Managed Healthcare Executive - November 2008 - (Page 31)

Editorial Index The following is a list of the companies that appear in this issue. Although every effort is made to ensure accuracy, this publication assumes no liability for errors or omissions. K Kaiser Commission on Medicaid and the Uninsured 20 Kaiser Family Foundation 8 Keystone Center for Patient Safety & Quality 24 Aetna Better Health 13 Aetna 9, 23 Agency for Healthcare Research and Quality 23 AIG 29 American Medical Assn 25 American Medical Group Assn 30 American Psychiatric Assn. 9 AmeriChoice 13 Availity 27 L Leapfrog Group 24 M Manpower 20 Martin J Wolff & Co. Inc 7 Medco Health Solutions 22 Medical Assistance Administration .20 Medical Care Administration 22 Michigan Health and Hospital Assn.24 Michigan State 1 Banner Page Hospital 8 Blue Cross and Blue Shield 23 Blue Cross Blue Shield of Louisiana 26 Blue Cross Blue Shield of Michigan 24 California Department of Public Health 24 Central Connecticut State University14 Charter Oak Health Plan 13 CIGNA 24 Circulation 8 CMS 8, 10, 23. 26, 30 Commonwealth Fund 8 Community Health Network of Connecticut 13 Connecticut Department of Social Services 13 N National Association of Insurance Commissioners 22 National Biodefense Science Board Disaster Medicine Working Group.28 National Business Group on Health ..9 National Quality Forum 23 NCQA 1 O Ochsner Health System 27 Office of Health Care Access 14 P Penn State 1 Providence 10 D2Hawkeye 20 Denver Health Medical Center 28 Department of Health and Human Services 7, 10, 25 Department of Veterans Affairs 7 Discern Consulting LLC 24 R Riverside Medical Group 30 Robert Wood Johnson Foundation 4 RSM McGladrey Inc. 30 S Stanford Graduate School of Business 20 Employee Benefits Research Institute 14 T Tenet 28 The Doctors Co. 25 Troutman Sanders 27 Families USA 16 H Health Management Associates 20 Humana 27 Huron Consulting Group 19 U U.S. Bureau of Labor Statistics 20 U.S. Census Bureau 8 UnitedHealthcare 13, 23 Urban Institute 8 I Independence Blue Cross 1 J Joint Commission 24 W Wall Street Journal 20 WellPoint 23 Ad Index The following is a list of the advertisers in this issue. Although every effort is made to ensure accuracy, this publication assumes no liability for errors or omissions. Eli Lilly/Daiichi-Sankyo Inc 21 Forest Labs Inc 31,32,CV3,CV4 Mddatacor 11 Prescription Solutions CV2 Trizetto Group Inc 15 Wellpoint Pharmacy 17 Wyeth Pharmaceuticals 05,06,07 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) INDICATIONS AND USAGE Major Depressive Disorder Lexapro (escitalopram) is indicated for the treatment of major depressive disorder. The efficacy of Lexapro in the treatment of major depressive disorder was established in three, 8-week, placebo-controlled trials of outpatients whose diagnoses corresponded most closely to the DSM-IV category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of Lexapro in hospitalized patients with major depressive disorders has not been adequately studied. The efficacy of Lexapro in maintaining a response, in patients with major depressive disorder who responded during an 8-week, acute-treatment phase while taking Lexapro and were then observed for relapse during a period of up to 36 weeks, was demonstrated in a placebo-controlled trial (see Clinical Efficacy Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Lexapro for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Generalized Anxiety Disorder Lexapro is indicated for the treatment of Generalized Anxiety Disorder (GAD). The efficacy of Lexapro was established in three, 8-week, placebo-controlled trials in patients with GAD (see CLINICAL PHARMACOLOGY). Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance. The efficacy of Lexapro in the long-term treatment of GAD, that is, for more than 8 weeks, has not been systematically evaluated in controlled trials. The physician who elects to use Lexapro for extended periods should periodically re-evaluate the longterm usefulness of the drug for the individual patient. 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 b

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Managed Healthcare Executive - November 2008 For Your Benefit Editorial Advisors Contents News Analysis State Report Politics &�Policy Letter of the Law Affordable Access Economic Ripple Effect Hospitals &�Providers Technology Managed Care Outlook Desktop Resource Ad/Edit Index

Managed Healthcare Executive - November 2008

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