New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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