Background Patients with altered liver function test (LFTs) do not qualify to enter into clinical trials for registration purposes. Therefore, scarce data are available for patients with altered liver function test entering into treatments with new medications.
Objectives To assess whether febuxostat has an impact in LFTs in patients with gout, and altered LFTs at baseline compared with patients with normal analysis.
Methods Data from a prospective cohort of patients initiating febuxostat for gout were analyzed. ASAT, ALAT, and GGT were measured at baseline and at 3-6-12 months during follow-up. General characteristics of patients were obtained at entrance in the cohort, including parameters of gout severity, previous urate-lowering therapy, ethanol intake, hyperlipidemia, renal function impairment, and diabetes. Altered LFTs were defined as > 1.5 upper normal limit (UNL).
Results From a cohort of 79 patients (including 1 Child –A liver cirrhosis, 1 liver transplant, and 1 liver adenomatosis) there were 73, 60, and 50 patients with data at 3, 6, and 12 months of follow-up, respectively. There were 89% men, 49% polyarticular, 59% tophaceous, and 96% with previous failure to at least one urate-lowering drug. Comorbidities were very frequent: 47% renal function impairment (11% CKD 4-5), 30% high ethanol intake, 69% hypertension, 52% hyperlipidemia, 22% diabetes, 40% on diuretics, 12% ischemic heart disease, and 22% previous heart failure. ASAT, ALAT, and GGT were altered in 4, 9, and 15 % respectively, 30% of patients showing any LFTs altered at baseline. No patient withdrew due to altered liver function test. There was no significant change in paired means in any LFTs but a descent in GGT at 6 and 12 months (Table). The distribution of altered vs. non altered any of the LFTs showed a transient increase in altered ASAT and ALAT only detected at 3 months, and a significant decrease in patients with altered GGT at 3 and 6 months.
Conclusions In this cohort of patients with severe gout and with frequent and severe comorbid conditions, patients with altered LFTs, including patients including chronic liver disease, showed no signal of worsening of LFTs compared to patients with normal LFTs at baseline and even there was an improvement in GGT in patients with previously altered LFTs.
Acknowledgements Thanks to Mrs. Rosario Lopez Santamaría for adminsitrative support and coordination
Disclosure of Interest F. Perez-Ruiz Consultant for: Ardea, Savient, Menarini, Astra, Metabolex, Pfizer, Novartis, SOBI, Speakers bureau: Menarini, A. Herrero-Beites: None Declared