Sitagliptin Pretreatment in Diabetics Presenting With ACS
The parameters in this study were derived from the Acute Coronary Syndrome Israeli Survey (ACSIS) 2010, a bi-annual nationwide survey of acute coronary syndrome patients that were admitted to all 26 public hospitals in Israel during a 2 month period of March-April 2010. Methods on data acquisition are specified elsewhere.
Included in this sub-analysis were all patients diagnosed with type 2 diabetes mellitus that received oral hypoglycemic medications. Excluded were patients who were on chronic insulin treatment (all types either as monotherapy or in combination with oral hypoglycemic medications) and those newly diagnosed with diabetes mellitus during the admission associated with the coronary event. Duration of treatment with oral hypoglycemic medication prior to hospitalization was not recorded.
The ACSIS survey is a nationwide survey conducted in several hospitals across Israel. The study was approved by each of the local IRB's as an observational study, precluding the need for informed consent.
Patients were divided into 3 groups according to the type of oral hypoglycemic medications received: 1) patients receiving DPP4i either alone or in combination with any other oral hypoglycemic medications, 2) patients receiving metformin either as monotherapy or in combination with other oral hypoglycemic medications (excluding DPP4i), and 3) other oral hypoglycemic medications, excluding DPP4i and Metformin.
Composite endpoints included: in-hospital complication (one or more of either acute renal failure, pulmonary edema, infection, killip ≥ 2 on admission) and 30-day MACE (one or more of either stent thrombosis, urgent revascularization, post event ischemia, 30 day mortality, re-infarction or re-ischemia, re-admission and stroke/TIA), In-hospital and 30-day outcome data were ascertained by hospital chart review, telephone contact, and clinical follow-up data. Mortality data during hospitalization and at 30 days were determined for all patients from hospital charts and by matching identification numbers of patients with the Israeli National Population Register.
Baseline characteristics including risk factors, clinical characteristic, laboratory values, hospital and 30-day course of the patients were compared by the prespecified three oral hypoglycemic treatment groups. Comparison of categorical variables was performed with Chi-square analysis and comparison of continuous variables was performed with the nonparametric Wilcoxon rank-sum and Kruskal-Wallis tests as appropriate. A logistic regression model was used to evaulate the effect of diabetes treatment on the in-hospital and 30-day composite outcome measures. Prespecified covariates in the multivariate models included the baseline diabetes treatment groups (using the other oral treatment [group 3] as the referemce group), age, gender, history of CHF, history of renal failure, history of peripheral vascular disease, history of hypertension, history of dyslipidemia and history of ischemic heart disease. Odds ratios with 95% confidence intervals were calculated using other oral treatment (group 3) as the referemce group.
The statistical software used for the analyses was SAS version 9.2 (SAS institute, Cary, North Carolina). A two-sided p-value <0.05 was used for declaring statistical significance.
Methods
The parameters in this study were derived from the Acute Coronary Syndrome Israeli Survey (ACSIS) 2010, a bi-annual nationwide survey of acute coronary syndrome patients that were admitted to all 26 public hospitals in Israel during a 2 month period of March-April 2010. Methods on data acquisition are specified elsewhere.
Included in this sub-analysis were all patients diagnosed with type 2 diabetes mellitus that received oral hypoglycemic medications. Excluded were patients who were on chronic insulin treatment (all types either as monotherapy or in combination with oral hypoglycemic medications) and those newly diagnosed with diabetes mellitus during the admission associated with the coronary event. Duration of treatment with oral hypoglycemic medication prior to hospitalization was not recorded.
The ACSIS survey is a nationwide survey conducted in several hospitals across Israel. The study was approved by each of the local IRB's as an observational study, precluding the need for informed consent.
Definitions and Endpoints
Patients were divided into 3 groups according to the type of oral hypoglycemic medications received: 1) patients receiving DPP4i either alone or in combination with any other oral hypoglycemic medications, 2) patients receiving metformin either as monotherapy or in combination with other oral hypoglycemic medications (excluding DPP4i), and 3) other oral hypoglycemic medications, excluding DPP4i and Metformin.
Composite endpoints included: in-hospital complication (one or more of either acute renal failure, pulmonary edema, infection, killip ≥ 2 on admission) and 30-day MACE (one or more of either stent thrombosis, urgent revascularization, post event ischemia, 30 day mortality, re-infarction or re-ischemia, re-admission and stroke/TIA), In-hospital and 30-day outcome data were ascertained by hospital chart review, telephone contact, and clinical follow-up data. Mortality data during hospitalization and at 30 days were determined for all patients from hospital charts and by matching identification numbers of patients with the Israeli National Population Register.
Statistical Analysis
Baseline characteristics including risk factors, clinical characteristic, laboratory values, hospital and 30-day course of the patients were compared by the prespecified three oral hypoglycemic treatment groups. Comparison of categorical variables was performed with Chi-square analysis and comparison of continuous variables was performed with the nonparametric Wilcoxon rank-sum and Kruskal-Wallis tests as appropriate. A logistic regression model was used to evaulate the effect of diabetes treatment on the in-hospital and 30-day composite outcome measures. Prespecified covariates in the multivariate models included the baseline diabetes treatment groups (using the other oral treatment [group 3] as the referemce group), age, gender, history of CHF, history of renal failure, history of peripheral vascular disease, history of hypertension, history of dyslipidemia and history of ischemic heart disease. Odds ratios with 95% confidence intervals were calculated using other oral treatment (group 3) as the referemce group.
The statistical software used for the analyses was SAS version 9.2 (SAS institute, Cary, North Carolina). A two-sided p-value <0.05 was used for declaring statistical significance.