Long-Term Safety of Febuxostat in Subjects With Gout. - Study Results

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Parallel Assignment
Condition:	Gout
Intervention:	Drug: Febuxostat

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled at 23 investigational sites in the United States from 21 March 2001 to 29 December 2006

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were to have completed 4 weeks of double-blind dosing in Study TMX-00-004 (NCT00174967) before enrollment in once daily (QD) treatment groups. Dose titrations will occur in order to obtain and maintain clinically acceptable serum urate levels.

Reporting Groups

	Description
Febuxostat 40 mg QD	Febuxostat 40 mg, orally, once daily, based on serum urate level.
Febuxostat 80 mg QD	Febuxostat 80 mg, orally, once daily, based on serum urate level.
Febuxostat 120 mg QD	Febuxostat 120 mg, orally, once daily, based on serum urate level.
Total Febuxostat	No text entered.

Participant Flow: Overall Study

	Febuxostat 40 mg QD	Febuxostat 80 mg QD	Febuxostat 120 mg QD	Total Febuxostat
STARTED	8^[1]	79^[2]	29^[3]	116
COMPLETED	6	41	11	58
NOT COMPLETED	2	38	18	58
Adverse Event	1	10	2	13
Protocol Violation	0	1	0	1
Lost to Follow-up	0	3	2	5
Personal Reason(s)	0	14	8	22
Gout Flare	0	4	4	8
Reason Not Specified	1	6	2	9

[1]	Subjects started on febuxostat 80mg. Number of subjects based on Final Stable Dose after titration.
[2]	Subjects started on febuxostat 80mg. Number of subjects based on Final Stable Dose after titration.
[3]	Subjects started on febuxostat 80mg. Number of subjects based on Final Stable Dose after titration.

Baseline Characteristics

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Reporting Groups

	Description
Febuxostat 40 mg QD	Febuxostat 40 mg orally, once daily, based on serum urate level.
Febuxostat 80 mg QD	Febuxostat 80 mg, orally, once daily, based on serum urate level
Febuxostat 120 mg QD	Febuxostat 120 mg, orally, once daily, based on serum urate level

Baseline Measures

	Febuxostat 40 mg QD	Febuxostat 80 mg QD	Febuxostat 120 mg QD	Total
Number of Participants [units: participants]	8	79	29	116
Age, Customized [units: Subjects]
<45 years	2	20	9	31
45 to <65 years	4	40	15	59
≥65 years	2	19	5	26
Age [units: years] Mean ± Standard Deviation	54.5 ± 11.44	53.9 ± 12.85	51.3 ± 13.01	53.3 ± 12.74
Gender [units: subjects]
Female	0	9	2	11
Male	8	70	27	105
History of Kidney Stone [units: Subjects]
Yes	0	11	3	14
No	8	68	26	102
Presence of Tophus [units: Subjects]
Yes	1	13	12	26
No	7	66	17	90
Race/Ethnicity [units: Subjects]
Asian	0	0	2	2
Black or African American	1	5	3	9
White	7	71	21	99
Hispanic	0	2	1	3
Other	0	1	2	3
Renal Function^[1] [units: Subjects]
Normal	3	33	12	48
Impaired	5	46	17	68
Urine Uric Acid [units: Subjects]
Underexcretor	5	62	21	88
Overproducer	3	16	7	26
Missing	0	1	1	2
Body Mass Index [units: kiligram per meter² (kg/m²)] Mean ± Standard Deviation	28.4 ± 2.78	32.9 ± 5.28	33.9 ± 6.82	32.9 ± 5.69
Serum Urate [units: mg/dL] Mean ± Standard Deviation	9.58 ± 1.18	9.48 ± 1.04	10.23 ± 1.74	9.7 ± 1.30

[1]	Impaired renal function was defined as serum creatinine >1.5 milligrams per deciliter (mg/dL) or a creatinine clearance of ≤80 milliliters per minute (mL/min)

Outcome Measures

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1. Primary:

Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit.

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2. Primary:

Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 12 Visit.

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3. Primary:

Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 18 Visit.

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4. Primary:

Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 24 Visit.

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5. Primary:

Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 36 Visit.

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6. Primary:

Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 48 Visit.

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7. Primary:

Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 60 Visit.

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8. Primary:

Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Final Visit.

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9. Secondary:

Percent Change in Serum Urate Levels From Baseline at Month 6 Visit.

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10. Secondary:

Percent Change in Serum Urate Levels From Baseline at Month 12 Visit.

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11. Secondary:

Percent Change in Serum Urate Levels From Baseline at Month 18 Visit.

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12. Secondary:

Percent Change in Serum Urate Levels From Baseline at Month 24 Visit.

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13. Secondary:

Percent Change in Serum Urate Levels From Baseline at Month 36 Visit.

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14. Secondary:

Percent Change in Serum Urate Levels From Baseline at Month 48 Visit.

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15. Secondary:

Percent Change in Serum Urate Levels From Baseline at Month 60 Visit.

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16. Secondary:

Percent Change in Serum Urate Levels From Baseline at Final Visit.

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Serious Adverse Events

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Other Adverse Events

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