A RANDOMIZED CONTROLLED TRIAL OF ALLOPURINOL FOR CARDIOVASCULAR DISEASE IN CHRONIC KIDNEY DISEASE: BASELINE CHARACTERISTICS OF THE STUDY POPULATION

 

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A RANDOMIZED CONTROLLED TRIAL OF ALLOPURINOL FOR CARDIOVASCULAR DISEASE IN CHRONIC KIDNEY DISEASE: BASELINE CHARACTERISTICS OF THE STUDY POPULATION

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Komal
Sharma
Komal Sharma komusharma383@gmail.com Postgraduate Institute of Medical Education and Research Nephrology Chandigarh India *
Piyush Mohania piyush1mohania@gmail.com Postgraduate Institute of Medical Education and Research Nephrology Chandigarh India -
Kanchan Thakur kanchan56nagwalthakur@gmail.com Postgraduate Institute of Medical Education and Research Nephrology Chandigarh India -
Vivek Kumar engima165@yahoo.co.in Postgraduate Institute of Medical Education and Research Nephrology Chandigarh India -
Ashok Kumar Yadav mails2ashok@gmail.com Postgraduate Institute of Medical Education and Research Experimental Medicine and Biotechnology Chandigarh India -
Harbir Singh Kohli kohlihs2009@gmail.com Postgraduate Institute of Medical Education and Research Nephrology Chandigarh India -
Vivekanand Jha vjha@george-services.com George Institute for Global Health Nephrology New Delhi India -
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Hyperuricemia has been associated with adverse cardiovascular outcomes in patients with chronic kidney disease (CKD). Although uric acid lowering therapy has shown short-term cardiovascular benefits, long-term effects remain uncertain. Previous studies have shown ineffectiveness of allopurinol in slowing CKD progression, though they were not primarily designed to assess cardiovascular endpoints. This study aimed to evaluate whether allopurinol, compared with placebo, reduces the risk of major adverse cardiovascular events (MACE) in CKD patients. Secondary objectives included assess its impact on all-cause mortality, need for renal replacement therapy (RRT), and ≥50% decline in estimated glomerular filtration rate (eGFR). Here, we present the descriptive of baseline characteristics of this study population

This study was a multi-centre, double-blind, placebo-controlled randomized trial conducted across 13 centres in India. Clinically stable adults with CKD (eGFR 10–45 ml/min/1.73m²) and serum uric acid ≥6 mg/dl were enrolled. Patients with acute gout, allopurinol hypersensitivity, chronic liver disease, or participation in another interventional study were excluded. Participants were randomized to receive either allopurinol 100 mg/day or a matching placebo, with a planned follow-up of 36 months. The trial was registered in the Clinical Trials Registry of India (CTRI/2020/05/025044).

A total of 890 participants were enrolled, with a mean age of 51 ± 12 years; 66% were male. CKD etiology was unknown in 43% of participants, while diabetic kidney disease and chronic interstitial nephritis accounted for 18% and 16%, respectively. The median CKD duration was 33 (6, 47) months. Histories of hypertension, diabetes, renal stone disease, coronary artery disease and smoking were present in 82%, 27%, 18%, 7% and 18% of patients, respectively (Table 1). Baseline mean serum creatinine, eGFR and uric acid were 3 ± 1 mg/dl, 26 ± 9 and 8 ± 1 mg/dl (Table 2).

This multi-centre trial represents the largest study evaluating allopurinol’s effect on cardiovascular outcomes in CKD patients with hyperuricemia.

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