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CV evaluation for 6.2 years from the long-term landmark ORIGIN trial1,2

 

  • No statistically significant differences between Lantus® and standard care in the co-primary endpoints (P=0.63 for first co-primary outcome, P=0.27 for second co-primary outcome)1
  • Similar results were observed between Lantus® and standard care for all-cause mortality1

 
 

  • Severe symptomatic: hypoglycemia was defined as an event with symptoms conslstent with hypoglycemia requiring the assistance of another person and associated with either a BG ≤36 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration.2

 
 

ORIGIN, Outcome Reduction with Initial Glargine Intervention.

Study Design

A randomized study of patients with IFG and/or IGT or early type 2 diabetes mellitus and established CV disease or CV risk at baseline. Patients received either Lantus® (n=6264) titrated to a target FPG of ≤95 mg/dL or standard care (n=6273). Standard care patients remained on their original treatment, if applicable, at randomization. Additional agents could be added as needed at the discretion of the investigator. The co-primary outcomes were nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes and these events plus revascularization or hospitalization for heart failure. Microvascular outcomes, incident diabetes, hypoglycemia, weight, and cancers were also compared between groups. Median follow-up: 6.2 years.1,2

 

No statistically significant differences between Lantus® and standard care in the incidence of CV events in the landmark ORIGIN trial1-3

 

ORIGIN, Outcome Reduction with Initial Glargine Intervention.

 

Study Design

A randomized study of patients with IFG and/or IGT or early type 2 diabetes mellitus and established CV disease or CV risk at baseline. Patients received either Lantus® (n=6264) titrated to a target FPG of ≤95 mg/dL or standard care (n=6273). Standard care patients remained on their original treatment, if applicable, at randomization. Additional agents could be added as needed at the discretion of the investigator. Median follow-up: 6.2 years.1,3

Safety results1

 

 
 

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References

  1. Lantus® Prescribing Information. August 2015.
  2. ORIGIN Trial Investigators. Am Heart J. 2008;155(1):26-32.
  3. ORIGIN Trial Investigators. N Engl J Med. 2012;367(4):319-328.