The SAVOR-TIMI 53 and DECLARE-TIMI 58 trials were multinational, randomized, placebo-controlled trials enrolling patients with T2DM and either a history of established cardiovascular disease or multiple risk factors for cardiovascular disease. We then evaluate this risk stratification scheme as it relates to the clinical efficacy of the SGLT2 inhibitor dapagliflozin.
VARIABLES OF TIMI RISK SCORE TRIAL
In the present analysis, we derive a practical, multivariable clinical risk score for HHF in patients with T2DM enrolled in the placebo arm of the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR)-Thrombolysis in Myocardial Infarction (TIMI) 53 trial 13 and externally validate this score in placebo-treated patients in the Dapagliflozin Effect on CardiovascuLAR Events (DECLARE)-TIMI 58 trial. We therefore sought to identify independent clinical risk predictors of HHF in patients with T2DM and to assess whether these clinical characteristics identify high-risk patients with T2DM who have the greatest reduction in risk of HHF with an SGLT2 inhibitor. 9– 12 The impact of SGLT2 inhibitors on HHF has highlighted the need for improved models of HF risk stratification in patients with T2DM, both to tailor individual treatment approaches and to inform future clinical trial design. 8 Sodium-glucose cotransporter-2 (SGLT2) inhibitors are a novel class of glucose-lowering therapies that have been shown to reduce the risk of hospitalization for HF (HHF) in patients with T2DM. 5– 7 Moreover, in contrast to the risks of myocardial infarction and stroke, the risk of HF in patients with T2DM persists even when traditional cardiovascular risk factors, such as smoking, hypertension, and LDL cholesterol, are well controlled. 1– 4 Even after adjusting for the presence of coronary artery disease and its risk factors, T2DM remains an important independent risk factor for HF. ST-segment depression on electrocardiography was helpful for ruling in ACS (LR+ = 5.3 95% CI, 2.1 to 8.6).Type 2 diabetes mellitus (T2DM) and heart failure (HF) are highly prevalent diseases associated with substantial morbidity and mortality. The only significant physical examination finding was pain reproduced by palpation, which was helpful for ruling out ACS (negative likelihood ratio = 1.2 95% CI, 1.0 to 1.2). Significant symptoms included pain radiating to both arms (LR+ = 2.6 95% CI, 1.8 to 3.7), pain similar to prior ischemia (LR+ = 2.2 95% CI, 2 to 2.6), and change in pain pattern over the previous 24 hours (LR+ = 2.0 95% CI, 1.6 to 2.5). Useful risk factors included a previous abnormal stress test result (LR+ = 3.1 95% CI, 2 to 4.7) and presence of peripheral arterial disease (LR+ = 2.7 95% CI, 1.5 to 4.8). Using only historical factors, the physician's overall clinical impression of definite ACS was moderately helpful for ruling in ACS (LR+ = 4.0 95% confidence interval, 2.5 to 6.6), but an impression of “definitely not” was not predictive. 1 The reference standard for diagnosis varied, but was commonly a discharge diagnosis of ACS or a cardiovascular event (cardiac death, myocardial infarction, or coronary revascularization) 14 to 42 days after presentation. A 2015 systematic review of 58 studies (N = 102,847) estimated the accuracy of individual factors in diagnosing ACS in patients of any age presenting to the emergency department with chest pain.
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