Lesinurad (Zurampic) was approved earlier this year as adjunctive therapy to other urate-lowering therapies (ULT). It is a selective uric acid reabsorption inhibitor (URAT-1 inhibitor) designed to treat gout, and be used in combination with other xanthine oxidase inhibitors.The results of the CLEAR 1 trial were pivotal in the FDA review of this drug and have been reported in the August issue of Arthritis & Rheumatology.
This was a 12-month, randomized, phase-III trial of lesinurad (200-mg or 400-mg qd) added to standard doses of allopurinol in gout patients with a serum urate (sUA) above <6.0 mg/dL and ≥2 gout flares in the prior year. Primary endpoint was achieving sUA <6.0 mg/dL at month 6.
Gout patients (N=603) were predominantly male, a mean gout duration 11.8±9.4 years, and mean baseline sUA 6.94.
Lesinurad at 200-mg and 400-mg doses, added to allopurinol, significantly increased proportions of subjects achieving the sUA target. At month 6, 54.2% of lesinurad 200 mg/d, 59.2% of lesinurad 400 mg/d, and 27.9% of allopurinol patients achieved the goal.
Surprisingly, lesinurad was not significantly superior in secondary endpoints: rates of gout flares and complete tophus resolution. The safety profile showed the drug to be generally well-tolerated; but, there was a higher incidences of predominantly-reversible serum creatinine elevation in those on lesinurad.
Lesinurad may prove to be a useful option for patients inadequately controlled on allopurinol, or those who cannot increase their allopurinol dose above 300 mg per day to reduce sUA levels to target.
July 1, 2016 • By Richard Quinn
Most patients with gout understand the basics of their condition, but only a minority recognizes the importance of achieving and maintaining their serum urate (SU) goals, according to anarticle accepted for publication in Arthritis Care & Research.1
“Knowledge for the other five questions was quite good. The lowest correct response rate was 62% and highest was 90%,” Dr. Mikuls says. “The majority of patients knew these other important elements of their disease … but they had very little knowledge of what the SU target was for a therapy (allopurinol) they already were on.”
Digging deeper into the study results, SU goal knowledge was associated with self-reported global health status, but not with self-reported health-related quality of life or gout-specific health status. Dr. Mikuls says the study shines a light on a gap in patient education.
“You need a well-informed patient. You need a proactive healthcare team. Both are key elements to doing things optimally,” he says. “We have gaps, not only in patient knowledge, but also in provider practices, and that has been shown in the literature. So it’s not going to be an easy problem to tackle. But I think this study shows that, on the patient end, this is a gap we need to begin filling if we are going to do this better.”
Dr. Mikuls recommends starting with the ACR guidelines, which suggest providers impart such knowledge to patients with gout.
“I think the physician taking the time to explain why different therapies are used and the goals of those different therapies are really key to successful gout management,” Dr. Mikuls says. “I think if patients understand that and are engaged in that, it can make a big difference.”
Richard Quinn is a freelance writer in New Jersey.
- Coburn BW, Bendlin KA, Sayles H, et al. Target serum urate: Do gout patients know their goal? Arthritis Care Res (Hoboken). 2016 Jan 19. doi: 10.1002/acr.22785. [Epub ahead of print]
By: M. ALEXANDER OTTO, Rheumatology News Digital Network SEPTEMBER 15, 2015
The presence of monosodium urate monohydrate crystals in a symptomatic joint, bursa, or tophus is sufficient to diagnose gout, according to new gout classification criteria from the American College of Rheumatology and the European League Against Rheumatism.
When symptomatic urate crystals are missing, other signs and symptoms are considered and scored; a score of 8 or more constitutes gout. “The threshold chosen for this classification criteria set yielded the best combination of sensitivity and specificity,” at 92% and 89%, respectively, and outperformed previous classification schemes, said the authors, led by Dr. Tuhina Neogi of Boston University.
|Dr. Tuhina Neogi
Times went by when we tried ‘to torture the patient with gout ‘ with excessive diet restrictions, in which almost anything was prohibited to eat. Two factors have changed our way of thinking:
1) With current medications, it is possible to reduce the levels of uric acid to normal levels (below 6 or better 5 mg/dl if it is a tophaceous gout)
2) Because a strict diet in purines (those which produce uric acid) only is capable of reducing the blood levels of uric acid in 10 %.
Nevertheless there exist a few guidelines that every patient with gout must know to avoid acute gout attacks:
1) To correct obesity or overweight
2) Work out 2 or times per week
3) Control blood pressure
4) To restrict to the maximum shellfish, seafood and red meat
5) restrict beer and spirits with high level of alcohol
6) Patients with gout should bear in mind that one of their major enemies are celebrations. A great feast with food and alcohol in abundance can trigger an acute attack of gout
7) On the other hand, and here are the good news, the patient with gout can drink wine moderately since it does not increase the levels of uric acid.