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

NCT ID: NCT05006001

Last Updated: 2021-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-01

Study Completion Date

2024-12-31

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.

Conditions

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Renal Impairment Gout Colchicine Adverse Reaction Nonsteroidals (NSAIDs)Toxicity

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Case

Cases were defined as patients with an event of renal impairment during follow-up, such as acute kidney injury.

Colchicine and NSAID

Intervention Type DRUG

Colchicine and nonsteroidal anti-inflammatory drug combination therapy

Control

Cases were defined as patients without an event of renal impairment during follow-up, such as acute kidney injury.

Colchicine and NSAID

Intervention Type DRUG

Colchicine and nonsteroidal anti-inflammatory drug combination therapy

Exposure

Exposure was defined as patients with colchicine and NSAIDs combination therapy.

No interventions assigned to this group

Non-Exposure

Non-Exposure was defined as patients with other gout therapy.

No interventions assigned to this group

Interventions

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Colchicine and NSAID

Colchicine and nonsteroidal anti-inflammatory drug combination therapy

Intervention Type DRUG

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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En Chu Kong Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ya-Ling Huang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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EnChuKongH

Identifier Type: -

Identifier Source: org_study_id

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