The Blood Pressure Effects of Febuxostat in Patients Previously Treated With Allopurinol: A Pilot Study
| Status: | Terminated |
|---|---|
| Conditions: | Gout, High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 1/14/2018 |
| Start Date: | January 2010 |
| End Date: | October 2011 |
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.
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.
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.
- 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.
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.
We found this trial at
1
site
2500 North State Street
Jackson, Mississippi 39216
Jackson, Mississippi 39216
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