San Diego, CA – October 27, 2006 – Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that many adults with a depressive disorder, Bipolar Disorder (BPD), or an anxiety disorder may also have undiagnosed Attention-Deficit/Hyperactivity Disorder (ADHD), according to a longitudinal retrospective medical claims analysis presented today at a major medical meeting of child and adolescent psychiatrists.
According to an analysis of medical claims derived from a large managed care database in the United States, approximately 2.5 percent of adults initially diagnosed with a depressive disorder, BPD or an anxiety disorder were also diagnosed with ADHD within the 12-month analysis period spanning January 1, 2005 through December 31, 2005. However, recent findings from the National Comorbidity Survey (NCS) showed that among adult patients surveyed ADHD existed comorbidly in 32.0 percent of those with a depressive disorder, 21.2 percent of those with BPD, and 9.5 percent of those with an anxiety disorder. When compared with these high overall levels of psychiatric comorbidity detected in the NCS, the low comorbid diagnosis rates of the medical claims analysis suggest that many adult patients with psychiatric disorders such as a depressive disorder, BPD or an anxiety disorder may also have undiagnosed ADHD.
"The large discrepancy between the known rates of ADHD comorbidity and the number of patients actually being diagnosed with comorbid ADHD clearly demonstrates that there is still a strong need for increased awareness of adult ADHD, and that physicians treating the adult population may benefit from additional training in evaluating and diagnosing this disorder," said Lenard A. Adler, M.D., lead researcher and director of the Adult ADHD Program in the Departments of Psychiatry and Neurology at New York University (NYU) School of Medicine and author of Scattered Minds: Hope and Help for Adults with ADHD (Putnam).
There are potentially serious consequences of ADHD in adults, including lower educational and occupational achievement, challenges with relationships, anti-social thoughts and poor self-esteem. "The NCS data show us that a fairly high proportion of adults with depressive, bipolar, or anxiety disorders may also suffer from ADHD, and evaluating adult patients for the symptoms of this disorder must become standard practice in the healthcare community," says Dr. Adler.
About the Study
Researchers conducted a retrospective analysis on data from a 12-month period spanning January 1, 2005 through December 31, 2005 using medical claims derived from a large managed care database in the United States. All claims used in the analysis were from adult patients 18 years and older and no claims with the same diagnosis in the 6 months preceding the index date were used.
Throughout the period analyzed, patients were tracked for claims citing one or more of the other targeted conditions with a total of 900,897 new diagnoses of ADHD; 12,036,905 new diagnoses of a depressive disorder; 1,148,175 new diagnoses of BPD and 6,573,576 new diagnoses of anxiety disorders. Of those patients initially diagnosed with BPD, 2.5 percent were also diagnosed with ADHD and of those patients initially diagnosed with a depressive or anxiety disorder, 1.7 percent were also diagnosed with comorbid ADHD.
Shire Development Inc. supported the study.
Approximately 7.8 percent of all school-age children, or about 4.4 million U.S. children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the U.S. Centers for Disease Control and Prevention (CDC). ADHD is one of the most common psychiatric disorders in children and adolescents. ADHD is a neurobiological psychiatric disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development. To be properly diagnosed with ADHD, a child needs to demonstrate at least six of nine symptoms of inattention; at least six of nine symptoms of hyperactivity/impulsivity; the onset of such symptoms before age 7 years; that some impairment from the symptoms is present in two or more settings (e.g., at school and home); that the symptoms have been present for at least six months; and that there is clinically significant impairment in social, academic or occupational functioning.
Although there is no "cure" for ADHD, there are accepted treatments that specifically target its symptoms. The most common standard treatments include educational approaches, psychological or behavioral modification, and medication.
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Notes to editors
Shire's strategic goal is to become the leading specialty pharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.
Shire's focused strategy is to develop and market products for specialty physicians. Shire's in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.
For further information on Shire, please visit the Company's website: www.shire.com.
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization; the impact of competitive products, including, but not limited to the impact of those on Shire's Attention Deficit and Hyperactivity Disorder (ADHD) franchise; patents, including but not limited to, legal challenges relating to Shire's ADHD franchise; government regulation and approval, including but not limited to the expected product approval dates of SPD503 (guanfacine extended release) (ADHD), SPD465 (extended release of mixed amphetamine salts) (ADHD), MESAVANCE (mesalamine) with MMX technology (SPD 476) (ulcerative colitis), ELAPRASE (idursulfase) (Hunter Syndrome) and NRP104 (lisdexamfetamine dimesylate) (ADHD), including its scheduling classification by the Drug Enforcement Administration in the United States; Shire's ability to secure new products for commercialization and/or development; and other risks and uncertainties detailed from time to time in Shire's and its predecessor registrant Shire Pharmaceuticals Group plc's filings with the Securities and Exchange Commission, particularly Shire plc's Annual Report on Form 10-K for the year ended December 31, 2005.
Poster # E43 Patterns of Psychiatric Comorbidity with Attention-Deficit/Hyperactivity Disorder. Lenard A. Adler, MD.
Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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