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Prediabetes: A Key to Curbing the Diabetes Epidemic
Michael E. Bowen, MD, MPHAssistant Professor Internal Medicine, Pediatrics, Clinical Sciences
Divisions of General Internal Medicine, General Pediatrics, and Outcomes and Health Services ResearchDedman Family Scholar in Clinical Care
University of Texas Southwestern Medical Center, Dallas, TX
Disclosures
Dr. Bowen has no financial interests or other relationships with commercial concerns directly
related to this program. Dr. Bowen will be discussing off-label uses of medications.
Objectives
• Define prediabetes
• Identify patients at risk for diabetes and prediabetes
• Describe evidence-based treatments and interventions for prediabetes
• Identify resources and develop strategies to improve the management of your patients with prediabetes
What is Prediabetes?• Glucose levels that are higher than normal, but not
high enough to be diagnosed as diabetes– Umbrella term including impaired fasting glucose and
impaired glucose tolerance
• Precursor to diabetes– Asymptomatic condition diagnosed in the process of
being tested for diabetes
• “Risk factor” for diabetes vs. a clinical entity– Topic of vigorous debate
– Bottom line• Diabetes risk increases across the glucose continuum
• Prediabetes is a high-risk glucose state at increased risk for developing diabetes
Natural History of Type 2 Diabetes
Figure courtesy of the AACE Diabetes Resource Center
Fasting glucose
Type 2 diabetes
Years from
diagnosis0 5–10 –5 10 15
Prediabetes
Onset Diagnosis
Postprandial glucose
Macrovascular complications
Microvascular complications
Insulin resistance
Insulin secretion
-Cell function
Summary: Hyperglycemia in Prediabetes and Diabetes
• Hyperglycemia results from a combination of:
–Beta-cell dysfunction Impaired insulin secretion
– Increased hepatic glucose production due to excessive glucagon
–Decreased uptake of peripheral glucose due to insulin resistance
Diabetes Care. 2013; 36, Suppl 2:127-138.
Diagnosis
Normal
Impaired Fasting Glucose
Diabetes
Normal
Impaired Glucose Tolerance
Diabetes
Normal
Prediabetes
Diabetes
Fasting Glucose
2 hour Glucose on OGTT
Hemoglobin A1C
100 mg/dL
126 mg/dL
140 mg/dL
200 mg/dL
5.7%
6.5%
Prediabetes
• Agreement between tests is poor• 7.7% of population has Prediabetes by BOTH A1c and fasting glucose criteria• 4.9% have Prediabetes by A1c criteria alone• 20.5% have PDM by fasting glucose but not A1C
• High variance in fasting glucose and 2 hour glucose values – confirm abnormal testsDiabetes Care. 2015;38 Suppl 1: S8-16. Diabetes Care. 2010;33 (10):2190-2195.
Diabetes is Just the Tip of the Iceberg!
NCDC and Prevention. National Diabetes Statistics Report, 2014. http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf.
MMWR Morbidity and Mortality Weekly Report. 2013;62:209-212.
29 Million with Type 2 Diabetes (9.3% of the
Population)
86 Million with Prediabetes (37% of the Population)
77 Million of those with Prediabetes are UNDIANOSED
Change in US Prevalence: 2007-2010
0
20
40
60
80
100
120
140
2007 2012
57
86
17.9
29
5.7
8.1
Pe
op
le (M
illio
ns)
Undiagnosed Diabetes
Diagnosed Diabetes
Prediabetes
Diabetes: 9.3% of Population
Prediabetes: 37% of Population
CDC and Prevention. National diabetes fact sheet, 2007. http://www.cdc.gov/Diabetes/pubs/pdf/ndfs_2007.pdf.
CDC and Prevention. National Diabetes Statistics Report, 2014. http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf.
Projecting the Future Burden of Diabetes
7.8
3.3
22.9
14.7
8.4
Estimated that 1 in 3 US adults will develop DM in
their lifetime
Boyle et al. Population Health Metrics 2010,8:29.
200-300% Increase in Prevalence (2010-2050)
Curbing the Diabetes Epidemic
Non-modifiable Risk Factors
• Age
• Family history
• Race/Ethnicity
Modifiable Risk Factors
• Overweight/obesity
• Hypertension
• Physical inactivity
• Abnormal lipid metabolism
• Prediabetes/elevated glucose levels
• Recognition and Modification of Risk Factors• Diagnosis and treatment of Prediabetes
Diabetes Care. 2014;37(suppl 1):S14-S80.
Case 1: Screening
Mrs. D is a healthy, 44 year old nulliparous African American female presenting for an annual exam. Her BP is 129/76 and BMI is 26 kg/m2. She takes no medications and does yoga 2 days per week and attends a spinning class at the YMCA 3 days per week. She has no family history of diabetes. Her lipid panel from today’s visit is pending. Diabetes screening is recommended based on which of the following risk factors:
A. Age
B. BMI
C. Physical inactivity
D. Race
E. Age and Race
F. BMI and Race
G. None of the above – screening is not indicated
Diabetes Screening Guidelines
• American Diabetes Association (and revised USPSTF)– All adults over age 45– BMI ≥ 25 (or ≥ 23 in Asians) and ANY of:
• Non-white race Hypertension• HDL<35 or TG >250 Family history• PCOS Baby > 9# or gestational DM• Cardiovascular disease Physical inactivity• Prediabetes
• Recommended Screening AND Diagnostic tests:– Hemoglobin A1C, Fasting glucose, Oral Glucose Tolerance Test
• Repeat screening every 3 years if normal– Annually if prediabetes
Diabetes Care. 2014;37(suppl 1):S14-S80.
Diabetes Screening
• Proactive diabetes screening
– Only 50% of eligible patients screened
• Prediabetes is ONLY identified through diabetes screening
– Improved diabetes screening is critical to:
• Diabetes detection
• Prediabetes detection
• Diabetes prevention
http://www.clinicalendocrinologynews.com/news/news/single-article/only-half-of-at-risk-adults-being-screened-for-diabetes/d23d462bfa6c020ddf93a82cd08c3d2e.html
Random Glucose as Opportunistic Screening?
• Random glucose is routinely tested– 95% of glucose tests in clinical practice are random
• Role for random glucose in screening is poorly defined
• Diagnosis: Random glucose≥ 200 mg/dL in the setting of polyuria/polydipsia
• What about random glucose values < 200mg/dL?
Diabetes Care. 2004;27:9-12. Diabetes Care. 2014;37(suppl 1):S14-S80
Random Glucose as a Diabetes Risk Factor?
Glucose Criteria Undiagnosed Pre-DM Undiagnosed DM
Random Glucose≥100mg/dL 3.3 (3.0, 3.8) 31.2 (21.3, 45.5)
RBG≥100mg/dL (Adjusted)* 2.4 (2.0, 2.7) 20.4 (14.0, 29.6)
Results Stratified by Random Glucose Level
Random glucose <100 mg/dL* Reference Reference
Random glucose 100-119 mg/dL* 2.2 (1.9, 2.5) 7.1 (4.4, 11.4)
Random glucose 120-139 mg/dL* 3.29 (2.6, 4.2) 30.3 (20.0, 46.0)
Random glucose ≥140 mg/dL* 3.5 (2.2, 5.5) 256.0 (150.0, 436.9)
Results presented as weighted odds ratios
*Adjusted for age, sex, race, BMI, HTN, HLD, CVD, FH Diabetes
J Clin Endocrinol Metab. 2015; http://press.endocrine.org/doi/abs/10.1210/jc.2014-4116
Case 1: Screening
Mrs. D is a healthy, 44 year old nulliparous African American female presenting for an annual exam. Her BP is 129/76 and BMI is 26 kg/m2. She takes no medications and does yoga 2 days per week and attends a spinning class at the YMCA 3 days per week. She has no family history of diabetes. Her lipid panel from today’s visit is pending. Diabetes screening is recommended based on which of the following risk factors:
A. Age
B. BMI
C. Physical inactivity
D. Race
E. Age and Race
F. BMI and Race
G. None of the above – screening is not indicated
Risks Associated with Prediabetes
• Increased risk for diabetes1,2
– Approximately 25% develop diabetes over 3-5 years
• Increased risk of cardiovascular disease1,2,3,4
• Increased risk of chronic kidney disease2,4
• Increased risk of neuropathy2,4
• Increased risk of Retinopathy1,2
• Increased risk of cancer5
– Liver, endometrial, stomach, colorectal
1Diabetes Care; 2007; (39(3). 753-759 2Endocrine Practice. 2008; 14(7):933-946. 3N Engl J Med.2010; 362(9): 800-811. 4J Am Coll Cardiol. 2012; 59: 635-643. 5Diabetologia. 2014; 57(11): 2261-2269.
What is the Evidence?
LIFESTYLE MODIFICATION AND DIABETES PREVENTION
Case 2: Prediabetes TreatmentMrs. K, a 46 year old Hispanic female with a BMI of 29 kg/m2, was recently diagnosed with prediabetes (fasting glucose 109 mg/dL and A1C 6.1%). Which of the following evidence based interventions should you recommend?
A. Metformin
B. Lifestyle intervention with goal 7% weight loss
C. Acarbose
D. Orlistat
E. Metformin + Lifestyle
Diabetes Prevention Program (DPP)• 1996-1999: randomized controlled trial• Multicenter trial (n=27) that enrolled 3,234 patients
without DM– BMI ≥ 24 kg/m2 (≥ 22 kg/m2 in Asians)– Fasting plasma glucose 95-125 mg/dL or 2H post prandial
glucose 140-199 mg/dL
• Randomized to:– Standard lifestyle + placebo– Standard lifestyle + metformin (started 850mg QD; increase to
850mg BID at 1 month) – Intensive lifestyle intervention
• Primary outcome: Diabetes (diagnosed by annual OGTT or twice yearly fasting plasma glucose)– Mean Followup: 2.8 years
N Engl J Med. 2002;346:393-403.
DPP: Lifestyle Intervention
• Intensive intervention– Goal 7% weight loss
• 25% of calories from fat
• 1200-1800 kcal/day goal based on initial body weight
– >150 minutes of physical activity each week• Intensity target: brisk walking
• At least 700 kcal/week
– Individualized, one-on-one 16 lesson curriculum over 24 weeks• Monthly individual and group sessions to reinforce
changes
N Engl J Med. 2002;346:393-403.
DPP: Baseline DemographicsCharacteristic DPP Study Population
(N=3234)
Age, year (SD) 50.6 (10.7)
Female sex, % 67.7
Race
White, % 54.7
African American, % 19.9
Hispanic, % 15.7
Asian, % 4
Family History of diabetes, % 69.4
BMI 34 (6.7)
Fasting plasma glucose 106.5 (8.3)
2 hour glucose (OGTT) 164.6 (17.0)
A1C, % 5.91 (0.50)
DPP: Diabetes IncidenceStudy Arm Crude DM Incidence/100
person yearsRelative Risk Reduction
Placebo 11% Reference
Metformin 7.8%* 31% (17-43)
Lifestyle Intervention 4.8%* 58% (48-66)
*P<0.001 vs. placebo
N Engl J Med. 2002;346:393-403. Circulation: Cardiovascular Quality and Outcomes.i 2009;2:279-285. DynaMed Weekly Update. 2014; 8(47).
Study Arm Cumulative DM Incidence at 3 y
Number Needed to Treat (3 years)
Placebo 28.9% ----
Metformin 21.7% 13.9 (5.4-9.5)
Lifestyle Intervention 14.4% 6.9 (5.4-9.5)
Statins: Primary CAD Prevention: 5-year NNT = 108 assuming 7.5% 10-year baseline riskAspirin: Primary CAD Prevention: 5-year NNT > 300
DPP: Goal Attainment in the Lifestyle Intervention
At 24 weeks At End of Study
Weight loss > 7% 50% 38%
Exercise > 150 minutes/week
74% 58%
N Engl J Med. 2002;346:393-403. 2Diabetes Care. 2006; 29.2012-2017.
• For every 1 kg in weight loss, a 16% reduction in diabetes risk over 3 years2
• Adjusted for changes in diet and activity
Changes in Weight, Activity, and Med Adherence
Mean Weight LossPlacebo: 0.1 kg
Metformin: 2.1 kgLifestyle: 5.6 kg
N Engl J Med. 2002;346:393-403.
DPP: Subgroup Analyses
• Subgroup analyses, underpowered
– Age, sex, race, BMI, fasting and 2H glucose levels
• Lifestyle Intervention – effective in all subgroups
– More effective if lower 2 hour OGTT glucose
• Metformin
– More effective at BMI ≥ 35 kg/m2
– Fasting glucose 110-125 mg/dL
N Engl J Med. 2002;346:393-403.
Lifestyle Modification and DM Prevention – Additional Trials
Study N Intervention Primary Outcome: Relative Risk Reduction
DPP (2002)1 3324 Diet+Exercise 58% at 2 years
Finnish DPS (2001)2
522 Diet+Exercise 58% at 3 years
Da Qing (1997)3, 4
577 Diet/Exercise/Diet+Exercise 51% at 6 years
Indian DPP (2006)5
531 Diet+exercise 28.5% at 2.5 years
1N Engl J Med. 2002;346:393-403. 2N Engl J Med. 2001;344:1343-1350. 3 Lancet.2008;371:1783-1789. 4Diabetes Care. 1997;20:537-544. 5Diabetologia. 2006;49(2):289-297.
Case 2: Prediabetes TreatmentMrs. K, a 46 year old Hispanic female with a BMI of 29 kg/m2, was recently diagnosed with prediabetes (fasting glucose 109 mg/dL and A1C 6.1%). Which of the following evidence based interventions should you recommend?
A. Metformin
B. Lifestyle intervention with goal 7% weight loss
C. Acarbose
D. Orlistat
E. Metformin + Lifestyle
Case 3: Long Term Treatment Effects
You recommended lifestyle modification with at least a 7% weight loss goal for Mrs. K based on the findings from the DPP. At 1 year, she successfully loses 6% of her body weight and has a fasting glucose of 95 mg/dL and an A1C of 5.7%. Twelve months later she has regained 10 pounds and has a fasting glucose of 109 mg/dL and an A1C of 6.0%. What is her 10 year risk of developing diabetes?
A. Unchanged compared to baseline riskB. Lower risk by virtue of reverting to normal
glycemia over the past yearC. Higher risk because she has shown she cannot
sustain her weight loss goals
Diabetes Prevention: Long Term Impact of Lifestyle Intervention?
Study N Intervention Followup Relative Risk Reduction
DPP (2002)1 3324 Diet+Exercise 10 years 24%
Finnish DPS (2001)2
522 Diet+Exercise 7 years 43%
Da Qing (1997)3
577 Diet+Exercise 20 years 43%
1Lancet. 2009;374:1677-1686. 2Lancet. 2006;368(9548):1673-1679. 3 Lancet.2008;371:1783-1789. 4Lancet. 2012;379:2243-2251.
• DPP4 – Participants going from prediabetes to normal glucose regulation at least once during the study had a 56% lower risk of diabetes over 10 years
— Reversion to normal glucose tolerance associated with younger age, weight loss, intensive lifestyle intervention
Case 3: Long Term Treatment Effects
You recommended lifestyle modification with at least a 7% weight loss goal for Mrs. K based on the findings from the DPP. At 1 year, she successfully loses 6% of her body weight and has a fasting glucose of 95 mg/dL and an A1C of 5.7%. Twelve months later she has regained 10 pounds and has a fasting glucose of 109 mg/dL and an A1C of 6.0%. What is her 10 year risk of developing diabetes?
A. Unchanged compared to baseline riskB. Lower risk by virtue of reverting to normal
glycemia over the past yearC. Higher risk because she has shown she cannot
sustain her weight loss goals
What is the Evidence?
PHARMACOLOGIC TREATMENT AND DIABETES PREVENTION
Case 4: Medications for Prediabetes
Mr. R is a 58 year old Caucasian male with a history of coronary artery disease. He is overweight (BMI 37 kg/m2), a smoker, and has hypertension and high cholesterol. He has severe peripheral vascular disease that limits his exercise. His fasting glucose is 117 mg/dL and his A1C is 6.3%. Which of the following medications is FDA approved to treat his prediabetes?
A. MetforminB. AcarboseC. Pioglitazone D. OrlistatE. All of the aboveF. None of the above
Medication RCTs for Diabetes Prevention
Study N Duration Medication Dose/day Relative Risk Reduction
Side Effects
DPP1 3324 3 y Metformin 1700mg 31% GI
IDPP2 531 2.5 y Metformin 500mg 26% GI
Stop NIDDM3
1429 3 y Acarbose 300mg 25% GI
ACT NOW4 602 2 y Pioglitazone 45mg 72% Weight gain,edema
DREAM5 5269 3 y Rosiglitazone 8 mg 60% CHF, weight gain
CANOE6 207 4 y Rosiglitazone + Metformin
4mg1000 mg
66% diarrhea
1N Engl J Med. 2002;346:393-403 2Diabetologia. 2006;49(2):289-297 3Lancet. 2002;359(9323):2072-2077. 4N Engl J Med. 2011;346:1104-1115. 5Lancet. 2006;368(9541):1096-1105. 6Lancet. 2010;376(9735):103-111.
Cardiovascular and Long Term Outcomes with Medications
• Acarbose (STOP-NIDDM Trial) may improve cardiovascular outcomes1
– 49% relative reduction (2.5% absolute risk reduction) in CV events
– Caveat: Study powered for diabetes incidence, not CVD (Only 84 events)
• 1.4% per year (placebo) vs. 0.7% per year (Acarbose)
1JAMA. 2003;290(4):486-494
What is the Durability of Medication Effects for Diabetes prevention?
• Most medications effects do no persist after discontinued
• Metformin is exception: 25% reduction after 2-week washout period2
• Relevance of this is unclear
1JAMA. 2003;290(4):486-494. 2Diabetes Care. 2003;6:977-980.
Weight loss Medications and Diabetes Prevention
• No adequately powered RCTs examining weight loss drugs and diabetes prevention
• Eligibility for weight loss medication1
– Failed weight loss goals by lifestyle alone
– BMI ≥ 30 kg/m2 or ≥ 27 kg/m2 with weight related complications
– Not pregnant, seeking pregnancy, nursing
1Obesity. 2013;22:S5-S39.
Weight Loss Medications and Diabetes Prevention
• Orlistat – lipase inhibitor– XENDOS1 – 4 year double blind placebo-controlled RCT powered to
detect progression to diabetes– Lifestyle + Orlistat 120mg TID vs. Lifestyle + placebo
• Included subjects with BMI≥30 kg/m2 and normal (79%) or IGT (21%)• 52% completion rate
– 36% risk reduction for incident diabetes (p=0.003)• Underpowered to examine conversion from preDM to DM
• Phentermine/Topiramate ER (Qsymia)– Subgroup analysis of Phase 3 Trial – underpowered– Phentermine/Topiramate ER vs. Placebo– 7.5 mg/46mg dose: 49% risk reduction – 15mg/92mg dose: 89% risk reduction– Greater weight loss, greater reduction in diabetes incidence
• greatest benefit ≥15% weight loss
1Diabetes Care. 2004;27:155-161. 2Diabetes Care. 2014;37:912-921
Medications for Diabetes Prevention: Summary
• No medications are currently FDA approved for treatment of prediabetes or diabetes prevention
• Thiazolidinediones– concerns about long term cardiovascular safety
• Acarbose– safe, but up to 40% discontinuation for GI side effects
• Orlistat– Safe, but use limited by GI side effects (up to 90% of
patients have GI side effects)
Diabetes Care 2015;38(Suppl1)S313-32.
Metformin – Off Label Recommendations in Prediabetes
• Recommendations based on the safety, tolerability, and efficacy relative to other medication options
• American Diabetes Association
– BMI > 35 kg/m2
– Age < 60
– Prior gestational diabetes
Diabetes Care 2015;38(Suppl1)S313-32.
Summary: Prediabetes Treatment
• Lifestyle modification
– Goal 5-10% weight loss
– Moderate intensity physical activity (approximately 30 minutes per day or 150 minutes per week)
• Metformin
– Off label use based on Diabetes Prevention Program findings
• Age < 60
• BMI > 35 kg/m2
• Prior gestational diabetes
Case 4: Medications for Prediabetes
Mr. R is a 58 year old Caucasian male with a history of coronary artery disease. He is overweight (BMI 37 kg/m2), a smoker, and has hypertension and high cholesterol. He has severe peripheral vascular disease that limits his exercise. His fasting glucose is 117 mg/dL and his A1C is 6.3%. Which of the following medications is FDA approved to treat his prediabetes?
A. MetforminB. AcarboseC. Pioglitazone D. OrlistatE. All of the aboveF. None of the above
Translating Evidence into Practice
Setting Goals with Your Patients
• Goals should be set by patients– Nutrition/dietary goal– Physical activity goal
• Partner with– Nutritionists– Wellness Coaches
• Healthcare team– Discuss goals with patient– Facilitate success– Provide support
• S – SpecificSimple and clear
• M – MeasurableKey to reaching goal
• A – AttainablePick goals you can reach
• R – RelevantPick goals important to you
• T – Timely Beginning and end
Characteristics of Successful Lifestyle Intervention Programs
• Intensive: small group or one-on-one for 6 –12 months
• Extended: > 2 years contact duration
• Multi-component– Reduced total caloric intake, reduced fat intake
– Exercise
– Increased fiber intake
• Well integrated behavioral principles
• Moderate weight loss: – 5-7% weight loss
– 3-4% long-term weight loss maintenance
Implementing the DPP Lifestyle Intervention in the Community
• DEPLOY (Diabetes Education & Prevention with a Lifestyle Intervention Offered at the YMCA
– Pilot Study at 2 YMCAs
• Randomized 92 participants
• Group Lifestyle vs. control (brief counseling)
– Eligibility:
• BMI ≥ 24 kg/m2 and ≥ 2 diabetes risk factors
• Random capillary glucose 110-199 mg/dL
Am J Prev Med. 2008;35:357-363.
DEPLOY: Outcomes
• Outcome at 4-6 months
Am J Prev Med. 2008;35:357-363.
Outcome Control (n=38) Intervention (n=38) P value
% weight loss -2% (-3.3, -0.6) -6% (-7.3, -4.7) <0.001
% BMI decrease -2.3% (-3.7, -0.8) -5.8% (-7.3, -4.4) 0.001
Change in Total Cholesterol
+6 mg/dL (-2.8, 14.8) -21.6 mg/dL (-29.2, -13.3) <0.001
• Effects sustained after 12 months• No differences by race and gender
YMCA Diabetes Prevention Program
• Community-based study based on DPP lifestyle intervention– Offered at 7 DFW YMCAs
• 12 month program– 16 one-hour weekly sessions
– Monthly small group session with lifestyle coach
• Program Goals– Lose 7% body weight
– Goal 150 minutes/week physical activity
http://www.ymcadallas.org/healthy_living/health_well-being__fitness/diabetes_prevention/
“Prevent Diabetes STAT”• CDC and AMA initiative
– Free toolkit to guide screening and referral
– Fact sheets
– Risk assessment tools
– Referral letters
– In-clinic flow process to identify high risk patients
– Logic for EMR query to identify at risk patients
• Online risk assessment for patients
http://www.ama-assn.org/sub/prevent-diabetes-stat/index.html
Diabetes Prevention and the ACA
• ACA eliminated out of pocket fees for preventative services (New commercial/individual health plans (September 23, 2010)
• Covers USPSTF “A” or “B” rated recommendations
• INCLUDES:– Diabetes screening (Currently only for adults with hypertension)
– Obesity screening
– Nutrition counseling for those at high risk for chronic disease such as diabetes and hypertension
http://intermountainhealthcare.org/ext/Dcmnt?ncid=522452203
ACA CoverageService Service Codes ICD-9 Code
Commercial and Private Insurance
Individual Diet/exercise counseling 99401-99404 278.X (Obesity)250.X (Diabetes)V65.3 (Dietary Counseling)V65.41 (Exercise Counseling)
Medical Nutrition Therapy (dietician) 97802-97804 Varies by plan
Medicare Plans
Intensive Behavioral Therapy for Obesity Month 1: 1 visit/weekMonth 2-6: 1 biweekly visitMonth 7-12: monthly visit only if lose
≥ 3kg at month 6
G0447 V85.30 to V85.39
Medical Nutrition Therapy (dietician) 97082-97084 Only if diabetes, renal disease, or renal transplant past 3 years
Bariatric Surgery Covered if BMI>35 and at least 1 obesity-related comorbidity if previously unsuccessful with medical obesity treatment.
http://intermountainhealthcare.org/ext/Dcmnt?ncid=522452203
Conclusions
• Prediabetes is a strong but modifiable risk factor for developing diabetes
• Early diagnosis and intervention is critical
• Lifestyle modification is the cornerstone of prediabetes treatment
• Insurance coverage is increasingly available for lifestyle modification and behavioral interventions
Questions and Comments
Prediabetes: Historical Perspective
• 1950s: Retrospective diagnosis in pregnancy– Associated with High birthweight baby family history of
diabetes
• 1980s: WHO abolished concept– Many with borderline glucose do not convert to
diabetes
– ‘prediabetic’ label created issues in insurance coverage and ‘false alarm’
• 2002: ADA endorsement of prediabetes term leads to widespread use of the term
Diabetes, Obesity, and Metabolism. 9(Suppl. 1.)2007. 12-18.
Statins and Diabetes Risk• Mild increase in diabetes incidence
– 9% increased risk for incident diabetes1
• Treatment of 255 (95% CI 150-852) patients with statins for 4 years results in 1 case of diabetes
• High-potency statins may increase risk for diabetes more than lower potency statins2
– 15% (95% CI 5-26%) increased risk in first 2 years after statin use for Rosuvastatin/Atorvastatin/Simvastatin (dose > 40mg) compared with all other statins• Retrospective study of patients hospitalized for new CV event
• FDA3 –– “A small increased risk of raised blood sugar levels and the
development of Type 2 diabetes have been reported for the use of statins.”
– “…we think the heart benefit of statins outweighs this small increased risk….but blood sugar levels may need to be assessed after instituting statin therapy.”
1Lancet. 2010; 375(9716): 735-742 2BMJ. 2014; 348:g3244. 3www.fda.gov/ForConsumers/ConsumerUpdates/ucm293330.htm
Antihypertensives and Diabetes Risk
• Thiazides-– RR 0.91 ( 95% CI 0.73-1.13) for incident diabetes
compared with those on no antihypertensive therapy
• Beta Blockers– RR 1.28 (95% CI 1.04-1.57) for incident diabetes
compared with those on no antihypertensives
• No increase in risk with ACE Inhibitors and Calcium Channel Blockers
N Engl J Med. 2000;342:905-912.
DPP
• Estimated number needed to treat over 3 years to prevent 1 case of diabetes
• Lifestyle intervention: 6.9 (95% CI: 5.4-9.5)
• Metformin: 13.9 (95% CI: 8.7-33.9)
• Adverse Events
• No treatment related deaths; no increase in hospitalizations
• Gastrointestinal: Metformin (77.8) vs. Placebo (30.7) events per 100 person years
• Musculoskeletal: Lifestyle (24.1) vs. Placebo (21.1) events per 100 person years
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