The FDA required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when the medicine was approved in 2009.
The fixed-dose product combines lesinurad, a uric acid transporter 1 (URAT1) inhibitor, with allopurinol, a xanthine oxidase inhibitor in one tablet.
The new labeling now recommends patients with severe renal impairment be limited to a dose of 40mg once daily.
This fixed-dose combination product combines lesinurad, a uric acid transporter 1 (URAT1) inhibitor, with allopurinol, a xanthine oxidase inhibitor in one tablet.
When lesinurad 400mg was added to febuxostat, significantly more patients achieved target sUA by Month 6 (76.1%; P<0.0001) vs. febuxostat alone (46.8%); however, this was not seen with adding lesinurad 200mg (56.6%; P=0.13).
Accidental patient dosing with Zurampic can potentially cause adverse renal effects such as acute renal failure; this is more common if Zurampic is given alone without a xanthine oxidase inhibitor.
In general, there was low quality evidence from three trials indicating no reduction in systolic (-6.2mmHg, 95% CI: -12.8 to 0.5) or diastolic (-3.9mmHg, 95% CI: -9.2 to 1.4) 24-hour ambulatory BP with uric acid lowering drugs vs. placebo.
The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Duzallo (lesinurad/allopurinol fixed-dose combination; Ironwood) for the treatment of hyperuricemia in patients with uncontrolled gout.
A retrospective chart review found that rates of urate-lowering therapy monitoring among United States veterans with gout were less than optimal. The full findings are published in the Annals of Pharmacotherapy.
Use of febuxostat (FBX) might cause skin reactions in some patients with gout who have experienced such reactions after allopurinol administration.
A treatment review for acute gout attacks and management has found strong evidence that colchicine, NSAIDs, and corticosteroids are effective in relieving pain in acute gout patients.
Zurampic is now available for combination use with a xanthine oxidase inhibitor for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone.
Adding lesinurad to allopurinol provided extra benefit vs. allopurinol alone in lower serum urate (sUA) levels and is an option for patients requiring additional urate-lowering, a study published in Arthritis & Rheumatology reported.
Arhalofenate (800mg) is safe and significantly decreases gout flares compared to allopurinol (300mg), according to a study published online July 27 in Arthritis & Rheumatology.
The European League Against Rheumatism (EULAR) have updated their recommendations on the management of gout to reflect novel treatments and evidence surrounding already established treatments.
A higher allopurinol dose provided a protective effect against incident renal failure in elderly patients, according to a study published in Annals of the Rheumatic Diseases.
A case of postoperative acute gouty arthritis following laparoscopic cholecystectomy with umbilical hernioplasty, secondary to hydrochlorothiazide use.
Findings from a new study published in Seminars in Arthritis and Rheumatism show significant racial disparities in the risk of gout patients developing a serious, sometimes fatal adverse reaction to urate-lowering drugs.
The Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Krystexxa (pegloticase; Horizon) Injection.
The efficacy and safety of febuxostat was noninferior to allopurinol for preventing tumor lysis syndrome (TLS) in patients with malignant tumors about to receive chemotherapy, according to a new study published in the journal, Oncology.
Treatment with febuxostat was effective and well tolerated in gout patients with moderate to severe renal impairment, findings from a study published in Arthritis and Rheumatology stated.
For patients with acute gout, prednisolone has similar analgesic effectiveness to indomethacin, according to a study published online February 23 in the Annals of Internal Medicine.
A new study has highlighted a possible knowledge-gap between healthcare professionals and gout patients, concerning their condition.
The FDA has approved Zurampic (lesinurad; AstraZeneca) to treat hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor (XOI).
Dietary omega-3 fatty acid-rich fish consumption, but not omega-3 supplements alone, confer a protective effect against recurrent gout attacks, reported MaryAnn Zhang, MD, from the Boston University School of Medicine, Boston, MA, at the 2015 ACR/ARHP Annual Meeting.
Xanthine oxidase inhibitors (XOIs) do not improve uric acid-associated risks for cardiovascular events or deaths among adults, according to a meta-analysis of data pooled from 61 randomized controlled clinical studies, which was reported at the 2015 ACR/ARHP Annual Meeting.
In patients with gout, chronic colchicine use has no effect on the rate of incident coronary artery disease (CAD), a study presented at the 2015 ACR/ARHP Annual Meeting concluded.
The selective human anti-interleukin-1β antibody canakinumab demonstrates long-term safety and efficacy for patients with acute gouty arthritis flares, according to a follow-up study reported at the 2015 ACR/ARHP Annual Meeting.