New Drug Update 2009-2010 - LAFP

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with type 2 diabetes mellitus. It can be use as monotherapy or in combination with other antidiabetic agents, including metformin, sulfonylureas, and thiazolidinediones. The safety and efficacy of combining saxagliptin with insulin has not been assessed. Saxagliptin and sitagliptin appear to have very similar efficacy in the treatment of patients with type 2 diabetes. Both drugs can be given once daily without regards to meals and are generally well tolerated. Postmarketing experience and direct comparative studies are necessary to determine which drug may be more efficacious and/or safer. 3-9-<strong>2010</strong> the companies announced a new outcome trial SAVOR – TIMI 53 whioch will enroll ~12,000 patients with CHD or multiple risk factors and follow them for about 5 years 30
Liraglutide – Victoza by Novo-Nordisk INDICATIONS: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use: •Not recommended as first-line therapy for patients inadequately controlled on diet and exercise. •Has not been studied sufficiently in patients with a history of pancreatitis. Use caution. •Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis. •Has not been studied in combination with insulin. CLINICAL PHARMACOLOGY: Liraglutide is a human analog of the glucagon-like peptide-1 (GLP-1) with 97% amino acid sequence homology to endogenous human GLP-1. It differs from human GLP-1 by the addition of a C14 fatty acid. As a GLP-1 analog, it induces its activity through a glucose-dependent stimulation of insulin secretion, inhibition of glucagon secretion, slowing of gastric emptying, and reduction in appetite. Liraglutide also improves beta cell function in patients with type 2 diabetes. GLP-1 has a half-life of 1.5-2 minutes due to degradation by the ubiquitous endogenous enzymes, dipeptidyl peptidase IV (DPP-IV) and neutral endopeptidases (NEP). Unlike native GLP-1, liraglutide is stable against metabolic degradation by both peptidases and has a plasma half-life of 13 hours after subcutaneous administration. The pharmacokinetic profile of liraglutide, which makes it suitable for once daily administration, is a result of self-association that delays absorption, plasma protein binding and stability against metabolic degradation by DPP-IV and NEP. Fasting and postprandial glucose was measured before and up to 5 hours after a standardized meal after treatment to steady state with 0.6, 1.2 and 1.8 mg liraglutide or placebo. Compared to placebo, the postprandial plasma glucose AUC0-300min was 35% lower after liraglutide 1.2 mg and 38% lower after liraglutide 1.8 mg. PHARMACOKINETICS: Liraglutide is slowly absorbed following subcutaneous administration, reaching peak levels at 9 to 12 hours after dosing. Absolute bioavailability is 51%. Pharmacokinetics were similar with administration in the upper arm, abdomen, and thigh. A dose-proportional increase in exposure was observed with increasing doses over a dose range of 1.25 to 12.5 mcg/kg. Liraglutide 20 mcg/kg administered once daily subcutaneously exhibited less peak to trough variation than exenatide 10 mcg/kg administered twice daily subcutaneously. Liraglutide has a half-life of 11 to 15 hours following subcutaneous administration; allowing for once daily subcutaneous administration. Liraglutide is metabolized to a number of minor metabolites, which are excreted in the urine and feces. Liraglutide excretion in the urine is negligible. Liraglutide pharmacokinetics were not substantially altered in subjects with renal function impairment, including subjects with severe renal function impairment (creatinine clearance less than 30 mL/min) or end-stage renal disease requiring dialysis. Liraglutide is not significantly removed by dialysis. Liraglutide exposure appears to be reduced in patients with hepatic function impairment. Patients with renal or hepatic function impairment should be dosed according to their glycemic control. Elderly -Age had no effect on the pharmacokinetics of liraglutide based on a pharmacokinetic study in healthy elderly subjects (65 to 83 years) and population pharmacokinetic analyses of patients 18 to 80 years of age. Gender -Based on the results of population pharmacokinetic analyses, females have 34% lower weightadjusted clearance of liraglutide compared to males. Based on the exposure response data, no dose adjustment is necessary based on gender. Race and Ethnicity -Race and ethnicity had no effect on the pharmacokinetics of liraglutide based on the results of population pharmacokinetic analyses that included Caucasian, Black, Asian and Hispanic/Non- Hispanic subjects. 31
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adjustment in hepatic impairment re
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dosing, inhibition of platelet aggr
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dronedarone and its N-debutyl metab
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ANDROMEDA Study (Increased Mortalit
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In clinical trials, patients treate
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Dronedarone was developed to lack a
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BENZYL ALCOHOL 5% LOTION - Ulesfia
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Table 2. Contraindications, Warning
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adolescents (ages 13-17), respectiv
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The most frequently observed advers
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New Drug Update 2009-2010 - LAFP

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