1. How does the response to therapy compare in elderly versus middle age adults with diabetes in a randomized trial?

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1 Jeff D. Williamson, MD, MHS Chief, Geriatric Medicine Sticht Center on Aging 1. How does the response to therapy compare in elderly versus middle age adults with diabetes in a randomized trial? 2. Are elderly adults with T2D more susceptible to treatment-related serious adverse events in a protocol driven trial? 3. What additional outcomes and trial design modifications are important in elderly? 1

2 BP Intensive (SBP<120) Standard (SBP<140) Statin + Masked Study Drug Lipid Statin + Masked Study Drug Intensive Glycemia (A1C<6%) * Standard Glycemia (A1C 7-7.9%) * 2362* 2371* 2753* 2765* 10,251 *Primary analyses compare the marginals for main effects 2

3 3

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5 # Events (% Annual Incidence) Outcome Intensive Standard Intensive to Standard Hazard Ratio (95% CI) P Value Primary Outcome 203 (1.61) 213 (1.72) 0.94 (0.78, 1.15) (2.76) 201 (3.10) 0.84 (0.69, 1.03) Nonfatal Myocardial Infarction 101 (0.80) 142 (1.14) 0.71 (0.55, 0.91) (1.65) 115 (1.77) 0.89 (0.68, 1.16) Cardiovascular Mortality 71 (0.55) 42 (0.33) 1.71 (1.17, 2.50) (1.03) 67 (0.98) 0.97 (0.70, 1.36) All-Cause Mortality 139 (1.06) 98 (0.75) 1.42 (1.10, 1.84) (2.11) 134 (1.93) 1.06 (0.84, 1.34) Favors Intensive Therapy Favors Standard Therapy Significant Interaction Previously Published 5

6 # Events (% Annual Incidence) Outcome Intensive Standard Intensive to Standard Hazard Ratio (95% CI) P Value Primary Outcome 114 (1.54) 128 (1.72) 0.89 (0.69, 1.14) (2.53) 109 (2.79) 0.88 (0.67, 1.17) Nonfatal Myocardial Infarction 65 (0.87) 79 (1.05) 0.82 (0.59, 1.15) (1.63) 67 (1.70) 0.93 (0.66, 1.32) Cardiovascular Mortality 30 (0.39) 28 (0.36) 1.10 (0.66, 1.85) (0.77) 30 (0.72) 1.03 (0.62, 1.71) All-Cause Mortality 70 (0.91) 73 (0.93) 0.99 (0.71, 1.38) (1.99) 71 (1.69) 1.16 (0.84, 1.60) Favors Intensive Therapy Favors Standard Therapy # Events (% Annual Incidence) Outcome Intensive Standard Intensive to Standard Hazard Ratio (95% CI) P Value Nonfatal Stroke 24 (0.32) 10 (0.26) 31 (0.41) 24 (0.59) 0.78 (0.46, 1.33) 0.43 (0.21, 0.90) 0.20 Primary Outcome + Revascularization + Hosp for CHF 314 (4.58) 207 (6.14) 313 (4.54) 239 (6.86) 1.00 (0.86, 1.17) 0.88 (0.73, 1.06) 0.27 Fatal MI / Nonfatal MI / Unstable Angina 147 (2.01) 106 (2.89) 148 (2.01) 122 (3.17) 1.00 (0.79, 1.25) 0.89 (0.68, 1.15) 0.51 Fatal/Nonfatal Stroke 25 (0.33) 33 (0.43) 0.76 (0.45, 1.29) (0.28) 29 (0.72) 0.39 (0.20, 0.79) Fatal/Nonfatal Congestive Heart Failure 45 (0.60) 38 (1.00) 47 (0.62) 44 (1.10) 0.97 (0.65, 1.46) 0.89 (0.58, 1.37) Favors Intensive Therapy Favors Standard Therapy 6

7 Hypoglycemia Requiring Medical Assistance Hypoglycemia Requiring Any Assistance Intensive Glycemia Standard Glycemia < < (2.45%) 262 (4.45%) 100 (0.80%) 89 (1.36%) 475 (4.04%) 374 (6.53%) 153 (1.23%) 121 (1.87%) Any Other SAE 65 (1.91%) 56 (3.23%) 47 (1.39%) 37 (2.12%) Hypoglycemia rates reported as annual incidence expressed as a % Other SAEs expressed as # (%) of individuals Hypoglycemia Requiring Medical Assistance Aged <65: Intensive to Standard HR = 2.94 (2.34 to 3.69) Aged 65+: Intensive to Standard HR = 2.93 (2.31 to 3.73) Miller, et al Under review 7

8 Intensive BP or FibrateTherapy Standard BP or Placebo < < BP Trial 59 (3.76%) 35 (4.41%) 24 (1.55%) 27 (3.28%) Lipid Trial 26 (1.41%) 28 (3.02%) 21 (1.15%) 18 (1.93%) Miller, et al Under review DSST Score %/y ( ) 1.42%/y ( ) HR 0.50 ( ) 1.21%/y ( ) HR 0.43 ( ) 1.21%/y ( ) HR 0.43 ( ) Punthakee, Williamson et. al Diabetes care

9 1. For longstanding T2D trying to normalize glucose is no longer the goal 2. In ACCORD, response to treatments was similar in participants 65+ compared to those <65 and both groups achieved similar deltas for glycemia and BP control when randomized. 3. The effect of the glycemia, BP and Lipid interventions on outcomes was similar or better for participants 65+ versus those <65 when randomized. 4. Within the glycemia trial, older participants had a higher rate of hypoglycemia-related AE (but not BP) during follow-up, but the hazard ratios for intensive to standard treated participants were almost identical in the two age groups. Aiming for too wide a range of generalizability in the elderly will hamper design and conduct of important trials focused prevention of CVD complications and preservation of functional independence Age is not a proper inclusion/exclusion criteria for trials aimed at preventing complications A better screening criteria would be based on baseline physical (gait speed) or cognitive function (TBD) In healthy elders, future trials focus on best first and second line therapy for achieving outcomes rather than more intense control Consider integrating cognitive and physical measures in most large trials 9

10 Ed Gregg, PhD All 10,251 ACCORD participants Investigators and staff of ACCORD CCNs and Field Centers Members of ACCORD DCC (particularly statisticians contributing to this report: Mike Miller, Walter Ambrosius, Bill Applegate,Tim Craven, Greg Evans) 10

11 Excess risk with intensive strategy vs standard occurred when intensive participants failed to reduce A1c in year 1 Adjusted Mortality Rates by Treatment Strategy Death rates per year Intensive strategy Standard strategy A1c decline from baseline over 12 months (%) Risk of Death over a Range of Average A1c Adjusted log(hazard Ratio) by Treatment Strategy Relative to Standard at A1c of 6% Steady increase of risk from 6 to 9% A1c with intensive strategy Intensive strategy Standard strategy Average A1c % Excess risk with intensive strategy vs standard occurred above A1c 7% 11

12 1. Older adults are most likely subgroup to suffer the diabetes-related CVD complications and the related physical and cognitive disabilities 2. The few clinical trials willing to include older adults have shown the largest benefit in this age group (SHEP, HYVET, ACCORD[?]) 3. These trials are often criticized for not representing the breadth of elders seen by practitioners. Multi-center, randomized, controlled, double 2x2 factorial Glycemia and BP Trials Open Label with Blinded Endpoint Assessment Lipid Trial placebo controlled Sample size goal 10,000, 1/3 age clinics in US and Canada Primary Outcome: First occurrence of nonfatal MI OR Nonfatal Stroke OR CV Death 12

13 Secondary/Other Outcomes: Each component of 1 0 Expanded CVD: Revasc & HF Hosp Total mortality Microvascular (nephropathy, neuropathy, eye) Eye photo substudy (N = 3537) HRQL (N = 2053); Cost (N = 4311) MIND: cognition, brain volume (MRI) Falls/Fractures/BMD Younger Adults (N=6776) Older Adults (N=3475) Weight (kg) / / BMI / /- 5.2 Waist Circum / / SBP / / DBP / / HbA1C 8.4 +/ /- 0.9 Glucose / /

14 Younger Adults (N=6776) Older Adults (N=3475) Age (min, med, max) (40, 59, 64) (65, 69, 89)* Females 2772 (40.2%) 1230 (35.4%) Minority 2671 (39.4%) 1187 (34.2%) Education: Less than High School 876 (12.9%) 645 (18.6%) High School Grad 1713 (25.3%) 991 (28.5%) 1888 pts 65-69; 1587 Pts 70+; 14

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