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Volume 10, Number 2 February 2007 - National Diabetes Education ...

THOMSON HEALTHCARERelease Date: February 2007Valid Until: April 2007SponsorThis educational activity is a component of theNational Diabetes Education Initiative ® (NDEI ® ),sponsored by Thomson Professional PostgraduateServices ® (PPS), Secaucus, NJ.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 thepost-test and evaluation form on our website,www.ndei.org. To apply for CME credit, returnthe completed post-test and evaluation form to:Thomson Professional Postgraduate Services ®CME Dept. T177150 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. 6139.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,and other healthcare professionals involved inthe care and management of patients withtype 2 diabetes, insulin resistance, and cardiovasculardisease.Learning ObjectivesAfter studying the literature presented in thisClinical Insights ® in Diabetes, participants shouldbe better able to:• Identify patients with type 2 diabetes andthe metabolic syndrome• Select an appropriate therapeutic regimenfor patients with type 2 diabetes and themetabolic syndrome• Summarize risk factors for cardiovasculardisease in patients with type 2 diabetes andthe metabolic syndromeAccreditationThomson 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 a maximumof .75 AMA PRA Category 1 Credit. Physiciansshould only claim credit commensurate with theextent of their participation in the activity.Clinical Insights ® in Diabetes (2006-2007) hasbeen reviewed and is acceptable for up to6 Prescribed credits by the American Academyof Family Physicians. AAFP accreditation begins04/01/06. Term of approval is for one year fromthis date. This issue is approved for .5 Prescribedcredit. Credit may be claimed for one year fromthe 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 thisissue may note uses not approved by the Foodand Drug Administration. Articles containing suchuses will be noted at the end of the article.CLINICAL INSIGHTS ®INDiabetesMAYER A. DAVIDSON, MD,* CO-EDITOR-IN-CHIEF; JAMES W. REED, MD, † REVIEWER;TERRENCE F. FAGAN, ‡ MANAGING EDITOR AND CO-WRITER; MARK A. PALANGIO, CO-WRITER §Sitagliptin Improves Glycemic Control in Patients WithType 2 Diabetes Not Controlled With Either Metformin orPioglitazone: The Results of Two StudiesSitagliptin is an orally administered, oncedaily, highly selective dipeptidyl peptidase-4(DPP-4) inhibitor that prolongs the actionsof incretins, hormones that stimulate postprandialinsulin secretion via direct action on pancreaticβ-cells and suppress glucagon secretion by theα-cells. The efficacy and tolerability of sitagliptinas an adjunctive therapy for type 2 diabetes wererecently evaluated in 2 controlled trials.In a 24-week, multinational study, Charbonneland colleagues examined the effects of addingsitagliptin to ongoing metformin therapy inpatients with type 2 diabetes who had inadequateglycemic control. A total of 701 patientswere randomized (2:1) to sitagliptin 100 mg/day(n=464) or placebo (n=237), added to continuingmetformin therapy (≥1,500 mg/day). At baseline,the mean disease duration was 6.2 years, themean A1C value was 8.0%, and the mean fastingplasma glucose (FPG) concentration was171.5 mg/dL.After 24 weeks, sitagliptin plus metformin,compared with placebo plus metformin, wasassociated with significant reductions in A1Cvalue (mean change from baseline: -0.67%; 95%confidence interval [CI], -0.77 to -0.57; P

CLINICAL INSIGHTS ®IN DIABETESClinical Insights ® in DiabetesWins Top AwardClinical Insights ® in Diabeteswon a 2006 Best Practice Awardfrom the North AmericanAssociation of MedicalEducation and CommunicationsCompanies (NAAMECC), whichrecognized this newsletter as“Outstanding” in the categoryof Educational Designand Evaluation.Sitagliptin Improves Glycemic Control in Patients WithType 2 Diabetes Not Controlled With Either Metformin orPioglitazone: The Results of Two StudiesContinuedincreased incidences of hypoglycemia (1.1% vs0%) or overall gastrointestinal adverse events(13.7% vs 6.2%). Furthermore, there was no significantincrease in body weight with sitagliptincompared with placebo.In both trials, sitagliptin added to either metforminor pioglitazone was effective and welltolerated in patients with type 2 diabetes, withsignificant reductions in A1C, FPG concentration,and several other measures of glycemic control.COMMENTARYCharbonnel B et al. Efficacy and safety of the dipeptidylpeptidase-4 inhibitor sitagliptin added to ongoing metformintherapy in patients with type 2 diabetes inadequatelycontrolled with metformin alone. DiabetesCare. 2006;29:2638-2643.Rosenstock J et al. Efficacy and safety of the dipeptidylpeptidase-4 inhibitor sitagliptin added to ongoingpioglitazone therapy in patients with type 2 diabetes:a 24-week, multicenter, randomized, double-blind,placebo-controlled, parallel-group study. Clin Ther.2006;28:1556-1568.JAMES W. REED, MD, Professor of Medicine and Associate Chair of Medicine for Research atMorehouse School of Medicine and Chief of Endocrinology and Chief of Internal MedicineServices for Morehouse at Grady Memorial Hospital, Atlanta, Georgia.The results are now emerging of clinical trials with sitagliptin as add-on therapy for type 2 diabetes patients who arenot at goal. These two trials show results for metformin and pioglitazone with very similar results. When sitagliptin isadded to metformin, there is significant improvement in A1C and fasting glucose. It is of significance to note thatthere is no additional weight loss. When added to pioglitazone, the results in A1C reduction and fasting glucosereduction are similar, but there is no weight gain. There were no significant adverse events when sitagliptin wasadded to either drug. In both trials there are indications that insulin sensitivity is improved, as indicated by decreasesin pro-insulin and C-peptide. These results suggest further studies to evaluate this drug with insulin secretory agentssuch as sulfonylureas to test their combined effect on insulin sensitivity. Sitagliptin could also be tested in type 2diabetes patients taking insulin to determine if insulin dosages can be significantly lowered.TWO NEW InteractiveCase Studies for on-demand CMEat www.ndei.org:“A 62-Year-Old Asian-American ManPresents With Type 2 Diabetes andHypertension,” authored byStanley S. Schwartz, MD.Earn 1.25 AMA PRA Category 1Credits–Free“A 52-Year-Old Latino Male WithType 2 Diabetes, Hypertension,Elevated A1C and Creatinine Levels,”authored by Thomas Blevins, MD.Earn 1.0 AMA PRA Category 1Credit–FreeIntensive Lipid-Lowering Therapy for Acute CoronarySyndrome and DiabetesThe Pravastatin or Atorvastatin Evaluation andInfection Therapy (PROVE IT) Thrombolysis inMyocardial Infarction (TIMI) 22 trial demonstratedthat intensive statin therapy with atorvastatin80 mg/day was associated with fewercardiovascular events than standard statin therapywith pravastatin 40 mg/day. Because patientswith diabetes are at increased risk of death andischemic complications following acute coronarysyndrome (ACS) compared with those withoutdiabetes, Ahmed and colleagues used data fromthis trial to examine the effect of intensiveversus standard statin therapy in patients withACS and diabetes.Outcomes were compared between patientswith diabetes (identified by history, fastingplasma glucose ≥126 mg/dL, or A1C >7%) (n=978)and without diabetes (n=3,184). Among patientswith diabetes, 499 received intensive statin therapy(atorvastatin 80 mg/day) and 479 receivedstandard statin therapy (pravastatin 40 mg/day).Among patients without diabetes, 1,600 receivedintensive statin therapy and 1,584 received standardstatin therapy. The primary endpoint was acomposite of death, myocardial infarction (MI),unstable angina requiring rehospitalization,revascularization with percutaneous coronaryintervention or coronary artery bypass occurringat least 30 days following randomization, orstroke. Also assessed were a triple endpoint of2death, MI, or unstable angina requiring rehospitalization,as well as a dual goal of low-densitylipoprotein cholesterol (LDL-C) level

CLINICAL INSIGHTS ®IN DIABETESClinical Insights ® in Diabetes Post-Test February 20071) In two studies of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, adding sitagliptin tometformin therapy or to pioglitazone therapy in patients with type 2 diabetes showed which ofthe following results compared with placebo?a. A significantly greater proportion of patients achieved A1C

CLINICAL INSIGHTS ®IN DIABETESCME Activity Evaluation/Registration FormActivity Code: T177-14Issue Date: February 2007CME Credit Availability: April 2007Participants who wish to obtain CME credit for this 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: Thomson ProfessionalPostgraduate Services ® , CME Dept. T177, 150 Meadowlands Parkway, Secaucus, NJ 07094-1505. You maydownload previous issues of Clinical Insights ® in Diabetes e-newsletters by visiting us online atwww.ndei.org.I have completed this activity as designed: ________________________________________________________________________________(signature)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 Primary careOther _________________________________________________________________________________________1. The activity met the stated objectives in such a way that I am better able to:StronglyDisagree Disagree AgreeStronglyAgreea. Identify patients with type 2 diabetes and the metabolic syndrome 1 2 3 4 5 6b. Select an appropriate therapeutic regimen for patients with type 2 diabetesand the metabolic syndrome 1 2 3 4 5 6c. Summarize risk factors for cardiovascular disease in patients withtype 2 diabetes and the metabolic syndrome 1 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.)I will:Identify patients with type 2 diabetes and the metabolic syndrome.Select an appropriate therapeutic regimen for patients with type 2 diabetes and the metabolic syndrome.Other (Please specify.)5. What topics should be dealt with in more detail? (List topics.)Thank you for your participation.5

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