Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC; Division of Cardiology, Department of Medicine, University of Saskatchewan, Saskatchewan, Canada; Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.
Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.
Am Heart J. 2019 Dec;218:92-99. doi: 10.1016/j.ahj.2019.09.013. Epub 2019 Oct 20.
The effects of β-blocker therapy in patients with type 2 diabetes (T2D) and established atherosclerotic cardiovascular disease (ASCVD) are unclear. We sought to evaluate associations between β-blocker use in T2D with ASCVD and cardiovascular (CV) outcomes.
In patients with T2D and ASCVD enrolled in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS), an inverse probability of treatment-weighted Cox proportional hazards model was used to examine the association between baseline β-blocker therapy (at randomization) and the primary CV composite (defined as CV death, non-fatal myocardial infarction [MI], non-fatal stroke, or hospitalization for unstable angina), including in subgroups with prior MI and heart failure (HF); other outcomes evaluated included individual components of the primary composite, hospitalization for HF, and severe hypoglycemic events.
Of the 14,671 patients randomized, 9322 (64%) were on a β-blocker at baseline; these patients were more likely to have prior MI or HF. Over a median 3.0 (25th, 75th percentile: 2.2, 3.6) years, the risk of the primary CV composite was significantly higher with baseline β-blocker use versus no β-blocker use (4.5 vs. 3.4 events/100-patient years, adjusted hazard ratio [HR] 1.17, 95% confidence interval [CI] 1.05-1.29); no significant interaction was noted for patients with versus without prior MI or HF. Baseline β-blocker use was not associated with risks for severe hypoglycemic events (HR 1.14, 95% CI 0.88-1.48).
In this observational analysis of T2D and ASCVD, baseline β-blocker use was not associated with risks for severe hypoglycemia yet also was not associated with CV risk reduction over 3 years of follow-up, supporting a randomized examination of chronic β-blocker therapy in this patient population. (TECOS ClinicalTrials.gov number, NCT00790205).
β受体阻滞剂在 2 型糖尿病（T2D）合并已确诊动脉粥样硬化性心血管疾病（ASCVD）患者中的疗效尚不明确。本研究旨在评估 T2D 合并 ASCVD 患者中β受体阻滞剂的使用与心血管（CV）结局之间的关联。
在接受评估沙格列汀心血管结局的临床试验（TECOS）的 T2D 合并 ASCVD 患者中，采用逆概率治疗加权 Cox 比例风险模型，以评估基线时β受体阻滞剂治疗（随机时）与主要 CV 复合终点（CV 死亡、非致死性心肌梗死[MI]、非致死性卒中和不稳定型心绞痛住院）之间的关联，包括既往有 MI 和心力衰竭（HF）的亚组；评估的其他结局包括主要复合终点的各个组成部分、HF 住院和严重低血糖事件。
在随机分组的 14671 例患者中，9322 例（64%）基线时正在使用β受体阻滞剂，这些患者既往 MI 或 HF 发生率更高。中位随访 3.0 年（25%分位数，75%分位数：2.2 年，3.6 年）时，与未使用β受体阻滞剂相比，基线时使用β受体阻滞剂的患者主要 CV 复合终点风险显著更高（4.5 例/100 患者年比 3.4 例/100 患者年，校正后 HR 1.17，95%CI 1.05-1.29）；在既往有 MI 或 HF 的患者与无既往 MI 或 HF 的患者之间未观察到显著的交互作用。基线时使用β受体阻滞剂与严重低血糖事件风险无关（HR 1.14，95%CI 0.88-1.48）。
在本项 T2D 合并 ASCVD 的观察性分析中，基线时使用β受体阻滞剂并未增加严重低血糖风险，但也未降低 3 年随访期间的 CV 风险，支持对此患者人群进行慢性β受体阻滞剂治疗的随机评估。（TECOS ClinicalTrials.gov 编号，NCT00790205）。
