean nighttime SBP/SBP while on allopurionol and febuxostat.


Secondary Outcome Measures:
  • If Patients With Hypertension Receive a Greater Reduction in Blood Pressure (BP) While on Febuxostat (Versus Allopurinol) [ Time Frame: Participants will be followed for an expected average of 4 to 5 weeks. ] [ Designated as safety issue: No ]
    measured by mean 24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and mean nighttime SBP/SBP while on allopurionol and febuxostat.


Enrollment: 1
Study Start Date: January 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Allopurinol, febuxostat
Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.
Drug: 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.

Other Name: Uloric

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701622

Locations
United States, Mississippi
University of Mississippi Medical Center General Medicine/Hypertension and Family Medicine Clinics
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
Principal Investigator: Amber S Holdiness, PharmD University of Mississippi Medical Center
  More Information

No publications provided

Responsible Party: Deborah Minor, Pharm D, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01701622     History of Changes
Other Study ID Numbers: 2009-0186
Study First Received: January 27, 2010
Results First Received: November 9, 2012
Last Updated: February 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Mississippi Medical Center:
Blood Pressure
Gout
allopurinol
febuxostat
uric acid

Additional relevant MeSH terms:
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Allopurinol
Febuxostat
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014