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A Large, Observational Study of Common Gout Treatment Allopurinol Shows Less Than Half of Patients Reach Recommended Treatment



  A Large, Observational Study of Common Gout Treatment Allopurinol Shows Less
  Than Half of Patients Reach Recommended Treatment Goal

2013 ACR/ARHP Annual Meeting

Business Wire

WILMINGTON, Del. -- October 28, 2013

AstraZeneca and Ardea Biosciences today presented results from a large study
of allopurinol, a treatment commonly used to lower uric acid in patients with
gout. The LASSO (Long-term Allopurinol Safety Study evaluating Outcomes in
gout patients) study was a multinational, 6-month, open, prospective
observational study involving 1,735 patients with gout and was designed to
evaluate the safety and efficacy of medically appropriate doses of
allopurinol. Results of the LASSO study showed no new safety signals with
allopurinol doses of approximately 300mg/day. The study also revealed that at
the time of last dose fewer than half (43%) of patients taking allopurinol
achieved the target serum uric acid (sUA) level of <6.0 mg/dL, the level
recommended by the American College of Rheumatology (ACR) and the European
League Against Rheumatism (EULAR). Results of the LASSO study were presented
today at the ACR Annual Meeting in San Diego, CA.

Allopurinol, the most commonly used treatment to lower blood uric acid levels
in gout, is a generic treatment that has been available for more than 50
years. It is a xanthine oxidase inhibitor, a class of drugs intended to reduce
the body’s production of uric acid. Allopurinol is recommended at doses
between 100mg and 900mg per day, depending upon disease severity. The LASSO
study encouraged investigators to increase, or titrate, the dose of
allopurinol over the six months of the study to a medically appropriate dose.
There was a high rate of adherence to therapy (97% across doses) and the most
commonly used dose was 300mg. Approximately 45% of patients finished on the
same dose as their baseline dose. Results show that even among patients
titrated to final doses above the most commonly used dose of 300mg/day,
approximately 46% did not reach target sUA levels of <6.0 mg/dL.

“Gout is a painful form of arthritis that is often misunderstood and
inadequately treated. The LASSO study demonstrates that many patients with
gout fail to reach the recommended treatment goal,” said study co-author
Nicola Dalbeth, MD of the University of Auckland. “Failing to reach the
recommended sUA target leaves patients with gout at risk for further disease
progression and long-term consequences of gout.”

The results of this large, multinational, prospective observational study of
gout are consistent with published literature confirming many patients do not
reach sUA targets with allopurinol therapy as currently used.

Specific findings from LASSO include:

  * The study revealed no new safety signals with allopurinol (approximately
    300mg/day).
  * There were no cases of allopurinol hypersensitivity syndrome in this
    study.
  * At the time of last dose 43% of all patients in the study achieved target
    sUA levels of <6.0 mg/dL.
  * Of patients in the study at final doses above 300mg/day, approximately 54%
    achieved target sUA levels of <6.0 mg/dL.

Gout is the most common form of inflammatory arthritis with a prevalence of 8
million in the U.S. Gout is commonly misrepresented as a lifestyle disease.
While diet can contribute to elevated levels of uric acid, the majority of
uric acid is produced by the body’s naturally occurring processes, and gout is
most often caused by the inefficient excretion of uric acid by the kidneys.

In patients with gout, abnormally high levels of uric acid in the blood known
as hyperuricemia lead to deposition of needle-like crystals in joints and soft
tissues throughout the body, causing inflammation. Hyperuricemia results when
the kidneys do not efficiently remove enough uric acid, or when the body
produces too much. A person’s genetics play a significant role in their risk
of developing gout. The most common symptom of gout is extremely painful
arthritis. Over time, the deposits of uric acid crystals may lead to joint
damage, visible nodules called tophi, and impaired quality of life.
Additionally, gout has been associated with serious health problems including
cardiovascular disease, diabetes and kidney damage.

NOTES TO EDITORS

About Ardea

Ardea Biosciences was acquired by AstraZeneca in June 2012. It is located in
San Diego, California and is a wholly owned subsidiary of AstraZeneca.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that
focuses on the discovery, development and commercialisation of prescription
medicines, primarily for the treatment of cardiovascular, metabolic,
respiratory, inflammation, autoimmune, oncology, infection and neuroscience
diseases. AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. For more information
please visit: www.astrazeneca.com

                                                    2923308 Last Updated 10/13

Contact:

AstraZeneca
US Media Inquiries:
Elizabeth Renz
+1 302-885-1936
Elizabeth.Renz@AstraZeneca.com
or
All Other Media Inquiries:
Christopher Sampson
+44 20 7604 8279
Christopher.Sampson@AstraZeneca.com
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