A Systematic Assessment of Cardiovascular Outcomes in the Saxagliptin Drug Development Program for Type 2 Diabetes

@article{Frederich2010ASA,
  title={A Systematic Assessment of Cardiovascular Outcomes in the Saxagliptin Drug Development Program for Type 2 Diabetes},
  author={Robert C. Frederich and John H. Alexander and Fred T. Fiedorek and Mark Donovan and Niklas Berglind and Susan Harris and Roland S. Chen and R. Wolf and Kenneth W. Mahaffey},
  journal={Postgraduate Medicine},
  year={2010},
  volume={122},
  pages={16 - 27}
}
Abstract Objective: The objective was to assess the relative risk (RR) for cardiovascular (CV) events across all 8 randomized phase 2/3 trials evaluating saxagliptin in patients with type 2 diabetes mellitus. Methods: Cardiovascular events (death, myocardial infarction [MI], stroke, revascularization procedures, and cardiac ischemia) were reported by investigators through standard adverse event reporting procedures and were systematically identified. Post hoc blinded adjudication of all deaths… 

Assessment of the cardiovascular safety of saxagliptin in patients with type 2 diabetes mellitus: pooled analysis of 20 clinical trials

Analysis of pooled data from 20 clinical trials in patients with type 2 diabetes mellitus suggests that saxagliptin is not associated with an increased CV risk.

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These results from a large Phase 3 programme support the hypothesis that linagliptin may have CV benefits in patients with T2DM.

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Although saxagliptin improves glycemic control, other approaches are necessary to reduce cardiovascular risk in patients with diabetes, and DPP-4 inhibition with saxgliptin did not increase or decrease the rate of ischemic events, though the rates of hospitalization for heart failure was increased.

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Linagliptin is not associated with increased CV risk versus pooled active comparators or placebo in patients with T2DM.

Saxagliptin Efficacy and Safety in Patients with Type 2 Diabetes Mellitus Stratified by Cardiovascular Disease History and Cardiovascular Risk Factors: Analysis of 3 Clinical Trials

In patients with T2DM, saxagliptin 5 mg/d was similarly effective in improving glycemic control, with an AE profile similar to that of placebo, irrespective of CVD history, number of CV risk factors, hypertension, or statin use.

Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes Mellitus and Cardiovascular Disease History or Cardiovascular Risk Factors: Results of a Pooled Analysis of Phase 3 Clinical Trials

Saxagliptin improved glycemic measures, resulted in low rates of confirmed hypoglycemia, and was well tolerated in patients with or without CVD and CV risk factors.

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

  • M. Fisher
  • Medicine
    British Journal of Diabetes
  • 2019
Al saxagliptin should be avoided in patients with heart failure or a reduced estimated glomerular filtration rate, and other dipeptidyl peptidase 4 (DPP-4) inhibitors are available which have not been associated with an increased risk of hospitalisation for heart failure.

Major adverse cardiovascular events with basal insulin peglispro versus comparator insulins in patients with type 1 or type 2 diabetes: a meta-analysis

Treatment with BIL versus comparator insulin in patients with type 1 diabetes or type 2 diabetes was not associated with increased risk for major CV events in the studies analyzed.

Postauthorization safety study of the DPP-4 inhibitor saxagliptin: a large-scale multinational family of cohort studies of five outcomes

Saxagliptin initiation was not associated with increased risk of MACE, infection, AKI, ALF, or severe hypersensitivity reactions in clinical practice settings, and meta-analyses demonstrated a reduced risk of hospitalization/death from MACE/death.
...

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