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Volume 8, Number 7 July 2005 - National Diabetes Education Initiative

THOMSON HEALTHCARERelease Date: January 2005Valid Until: June 2006This educational activity is a component ofthe National Diabetes Education Initiative ®(NDEI ® ) sponsored by Thomson ProfessionalPostgraduate Services ® (PPS), Secaucus, NJ.Issue No. 7, July 2005, is part of a 12-partCME activity (January–December 2005).Physicians who wish to receive CME credit forthis educational activity should do the following:(1) read each of the 12 monthly issues inthe series and retain them for future reference;(2) review the original articles discussed in theirentirety; and (3) after completing the last issueof the year (December 2005), obtain the posttestto complete the CME activity. The post-testmay be obtained from www.ndei.org or bycalling 1 (800) 606-6106 and requesting thepost-test. You will receive the post-test, registration,and evaluation forms by fax. To receiveCME credit, the participant must complete the12-part series and post-test and return thecompleted registration and evaluation forms to:Thomson Professional Postgraduate Services,Attn: CME Dept. T150, PO Box 1505, Secaucus,NJ 07096-1505 (Fax: 1 [201] 430-1441).Applicants will receive a certificate of participationfrom PPS by return mail within6 to 8 weeks of the date of receipt of thecompleted evaluation/registration form.Learning ObjectivesAfter studying the literature presented inthis Clinical Insights in Diabetes series,participants will be able to:• Identify patients with type 2 diabetesand the metabolic syndrome• Select an appropriate therapeutic regimenfor patients with type 2 diabetesand the metabolic syndrome• Summarize risk factors for cardiovasculardisease in patients with type 2 diabetesand the metabolic syndromeThis CME activity is sponsored by ThomsonProfessional Postgraduate Services ® ,Secaucus, NJ.Thomson Professional Postgraduate Services ®is accredited by the Accreditation Council forContinuing Medical Education to providecontinuing medical education for physicians.Thomson Professional Postgraduate Services ®designates this educational activity for amaximum of 4 category 1 credits toward theAMA Physician’s Recognition Award. Eachphysician should claim only those credits thathe/she actually spent in the activity.This CME activity is supported by anunrestricted educational grant fromTakeda Pharmaceuticals North America, Inc.National Diabetes Education Initiative,NDEI, and Clinical Insights in Diabetes aretrademarks used herein under license.Copyright © 2005 ThomsonProfessional Postgraduate Services ® .All rights reserved.CLINICAL INSIGHTS INDiabetesSILVIO E. INZUCCHI, MD,* CO-EDITOR-IN-CHIEF; HENRY N. GINSBERG, MD, † REVIEWER;TERRENCE F. FAGAN, ‡ MANAGING EDITORElevated Glucose Leads to Greater Risk ofMortality in Elderly AMI Patients With andWithout Diagnosed DiabetesIn a study of data from 141,680 elderlypatients admitted to hospitals for acutemyocardial infarction (AMI), it was foundthat those with elevated glucose levelshad a greater risk of mortality, particularlypatients without recognized diabetes.Kosiborod and colleagues derived the datafrom the Cooperative CardiovascularProject, a nationally based representativesample of elderly patients hospitalizedwith AMI from 1994to 1996. Excludedpatients includedthose 110 to140 mg/dL, >140 to 170 mg/dL, >170 to240 mg/dL, and >240 mg/dL. Outcomeswere 30-day and 1-year all-cause mortalityfrom day of admission. Medianadmission glucose was 150 mg/dL; 30.4%of patients had documented diabetes.A substantial proportion of patientswith glucose >170 mg/dL had not beendiagnosed with diabetes (58% of the>170-mg/dL to 240-mg/dL group and26% of the >240-mg/dL group).VOLUME 8, NUMBER 7 • JULY 2005Insulin administration ratesduring hospitalization werefar lower for hyperglycemicpatients without recognizeddiabetes than for those whohad been diagnosed.Higher admission glucose levels wereassociated with successively higher crude30-day and 1-year mortality rates in bothgroups. The increase was steep and gradedin the group without recognized diabetes(for glucose range from ≤110 mg/dL to>240 mg/dL, mortality was 10% to 39% at30 days and 22% to 55% at 1 year). In thediagnosed diabetes group, mortality was16% to 24% at 30 days and 35% to 41% at1 year for the sameranges. Overall,higher glucose levelswere associated witha significantly greaterincrease in 30-dayand 1-year mortalityrisk in patients whodid not have recognizeddiabetes thanin those who did (P140-mg/dL to 170-mg/dL, >170-mg/dL to240-mg/dL, and >240-mg/dL glucose groups,insulin was administered to 2.7%, 5.6%, and21.8%, respectively, of the patients withoutdiagnosed diabetes and 37.5%, 49.0%, and73.4%, respectively, of the patients withdiabetes (P

CLINICAL INSIGHTS IN DIABETESElevated Glucose Leads to Greater Risk of Mortalityin Elderly AMI Patients With and Without DiagnosedDiabetesContinuedglucose levels in patients with undiagnoseddiabetes remained associated at all levelswith a graded increased risk of 30-daymortality: from hazard ratio (HR) 1.17,95% confidence interval (CI), 1.11-1.24 at>110 mg/dL to 140 mg/dL, to HR 1.87, 95%CI, 1.75-2.00, at >240 mg/dL. In the diagnosedgroup, only patients with glucoselevels >240 mg/dL showed greater risk (HR1.32, 95% CI, 1.17-1.49). Results were similarfor both groups at 1-year mortality.The study’s authors note that the analysiswas limited to admission glucose values,and so they could not assess the effectivenessof in-hospital insulin therapy. They concludethat elevated glucose among AMIpatients is common, rarely treated, andassociated with a much greater risk ofmortality in patients not recognized withdiabetes compared with those diagnosedwith the disease, and that aggressiveglycemic control, diabetic screening, andrisk-factor modification during and afterhospitalization may represent opportunitiesfor improved care of these patients.Kosiborod M et al. Admission glucose and mortalityin elderly patients hospitalized with acute myocardialinfarction: implications for patients with andwithout recognized diabetes. Circulation. 2005;111:3078-3086.Compared withthe placebo group,the atorvastatingroup hada significantlylower incidenceof CV eventsand procedures.Atorvastatin Reduces CV Events in Patients With Type 2Diabetes Without a History of CHD—the ASCOT-LLA StudyIn a study of 2,532 patients with diabetes,well-controlled hypertension, and nohistory of coronary heart disease, a 10-mgper day dose of atorvastatin significantlylowered the risk of major cardiovascular(CV) events. The study was part of the lipidloweringarm of the Anglo-ScandinavianCardiac Outcomes Trial (ASCOT-LLA), arandomized, double-blind study comparingthe CV effects of atorvastatin with that ofplacebo.Participants were aged 40 to 79 years(mean age of 64 years). Ninety percentwere white, 76% were male, and all hadtype 2 diabetes, hypertension, and at least3 CV risk factors at baseline (including diabetes).At the initial screening, all patientshad a total cholesterol level of ≤251 mg/dLand were untreated with a fibrate or statin.They were then randomly assigned toreceive atorvastatin 10 mg daily (n=1,258)or matching placebo (n=1,274). At eachfollow-up visit (median study follow-uplength, 3.3 years), antihypertensive drugtherapy was titrated to achieve targetblood pressure of

CLINICAL INSIGHTS IN DIABETESAtorvastatin Reduces CV Events in Patients With Type 2Diabetes Without a History of CHD—the ASCOT-LLA StudyContinuedThe authors note that 14% of patientsin the placebo group were allocated openlabelstatins by their physicians before theend of the study, which may partially explainthe lower cholesterol differences atend of study as compared with year 1 ofstudy. They add that this study’s findingssupport the data of earlier trials supportingrecommendations that all patients withtype 2 diabetes and hypertension should beconsidered for statin therapy.Sever PS et al. Reduction in cardiovascular eventswith atorvastatin in 2,532 patients with type 2diabetes: Anglo-Scandinavian Cardiac OutcomesTrial—Lipid-Lowering Arm (ASCOT-LLA). DiabetesCare. 2005;28:1151-1157.At week 28, meanpercent changesin body weightwere –1.9% forplacebo, –5.9%for 96 mg/dtopiramate,and –6.5%for 192 mg/dtopiramate.Topiramate Demonstrates Significant Reduction inWeight and Diastolic BP in an Obese PopulationWithout DiabetesTreatment with topiramate demonstratedclinically relevant effects indecreasing body weight and blood pressure(BP) in obese patients with mild to moderatehypertension. A sulfamate-substitutedmonosaccharide prescribed to treatepilepsy and migraines, topiramate hasdemonstrated weight loss in several previousstudies that also noted improved BPmeasurements.To assess the efficacy of topiramatetreatment on weight loss and loweringof BP, Tonstad and colleagues initiated astudy of 531 obese patients (body massindex 27 kg/m 2 to 50 kg/m 2 ) with mild tomoderate hypertension (sitting systolic BP140 mm Hg to 180 mm Hg and/or diastolicBP 90 mm Hg to 110 mm Hg) randomly assignedto placebo, 96 mg/d of topiramate,or 192 mg/d of topiramate. Participantswith significant renal or cardiovasculardisease or diabetes were excluded.The study was randomized, doubleblind,placebo-controlled, and initiallyplanned for 60 weeks on medication. However,the sponsor discontinued the studyearly to develop a controlled-release formulaof the drug. To avoid bias, the authorsused a modified intent-to-treat population(n=158) to determine efficacy. Thispopulation included only participants whohad ≥1 dose of study medication, ≥1 efficacyevaluation, and had been enrolledearly enough to have the opportunity tocomplete at least 28 weeks on the medicationbefore termination of the study.Patients in the topiramate groups weregradually titrated until the assigned dose wasreached, with dosing maintained at that leveluntil end of study. Primary end points werepercent change in diastolic BP and bodyweight from baseline to week 28. Secondaryend points included change in systolic BP,proportion of participants who developednormalization of BP, or who achieved a ≥5%or ≥10% weight loss or decrease in BP.At week 28, mean percent changes inbody weight ± SD were –1.9% ± 3.4% forthe placebo group, –5.9% ± 5.2% for the96 mg/d topiramate group, and –6.5 ± 4.9%for the 192 mg/d topiramate group (P

CLINICAL INSIGHTS IN DIABETESTopiramate Demonstrates Significant Reduction inWeight and Diastolic BP in an Obese PopulationWithout DiabetesThe authors conclude that topiramateoffers clinically relevant reductions in weightand BP, but note that the study’s sponsorlater discontinued clinical research of thedrug for obesity and diabetes after a laterstudy of a controlled-release formula failedto demonstrate significant advantages overthe earlier version of the drug.NOTE: the FDA has not approved the discusseduse of the drug in this study.Tonstad S et al. Efficacy and safety of topiramatein the treatment of obese subjects with essentialhypertension. Am J Cardiol. 2005;96:243-251.NDEI MISSIONSTATEMENTThe NDEI is a multicomponenteducational program ontype 2 diabetes designed forendocrinologists, diabetologists,cardiologists, primarycare physicians, and otherhealthcare professionalsinvolved in the care andmanagement of patients withtype 2 diabetes and insulinresistance. NDEI programsaddress issues concerninginsulin resistance and type 2diabetes, from the epidemiologyand pathophysiology ofthe disease and its associatedcomplications to the therapeuticoptions for treatment andprevention.NDEI CME Programs• CME-Certified Satellite Dinner Symposium at the American Academy of FamilyPhysicians in San Francisco, September 28, 6:30 PM “The Impact of InsulinSensitizers on Cardiovascular Disease in Type 2 Diabetes.” Register by phone1 (877) 251-0943 or online at www.ndei.org.• CME Managed Care Dinner Meeting Series, “Getting to the Heart of Type 2Diabetes and the Metabolic Syndrome.” To register for a program in your area,please call 1 (877) 251-0943 or log on at www.ndei.org.• Two New Case Studies for On-Demand CME at www.ndei.org:o “A 48-Year-Old Executive With Newly Diagnosed Diabetes PresentsWith ED,” authored by Bernard Zinman, MDCM; earn 1 category 1credit – free.o “A 58-Year-Old African-American Man With a Recently TreatedUncomplicated MI Presenting With Elevated BG,” authored byFrank Lavernia, MD; earn 1 category 1 credit – free.• New On-Demand CME Program, “PPARs as Therapeutic Targets in Type 2Diabetes and Atherosclerosis.” Explore the current thinking on PPARs andPPAR agonists and earn free CME online at www.ndei.org; earn 2 category 1credits – free.For more information about upcoming NDEI CME and CE activities, visit us atwww.ndei.org or call 1 (800) 606-6106.Visit www.ppscme.org for information on other CME or CE activities.Clinical Insights in Diabetes is co-edited by NDEI faculty members Mayer B. Davidson, MD,and Silvio E. Inzucchi, MD.If you have any friends or colleagues who would like to receive this newsletter via email,please fill in their information on the line below and fax this page to us at1 (800) 471-7716 so they can be added to our subscriber list.Name:________________________________________________________________________________Specialty:_____________________________________________________________________________Email Address: ________________________________________________________________________You have received this email because we believe it may be of interest to you. If you wouldlike your name to be removed from our mailing list, please choose from the following:1) Reply to this email and place REMOVE in the subject line.2) Call 1 (800) 873-1362 and leave a message with your name and email address indicatingthat you would like to be removed.Copyright © 2005 Thomson Professional Postgraduate Services ® . All rights reserved.EM-T150-PHYCMEem-0705-17.7K4R:\NDEI-2\2005-2006 Grant\T150\05-06 Clinical Insights\Manuscrp\July 2005\July 05 Newsletter Email Color.doc

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