Fixed dose combination for Trusted Diabetes Control Lobna Farag Eltooy Head of Internal Medicine Department Assiut University
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1 Fixed dose combination for Trusted Diabetes Control By Lobna Farag Eltooy Head of Internal Medicine Department 1 Assiut University 3/18/2018
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4 Diabetes Complications with Increasing HbA1c * 4 Hashim Azam, et.al., Glycemic Control, Diabetic Complications and Their Awareness, J. Med. Sci. January 2009, Vol. 17, No.1 PVC: Peripheral Vascular Disease
5 Benefits of good diabetes control 50% of patients of T2DM already have complications at first diagnosis 2 Each HbA 1c percentage point reduction counts 3 HbA 1c -1% -14% risk -37% risk -21% risk Myocardial infarction Microvascular complications Death related to diabetes 1. Holman, et al. NEJM 2008;359: UKPDS 6. Diabetes Res 1990;13(1): Stratton, et al. BMJ 2000;321(7258):405-12
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9 Nutrition Therapy, Exercise and Lifestyle Changes Nutrition therapy Decrease carbohydrates and fat content Decrease salt to avoid hypertension Healthy diet Weight reduction for obese patients Exercise Increase energy consumption with moderate-intensity exercise Lifestyle changes - Reduce cardiovascular risk factors (eg, smoking cessation) -Training in self-management and SMBG (Self Monitoring of Blood Glucose) 9 3/18/2018
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11 Diabetes Care, Diabetologia. 19 April 2013 [Epub ahead of print] Treatment Algorithm for Type 2 Diabetes
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13 HbA 1c reduction (%) Clinical challenge: Selecting the appropriate treatment for your patient Sulfonylureas Biguanides (metformin) Glinides DPP-IV GLP-1 inhibitors TZDs agonists Insulin Anti diabetic agents 3.0 Efficacy as mono therapy Hb A1c lowering effect Adapted from Nathan DM. N Engl J Med. 2007;356: and Nathan et al. Diabetes Care. 2009;32:
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17 Sulfonylureas vs Newer Second-Line Agents for Type 2 Diabetes News Author: Miriam E. Tucker CME Author: Charles P. Vega, MD, FAAFP Faculty and Disclosures CME/CE Released: 5/2/2014; Valid for credit through 5/2/2015 3/18/2018
18 Design of the Simulation Model The findings are based on a simulation model involving 8 years of claims data from more than 37,000 patients Four treatment regimens were evaluated All of the models included metformin monotherapy with the addition of one of the following four second-line agents when a patient s A1c level reached a pre-specified level: DPP-4 inhibitors, GLP-1 agonists, Sulfonylurea, Insulin. Outcome measures included: Life-years (LYs), Quality-adjusted life-years (QALYs), Mean time to insulin dependence, Expected medication cost per QALY from diagnosis to first Diabetes complication (ischemic heart disease, myocardial infarction, congestive heart failure, stroke, blindness, renal failure, amputation) or death 18 3/18/2018
19 Results: All regimens resulted in similar LYs (life -years )and QALYs (Quality adjusted life years ), The regimen with Sulfonylurea was significantly lower cost and resulted in the longest time to insulin dependence Conclusions: Use of Sulfonylureas as second-line therapy for type 2 diabetes generated glycemic control comparable with those associated with other agents but at lower cost There is a lack of evidence about the long-term effects of the newer medications. All of the medications have pros and cons, but the difference in cost is quite clear." 19 3/18/2018
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22 Adapted Recommendations: When Goal is to Get Max. Control with Minimize Costs Diabetes Care, Diabetologia. 19 April 2014
23 Glybofen contains Micronized Glyburide D:\Liptis\Glybofen\Glybofen 2014\glyburide-micronized - Copy.pdf 23 3/18/2018
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![1.Facts and Comparisons [Internet database]. St. Louis, MO: Wolters Kluwer Health. Updated periodically. 2.](/docs-images/80/80806637/images/27-1.jpg "Micronase [package insert]. New York, NY: Pharmacia and Upjohn Company; 2010. 3. Glucotrol [package insert].")
27 1.Facts and Comparisons [Internet database]. St. Louis, MO: Wolters Kluwer Health. Updated periodically. 2. Micronase [package insert]. New York, NY: Pharmacia and Upjohn Company; Glucotrol [package insert]. New York, NY: Roerig; /18/2018
28 Glybofen (Micronized Glyburide) provides: Higher bioavailability (40%) Prolonged duration (lasts 24 hrs) Extensively bound to plasma protein 3/18/2018
29 How could that help my patients? 3/18/2018
30 Delays secondary failure (3mg micronized equals 5mg non micronized) Less hypoglycemic episodes (Better continuation ratios) Better compliance (single dose will last for 24 hrs) 3/18/2018
31 Combined therapy VS. Co-administration 3/18/2018
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36 The Synergistic Effects of Glyburide & Metformin in Insulin secretion Sensitivity of insulin receptors Glucose uptake by body tissues Gluconeogenesis Glucose absorption from GIT 42 3/18/2018
37 Patient compliance is one of the most important therapeutic goals to be achieved 3/18/2018
38 DIABETES, OBESITY AND METABOLISM L. Blonde,1 J. Wogen,2 C. Kreilick2 and A. A. Seymour3 1Ochsner Clinic Foundation, New Orleans, LA, USA 2The Institute for Effectiveness Research L.L.C., Bridgewater, NJ, USA 3Bristol-Myers Squibb, Plainsboro, NJ, USA.Glyburide/metformin initiation reduces A1C in type 2 diabetic patients 1421 patient were assigned to treatment for 6 months D:\Liptis\Glybofen\trials\sugar bars\ref 2 combined vs co therapy.pdf 3/18/2018
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41 52% greater reduction in A1c 3/18/2018
42 CONCLUSION: -Combination therapy (Glybofen ) provided a 52% greater reduction in A1C than glyburide co-administered with metformin in patients with type 2 diabetes, especially when baseline A1C 8%..\..\trials\sugar bars\ref 2 combined vs co therapy.pdf 50 3/18/2018
43 1. Minimal hypoglycemia (micronization) 2. Delays onset of secondary failure (micronization) 3. Better compliance (effect lasts for 24 hrs) 4. Synergistic effect of combination offers superior control with lower dosage 5. Dosage flexibility (scored tablets) 6. Affordable price ( 30 tabs/27 L.E) 52 3/18/2018
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