Serum Creatinine Change / Renal Adverse Effect With Use of Non-steroidal Painkillers in Axial Spondyloarthritis Patients

• Status: Completed
• Trial end date: 2016-06-23
• Target enrollment: 0
• Participant gender: All

Summary

2 Non-steroidal anti-inflammatory drugs (NSAIDs), indomethacin and etoricoxib were prescribed sequentially in Axial Spondyloarthritis patients according to the internationally accepted guidelines to determine serum creatinine change with NSAIDs use.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Treatments: Etoricoxib; Indomethacin

Criteria

Inclusion Criteria:

• SpA (axial) patients according to Assessment of Spondyloarthritis International Society (ASAS) criteria with BASDAI > 4

Exclusion Criteria:

• Inadequate response to therapeutic dose of indomethacin or etoricoxib, taken for at least 2 weeks continuously

• Abnormal serum creatinine : serum creatinine >1.3 mg/dl

• Abnormal SGPT: SGPT > 40 U/L

• Hypertension: Systolic blood pressure > 140 mm Hg and/ or diastolic blood pressure >90 mm Hg or on anti-hypertensive drug

• Dyspepsia or active peptic ulcer disease : upper abdominal discomfort or upper abdominal pain related with food or peptic ulcer disease diagnosed by upper gastrointestinal endoscopy

• Diabetes mellitus: abnormal random plasma glucose or diagnosed case of diabetes mellitus

• Ischemic heart disease: history of angina or ECG changes suggestive of ischemic heart disease

• Active congestive heart failure: pedal edema with tender hepatomegaly with raised JVP or diastolic dysfunction on echocardiography

• Asthma: diagnosed case of asthma or rhonchi on chest auscultation

• Bleeding problems: having a history of prolonged bleeding

• Pregnancy: missed period followed by positive pregnancy test

• Simultaneous use with certain medications such as warfarin, phenytoin, cyclosporine, probenecid, lithium, digoxin, ACE inhibitor, thiazide