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.
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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
Copyright Business Wire 2013