Innovative, Unusual Therapies for DM-2: Insulin U-500, Bromocriptine, Colesevelam, and SGLT2 inhibitors. April 3 rd, 2014
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1 Innovative, Unusual Therapies for DM-2: Insulin U-500, Bromocriptine, Colesevelam, and SGLT2 inhibitors April 3 rd, 2014 KM Pantalone Associate Staff Endocrinology Speaker Bureau: Disclosures Bristol-Myers Squibb, Eli Lilly Consultant: Novo Nordisk, Eli Lilly, Sanofi
2 Objectives Review the newer and unusual therapies for patients with DM-2 Review indications, mechanisms of action, and common side effects of insulin U-500, bromocriptine (Cycloset), colesevelam (Welchol) and canagliflozin (Invokana)/dapagliflozin(Farxiga) Learn to identify patients for whom these therapies are therapeutic options Review the medications indications and contraindications Discuss patient populations which are good candidates for these therapies Available Medications SGLT-2 inhibitors
3 Things to consider when deciding on a therapy Efficacy ( HbA1C) Hypoglycemia Weight Individualize Care! Side Effects Cost Inzucchi SE et al. Diabetes Care. 2012; 35(6): Inzucchi SE et al. Diabetologia. 2012; 55(6): Humulin R U-500 Concentrated Insulin 500 units/ml vs. 100 units/ml (U-100) Indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with DM-1 and DM-2
4 Humulin R U-500 It is useful for the treatment of insulinresistant patients requiring more than 200 units of insulin per day Allows for a large dose of insulin to be administered sc in a reasonable volume Complete a thorough H&P If a patient is on large doses of insulin, ask them if they are really taking the prescribed doses? Check for lypohypertrophy at favored sites of insulin administration!
5 PK Profiles of U-500 and U-100 Pork Insulins 100 Serum Insulin ( µu/ml) ARI U-500 Insulin NRI U-100 Insulin NPH U-100 Insulin 0 Serum insulin responses of normal fasted subjects to SC administration of acid and neutral regular (ARI and NRI) and NPH pork insulin (0.25 units/kg) using the concentrations (μu/ml) indicated. Adapted from: Galloway JA, et al. Diabetes Care. 1981;4: Time in Hours U-500 de la Peña A et al. Diabetes Care Dec;34(12):
6 Dosage and Administration An injection of U-500 should always be followed by a meal within ~ 30 minutes of administration Should only be administered subcutaneously Do not administer IV or IM Do not mix U-500 with other insulins in the same syringe Hypoglycemia Extreme caution must be observed in the measurement of doses Need to educate patients (and spouses/caregivers) and be sure they understand the dose being prescribed, how to draw up and administer a dose correctly, and the importance of taking the injection with meals Severe, life threatening hypoglycemia may occur, as with any insulin therapy Hypoglycemia is the most common adverse reaction of all insulin therapies, including Humulin R U-500
7 U-500 Oral anti-diabetic therapies can be (and are often) used in combination with insulin Insulin sensitizers are often used in an attempt to reduce the doses of insulin which are required to obtain glycemic control Fluid retention and CHF may occur with concomitant use of TZDs U-500 Hepatic and Renal Impairment Need to take these into consideration Frequent BG monitoring and insulin dose reduction may be required
8 U-500 No randomized controlled trials are available to guide dosing Need to take the patient s weight, hepatic and renal function, current doses of insulin U-100, and current level of glycemic control into consideration when deciding on the initial dose of U-500 U-500 Dosing The prescribed dose of Humulin R U-500 should always be expressed in actual units of U-500 along with the corresponding markings on the syringe the patient is using In terms of U-100 insulin syringe markings Volumetric, i.e. tuberculin syringe All available insulin syringes are U-100 There are NO U-500 insulin syringes U-500 does not come in pens
9 Dosing BID Dosing Humulin R U-500 (500 units/ml) Dispense # 1 vial (20 ml) Sig: Administer 120 units (draw to 24 unit markings on a U-100 insulin syringe Or 0.24 ml on a volumetric syringe sc 30 minutes AC-breakfast and evening meal Preferred syringe: insulin syringe or volumetric TID Dosing Humulin R U-500 (500 units/ml) Dispense # 1 vial (20 ml) Sig: Administer 80 units (draw to 16 unit markings on a U-100 insulin syringe Or 0.16 ml on a volumetric syringe sc 30 minutes AC-breakfast, lunch, and evening meal Preferred syringe: insulin syringe or volumetric Dosing
10 U-500 I prefer TID dosing vs. BID dosing Allows for the administration of three smaller doses of U-500 at the three main meals I have found this to reduce the risk of hypoglycemia Initially, the doses at each meal may be the same, but eventually, many patients may require different doses at different times of day U-500 When a patient is using U-500, this serves as both the basal and bolus insulin No utility in continuing other insulin analogues Need to consider the patient s perceptions of U-500 insulin Use of this insulin is not necessarily a sign of failure on the part of the patient or practitioner
11 Potential Benefits of U-500 Can often get better control by switching to U-500 insulin Less insulin products required Patient stops prandial insulin analogue and basal insulin analogue and just takes the U- 500 Sometimes less injections required TID or BID U-500 vs. 4 or 5 injections of prandial insulin and basal insulin per day U-500 Pregnancy Category B: There are no adequate and well-controlled clinical studies of the use of Humulin R U-500 in pregnant or nursing women or during labor and delivery Pediatric Use: There are no well-controlled studies of the use of Humulin R U-500 in children
12 Insulin Syringes Patient should be given a prescription for the smallest U-100 insulin syringe required 0.3 ml in most cases Many patients have larger syringes than required from their prior U-100 therapy Not safe to have a bunch of pre-drawn syringes in the refrigerator, especially in a household with multiple diabetics Education Education of spouse and/or caregivers is critical Patients need reminded that they can t skip or delay meals when using U-500 Re-education on the signs and symptoms of hypoglycemia is necessary Many of these patients being switched to U- 500 have been under poor control for years Many may not have had a hypoglycemic event in the recent past
13 Safety Errors with U-500 dosing/administration tend to occur at the transitions of care ED visits Admission to hospital, nursing homes, switch of providers, etc. This is why it is critical that the absolute dose of U-500 insulin is clearly written on the prescription, as well as the number of U-100 insulin syringe unit markings Differences in Box and Bottle medscape
14 Oral Anti-diabetic Agents Used to be two main categories: Insulin sensitizers Insulin secretagogues However, the new agents do not fit nicely into these two categories Many of the new oral anti-diabetic agents work by novel mechanisms Anti-diabetic Agents: Major Sites of Action CNS Dopamine endotext.org
15 Dopamine Agonist Bromocriptine (Cyloset ) FDA approved for treatment of DM-2 in adults The exact mechanism by which Cycloset improves glycemic control is unknown Morning administration of Cycloset improves glycemic control in patients with type-2 diabetes without increasing plasma insulin concentrations Centrally acting insulin sensitizer Dopamine Defronzo RA. Diabetes Care Apr;34(4):
16 Dopamine Agonist Cycloset should be administered once daily within two hours upon awakening in the morning to augment low hypothalamic dopamine It is a quick acting formulation of bromocriptine which results in an increase in circulating levels of bromocriptine for 4-5 hours after administration Defronzo RA. Diabetes Care Apr;34(4): Cycloset When ingested on an empty stomach, the peak plasma concentration is reached within 60 min Absorption is delayed by food and peak plasma levels are achieved at ~ 120 min in the fed state Defronzo RA. Diabetes Care Apr;34(4):
17 Cycloset Cycloset differs from traditional bromocriptine formulations, such as Parlodel, in its quick release that provides peak concentrations within 60 min (~120 minutes in the fed state) Off label generic bromocriptine should NOT be prescribed as therapy for DM-2 Defronzo RA. Diabetes Care Apr;34(4): Cycloset Should be taken with food to potentially reduce gastrointestinal side effects such as nausea Cycloset comes as 0.8 mg tablets The starting dose is 0.8 mg/day and can be titrated to a maximum of 4.8 mg/day (6 tablets) Cycloset is administered as a once daily dose within 2 hours of awaking Defronzo RA. Diabetes Care Apr;34(4):
18 Efficacy Defronzo RA. Diabetes Care Apr;34(4): Side Effects No hypoglycemia Weight neutral Common side effects: Nausea Hypotension Including orthostatic hypotension Somnolence
19 Cautions/Concerns Hypotension Use caution in patients taking anti-hypertensive medications Psychosis May exacerbate psychotic disorders Beware of possible interaction with dopamine receptor antagonists (antipsychotics) Beware of possible interaction with other dopamine agonist therapies Used in the treatment of Parkinson s disease, hyperprolactinemia, restless leg syndrome, etc. CV Risk Reduction?
20 To date. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with any antidiabetic drug Observation with Cycloset is intriguing and requires further study Bile Acid Sequestrant The exact mechanism by which bile acid sequestrants improve glycemic control is unknown Colesevelam (Welchol ) Specifically indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus
21 Colesevelam Common side effect : Constipation Contraindications/Concerns: GI disease: Use with caution in patients with GI motility disorders, or a history of major GI tract surgery Secondary to the constipating effects of colesevelam Hypertriglyceridemia: Use with caution in patients with serum triglyceride concentrations >300 mg/dl Discontinue if triglyceride concentrations exceed 500 mg/dl or if hypertriglyceridemia-induced pancreatitis occurs Sodium-glucose co-transporter 2 (SGLT2) inhibitor Block the normal glucose reabsorption function of the kidney, resulting in the excretion of excess glucose up to 10% of daily calorific intake in patients' urine Dokken B. Diabetes Spectr 2012;25:29 36.
22 Glucose reabsorption by the proximal convoluted tubule Dokken B. Diabetes Spectr 2012;25: Copyright 2011 American Diabetes Association, Inc. SGLT-2 inhibitor Dapagliflozin (Farxiga (Forxiga )-approved ) approved by FDA in January Europe 2014 Rejected by U.S. FDA in 2012 citing a need for more clinical information on the drug's risk-benefit profile and, possibly, additional trials Concerns regarding breast and bladder cancers as well as increased frequency of genital and urinary tract infections Canagliflozin (Invokana ) Approved by FDA March 2013 FDA requested 5 post-marketing studies for the drug, including a cardiovascular outcomes trial
23 Canagliflozin A clinical study of patients at especially high risk of cardiovascular disease initially found that within the first 30 days, 13 patients taking canagliflozin suffered a major cardiovascular event vs. just 1 patient taking placebo After that, the imbalance was reversed? Elevated risk of stroke Need to await results of ongoing trials Most common adverse reactions 5% incidence: female genital mycotic infections, urinary tract infection, and increased urination Canagliflozin Slight increase in LDL cholesterol Hypotension Intravascular volume contraction Weight loss No hypoglycemia Requires renal adjustment Monitor potassium in patients with impaired renal function
24 Canagliflozin Canagliflozin
25 Canagliflozin Blood Pressure
26 Metformin + SFU + Add-on Therapy Sitagliptin 100 mg daily Canagliflozin 300 mg daily At 52 weeks, canagliflozin demonstrated noninferiority and, in a subsequent assessment, showed superiority to sitagliptin 100 mg in reducing A1C, -1.03% and -0.66%, respectively Schernthaner G et al. Diabetes Care Sep;36(9): Add-on Therapy Greater reductions in FPG, body weight, and systolic BP were observed with canagliflozin versus sitagliptin (P < 0.001). Schernthaner G et al. Diabetes Care Sep;36(9):
27 Add-on Therapy Overall AE rates were similar between groups Incidence of serious AEs and AE-related discontinuations was low for both groups Higher incidences of genital mycotic infections and osmotic diuresis-related AEs were observed with canagliflozin, which led to one discontinuation Hypoglycemia rates were similar in both groups Schernthaner G et al. Diabetes Care Sep;36(9): GFR The dose of canagliflozin is limited to 100 mg once daily in patients with moderate renal impairment GFR 45 to <60 ml/min/1.73 m2 Canagliflozin should not be initiated in patients with an GFR <45 should be discontinued when GFR is persistently <45
28 Dapagliflozin The recommended starting dose is 5 mg once daily, dose can be increased to 10 mg once daily who require additional glycemic control, if tolerated Not recommended if egfr is below 60 Dapagliflozin Nauck MA et al. Diabetes Care Sep;34(9):
29 Dapagliflozin Risk vs. Benefits Benefits Improved glycemic control Weight loss No hypoglycemia Risks Slight increase in LDL cholesterol Increased frequency/risk of UTI and genital mycotic infections Hypotension (volume contraction) Impaired renal function (monitor and d/c if GFR persistently < 60) Dapagliflozin Bladder Cancer Across 22 clinical studies, newly diagnosed cases of bladder cancer were reported in 0.17% of dapagliflozin treated patients and 0.03% of placebo or comparator-treated patients
30 Dapagliflozin Bladder Cancer After excluding patients in whom exposure to study drug was < 1 year at the time of diagnosis of bladder cancer, there were 4 cases with dapagliflozin and no cases with placebo/comparator Study arms were balanced at baseline with respect to bladder cancer risk factors and hematuria Bottom line, there were too few cases to determine whether the emergence of these events were related to dapagliflozin Individualized Goals Inzucchi SE et al. Diabetes Care. 2012; 35(6): Inzucchi SE et al. Diabetologia. 2012; 55(6):
31 2012 ADA/EASD Position Statement Inzucchi SE et al. Diabetes Care. 2012; 35(6): Inzucchi SE et al. Diabetologia. 2012; 55(6): References Galloway JA, et al. Diabetes Care. 1981;4: de la Peña A et al. Diabetes Care Dec;34(12): Defronzo RA. Diabetes Care Apr;34(4): Dokken B. Diabetes Spectr 2012;25:29 36 Schernthaner G et al. Diabetes Care Sep;36(9): Nauck MA et al. Diabetes Care Sep;34(9): Inzucchi SE et al. Diabetes Care. 2012; 35(6): Inzucchi SE et al. Diabetologia. 2012; 55(6): Package Inserts: Invokana, Farxiga, Humulin R U 500, Welchol, Cycloset
32 Thank You! Questions?????
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