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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case | Cases were defined as patients with an event of renal impairment during follow-up, such as acute kidney injury. |
| |
| Control | Cases were defined as patients without an event of renal impairment during follow-up, such as acute kidney injury. |
| |
| Exposure | Exposure was defined as patients with colchicine and NSAIDs combination therapy. | ||
| Non-Exposure | Non-Exposure was defined as patients with other gout therapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine and NSAID | Drug | Colchicine and nonsteroidal anti-inflammatory drug combination therapy |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with gout and initiating anti-gout drug
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D006073 | Gout |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
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| Through study completion, an average of 1 year |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D018689 |
| Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |