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

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh64 enrolled

Overview

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.

The study had 2 phases. In phase 1, Patients of axial Spondyloarthritis were randomized into 2 groups; group A and group B. they were put on indomethacin 150 mg/day and indomethacin 100 mg/day respectively and were followed up at 3rd week. Those who had normal serum creatinine and responded with the drug were followed up to 24th week. Those who did not respond were excluded from phase 1 and were enrolled in phase 2. Non-responders of indomethacin 150mg and indomethacin 100 mg were put on etoricoxib 90 mg and etoricoxib 60 mg respectively. Again followed up to 24th week.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Axial Spondyloarthritis

Interventions

Indomethacin SR, 75 Mg Oral Capsule, Extended ReleaseDRUG

Indomethacin SR, 75 Mg Oral Capsule, Extended Release orally twice daily

Indomethacin 25 Mg Oral CapsuleDRUG

Indomethacin 25 Mg Oral Capsule, 2 capsule orally twice daily

Etoricoxib 90 mgDRUG

Etoricoxib 90 mg once daily orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Serum creatinine change

change in serum creatinine \>25% from baseline with use of indomethacin and etoricoxib in Axial Spondyloarthritis patients

Time frame: 3rd week and 24th week

Secondary Outcomes

Bath Ankyiosing Spodylitis Disease Activity Index (BASDAI)

\<4 responded to treatment, 4 or more means not responded to treatment

Time frame: 3rd week and 24th week

Ankylosing Spondylitis Disease Activity Score (ASDAS)

ASDAS: \<1.3 between "inactive disease" and "moderate disease activity", \<2.1 between "moderate disease activity" and "high disease activity", and \>3.5 between "high disease activity" and "very high disease activity"

Time frame: 3rd week and 24th week

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.