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Volume 10, Number 9 September 2007 - National Diabetes ...

P r o f e s s i o n a l P o s t g r a d u a t e S e r v i c e s ®Release Date: September 2007Valid Until: January 2008SponsorThis educational activity is a component of theNational Diabetes Education Initiative ® (NDEI ® ),sponsored by Professional PostgraduateServices ® (PPS).Clinicians who wish to receive CME credit forthis educational activity should do the following:(1) read the current issue; and (2) complete thepost-test and evaluation form included to concludethis CME activity. You may also complete the posttestand evaluation form on our website,www.ndei.org. To apply for CME credit,return thecompleted post-test and evaluation form to:Professional Postgraduate Services ®CME Dept. T196150 Meadowlands ParkwaySecaucus, NJ 07094-1505You may also fax the completed materials to1 (201) 430-1441. If you have any questions,please call 1 (800) 606-6106 Ext. 6014.Applicants will receive a certificate of participationfrom PPS by return mail within 6 to 8 weeks of thedate of receipt of the completed evaluation formand post-test. Online applicants will automaticallyreceive their CME credit certificate upon completionof the online post-test and evaluation form.Target AudienceThis educational activity is designed for primarycare physicians, internal medicine specialists,endocrinologists, diabetologists, cardiologists, andother healthcare professionals involved in the careand management of patients with type 2 diabetes,insulin resistance, and cardiovascular disease.Learning ObjectivesWith information from the latest evidence-basedstudies, participants should be able to:• Identify patients with insulin resistance, type 2diabetes, and/or cardiovascular disease• Select the most appropriate therapeutic regimenfor patients with type 2 diabetes and itsmacrovascular and microvascular complications• Identify risk factors for cardiovascular disease inpatients with type 2 diabetes and select anappropriate therapeutic regimenAccreditationProfessional Postgraduate Services ® is accredited bythe Accreditation Council for Continuing MedicalEducation to provide continuing medical educationfor physicians.Professional Postgraduate Services ® designates thiseducational activity for a maximum of .75 AMAPRA Category 1 Credit. Physicians should onlyclaim credit commensurate with the extent of theirparticipation in the activity.AAFP creditClinical Insights in Diabetes has been reviewed andis acceptable for up to 9 Prescribed credits by theAmerican Academy of Family Physicians. AAFPaccreditation begins 5/1/07. Term of approval isfor one year from this date. This issue is approvedfor .75 Prescribed credit. Credit may be claimed forone year from the date of this issue.GrantorThis CME activity is supported by an educationalgrant from Takeda Pharmaceuticals NorthAmerica, Inc.Off-Label DisclosureSome of the drug treatments discussed in this issuemay note uses not approved by the Food and DrugAdministration. Articles containing such uses will benoted at the end of the article.Professional Postgraduate Services is a businessunit of KnowledgePoint360 Group, LLC,Secaucus, NJ.C L I N I C A L I N S I G H T S ®I NDiabetesV O L U M E 1 0 , N U M B E R 9 • S E P T E M B E R 2 0 0 7SILVIO E. INZUCCHI, MD,* CO-EDITOR-IN-CHIEF; JAMES W. REED, MD, † REVIEWER;TERRENCE F. FAGAN, ‡ MANAGING EDITOR AND CO-WRITER; CHING-LING CHEN, PhD ‡ CO-WRITERAn Analysis of Thiazolidinediones and Heart Failure RiskThiazolidinediones (TZDs) play an importantrole in the treatment of patients with type2 diabetes. This class of drugs, however,also presents a greater risk for edema and thedevelopment of heart failure in some patients.Singh and colleagues performed an analysis togauge the magnitude and characteristics of thepossible role of TZDs in the risk of heart failure.The analysis used data from randomizedcontrolled trials (RCTs) and controlled observationalstudies to estimate the magnitude of risk;it also used data from published case reports andspontaneous reports from the Canadian DrugReaction Monitoring Program (CADRMP) toclassify specific characteristics of adverse effects.The researchers compiled the results into a teleoanalysis,which combines data from differenttypes of studies to determine the adverse effectof a drug.The RCTs included 3 trials with a total of10,731 patients. The trials were direct comparisonsbetween a TZD (pioglitazone or rosiglitazone)alone and placebo alone, of at least 6months’ duration of TZD use for preventingor treating type 2 diabetes, and they were designedto provide numerical data on patientsexperiencing heart failure. The observationalstudies included 67,382 patients. The authorsalso identified 28 published case reports and1,025 spontaneous reports, reviewing all adversedrug reactions reported to CADRMP for pioglitazone(n=195) or rosiglitazone (n=830). Excludingreports of edema alone, a total of 51 reports ofheart failure with pioglitazone and 163 withrosiglitazone were identified.The pooled odds ratio for heart failure inpatients randomized to TZDs compared withpatients on placebo was 2.10 (95% confidenceinterval [CI], 1.08-4.08; P=0.03) in the RCTsand 1.55 (95% CI, 1.33-1.80; P

C L I N I C A L I N S I G H T S ®I N D I A B E T E SYou have received this faxbecause we believe it may beof interest to you. If you wouldlike your name to be removedfrom the Clinical Insights ®newsletter fax list, pleasefollow these instructions:Call toll-free 1 (866) 860-3439,enter PIN 6114, followed bythe # key and fax number.On-Demand CMEActivity at www.ndei.org:“A 54-Year-Old Taxi DriverWho Presents for Reassessmentof His Type 2 Diabetes andNew Dyspnea on Exertion.”For primary care physicians andother healthcare professionalsinvolved in the care of patientswith type 2 diabetes. Earn .75 AMAPRA Category 1 Credit—Free.On-Demand CMEActivity at www.ndei.org:“Incretins and Glycemic Control:Understanding the Science forBetter Diabetes Management.”For primary care physicians,endocrinologisits, and nursepractitioners. Earn 2.5 AMAPRA Category 1 Credits and2.4 AANP contact hours—Free.COMMENTARYJAMES W. REED, MD. Professor of Medicine, Chief of Endocrinology, and Associate Chair ofMedicine for Research, Morehouse School of Medicine; Chief of Internal Medicine Service atGrady Memorial Hospital for Morehouse School of Medicine, Atlanta, Georgia.This article analyzed heart failure risk using a type of meta-analysis using the drug reporting system from theCanadian Drug Reaction Monitoring Program for adverse effects. In addition to using clinical trial data, it includedspontaneous reports and case reports in a teleo-analysis. It included both pioglitazone and rosiglitazone so itconsiders heart failure a class effect. It confirms what has been previously known about edema as a side effect ofthe thiazolidinediones (TZDs). The combined odds ratio from controlled clinical trials is 2.10 for heart failure. It isimportant to note that there is no sex difference or dose relation difference. The study’s conclusion that the effectof TZDs is mediated through fluid retention rather than a direct effect upon the myocardium is reasonable butwill need further investigation to prove. The article does not shed any further light on the coronary artery diseaserisk that is currently being debated for rosiglitazone.Mortality Rates Reduced in Men but Not in Women WithDiabetes, 1971 to 2000The management of diabetes and certainassociated cardiovascular disease (CVD) riskfactors has substantially improved among USadults with diabetes in recent years. It is, however,unclear whether mortality rates have alsodeclined among these patients. The only nationallyrepresentative study designed to examinemortality rates among adults with diabetesbetween 1971 and 1992 found no improvement.In addition, no national studies of mortalitytrends in this group have extended through the1990s, a period with significant advancement inthe management of diabetes and CVD.In the present study, Gregg and colleaguesreviewed 3 consecutive nationally representativepopulation-based health surveys, the NationalHealth and Nutrition Examination Surveys(NHANES). The surveys were conducted from1971 to 1975 (NHANES I), 1976 to 1980 (NHANESII), and 1988 to 1994 (NHANES III), and all-causeand CVD mortality rates were determined with afollow-up of 12.2 years through 1986, 1992, and2000 for the 3 surveys, respectively. Participantswere limited to adults aged 35 to 74 years. Diabeteswas determined by self-report.In the population without diabetes (bothmen and women), all-cause mortality rates decreasedfrom 14.4 to 9.5 annual deaths per 1,000persons (P

C L I N I C A L I N S I G H T S ®I N D I A B E T E SBiology of Leg Disorders(BOLD) InitiativeCOMING TO A LOCATIONNEAR YOU! A 25-CityEducational SimulcastDifferentiating Leg Disorders:Strategies for Diagnosis andTreatment in the PrimaryCare SettingBroadcast simultaneously to 25exclusive sites across the country,this certified activity will includean in-depth review of the multiplepathways involved in dozens ofleg disorders, focusing on thechallenge of differential diagnosis,often complicated by primary andsecondary symptoms and comorbiddisease, and a critical examinationof treatment options.Saturday, November 3, 2007 –3.0 CME/CE CreditsRegister on LegDisorders.orgDecreased Myocardial Reperfusion in Patients WithDiabetes Undergoing Percutaneous CoronaryIntervention for ST-Segment Segment Elevation Acute MyocardialInfarction: the EMERALD TrialType 2 diabetes was shown to increase cardiovascularmorbidity and mortality in patientswith ST-segment elevation myocardial infarction(MI). To improve the poor prognosis in patientswith diabetes and ST-segment elevation MI,Marso and colleagues investigated the effectivenessof primary percutaneous coronary intervention(PCI) in establishing myocardial perfusion inpatients with diabetes versus those withoutdiabetes in the Enhanced Myocardial Efficacyand Removal by Aspiration of Liberated Debris(EMERALD) trial.The EMERALD trial was a prospective, randomized,multicenter study evaluating distalembolic protection during primary PCI inST-segment elevation MI. Using the EMERALDdatabase, the authors compared myocardial perfusionand infarct sizes between patients withand without diabetes undergoing PCI for acuteST-segment elevation MI. Endpoints of this studyincluded final myocardial blush grade (MBG),rates of complete ST-segment resolution (STR)30 minutes after PCI, and final infarct size asdetermined by computed tomography measuredbetween days 5 and 14.Of 501 patients enrolled in the EMERALDstudy, 62 (12%) had type 2 diabetes. A higherincidence of hypertension and dyslipidemia wasnoted in patients with diabetes. Myocardial perfusionafter PCI was significantly decreased inpatients with diabetes as measured by MBG 0/1(34% vs 16%; P=0.002) immediately after the PCIprocedure and lower rates of complete STR at 30minutes (45% vs 65%; P=0.005). Consistent withimpaired myocardial reperfusion, final infarctsize was substantially larger in patients withdiabetes than those without diabetes (median20% vs 11%; P=0.005). This was true for left anteriordescending and non-left anterior descendinginfarctions.Additionally, development of new-onsetsevere congestive heart failure at 6 months (6%vs 1%; P=0.04), and 30-day mortality (10% vs 1%;P

C L I N I C A L I N S I G H T S ®I N D I A B E T E SClinical Insights ® in Diabetes Post-Test September 20071) In an analysis of the possible role of thiazolidinedione (TZD) use in the risk of heart failure, Singhand colleagues noted all but one of the following:a. Use of TZDs is associated with an increased magnitude of risk of heart failure in some patientswith diabetesb. The class effect of TZDs is mediated through increased plasma volume, not any direct effect onthe myocardiumc. Diabetes and the use of any treatment is associated with an increased risk of heart failured. Heart failure was more likely to occur in women taking higher doses of TZDs2) Which one of the following was not shown in a study by Gregg and colleagues comparing mortalityrates in US adults with and without diabetes between 1971 and 2000?a. All-cause mortality rates declined in women with diabetesb. All-cause mortality rates increased in women with diabetesc. CVD mortality rates declined in both men and women with diabetesd. All-cause mortality rates declined in men with diabetes3) In patients with diabetes and ST-segment elevation myocardial infarction undergoing primarypercutaneous coronary intervention, diabetes is an independent predictor of all but one of thefollowing:a. Larger infarctb. Increased myocardial reperfusionc. Development of congestive heart failured. Decreased survivalANSWER KEY1. d. Heart failure was more likely to occur in women taking higher doses of TZDs. No susceptibility factorswere identified, with heart failure occurring equally in high and low doses and in men and women.2. a. All-cause mortality rates declined in women with diabetes. Among women with diabetes, the all-causemortality rate increased (18.4 to 25.9 annual deaths per 1,000 persons) between 1971 to 1986 and1988 to 2000.3. b. Increased myocardial reperfusion. Myocardial reperfusion after percutaneous coronary intervention (PCI)was significantly decreased in patients with diabetes immediately after the PCI procedure.NDEI MISSION STATEMENTThe National Diabetes EducationInitiative ® (NDEI ® ) is a multicomponenteducational program on type 2 diabetesdesigned for endocrinologists, diabetologists,cardiologists, primary carephysicians, and other healthcareprofessionals involved in the care andmanagement of patients with type 2diabetes and insulin resistance. NDEIprograms address issues concerninginsulin resistance and type 2 diabetes,from the epidemiology and pathophysiologyof the disease and its associatedcomplications to the therapeuticoptions for treatment and prevention.National Diabetes Education Initiative,NDEI, and Clinical Insights are trademarksused herein under license.Copyright © 2007 ProfessionalPostgraduate Services ® .All rights reserved.Clinical Insights ® in Diabetes is co-edited by NDEI faculty members Mayer B. Davidson, MD, and Silvio E. Inzucchi, MD.You have received this email because we believe it may be of interest to you. If you would like yourname to be removed from the Clinical Insights ® newsletter email list, please click on the following linkwww.pps-sso.com.If you have any colleagues who are not receiving this free, CME e-newsletter via email, please fill in theirinformation on the lines below and fax this page back to us at 1 (800) 471-7716 and we will add them toour subscriber list.PLEASE PRINT CLEARLY:Name:Address:City:Phone:For more information about upcoming NDEI CME and CE activities, visit us at www.ndei.org or call1 (800) 606-6106, ext. 6139. Visit www.ppscme.org for information on other CME or CE activities.Email Address: State: ZIP Code: - - Fax: - - Professional Classification: MD DO PharmD RN NPSpecialty: Endocrinology Cardiology Internal medicine Family medicineOther ________________________________________________________________________EM-T196-6-PHYCME-09074

C L I N I C A L I N S I G H T S ®I N D I A B E T E SActivity Code: T196-6Issue Date: September 2007CME Credit Availability: Through January 2008CME Activity Evaluation/Registration FormParticipants who wish to obtain CME credit for this educational activity, please complete the contact information below, sign this form,and fax it with the completed post-test to 1 (201) 430-1441 or mail to: Professional Postgraduate Services ® , CME Dept. T196, 150Meadowlands Parkway, Secaucus, NJ 07094-1505. You may download previous issues of Clinical Insights ® in Diabetes e-newsletters byvisiting us online at www.ndei.org.I have completed this activity as designed: _______________________________________________________________________________(Signature)(Date)PLEASE PRINT CLEARLY:Name:Address:City:Phone:Email Address: State: ZIP Code: - - Fax: - - Professional Classification: MD DO PharmD RN NPOther __________________________________________________________________________________Specialty: Endocrinology Cardiology Internal medicine Family medicineOther ___________________________________________________________________________________________________1. The activity met the stated objectives in such a way that I am better able to:a. Identify patients with insulin resistance, type 2 diabetes, and/orcardiovascular diseaseb. Select the most appropriate therapeutic regimen for patients with type 2diabetes and its macrovascular and microvascular complicationsc. Identify risk factors for cardiovascular disease in patients with type 2 diabetesand select an appropriate therapeutic regimenStronglyDisagree Disagree AgreeStronglyAgree1 2 3 4 5 61 2 3 4 5 61 2 3 4 5 62. Overall, the activity was presented in a fair-balanced manner. Yes No** If you checked “No,” please explain.3. Overall, the activity was free from commercial bias. Yes No** If you checked “No,” please explain.4. In reflecting on your practice, what type of impact will this educational activity have?This program has validated my practice in the treatment of type 2 diabetes and its cardiovascular complications.Need more information before making a change.(Please specify what information you would require.)5. What is the largest challenge or unmet educational need in your practice?6. What other clinical issues are you and your colleagues challenged by that could be addressed in a CME activity? (Please specify.)Thank you for your participation.5

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