PracticeUpdate: Conference Series | ADC 2018
Choose JANUVIA as your DPP4i of choice in T2DM
DPP4i = dipeptidyl peptidase 4 inhibitor, T2DM = type 2 diabetes mellitus
Study Designs Nauck MA et al. 2007 2 A randomised, double-blind, parallel-group study evaluating the effect of adding sitagliptin (100 mg once daily) vs glipizide (≤20 mg/day) to metformin in 1,172 patients with type 2 diabetes inadequately controlled with ≥1500 mg/day metformin (HbA1c ≥6.5% to ≤10%). The primary analysis assessed non-inferiority for HbA1c change from baseline at week 52 using a PP approach (patients who completed all 52 weeks of treatment and did not have any reason for exclusion). Arjona Ferreira JC et al. Am J Kidney Dis 2013 3 A randomised, double-blind, parallel-arm study assessing the efficacy and safety of sitagliptin and glipizide monotherapy in patients with T2DM and end-stage renal disease on dialysis therapy (baseline HbA1c=7.8%). Patients (n=129) received sitagliptin 25 mg once daily or glipizide (n=64) initiated at 2.5 mg daily and titrated in 2-week intervals to a potential maximum dose of 10 mg twice daily. Primary endpoints were change in HbA1c level from baseline and tolerability with sitagliptin. Arjona Ferreira JC et al. Diabetes Care 2013 4 A randomised, double-blind, parallel-group study comparing the efficacy and safety of sitagliptin with glipizide in patients with T2DM mellitus and moderate-to-severe chronic renal insufficiency and inadequate glycaemic control. Patients (n=426) received sitagliptin 50 mg once daily for moderate renal insufficiency, sitagliptin 25 mg once daily for severe renal insufficiency or glipizide 2.5 mg once daily (adjusted for glycaemic control to a 10 mg twice a day maximum dose). Primary endpoint was change from baseline in HbA1C at week 54. Green JB et al. 2015 5 A multinational, randomised, double-blind, placebo-controlled, event-driven trial that assessed the long-term CV safety of adding sitagliptin to usual care, as compared with usual care alone, in 14,671 patients ≥50 years old with T2DM and established CVD. ^ Patients were randomised to sitagliptin + usual care* (n=7,332), placebo + usual care* (n=7,339) with median follow up of 3 years. Starting dose of once-daily sitagliptin was 100 mg or 50 mg for patients with eGFR 30–50 mL/min/1.73m 2 ; if eGFR fell to <30 mL/ min/1.73m 2 , the dose was reduced to once daily sitagliptin 25 mg; if eGFR showed sustained recovery, dose was uptitrated. Primary endpoint: composite CV outcome (CV death, nonfatal MI, nonfatal stroke, or hospitalisation for unstable angina). ^Established cardiovascular disease was defined as a history of major coronary artery disease, ischaemic cerebrovascular disease, or atherosclerotic peripheral arterial disease. *Antihyperglycemic medication could have included metformin, sulfonylurea, pioglitazone, or insulin with or without metformin, excluding other DPP-4 inhibitors and GLP-1 RAs or thiazolidinedione (other than pioglitazone) during the preceding 3 months. CV=cardiovascular, DPP-4=dipeptidyl peptidase-4, GLP-1=glucagon-like peptide-1 receptor agonist, MI=myocardial infarction Chan JCN et al . 2008 6 A 54-week, randomised, double-blind, parallel-group study to test the safety of sitagliptin in T2DM patients with moderate (CrCl ≥30 to <50 mL/min) or severe renal insufficiency (CrCl <30 mL/min). The trial included a 12-week double-blind, placebo-controlled phase in which patients (baseline HbA1c=7.7%) with normal renal function were randomised to sitagliptin 100 mg/day (n=65), 50 mg/day with moderate and 25 mg/day with severe renal insufficiency or placebo (n=26) and a 42-week extension in which all patients were eligible for active therapy (patients either continued treatment with sitagliptin or patients on placebo transitioned to glipizide). PLEASE REVIEW THE PRODUCT INFORMATION BEFORE PRESCRIBING. PRODUCT INFORMATION IS AVAILABLE AT WWW.MSDINFO.COM.AU/JANUVIAPI Copyright © 2018 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, U.S.A. All rights reserved. Merck Sharp & Dohme (Australia) Pty Limited. Level 1, Building A, 26 Talavera Road, Macquarie Park NSW 2113. DIAB-1268045-0000. First Issued August 2018. Bloe Agency MSD13139. References: 1. JANUVIA Approved Product Information, April 2017. 2. Nauck MA et al. Diabetes Obes Metab 2007;9(2):194–205. 3. Arjona Ferreira JC et al. Am J Kidney Dis 2013;61(4): 579-587. 4. Arjona Ferreira JC et al. Diabetes Care 2013;36(5): 1067-1073. 5. Green JB et al. N Engl J Med 2015; 373(3): 232–242. 6. Chan JCN et al. Diabetes Obes Metab 2008;10:545–555. 7. Melizide (glipizide) Approved Product Information, October 2015. Indications: To improve glycaemic control in patients ≥ 18 years old with Type 2 Diabetes Mellitus. Either as monotherapy (when metformin cannot be used and when dietary and exercise measures have failed), or as dual combination therapy with metformin or with a sulfonylurea, or with a thiazolidinedione where its use is considered appropriate, or as triple combination therapy with metformin and a sulfonylurea, or as add-on to insulin (with or without metformin). Contraindications: Hypersensitivity to any component. Precautions: Not for Type 1 Diabetes Mellitus or diabetic ketoacidosis. Acute pancreatitis (discontinue treatment), renal insufficiency, hypoglycaemia in combination with a sulfonylurea or with insulin, hypersensitivity, bullous pemphigoid (discontinue treatment). Pregnancy (Cat B3), lactation, children. Interactions: No clinically significant interactions observed with sitagliptin and metformin, glibenclamide, simvastatin, rosiglitazone, warfarin, oral contraceptives, digoxin or cyclosporine (see full PI). Adverse reactions: URTI, headache, hypoglycaemia, nasopharyngitis. Postmarketing Experience: Hypersensitivity reactions, bullous pemphigoid, Acute pancreatitis, Worsening renal function (including acute failure), constipation, vomiting, headache, arthralgia, myalgia, pain in extremity, back pain (see full PI). Dosage: 100 mg once daily with or without food. Adjust dose for moderate/severe renal insufficiency. Moderate renal insufficiency (CrCl ≥ 30 to < 50 mL/min): 50 mg once daily. Severe renal insufficiency (CrCl < 30 mL/min) or with end-stage renal disease: 25 mg once daily (see full PI). To reduce the risk of hypoglycaemia, consider reduced dose of sulfonylurea/insulin when used in combination. Based on PI amended: JANUVIA : 06 April 2017. PBS INFORMATION: Dual, Triple, Insulin add on therapy listings. Authority required (Streamlined). Refer to PBS Schedule for full authority information. Initial combination therapy is not listed on the PBS. Sitagliptin monotherapy is not listed on the PBS.
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