New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 Liraglutide – Victoza Liraglutide – Victoza LEAD 6 Trial (Lancet 2009; 374:39-47) • Inadequately controlled type 2 diabetes patients on maximally tolerated doses of metformin, sulfonylurea, or both, were stratified by previous oral antidiabetic therapy and randomly assigned to receive additional liraglutide 1·8 mg once a day (n=233) or exenatide 10 g twice a day (n=231) in a 26-week open-label study. • Liraglutide reduced mean HbA1c significantly more than did exenade (1·12% vs 0·79%; esmated treatment dierence 0·33; 95% CI 0·47 to 0·18; p
2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 Liraglutide – Victoza Risk of Thyroid C-cell Tumors BLACK BOX WARNING • Liraglutide causes dose-dependent and treatmentduration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice. • In the clinical trials, there have been 4 reported cases of thyroid C-cell hyperplasia among Victoza-treated patients and 1 case in a comparator-treated patient (1.3 vs. 0.6 cases per 1000 patient-years). – a 5 year epidemiological study using a large healthcare claims database to compare the development of thyroid cancer among patients with T2DM who use Victoza to those who are not using this medicine. – develop a medullary thyroid cancer registry to monitor how many cases of medullary thyroid cancer occur each year for at least 15 years Liraglutide – Victoza • It is unknown whether Victoza will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans • Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea or persistent hoarseness). Wayne Weart New Drug Update Part I
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New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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