Evaluation of Colchicine and Nonsteroidal Anti-inflammatory Drug Combination Therapy and Renal Function in Gout Patients

Active, not recruiting

• Conditions: Renal Impairment; Gout; Colchicine Adverse Reaction; Nonsteroidals (NSAIDs)Toxicity
• Interventions: Drug: Colchicine and NSAID

• Registration Number: NCT05006001
• Lead Sponsor: En Chu Kong Hospital

Brief Summary

Our findings are expected to provide real-world evidence of the renal-adverse effects of colchicine and NSAIDs combination therapy in patients with gout, which will guide healthcare professions in optimizing gout treatment regimens and evaluating risks of renal impairment.

Detailed Description

Background: Gout is a common prevalent disease, which causes a low quality of life and poses a significant health burden nationally and internationally. Colchicine and Nonsteroidal anti-inflammatory drug (NSAID) are the mainstay treatment of gout. Concurrent use of colchicine and NSAIDs are more than half in all prescriptions of the gout patients. Both colchicine and NSAIDs may cause renal impairment. However, the empirical evidence of renal impairment of colchicine and NSAIDs combination therapy is limited and even absent.

Objectives: This proposal will assess the association between colchicine and NSAIDs combination therapy and acute kidney injury. The investigators further evaluate the relationships of duration-response, recency-response, and dose-response.

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2019-12-31
• Study First Submitted: 2021-05-27
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-12
• Last Update Submitted: 2021-08-12
• Study First Posted: 2021-08-16
• Last Update Posted: 2021-08-16
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Clinical diagnosis of a gout diagnosis
• Initially receiving at least one anti-gout drug

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Exclusion Criteria

• <1 year of continuous health insurance enrollment
• Colchicine and NSAID use before the cohort entry date
• Patients with hemodialysis or peritoneal dialysis before the cohort entry date
• Patients with acute kidney injury before the cohort entry date

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case	Colchicine and NSAID	Cases were defined as patients with an event of renal impairment during follow-up, such as acute kidney injury.
Control	Colchicine and NSAID	Cases were defined as patients without an event of renal impairment during follow-up, such as acute kidney injury.

Primary Outcome Measures

Name	Time	Method
Acute kidney injury	Through study completion, an average of 1 year	Number of participants with a diagnosis of acute kidney injury

Secondary Outcome Measures

Name	Time	Method
Hemodialysis or peritoneal dialysis	Through study completion, an average of 1 year	Number of participants with a dialysis record
All cause mortality	Through study completion, an average of 1 year	Number of participants with a death record