of patients with type 2 diabetes, insulin. resistance, and cardiovascular disease. longer diabetes duration, a curious trend. occurred in HDL-C levels, …


THOMSON HEALTHCARE CLINICAL INSIGHTS IN

Release Date: January 2006 Valid Until: June 2007
Sponsor This educational activity is a component of the National Diabetes Education Initiative NDEI , sponsored by Thomson Professional Postgraduate Services PPS, Secaucus, NJ Issue No 3, March 2006, is part of a 12-part CME activity JanuaryDecember 2006 Clinicians who wish to receive CME credit for this educational activity should do the following: 1 read each of the 12 issues in the series and retain them for future reference; 2 review the original articles discussed in their entirety; and 3 after completing the last issue of the year December 2006, complete the post-test and evaluation form included in the December issue to conclude this CME activity You may also complete the post-test and evaluation form on our website wwwndeiorg To receive CME credit, participants must read the 12-part series, complete the post-test and evaluation form, and return them to: Thomson Professional Postgraduate Services , Attn: CME Dept T150, PO Box 1505, Secaucus, NJ 07096-1505, or fax the completed materials to 1 201 430-1441, or complete the post-test and evaluation form online If you have any
questions, please call 1 800 606-6106 Ext 6126 Applicants will receive a certificate of participation from PPS by return mail within 6 to 8 weeks of the date of receipt of the completed evaluation form and post-test Online applicants will automatically receive their CME credit certificate upon completion of the online post-test and evaluation form Target Audience This educational activity is designed for primary care physicians, internal medicine specialists, endocrinologists, diabetologists, cardiologists, and other healthcare professionals involved in the care and management of patients with type 2 diabetes, insulin resistance, and cardiovascular disease Learning Objectives After studying the literature presented in this Clinical Insights in Diabetes series, participants should be better able to: 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 Summarize risk factors for cardiovascular disease in patients with type 2 diabetes and the metabolic syndrome Accreditation Thomson Professional Postgraduate Services is accredited by the Accreditation Council for
Continuing Medical Education to provide continuing medical education for physicians Thomson Professional Postgraduate Services designates this educational activity for a maximum of 4 AMA PRA Category 1 CreditsTM Physicians should only claim credit commensurate with the extent of their participation in the activity This activity has been reviewed and is acceptable for up to 4 Prescribed credits by the American Academy of Family Physicians AAFP accreditation begins 01/01/06 Term of approval is for one-year from this date, with option for yearly renewal Grantor This CME activity is supported by an unrestricted educational grant from Takeda Pharmaceuticals North America, Inc

Diabetes
VOLUME 9, NUMBER 3 MARCH 2006

SILVIO E INZUCCHI, MD, CO-EDITOR-IN-CHIEF; JAMES W REED, MD, REVIEWER; TERRENCE F FAGAN, MANAGING EDITOR; MARK PALANGIO, CO-WRITER

Achievement of ADA Guidelines Among US Adults With Diabetes: NHANES

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body mass index of 318 kg/m , and mean dianly half of surveyed American adults with diabetes met an A1C goal of 7 as set betes duration of 115 years NHANES assessby the American Diabetes Association ADA ments were made with in-home interviews, clinical practice
recommendations, an in-office medical exams, and lab results from improvement of only 5 percentage points those exams over a related survey performed 10 years Although 498 of persons with diabetes earlier That is one of the conclusions of a achieved the ADA A1C target of 7, 297 recent study that examined data from the of the total had an A1C of 8 These findings National Health and Nutrition Examination are similar to the results of NHANES III [1988Survey NHANES 1999-2002 1994], which showed that 446 of adults aged NHANES is an ongoing data collection 20 years with diabetes met the ADA goal Oral initiative The surveys are stratified, multihypoglycemic drugs were taken by 653, stage probability samples conducted by the 274 were taking insulin, and 104 were National Center for Health Statistics of the taking a combination of the two Cardiovascular Centers for Disease Control and Prevention disease was reported by 239 of the group, Using the NHANES data, Resnick and coland 60 had hypertension Lipid-level measleagues estimated the urements showed that 274 proportion of US adults were in the low-risk category for Although 498 of with diabetes who met HDL-cholesterol 45 mg/dL for selected
ADA 2001 recmen, 55 mg/dL for women, persons with diabetes ommendations, and 36 had low-risk LDL-C levels achieved the ADA A1C 100 mg/dL, and 65 had detailed the association between clinical and low-risk triglyceride levels target of 7, 297 demographic character200 mg/dL The albumin-toof the total had an istics and achievement creatinine ratio was normal of ADA guideline goals 30 mg/g in 658 of particiA1C of Of the 11,441 indipants, while 24 had microalviduals aged 18 years buminuria and 101 had who participated in NHANES 1999-2002, 998 albuminuria Although reaching ADA goals reported having diabetes, representing 63 in most measurements became less likely with of US noninstitutionalized adults aged 18 longer diabetes duration, a curious trend years 95 confidence interval, 57-69 occurred in HDL-C levels, with an apparent This population was 509 women and 617 improvement in reaching target levels with white, with a mean age of 591 years, a mean longer diabetes duration

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8

Continued

Dr Inzucchi is a Professor of Medicine at Yale University School of Medicine in New Haven, Connecticut He has indicated the following relevant financial relationships: retained consultant, Takeda
Pharmaceuticals North America, Inc; speakers bureau, GlaxoSmithKline, Merck and Co, Inc, and Takeda Pharmaceuticals North America, Inc Dr Reed is Professor of Medicine and Associate Chair for Research at Morehouse School of Medicine and Chief of Endocrinology and Chief of Internal Medicine Services for Morehouse at Grady Memorial Hospital, Atlanta, Georgia He has disclosed the following relevant financial relationships: clinical investigator, National Institutes of Health; retained consultant, Abbott Laboratories, AstraZeneca, Bristol-Myers Squibb Company, Novartis, Pfizer Inc; speakers bureau, AstraZeneca, Novartis, Pfizer Inc, Reliant Mr Fagan is a managing editor for Thomson Professional Postgraduate Services He has indicated that he has no relevant financial relationships Mr Palangio is a medical writer for Thomson Professional Postgraduate Services He has indicated that he has no relevant financial relationships

CLINICAL INSIGHTS

IN DIABETES

Achievement of ADA Guidelines
Continued
In the area of lifestyle achievements, 64 of the group reported eating recommended daily levels of protein 10-20 daily caloric intake and 483 reached the goal for daily saturated fat intake
10, but only 283 did the same for unsaturated fat 10 and only 183 had enough fiber 20g-35g in their daily diet Regarding smoking, 812 of participants were nonsmokers, although 323 reported being former smokers Only 282 of physically able participants aged 20 years met the recommended physical activity level 5 or more moderate to vigorous activities or 3 or more vigorous activities lasting at least 30 minutes per week Only 382 of diabetes patients reported having ever had an ADA-recommended pneumococcal immunization There were racial and economic differences as well Blacks met HDL-C and triglyceride goals more frequently than whites or Mexican Americans, and whites had better renal function and A1C levels than blacks or Mexican Americans Higher income and higher educational levels were associated, although not significantly, with more frequent achievement of goals for blood pressure 120/80 mm Hg and albumin-to-creatinine ratio, but not with HDL-C or A1C The authors concluded that achievement of ADA clinical practice goals is far from optimal in US adults with diabetes, and that public health resources should be focused on improving patients diabetes self-management skills and
finding ways to enhance the efficacy of physician-patient relationships to achieve ADA recommendations
Resnick HE et al Achievement of American Diabetes Association clinical practice recommendations among US adults with diabetes, 1999-2002 The National Health and Nutrition Examination Survey Diabetes Care 2006;29:531-537

The rate of dysglycemia-related hospital visits for each course of antibiotic treatment was substantially higher with gatifloxacin than with any other studied antibiotic

COMMENTARY
JAMES W REED, MD, Professor of Medicine and Associate Chair for Research at Morehouse School of Medicine and Chief of Endocrinology and Chief of Internal Medicine Services for Morehouse at Grady Memorial Hospital, Atlanta, Georgia
This article, based on the NHANES 1999-2002, points out some critical deficiencies in our efforts to control and prevent the development of type 2 diabetes and its complications in the United States The meager improvement of the past 15 years is not encouraging It clearly demonstrates that there is a gap in control based on socioeconomic status and ethnicity Based upon ADA data, the 498 level of achievement of ADA A1C goals appears to be overstated Even so,
this is not satisfactory, because the majority of patients are still not at goal This article shows the need to launch greater efforts in educating the public about self-management of diabetes It also informs us that improved professional education about diabetes control guidelines is required for the majority of physicians who treat these patients in order to lessen morbidity and mortality from this disease

Outpatient Gatifloxacin Therapy Associated With Dysglycemia in Older Adults
luoroquinolones have been accepted as generally safe and well-tolerated broadspectrum antibiotics However, compared with other fluoroquinolones, gatifloxacin has been associated with increased risks of both hypoglycemia and hyperglycemia in small studies Park-Wyllie and colleagues further investigated the relationship between gatifloxacin therapy and subsequent hypoglycemia or hyperglycemia in 2 population-based, nested case-control studies in a population of approximately 14 million residents of Ontario, Canada, who were 66 years of age or older Case patients were individuals treated in the hospital for hypoglycemia in the first study or hyperglycemia in the second study after outpatient treatment
with a macrolide eryth-

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romycin, clarithromycin, or azithromycin, a second-generation cephalosporin cefuroxime axetil or cefaclor, or a respiratory fluoroquinolone gatifloxacin, levofloxacin, moxifloxacin, or ciproflo xacin during the previous 30 days Up to 5 controls matched by age, sex, the presence or absence of diabetes, and the timing of antibiotic therapy were identified for each case patient The association between antibiotic use and hospitalization for hypoglycemia or hyperglycemia was assessed in a conditional logistic regression Because they do not directly affect glycemic control, macrolide antibiotics served as the reference group In the first study, 788 patients who were treated in the hospital for hypoglycemia within 30 days after antibiotic therapy were identfied
Continued

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CLINICAL INSIGHTS

IN DIABETES

Outpatient Gatifloxacin Therapy Associated With Dysglycemia in Older Adults
Continued
In this group, the mean age was 780 years, and 426 were male Gatifloxacin was associated with an increased risk of hypoglycemia more than 4 times that of macrolide antibiotics adjusted odds ratio [OR], 43; 95 confidence interval [CI], 2963 Levofloxacin was associated with a
significant but weaker increased risk of hypoglycemia adjusted OR, 15; 95 CI, 1220 There was no increased risk of hypoglycemia with moxifloxacin, ciprofloxacin, or second-generation cephalosporins Stratification by the presence or absence of diabetes yielded similar results In the second study, 470 patients who were treated in the hospital for hyperglycemia within 30 days after antibiotic therapy were identified Among these patients, the mean age was 774 years, and 434 were male Gatifloxacin was associated with an increased risk of hyperglycemia almost 17 times that of macrolide antibiotics adjusted OR, 167; 95 CI, 104268 There was no increased risk of hyperglycemia with the other antibiotics As in the first study, findings were not affected by the presence or absence of diabetes In this analysis, the rate of dysglycemiarelated hospital visits for each course of antibiotic treatment was substantially higher with gatifloxacin 11 than with ciprofloxacin 03, levofloxacin 03, moxifloxacin 02, second-generation cephalosporins 02, or macrolide antibiotics 01 Study limitations included the inability to detect dysglycemic events not requiring hospitalization, lack of data for blood glucose
levels, and lack of inclusion of younger patients These results indicate that, compared with the use of other broad-spectrum oral antibiotics, the use of gatifloxacin among older outpatients is associated with an increased risk of hospital treatment for both hypoglycemia and hyperglycemia Given that gatifloxacin offers little benefit over alternative antibiotics and that dysglycemia can potentially be life threatening, the investigators suggested that some clinicians might consider avoiding the use of gatifloxacin entirely

Park-Wyllie LY et al Outpatient gatifloxacin therapy and dysglycemia in older adults N Engl J Med [Epub ahead of print] 2006;354

Concomitant Risk Factors Determine CHD Risk
ype 2 diabetes is a well-recognized risk factor for cardiovascular disease CVD, contributing to both increased morbidity and mortality However, the prevention of CVD among patients with diabetes has only recently been delineated as an important therapeutic goal Howard and associates recently examined the influence of single and multiple risk factors on the 10-year cumulative incidence of fatal and nonfatal coronary heart disease CHD and CVD among individuals with or without diabetes taking
part in the Strong Heart Study SHS The SHS involved 4,549 men and women from 13 American Indian tribes or communities who were followed for a median of 107 years This study contained the largest population-based cohort of individuals with diabetes in the United States to be followed continuously Diabetes status was assessed in 4,465 of the 4,549 individuals aged 45 to 74 years who underwent the baseline examination A total of 2,124 of these participants had diabetes Baseline risk factors included in this analysis were low-density lipoprotein cholesterol level 100 mg/dL, albuminuria 300 mg/g creatinine, hypertension, high-density lipoprotein

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cholesterol level 40 mg/dL, triglyceride level 150 mg/dL, current smoking, fourth quartile of fibrinogen level 352 mg/dL, and diabetes duration 20 years Among individuals without CHD at baseline, diabetes increased the risk for CHD in men age-adjusted hazard ratio [HR], 195; 95 confidence interval [CI], 157242 as well as women age-adjusted HR, 282; 95 CI, 225353 The 10-year cumulative incidences of CHD for men and women with diabetes but without previous CHD were 259 and 191, respectively In contrast, the 10-year cumulative incidences of CHD
for men and women without diabetes but with previous CHD were 574 and 584, respectively Among individuals with diabetes and previous CHD, the 10-year cumulative incidences of CHD for men and women were 611 and 581, respectively A similar pattern was evident when only considering fatal events Among individuals without previous CHD, fatal CHD occurred more frequently in those with diabetes than in those without diabetes 105 vs 40 in men and 77 vs 20 in women When using CVD CHD plus stroke rather than CHD, individuals
Continued 3

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CLINICAL INSIGHTS

IN DIABETES

Concomitant Risk Factors Determine CHD Risk
continued

Only diabetes patients with higher multiples of risk factors had a 10-year CHD incidence approaching that of CHD patients without diabetes

with diabetes and without previous CVD had 10-year cumulative incidences of 340 in men age-adjusted HR 186; 95 CI, 152226 and 243 in women age-adjusted HR, 289; 95 CI, 236354 The 10-year cumulative incidence of CHD varied according to the number of risk factors In comparison with individuals without diabetes, those with the
disease and 1 or 2 risk factors demonstrated only a 14 times higher CHD rate 10-year cumulative incidence, 14 However, the 10-year cumulative CHD incidence in individuals with diabetes and 7 to 9 risk factors was 40 The incidence in individuals without diabetes and with previous CHD was 60 Considering only fatal CHD, the incidence in those with diabetes and 7 to 9 risk factors exceeded the incidence in individuals without diabetes but with baseline CHD 300 vs 203; P002 A similar pattern occurred with data for CVD

These results reveal that the rate of CHD in patients with diabetes depends on existing risk factors In this study, the majority of individuals with diabetes had a 10-year cumulative incidence of CHD exceeding the level defined by the National Cholesterol Education Program Adult Treatment Panel III guidelines 20 However, only those with higher multiples of risk factors had a 10-year incidence approaching that of patients without diabetes but with CHD Limitations of this analysis included the use of a specific ethnic group, hampering generalization With these findings in mind, the investigators suggested that clinicians should consider therapeutic targets based on the
entire risk factor profile rather than merely the presence of diabetes
Howard BV et al Coronary heart disease risk equivalence in diabetes depends on concomitant risk factors Diabetes Care 2006;29:391-397

NDEI upcoming CME events

Save the Date - NDEI CME Dinner Symposium at the AACE in Chicago Friday April 28, 6:30 PM,
Implications of Recent Clinical Trials: A New Perspective on Insulin Sensitizers You must be registered for the American Association of Clinical Endocrinologists AACE Annual Meeting to attend this symposium CE Dinner Meetings for Pharmacists, Type 2 Diabetes, Metabolic Syndrome, and CVD: Opportunities for Treatment, Management, and Prevention To find out if there is a program in your area, please visit us online at wwwndeiorg or call 1 877 251-0943

NEW: Two Case Studies for On-Demand CME at wwwndeiorg:
- A 53-Year-Old Female With Type 2 Diabetes Presents With Dyspnea, authored by Robert J Chilton, DO, FACC Earn 15 AMA PRA Category 1 CreditsTMFree - An 80-Year-Old Noncompliant Female Patient With Type 2 Diabetes and a Recent AMI, authored by William M Simpson, Jr, MD Earn 1 AMA PRA Category 1 CreditsTMFree

NDEI MISSION STATEMENT
The National Diabetes
Education Initiative NDEI is a multicomponent educational program on type 2 diabetes designed for endocrinologists, diabetologists, cardiologists, primary care physicians, and other healthcare professionals involved in the care and management of patients with type 2 diabetes and insulin resistance NDEI programs address issues concerning insulin resistance and type 2 diabetes, from the epidemiology and pathophysiology of the disease and its associated complications to the therapeutic options for treatment and prevention

On-Demand CME Activity at wwwndeiorg:
- NEW: New Understanding in Treating Type 2 Diabetes and Cardiovascular Disease Learn to identify markers of dyslipidemia, CVD, and inflammation present in patients with insulin resistance and type 2 diabetes Earn 125

AMA PRA Category 1 CreditsTMFree
- The Impact of Insulin Sensitizers on Cardiovascular Disease in Type 2 Diabetes Learn to identify the risk factors and components of the metabolic syndrome and the relationship between the metabolic syndrome and type 2 diabetes and CVD Earn 225 AMA PRA Category 1 CreditsTMFree - PROactive Outcome Results: Implications for Patients With Type 2 Diabetes and CVD, a panel of
nationally recognized experts in cardiology and endocrinology explore the recently published clinical study Earn 15 AMA PRA Category 1

CreditsTMFree

For more information about upcoming NDEI CME and CE activities, visit us at wwwndeiorg or call 1 800 606-6106 Visit wwwppscmeorg 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 are not receiving this free, CME e-Newsletter via email, please fill in their information on the lines below and fax this page back to us at 1 800 471-7716 and we will add them to our subscriber list Name: Please print _____________________________________ Specialty: ____________________________________ Email Address: _________________________________________________________________________________________ You have received this email because we believe it may be of interest to you If you would like 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
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National Diabetes Education Initiative, NDEI, and Clinical Insights are trademarks used herein under
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