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 Linagliptin – Tradjenta Add on to Metformin: • 701 patients on at least 1500 mg/d metformin and not at goal A1c (mean baseline 8.1 and 8.0%) had either linagliptin 5 mg or placebo added for 24 weeks – A1c -0.5% L vs. +0.15% P (difference from placebo -0.6%) – Patients achieving A1c
2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 Linagliptin – Tradjenta Add on to pioglitazone (30mg) for 24 weeks • 389 patients (baseline A1c 8.6%) linagliptin 5 mg plus pioglitazone 30mg (LP) vs. piogltazone plus placebo (PP) (patients who did not get to goal could have rescue therapy with metformin added) – A1c -1.1% LP vs. -0.6% PP – FPG -32.6 mg/dl LP vs. -18.4 mg/dl PP – Metformin rescue was added on 7.9% with LP vs. 14.1% PP – Weight changes +2.3 Kg LP and +1.2 Kg PP • Diabetes Obes Metab. 2011;13(7):653-661. 10.111/j.1463- 1326.2011.01391.x. Linagliptin – Tradjenta Contraindication: • Linagliptin is contraindicated in patients with a history of hypersensitivity reactions (eg, urticaria, angioedema, bronchial hyperreactivity). Adverse Effects: • In the clinical trial program, pancreatitis was reported in 8 of 4687 patients (4311 patient years of exposure) while being treated with linagliptin compared with 0 of 1183 patients (433 patient years of exposure) treated with placebo. Three additional cases of pancreatitis were reported following the last administered dose of linagliptin • When linagliptin was administered in combination with metformin and a sulfonylurea, 181 of 791 (22.9%) of patients reported hypoglycemia compared with 39 of 263 (14.8%) of patients administered placebo in combination with metformin and a sulfonylurea – When used in combination with an insulin secretagogue (e.g., sulfonylurea), a lower dose of the insulin secretagogue may be required to reduce the risk of hypoglycemia Wayne Weart New Drug Update Part I
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New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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