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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gout, Renal Impairment, Colchicine Adverse Reaction, Nonsteroidals (NSAIDs)Toxicity

Intervention / Treatment
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* Drug: Colchicine and NSAID


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of a gout diagnosis Initially receiving at least one anti-gout drug 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case<br>Cases were defined as patients with an event of renal impairment during follow-up, such as acute kidney injury. | Drug: Colchicine and NSAID<br>* Colchicine and nonsteroidal anti-inflammatory drug combination therapy<br>|
| Control<br>Cases were defined as patients without an event of renal impairment during follow-up, such as acute kidney injury. | Drug: Colchicine and NSAID<br>* Colchicine and nonsteroidal anti-inflammatory drug combination therapy<br>|
| Exposure<br>Exposure was defined as patients with colchicine and NSAIDs combination therapy. | |
| Non-Exposure<br>Non-Exposure was defined as patients with other gout therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute kidney injury | Number of participants with a diagnosis of acute kidney injury | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality | Number of participants with a death record | Through study completion, an average of 1 year | 
| Hemodialysis or peritoneal dialysis | Number of participants with a dialysis record | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute kidney injury, Renal impairment, Nonsteroidal antiinflammatory drug, Drug-drug interaction