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

En Chu Kong Hospital

Status: Active, not recruiting

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

Treatments: Drug: Colchicine and NSAID

Study type: Observational

Funder types: Other

Identifiers

NCT05006001

EnChuKongH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 20 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

2,000 participants in 4 patient groups

Case

Description:

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

Treatment:

Drug: Colchicine and NSAID

Control

Description:

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

Treatment:

Drug: Colchicine and NSAID

Exposure

Description:

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

Non-Exposure

Description:

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