Published on May 13, 2016
1. ACCORD-BP ACCORD STUDY GROUP. "EFFECTS OF INTENSIVE BLOOD-PRESSURE CONTROL IN TYPE 2 DIABETES MELLITUS". THE NEW ENGLAND JOURNAL OF MEDICINE. 2010. 362(17):1575-1585. SALT-E: OVMC LANDMARK TRIALS SERIES 2016 ACCESS THIS ONLINE HTTP://TINYURL.COM/SALTE4
2. The 2010 Action to Control Cardiovascular Risk in Diabetes-Blood Pressure (ACCORD BP) trial compared intensive BP control (SBP<120) vs. standard BP control (SBP<140) with median f/u of 4.7 years among diabetic patients. No difference in nonfatal MI, nonfatal stroke, or CV mortality between the two groups was found. Very small reduction in stroke risk with intensive BP control (0.32%/yr vs. 0.53%/yr). The intensive therapy group was on more medications, subsequently had more serious adverse events due to medications (hypotension, syncope, bradycardia, hyperkalemia, angioedema, renal failure). Given findings of ACCORD BP, the JNC 8 raised its goal of BP targets for diabetics to <140/90 MAJOR POINTS
3. • Multicenter, open-label, RCT • N=4,733 • Intensive BP Control (n=2,362) • Conventional BP Control (n=2,371) • Mean follow-up: 4.7 years • Primary outcome: Nonfatal MI, nonfatal stroke, or CV mortality DESIGN
4. Inclusion criteria: • T2DM • Age>= 40 YO with CVD • Age>= 55 YO with any of the following: • Atherosclerosis • Albuminuria • LVH • >= 2 CV risk factors (DL, HTN, smoking, or obesity) Exclusion criteria: • BMI>45 kg/m2 • Cr>1.5mg/dL • Other serious illness POPULATION
5. • Age 62 YO, 48% female • Non-Hispanic white 61%, black 24%, Hispanic 7% • PMH: Prior CV event 34%, prior HF 4%, smoker 13.2% (former 42%) • Diabetes: A1C 8.3%, FG 175 mg/dL, duration of DM 10 yrs • BP 139/76 (Average Baseline BP) • Other: LDL 110, cr 0.9, albumin:creatinine 14.3 DEMOGRAPHICS
6. • The intensive group’s SBP was close to goal of <120, whereas, the standard therapy group’s average SBP was in the low 130’s. • BP at 4 months: SBP 119.3 vs. 133.5 • BP medications in first year: 3.4 vs. 2.1 • Nonfatal MI 1.87%/yr vs. 2.09%/yr (HR 0.88; 95% Cl 0.73-1.06; P=0.20) • BP medications in first year: 3.4 vs. 2.1 • See full article for breakdown of outcomes OUTCOMES
7. In patients with type 2 Diabetes Mellitus at high risk for CV events, targeting SBP<120 mmHg did not reduce rates of nonfatal MI, nonfatal stroke, or CV mortality when compared to a target SBP<140 mmHg. BOTTOM LINE
8. SPRINT: pts at high risk of CVD, but who do not have h/o stroke or DM, intensive BP control (SBP<120mmHg), improved CV outcomes and overall survival compared to standard therapy (target SBP 135-140 mm Hg), modestly increasing the risk of some serious adverse events. ACCOMPLISH: Among pts with HTN, at high risk for CV complications, benazepril/amlodipine decreases the rate of CV events compared to benazepril/HCTZ OTHER HTN TRIALS
9. • Patients were late in disease process and may have missed opportunity for benefit (mean age 62, 34% had CV events before trial, avg 10 yrs of DM • Not blinded • Lower than expected rate of events underpowered • Follow-up duration not sufficient • No comparison of JNC 7’s recommendation of 130 mmHg to 140 mmHg • BP lowering too aggressive • Few Hispanics enrolled (applicability to OV’s patient population) CRITICISMS
10. DISCUSSION QUESTIONS: • What is the primary end point of this study? • What should be the blood pressure goal in a diabetic patient? • What are some of the weaknesses of this study? • In Patients who are at high risk for CVD, but who do not have DM, what are the recommendations for BP control?
11. CLINICAL APPLICATION You just admitted a patient with DM and multiple sclerosis for optic neuritis (stroke already ruled out). His vitals are 37.2, 132/88, 75, 18, 96% on RA. No blood pressure med. Would you start BP medication?
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