scholarly journals Series: Cardiovascular outcome trials for diabetes drugs Saxagliptin and SAVOR-TIMI 53

2019 ◽  
Vol 19 (1) ◽  
pp. 34-36
Author(s):  
Miles Fisher

SAVOR-TIMI 53 was the first FDA-mandated cardiovascular outcome trial to be presented and published. It compared saxagliptin and placebo in 16,492 patients with type 2 diabetes. SAVOR-TIMI 53 demonstrated non-inferiority for major cardiovascular events (cardiovascular death, myocardial infarction, stroke) but not superiority. An unexpected statistically significant increase in adjudicated hospitalisation for heart failure was seen in the saxagliptin group. Post hoc analysis demonstrated that subjects at greatest risk for hospitalisation for heart failure had previous heart failure, an estimated glomerular filtration rate <60 mL/min, or elevated baseline levels of N-terminal pro-B type natriuretic peptide. As other dipeptidyl peptidase 4 (DPP-4) inhibitors are available which have not been associated with an increased risk of hospitalisation for heart failure, saxagliptin should be avoided in patients with heart failure or a reduced estimated glomerular filtration rate.

2021 ◽  
Vol 8 ◽  
Author(s):  
Zhuo Chen ◽  
Qian Lin ◽  
Jingen Li ◽  
Xinyi Wang ◽  
Jianqing Ju ◽  
...  

Background: Renal dysfunction is associated with adverse cardiovascular outcomes in patients with heart failure (HF), but its impact on patients with heart failure with preserved ejection fraction (HFpEF) remains unclear.Methods: 3,392 subjects of the TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist) trial were assigned to two groups by estimated glomerular filtration rate (eGFR) ≥ 60 ml/min/1.73 m2 or 30–59 ml/min/1.73 m2. The outcomes, including all-cause death, cardiovascular death and HF hospitalization, were examined by multivariable cox models.Results: Over a median follow-up of 3.4 ± 1.7 years, a total of 524 all-cause deaths, 334 cardiovascular deaths and 440 HF hospitalizations occurred. Compared with patients with eGFR ≥ 60 ml/min/1.73 m2, those with eGFR 30–59 ml/min/1.73 m2 were associated with an increased risk of the all-cause death [adjusted hazard ratio (HR), 1.47; 95% confidence interval (CI), 1.24–1.76; P &lt; 0.001], cardiovascular death (adjusted HR, 1.53; 95% CI: 1.23–1.91; p &lt; 0.001), and HF hospitalization (adjusted HR: 1.21; 95% CI: 1.00–1.47; p = 0.049) after multivariable adjustment for potential confounders.Conclusions: eGFR 30–59 ml/min/1.73 m2 was related to an increased risk of all-cause death, cardiovascular death and HF hospitalization in HFpEF patients.


Author(s):  
Yuting Yu ◽  
Qi Zhao ◽  
Yonggen Jiang ◽  
Na Wang ◽  
Xing Liu ◽  
...  

In previous studies, it has been documented that a short reproductive period is associated with a higher risk of diabetes, cardiovascular disease, and chronic kidney disease. This study aims to investigate the association of the reproductive period length with decreased renal function. This study obtained data from “the Shanghai Suburban Adult Cohort and Biobank”. An estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m2 indicated decreased renal function during follow-up. Participants were grouped into quintiles by reproductive period. Logistic regression analysis was performed to examine the association between the reproductive period and decreased renal function. A total of 5503 menopausal women with baseline eGFR > 60 mL/min/1.73 m2 were included. Age, eGFR, and metabolic equivalent of task (MET) at baseline were 61.0 (range, 36.0–74.0) years, 92.2 (range, 60.1–194.5) mL/min/1.73 m2, and 1386 (range, 160–6678), respectively. A reproductive period of 37–45 years was associated with a lower risk of decreased eGFR (OR: 0.59, 95% CI: 0.35–1.00, p = 0.049) after adjusting for confounding variables. METs decreased the risk of decreased eGFR in women with a reproductive period of 37–45 years (OR: 0.43, 95% CI: 0.23–0.81, p = 0.010). Women with a longer reproductive period have a lower risk of decreased renal function. METs had an opposite influence on renal function in women with longer (decreased risk) or shorter (increased risk) reproductive periods.


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