The safety and efficacy of benzbromarone in gout in Aotearoa New Zealand

Stamp, Lisa K.; Haslett, Janine; Frampton, Chris; White, Doug; Gardner, David P.; Stebbings, Simon; Taylor, Guy; Grainger, Rebecca; Kumar, Rajesh; Kumar, Sunil; Kain, Tracey; Porter, David; Corkill, Michael; Cathro, Angela; Metcalfe, Scott; Wyeth, John; Dalbeth, Nicola

doi:10.1111/imj.13173

Cited by 28 publications

(20 citation statements)

References 10 publications

(21 reference statements)

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“…Benzbromarone has been reported to have a serious side effect in terms of adversely affecting hepatic function, but no such side‐effects were observed in this study. This supports a prospective study in New Zealand that showed benzbromarone led to minimal adverse liver events . These results also suggest that allopurinol and benzbromarone cause no significant adverse reactions.…”

Section: Discussionsupporting

confidence: 88%

Efficacy of uric acid‐lowering therapy on hypercholesterolemia and hypertriglyceridemia in gouty patients

Zhang

Yuan

et al. 2019

Int J of Rheum Dis

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Aim:To investigate the effects on hypercholesterolemia and hypertriglyceridemia in gouty patients receiving uric acid-lowering therapy (UALT). Methods:A retrospective study was performed from January 2015 to December 2017 in gouty patients receiving UALT. A total of 124 gouty patients with hypercholesterolemia or hypertriglyceridemia who were administered UALT were monitored.Of the 124 patients with gout, 52 were treated with febuxostat, 29 were treated with allopurinol, and 43 were treated with benzbromarone. Cholesterol and triglyceride levels were recorded and analyzed following treatment for 8-10 weeks. Results:We compared the efficacy of febuxostat, allopurinol, and benzbromarone.All therapies mildly influenced serum cholesterol and triglyceride levels. Febuxostat significantly decreased cholesterol and triglyceride levels in patients who did not receive lipid-lowering therapy. Allopurinol and benzbromarone modestly decreased triglyceride levels, but cholesterol levels were unaffected. Conclusion:Uric acid-lowering therapy benefits hyperlipidemia in gouty patients.Febuxostat effectively improved serum cholesterol and triglyceride levels compared to allopurinol and benzbromarone in patients with gout. K E Y W O R D Sfebuxostat, gout, hypercholesterolemia, hypertriglyceridemia

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Section: Discussionsupporting

confidence: 88%

Efficacy of uric acid‐lowering therapy on hypercholesterolemia and hypertriglyceridemia in gouty patients

Zhang

Yuan

et al. 2019

Int J of Rheum Dis

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“…In our literature search, we found several other studies published in or after 2008 that directly or indirectly evaluated the safety of benzbromarone [19-21, 26, 28, 37-39]. Among these, a one-year prospective analysis of 123 patients in New Zealand and a three-year Chinese retrospective study both reported no serious events related to benzbromarone treatment [19,21]. Two other systematic reviews reported similar results [20,38].…”

Section: Studies Evaluating Benzbromarone's Safetymentioning

confidence: 86%

“…Several studies and meta-analyses have demonstrated benzbromarone's efficacy in reducing sUA levels and preventing gout flares. The usual dosage varies between 50 mg and 200 mg daily [16,[19][20][21].…”

Section: Efficacy Evidencementioning

confidence: 99%

Section: Studies Evaluating Benzbromarone's Safetymentioning

confidence: 99%

“…Regarding benzbromarone use in patients with chronic kidney disease, there is satisfactory evidence for its efficacy with creatinine clearance levels of at least 20 ml/ min/1.73 m2 [19,25]. Furthermore, studies have shown an incidence of approximately 3% for urolithiasis in patients treated with benzbromarone 75-120 mg/d or a median dose of 100 mg/day [15,19]. The 5 published reported cases include 2 deaths related to fulminant hepatitis, one case of fulminant hepatitis with response to steroid treatment, one case of hepatotoxicity responsive to withdrawal and one case of auto-immune hepatitis in which benzbromarone was co-administered with camostat mesilate [32][33][34][35][36].…”

Section: Studies Evaluating Benzbromarone's Safetymentioning

confidence: 99%

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Benzbromarone in the treatment of gout

Azevedo

Kos²,

Vargas-Santos

et al. 2019

Adv Rheumatol

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Background: Benzbromarone is a uricosuric drug that has been used in the treatment of gout over the last 30 years. Due to its potent inhibition of the dominant apical (luminal) urate exchanger in the human proximal tubule URAT1, it reduces the urate reabsorption, diminishing serum urate levels and therefore preventing gout flares. Main body of the abstract: Through several clinical trials, Benzbromarone has been proved effective and safe, inclusive in patients with chronic kidney disease and as combination therapy with allopurinol. Due to hepatotoxicity reports, it was withdrawn from the European market by the manufacturer, however many authors have questioned the product's withdrawal due to a lack of clinical evidence in order to support its hepatotoxicity. Benzbromarone is still available in several European countries, New Zealand, Brazil and several other countries. Despite the product's marketing over more than 20 years after the first hepatotoxicity reports, we have found only five reports in our literature search, and no prospective or retrospective study correlating hepatotoxicity with benzbromarone use. Short conclusion: Benzbromarone is a safe and effective molecule for the treatment of gout. However, due to in vitro and in vivo data related to hepatotoxicity, it is prudent to prescribe it with some caution, especially for patients with an already known liver condition.

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Superiority of Low‐Dose Benzbromarone to Low‐Dose Febuxostat in a Prospective, Randomized Comparative Effectiveness Trial in Gout Patients With Renal Uric Acid Underexcretion

Yan

Xue

Lü

et al. 2022

Arthritis & Rheumatology

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Objective. The predominant mechanism driving hyperuricemia in gout is renal uric acid underexcretion; however, the standard urate-lowering therapy (ULT) recommendation is first-line xanthine oxidase inhibitor (XOI), irrespective of the cause of hyperuricemia. This comparative effectiveness clinical trial was undertaken to compare first-line nontitrated low-dose benzbromarone (LDBen) uricosuric therapy to XOI ULT with low-dose febuxostat (LDFeb) in gout patients with renal uric acid underexcretion.Methods. We conducted a prospective, randomized, single-center, open-label trial in men with gout and renal uric acid underexcretion (defined as fractional excretion of urate <5.5% and uric acid excretion ≤600 mg/day/1.73 m 2 ). A total of 196 participants were randomly assigned to receive LDBen 25 mg daily or LDFeb 20 mg daily for 12 weeks. All participants received daily urine alkalization with oral sodium bicarbonate. The primary end point was the rate of achieving the serum urate target of <6 mg/dl.Results. More participants in the LDBen group achieved the serum urate target than those in the LDFeb group (61% compared to 32%, P < 0.001). Rates of adverse events, including gout flares and urolithiasis, did not differ between groups, with the exception of greater transaminase elevation in the LDFeb group (4% for LDBen compared to 15% for LDFeb, P = 0.008).Conclusion. Compared to LDFeb, LDBen has superior urate-lowering efficacy and similar safety in treating relatively young and healthy patients with renal uric acid underexcretion-type gout.

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The safety and efficacy of benzbromarone in gout in Aotearoa New Zealand

Abstract: Benzbromarone provides useful urate-lowering efficacy and does not appear unsafe in patients with gout. Urate-lowering therapy prescribing requires further optimisation.

Cited by 28 publications

References 10 publications

Efficacy of uric acid‐lowering therapy on hypercholesterolemia and hypertriglyceridemia in gouty patients

Efficacy of uric acid‐lowering therapy on hypercholesterolemia and hypertriglyceridemia in gouty patients

Benzbromarone in the treatment of gout

Superiority of Low‐Dose Benzbromarone to Low‐Dose Febuxostat in a Prospective, Randomized Comparative Effectiveness Trial in Gout Patients With Renal Uric Acid Underexcretion

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