Uloric (febuxostat) demonstrated efficacy for management of hyperuricemia in patients with gout

October 19, 2009

Philadelphia, October 17, 2009 - Data presented at the 73rd Annual Scientific Meeting of the American College of Rheumatology highlight effects of baseline characteristics on achievement of serum uric acid (sUA) levels to <6.0 mg/dL and the frequency of flares with ULORIC® (febuxostat) treatment.

A subset of subjects from the CONFIRMS trial who received prior urate-lowering therapy for up to five years achieved sUA <6.0 mg/dL more often, and had a lower rate of acute gout flares than patients who had not received prior long-term urate-lowering therapy.

According to Michael Becker, M.D., professor emeritus of medicine, rheumatology section, The University of Chicago School of Medicine, gout associated with hyperuricemia is a chronic condition that requires long-term management. "One of the hallmarks of gout is the painful and disabling acute flare of arthritis that patients experience. The results of the CONFIRMS trial suggest that by achieving and maintaining sUA <6.0 mg/dL over time the risk of future gout flares can be diminished."

Study Design & Results:

Baseline (BL) Characteristics of Gout Subjects Influence Urate-Lowering (UL) Efficacy During Febuxostat and Allopurinol Treatment

The CONFIRMS trial randomized 2,269 patients with gout and sUA 8.0 mg/dL to receive six months of daily treatment with ULORIC 40 mg, 80 mg or allopurinol 300 mg (or 200 mg if baseline estimated creatinine clearance was <60 ml>

Results from this study showed that 45 percent of the ULORIC 40 mg group and 67 percent of the ULORIC 80 mg group achieved sUA <6.0 mg/dL at their final visit, compared with 42 percent of the allopurinol group.

In subjects with BL moderate renal impairment (estimated creatinine clearance 30 to 59 mL/min), ULORIC 40 mg resulted in a significantly higher response rate than was the case in subjects receiving allopurinol 200 mg (p<0.05).

Documentation of Fewer Gout Flares After Long-Term Urate-Lowering Treatment

Researchers also examined gout flare rates among patients in the CONFIRMS trial and from a subset of 276 patients who had previously participated in the five-year FOCUS or three-year EXCEL trials maintaining sUA <6.0 mg/dL for up to five years while receiving ULORIC 40 mg, 80 mg or 120 mg or allopurinol 300 mg. Patients were randomized by renal function and whether or not patients had already participated in long-term urate-lowering therapy studies. Patients also received gout flare prophylaxis with colchicine or naproxen throughout the six-month study.

Patients who had previously received long-term urate-lowering therapy with ULORIC 40 mg, ULORIC 80 mg or allopurinol achieved goal range sUA (<6.0 mg/dL) more often (57 percent, 77 percent and 52 percent, respectively) than patients who had not received long-term urate-lowering therapy (43 percent, 66 percent and 41 percent, respectively) and had lower rates of acute gout flares (p 0.0001).

Rates of adverse events were similar regardless of prior participation with the most frequent being upper respiratory infection, abnormal liver function tests, musculoskeletal pain and diarrhea.

Overall study results from the CONFIRMS trial demonstrated ULORIC 80 mg was superior in lowering sUA levels compared to ULORIC 40 mg and allopurinol 300 mg (67 percent, 45 percent and 42 percent, respectively).
-end-
About Gout and Uric Acid

Gout is the most common inflammatory arthritis in men. According to the National Health and Nutrition Examination Survey III 1988-1994, an estimated 5.1 million Americans suffer from gout. It is a chronic condition associated with hyperuricemia and is characterized by attacks, or "flares," marked by intense pain, redness, inflammation and warmth in the affected joint. These symptoms are the result of an acute inflammatory response to the presence of urate crystals in the joint(s). As the disease progresses, attacks may become more frequent and patients may develop large urate crystal deposits, known as tophi, in the skin, joints and bones. Tophi can result in joint deformity.

Uric acid is an end-product created when the body breaks down naturally occurring substances called purines. Hyperuricemia occurs when either overproduction or underexcretion of uric acid or a combination of the two leads to elevated urate levels in the body. Hyperuricemia is a precursor of gout, and the risk for developing gout increases with increasing sUA.

ULORIC® is a registered trademark of Teijin Pharma Limited and used under license by Takeda Pharmaceuticals America, Inc.

Indication

ULORIC is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout. ULORIC is not recommended for the treatment of asymptomatic hyperuricemia.

Important Safety Information

Please see complete Prescribing Information and visit the ULORIC Web site at www.uloric.com.

About Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.



Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc., and Takeda Global Research & Development Center, Inc., are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about these Takeda companies, visit www.tpna.com.

Takeda Pharmaceuticals North America

Related Achievement Articles from Brightsurf:

Academic achievement is influenced by how pupils 'do' gender at school
Pupils' achievements at school are often shaped by the way that they 'act out' specific gender roles, according to a new study which warns against over-generalising the gender gap in education.

Achievement gaps may explain racial overrepresentation in special education
US school districts may be flagged as over-identifying students of color as having disabilities when other factors, such as achievement gaps, may explain these disparities, according to new Penn State research.

Weighing more than your twin at birth may predict better achievement at school
Research has shown that children who are born at a low birthweight are less likely to do well in school and more likely to live in lower-income neighborhoods as adults.

Teacher incentive programs can improve student achievement
Teacher incentive pay programs with a hybrid structure involving both individual and group incentives can have good results.

Kindergarten difficulties may predict academic achievement across primary grades
Identifying factors that predict academic difficulties during elementary school should help inform efforts to help children who may be at risk.

University choice and achievement partly down to DNA
Research from King's College London has shown for the first time that genetics plays a significant role in whether young adults choose to go to university, which university they choose to attend and how well they do.

Multilingual students have improved in academic achievement since 2003
Multilingual students, who speak a language or more than one language other than English at home, have improved in reading and math achievement substantially since 2003, finds a new study published in Educational Researcher by Michael J.

Rules about technology use can undermine academic achievement
Parents who restrict their children's use of new media technologies may be acting counterproductively in the long run, particularly if they invoke afterschool homework time as the reason.

Study explores link between curiosity and school achievement
The more curious the child, the more likely he or she may be to perform better in school -- regardless of economic background -- suggests a new University of Michigan study.

U of M study affirms new strategies for reducing achievement gap
Successful implementation of preschool to third grade programs yields benefits in increasing school readiness, improving attendance, and strengthening parental involvement in school education -- strategies that can close the achievement gap for children at risk, according to a new University of Minnesota study.

Read More: Achievement News and Achievement Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.