Managed Healthcare Executive - October 2008 - (Page 35)

STATEMENT OF OWNERSHIP, MANAGEMENT, AND CIRCULATION (Requester Publications Only) (Required by 39 USC 3685) Publication Title: Managed Healthcare Executive Publication Number: 1533-9300 Filing Date: 9/28/08 Issue Frequency: Monthly Number of Issues Published Annually: 12 Annual Subscription Price (if any): $99.00 Complete Mailing Address of Known Of ce of Publication: 131 West First Street, Duluth, St. Louis County, Minnesota 55802-2065 Contact Person: Joe Martin Telephone: 218-740-6375 8. Complete Mailing Address of Headquarters or General Business Of ce of Publisher: 6200 Canoga Avenue, 2nd Floor, Woodland Hills, CA 91367. 9. Full Names and Complete Mailing Addresses of Group Publisher: John Grasha - Great Northern Corporate Center II, 24950 Country Club Blvd , North Olmsted, OH 44070 Editor In Chief: Julie Miller - Great Northern Corporate Center II, 24950 Country Club Blvd , North Olmsted, OH 44070 Senior Editor: Tracey L. Walker - Great Northern Corporate Center II, 24950 Country Club Blvd, North Olmsted, OH 44070 10. This publication is owned by: Advanstar Communications Inc., 6200 Canoga Avenue, 2nd Floor, Woodland Hills, CA 91367. The sole shareholder of Advanstar Communications Inc. is: Advanstar, Inc., whose mailing address is 6200 Canoga Avenue, 2nd Floor, Woodland Hills, CA 91367. 11. Advanstar Communications Inc. is the Mortgagor under Credit Agreements dated May 31, 2007, with various lenders as named therein from time to time. The agent for the lenders is: Credit Suisse, Administrative Agent, Eleven Madison Avenue, New York, NY 10010. There are no Other Securities as of June, 2008. 12. 13. 14. 15. Does Not Apply Publication Title: Managed Healthcare Executive Issue Date for Circulation Data Below: Extent and Nature of Circulation 1. 2. 3. 4. 5. 6. 7. August 2008 Average Each Issue During Preceding 12 Months No. Copies of Single Issue Published Nearest to Filing Date 44,251 A. Total Number of Copies B. Legitimate Paid and/or Requested Distribution 1. Outside County Paid/Requested Mail Subscriptions Stated on PS Form 3541 2. In-County Paid/Requested Mail Subscriptions Stated on PS Form 3541 3. Sales Through Dealers and Carriers, Street Vendors, Counter Sales, and Other Paid or Requested Distribution Outside USPS 4. Requested Copies Distributed by Other Mail Classes Through the USPS C. Total Paid and/or Requested Circulation (Sum of 15b (1), (2), (3), and (4) D. Non-requested Distribution 1. Outside County Non-requested Copies as Stated on PS Form 3541 2. In-County Non-requested Copies Stated on PS Form 3541 3. Non-requested Copies Distributed Through the USPS by Other Classes of Mail 4. Non-requested Copies Distributed Outside the Mail Total Non-requested Distribution (Sum of 15d (1), (2), (3) and (4)) Total Distribution (Sum of 15c and e) Copies not Distributed Total (Sum of 15f and g) Percent Paid and/or Requested Circulation 43,999 31,740 32,426 31,754 32,435 11,506 10,908 703 12,209 43,962 36 43,999 72.23% 835 11,743 44,178 73 44,251 73.42% E. F. G. H. I. 16. Publication for a Requester Publication is required. Will be printed in the October 2008 issue of this publication 17. Name and Title of Editor, Publishers, Business Manager, or Owner: Mark Rosen Audience Development Director Signature: Date: I certify that the statements made by me above are correct and complete. LEXAPRO (escitalopram oxalate) TABLETS/ORAL SOLUTION Rx Only Brief Summary: For complete details, please see full Prescribing Information for Lexapro. Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Lexapro or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Lexapro is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use) CONTRAINDICATIONS Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated (see WARNINGS). Concomitant use in patients taking pimozide is contraindicated (see Drug Interactions – Pimozide and Celexa). Lexapro is contraindicated in patients with a hypersensitivity to escitalopram or citalopram or any of the inactive ingredients in Lexapro. WARNINGS WARNINGS-Clinical Worsening and Suicide Risk Clinical Worsening and Suicide Risk Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older. The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 1. TABLE 1: Age Range and Drug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated: Increases Compared to Placebo; <18 (14 additional cases); 18-24 (5 additional cases); Decreases Compared to Placebo; 25-64 (1 fewer case); ≥65 (6 fewer cases). No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide. It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression. All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality. Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can be associated with certain symptoms (see PRECAUTIONS and DOSAGE AND ADMINISTRATION—Discontinuation of Treatment with Lexapro, for a description of the risks of discontinuation of Lexapro). Families and caregivers of patients being treated with antidepressants for major depressive

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Managed Healthcare Executive - October 2008 For Your Benefit Editorial Advisors Contents News Analysis State Report Politics &�Policy Healthcare Reform Trends in 2009 Cost Control Strategies Predicted Premium Increase Top Challenges in 2009 IT System Integration Technology Innovation Disease Management Health Management Pharmacy Best Practices Technology Desktop Resource Ad/Edit Index Managed Care Outlook Statement of Ownership

Managed Healthcare Executive - October 2008

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