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Potency on lowering serum uric acid in gout patients: a pooled analysis of registrative studies comparing febuxostat vs. allopurinol.
Eur Rev Med Pharmacol Sci. 2017 Sep; 21(18):4186-4195.ER

Abstract

OBJECTIVE

Hyperuricemia leading to urate crystal formation in tissues represents the pathophysiological mechanism of gout. Guidelines recommend a therapeutic target of serum urate concentration (sUA) <6 mg/dL, or even lower (≤5 mg/dL) in patients with large deposits. We conducted an analysis with the aim to achieve additional insights into the urate-lowering efficacy of two xanthine oxidase inhibitors, allopurinol and febuxostat.

PATIENTS AND METHODS

This was a pooled analysis of phase III trials on allopurinol and febuxostat, including 4101 patients with gout and hyperuricemia. The efficacy outcomes were: mean reduction of sUA concentration from baseline; number of patients with target sUA levels (<6.0 mg/dL or ≤5 mgdL); time to reach target sUA levels.

RESULTS

Three registrative, phase III, randomized, multicenter, placebo-controlled/allopurinol-controlled trials assessing the efficacy of febuxostat, were included. The mean reduction of sUA concentration with any dose of febuxostat was higher (-2.92±2.87 mg/dL; -27%), with respect to placebo- (-0.62±1.84 mg/dL; -5%) and allopurinol-pooled groups (-2.41±2.20 mg/dL; -24%). Moreover, febuxostat showed a higher probability to achieve the recommended target sUA concentration than allopurinol [odds ratio: 2.43 (95% CI: 2.119-2.789) and 4.05 (95% CI: 3.41-4.82) for sUA levels <6 mg/dL and ≤5 mg/dL, respectively]. Patients on any-dose febuxostat reached target sUA faster than allopurinol-treated patients (86.04±71.47 vs. 98.76±70.88 days and 52.08±49.97 vs. 90.42±68.03 days for reaching sUA levels <6 mg/dL and ≤5 mg/dL, respectively; p <0.001 for both comparisons).

CONCLUSIONS

In patients with gout and hyperuricemia, febuxostat was significantly more effective and faster than allopurinol in obtaining the recommended target sUA levels, which were reached by a higher number of patients. Therefore, febuxostat was confirmed as an effective option for the treatment of hyperuricemia in gout.

Authors+Show Affiliations

Department of Internal Medicine, Research Laboratory and Academic Division of Clinical Rheumatology, University of Genova, Genoa, Italy. cimmino@unige.it.No affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Meta-Analysis
Multicenter Study

Language

eng

PubMed ID

29028079

Citation

Cutolo, M, et al. "Potency On Lowering Serum Uric Acid in Gout Patients: a Pooled Analysis of Registrative Studies Comparing Febuxostat Vs. Allopurinol." European Review for Medical and Pharmacological Sciences, vol. 21, no. 18, 2017, pp. 4186-4195.
Cutolo M, Cimmino MA, Perez-Ruiz F. Potency on lowering serum uric acid in gout patients: a pooled analysis of registrative studies comparing febuxostat vs. allopurinol. Eur Rev Med Pharmacol Sci. 2017;21(18):4186-4195.
Cutolo, M., Cimmino, M. A., & Perez-Ruiz, F. (2017). Potency on lowering serum uric acid in gout patients: a pooled analysis of registrative studies comparing febuxostat vs. allopurinol. European Review for Medical and Pharmacological Sciences, 21(18), 4186-4195.
Cutolo M, Cimmino MA, Perez-Ruiz F. Potency On Lowering Serum Uric Acid in Gout Patients: a Pooled Analysis of Registrative Studies Comparing Febuxostat Vs. Allopurinol. Eur Rev Med Pharmacol Sci. 2017;21(18):4186-4195. PubMed PMID: 29028079.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Potency on lowering serum uric acid in gout patients: a pooled analysis of registrative studies comparing febuxostat vs. allopurinol. AU - Cutolo,M, AU - Cimmino,M A, AU - Perez-Ruiz,F, PY - 2017/10/14/entrez PY - 2017/10/14/pubmed PY - 2018/7/17/medline SP - 4186 EP - 4195 JF - European review for medical and pharmacological sciences JO - Eur Rev Med Pharmacol Sci VL - 21 IS - 18 N2 - OBJECTIVE: Hyperuricemia leading to urate crystal formation in tissues represents the pathophysiological mechanism of gout. Guidelines recommend a therapeutic target of serum urate concentration (sUA) <6 mg/dL, or even lower (≤5 mg/dL) in patients with large deposits. We conducted an analysis with the aim to achieve additional insights into the urate-lowering efficacy of two xanthine oxidase inhibitors, allopurinol and febuxostat. PATIENTS AND METHODS: This was a pooled analysis of phase III trials on allopurinol and febuxostat, including 4101 patients with gout and hyperuricemia. The efficacy outcomes were: mean reduction of sUA concentration from baseline; number of patients with target sUA levels (<6.0 mg/dL or ≤5 mgdL); time to reach target sUA levels. RESULTS: Three registrative, phase III, randomized, multicenter, placebo-controlled/allopurinol-controlled trials assessing the efficacy of febuxostat, were included. The mean reduction of sUA concentration with any dose of febuxostat was higher (-2.92±2.87 mg/dL; -27%), with respect to placebo- (-0.62±1.84 mg/dL; -5%) and allopurinol-pooled groups (-2.41±2.20 mg/dL; -24%). Moreover, febuxostat showed a higher probability to achieve the recommended target sUA concentration than allopurinol [odds ratio: 2.43 (95% CI: 2.119-2.789) and 4.05 (95% CI: 3.41-4.82) for sUA levels <6 mg/dL and ≤5 mg/dL, respectively]. Patients on any-dose febuxostat reached target sUA faster than allopurinol-treated patients (86.04±71.47 vs. 98.76±70.88 days and 52.08±49.97 vs. 90.42±68.03 days for reaching sUA levels <6 mg/dL and ≤5 mg/dL, respectively; p <0.001 for both comparisons). CONCLUSIONS: In patients with gout and hyperuricemia, febuxostat was significantly more effective and faster than allopurinol in obtaining the recommended target sUA levels, which were reached by a higher number of patients. Therefore, febuxostat was confirmed as an effective option for the treatment of hyperuricemia in gout. SN - 2284-0729 UR - https://www.unboundmedicine.com/medline/citation/29028079/Potency_on_lowering_serum_uric_acid_in_gout_patients:_a_pooled_analysis_of_registrative_studies_comparing_febuxostat_vs__allopurinol_ L2 - http://www.europeanreview.org/article/13437 DB - PRIME DP - Unbound Medicine ER -