11/4/2014. Outline. Pharmacists Objectives. Diabetes Update: What s New in Pharmacy Technician Objectives. Overview: Type 2 Diabetes Mellitus

Transcription

1 Diabetes Update: What s New in 2014 Dr. Amy P. Witte, Pharm.D. Associate Professor, Pharmacy Practice UIW Feik School of Pharmacy CTSHP Fall Seminar La Cantera Hill Country Resort October 25, 2014 Pharmacists Objectives Review changes to the management of diabetes recommended by the 2014 American Diabetes Association s Standards of Medical Care in Diabetes Discuss highlights of the new hypertension and lipid guidelines as it relates to diabetes patients Given a patient case, select appropriate statin therapy based on the patient s risk factors Identify new diabetes drugs approved and in the pipeline Pharmacy Technician Objectives Define type 2 diabetes, hypertension and hyperlipidemia Discuss revisions made to the diabetes standards of medical care, hypertension and hyperlipidemia guidelines Given a patient case, recognize a moderate intensity statin dose Identify new diabetes drugs approved and in the pipeline Outline Overview of Type 2 Diabetes Mellitus, Hypertension and Dyslipidemia ADA Guidelines: Summary of Revisions to the Standards of Medical Care Blood Pressure Management Differences between ADA, JNC 7 and JNC 8 Guidelines Lipid Management Differences between ADA and ACC/AHA Cholesterol Guidelines New Kids on the Block Drugs in the Pipeline Patient Case Overview: Type 2 Diabetes Mellitus A group of metabolic disorders associated with abnormalities in carbohydrate, fat, and protein metabolism Overview: Type 2 Diabetes Mellitus Insulin Resistance Skeletal Muscle Characterized by two major defects Insulin resistance Decreased insulin secretion Liver Adipose Tissue 1

2 Overview: Type 2 Diabetes Mellitus Insulin Resistance Normal β cell Abnormal β function cell function Overview: Epidemiology In the United States, 29.1 million people or 9.3% of the population have diabetes 21.1 million are diagnosed 8.1 million are undiagnosed Like many other chronic illnesses, it affects older people and its prevalence is higher among racial and ethnic minority populations. Hyperinsulinemia Metabolic Syndrome Insulin deficiency Hyper glycemia The annual economic burden of diabetes is estimated to be $245 billion $176 billion for direct medical costs $69 billion for indirect costs Type 2 Diabetes National Diabetes Statistics Report, 2014 Overview: Complications Overview: Treatment Options Oral therapy Biguanide - Metformin Thiazolidinediones Sulfonylureas Non-sulfonylureas Dipeptidyl peptidase-4 (DPP-4) inhibitor Alpha-glucosidase inhibitors SGLT2 inhibitors*newest agents Injectables Glucagon-like peptide-1 (GLP-1) receptor agonists An amylin analogue Insulin therapy Long, short and rapid acting formulations www. activedisease.com, accessed October 2014 Summary of Revisions Diagnosis of diabetes Re-emphasized that A1C is one of the three available methods to diagnose diabetes 2014 ADA Guidelines: Standards of Medical Care in Diabetes Pharmacological Therapy Treatment time frame for non-insulin monotherapy was changed from 3-6 months to 3 months if A1C goals are not achieved 2

3 Summary of Revisions Antiplatelet Therapy Terminology changed from combination therapy with aspirin and clopidogrel to dual antiplatelet therapy Nephropathy Terminology revised to remove terms microalbuminuria and macroalbuminuria Albuminuria mg/24 hr (previously microalbuminuria) Albuminuria 300 mg/24 hr (previously macroalbuminuria) Summary of Revisions Retinopathy Recommends eye exam every 2 years versus 2-3 years if no retinopathy is present Neuropathy Provides more descriptive treatment options for neuropathic pain Diabetes care in the hospital setting Updated to discourage the use of sliding scale Recommend use of scheduled insulin doses Comorbid Conditions Overview: Hypertension Diabetes Hypertension is the most common medical condition treated by primary care physicians If untreated, high blood pressure increases risk for heart attack, stroke, renal failure, and death Hypertension Dyslipidemia 67 million Americans (31%) are diagnosed with high blood pressure Centers for Disease Control and Prevention, High Blood Pressure Fact Sheet, accessed October 2014 Overview: Hypertension Only about ½ of the people diagnosed have their blood pressure under control Most patients will require 2 or more antihypertensive medications to control their blood pressure The annual economic burden of hypertension is estimated to be $47.5 billion JNC 8 Hypertension Guidelines Centers for Disease Control and Prevention, High Blood Pressure Fact Sheet, accessed October

4 ADA Guidelines HTN Management Target goal is <140/80 mm Hg JNC 7: Treatment Algorithm Treatment options include ACE, ARB or diuretics Two or more agents at maximum doses is required to achieve blood pressure control JNC 8: Target Blood Pressure Goals JNC 8: Treatment Recommendations JNC 8: Treatment Recommendations Recommendation 5 Patients aged 18 years or older with diabetes treat to a goal of <140/90 mmhg (Expert Opinion Grade E) Recommendation 6 Nonblack population including those with diabetes, initial treatment should include a thiazide, ACE, ARB or CCB (Moderate recommendation Grade B) Recommendation 7 Black population including those with diabetes, initial treatment should include a thiazide or CCB (Weak recommendation Grade C) 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults Report From the Panel M embers Appointed to the Eighth Joint National Committee (JNC 8); JAMA. 2014;311(5): JNC 8: Overview of Major Changes BP target goals Higher goals for elderly, DM, and CKD Treatment Thiazides no longer recommended as initial therapy Specific recommendations given for African Americans De-emphasis on choice of agent for compelling indications Treatment is focused using four versus five medication classes based on outcomes evidence from RCTS PL Detail-Document, Treatment of Hypertension: JNC 8 and More. Pharmacist s Letter/Prescriber s Letter. February

5 JNC 8: Overview of Major Changes Diabetes 1 st line: ACE or ARB *CCB or thiazide in African Americans 2 nd line: add CCB or thiazide *add ACE or ARB in African Americans 3 rd line: CCB +ACE or ARB + thiazide ACC/AHA Cholesterol Guidelines PL Detail-Document, Treatment of Hypertension: JNC 8 and More. Pharmacist s Letter/Prescriber s Letter. February ADA Guidelines Lipid Management Statin therapy should be added to lifestyle therapy in diabetic patients: With overt CVD (Level A evidence) Without CVD who are over the age of 40 years and have one or more other CVD risk factors (Level A evidence) In patients <40 years of age without overt CVD statin therapy should be considered (Level C evidence) ADA Guidelines Lipid Management In individuals without overt CVD, LDL goal <100 mg/dl In individuals with overt CVD, LDL <70 mg/dl with a high dose statin is an option If patients do not reach the above targets on maximum tolerated statin therapy, a reduction in LDL of 30 40% from baseline is an alternative therapeutic goal Does not recommend titrating the statin to achieve a specific LDL target or goal Patients receive high, moderate or low intensity statins based on risk Statin Benefit Patient Groups Age yrs with clinical atherosclerotic cardiovascular disease (ASCVD) Age > 21 yrs LDL > 190 mg/dl Age yrs with diabetes and LDL mg/dl Statin Dose High High Moderate Introduce a new risk calculator available at Age yrs without diabetes or ASCVD and estimated 10-year risk of > 7.5% Moderate-high 5

6 Moderate-dose statins Atorvastatin 10-20mg daily Fluvastatin 40mg BID or 80mg daily Lovastatin 40mg daily Pitavastatin 2-4mg daily Pravastatin 40-80mg daily Rosuvastatin 5-10mg daily Simvastatin 20-40mg daily High-dose statins Atorvastatin 80mg once daily (40mg if not tolerated) Rosuvastatin 20-40mg once daily Monitoring Parameters Lipid panel 4-12 weeks after initiation; check adherence to therapy LFTs baseline and repeat only if clinically warranted or symptoms of hepatotoxicity occur Consider statin dose reduction if 2 consecutive LDL measurements less than 40mg/dL New Kids on the Block New Drugs 2014 Brand Generic Company Description Farxiga dapagliflozin Bristol-Myers Squibb Jardiance empagliflozin Boehringer Ingelheim SGLT2 inhibitor for Type 2 DM SGLT2 inhibitor for Type 2 DM Trulicity dulaglutide Eli Lilly GLP-1 agonist for Type 2 DM Tanzeum albiglutide GSK GLP-1 agonist for Type 2 DM Afrezza insulin human MannKind Inhaled rapidacting insulin for diabetes Farxiga (dapagliflozin) Approved January 2014 Indication: Sodium glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus Dosing: 5mg or 10mg once daily in the morning with or without food Farxiga (dapagliflozin) prescribing information, January

7 Farxiga (dapagliflozin) Adverse effects: Urinary tract infections Female genital infections Nasopharyngitis Contraindications/Warnings: Avoid in patients with GFR <60 ml/min Special populations: Has not been studied in pregnant women or nursing mothers Jardiance (empagliflozin) Approved August 2014 Class: Sodium glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus Dosing: 10mg once daily taken in the morning with or without food Dose may be increased to 25mg once daily Farxiga (dapagliflozin) prescribing information, January Jardiance (empagliflozin) prescribing information, August Jardiance (empagliflozin) Adverse effects: Urinary tract infections Female genital infections Contraindications/Warnings: Avoid in patients with GFR <45 ml/min Special Populations: Has not been studied in pregnant women or nursing mothers Trulicity (dulaglutide) Approved September 2014 Class: glucagon-like peptide (GLP-1) receptor agonist indicated as adjunct therapy in patients with type 2 diabetes mellitus Not recommended as first-line therapy Dosing: 0.75mg-1.5mg subcutaneously once weekly at any time of the day Both doses are available as a single-dose pen or prefilled syringe If dose is missed, administer within 3 days of missed dose Jardiance (empagliflozin) prescribing information, August Trulicity (dulaglutide) prescribing information, September Trulicity (dulaglutide) Adverse effects: Nausea Diarrhea Vomiting Abdominal pain Decreased appetite Contraindications/Warnings: Do not use in patients with a family history of medullary thyroid carcinoma Avoid use in patients with a history of pancreatitis Special populations No dosage adjustment required in renal impairment Avoid use in pregnant women, may cause fetal harm Avoid use in nursing mothers Afrezza (insulin human) Approved June 2014 Class: Rapid acting inhaled insulin indicated in adult patients with diabetes mellitus Must use along with a long-acting insulin in patients with type1diabetes mellitus Dosing: 4 or 8 units before a meal Available in single use cartridges Administer using a single inhalation per cartridge Dosing must be individualized Trulicity (dulaglutide) prescribing information, September Afrezza (insulin human) prescribing information, June

8 Afrezza (insulin human) Afrezza (insulin human) Adverse effects: Hypoglycemia Cough Throat pain or irritation Contraindications/Warnings: Chronic lung disease such asthma or COPD Before prescribing, perform detailed history, PE, and spirometry to rule out potential lung disease Special Populations: Pregnancy category C Discontinue use in nursing mothers Has not been studied in patients <18 years of age or in patients with hepatic and renal impairment Afrezza (insulin human) prescribing information, June Afrezza (insulin human) prescribing information, June Drugs in the Pipeline Smart Sponge Insulin nanoparticle delivery system Midaform oral film formulation of insulin-coated nanoparticles for transbuccal delivery FIAsp faster-acting formulation of insulin aspart Tresiba (insulin degludec) - ultra-long acting basal insulin Ryzodeg 70/30 insulin (insulin degludec and insulin aspart) Ideglira GLP-1/basal insulin combination Patient Case Patient Case JT is a 68 year old male with DM, HTN, and HLP. Pt is here today in clinic for lipid management. He reports being hospitalized at Methodist 3 weeks ago for a heart attack and 3 stent placement. Current labs: TC 209, LDL 167, HDL 40, TG 165, A1C 8.8% Medications: Glipizide 10mg bid Metformin 1000mg bid Insulin NPH 30 units QAM and QHS Lisinopril 20mg daily HCTZ 25mg daily Metoprolol tartrate 50mg twice daily Simvastatin 20mg bedtime Aspirin 81mg daily Patient Case 1. What is your recommendation for this patient? 2. When would you follow-up and what labs would you order? 8

9 Helpful Diabetes Resources ADA guidelines VA DoD guidelines Diabetes Care Journal Pharmacist s Letter/Pharmacy Technician s Letter Metformin Use in Moderate-Severe Renal Insufficiency, Diabetes Care Article June 2011, Volume 34 Narrative Review: A Rationale Approach To Starting Insulin Therapy, Annals of Internal Medicine Article 2006;145: Post Test Questions 1. Which of the following was recently approved by the FDA as the new shortacting inhaled insulin device for the treatment of type 1 and type 2 diabetes? Afrezza* Farxiga Tresiba Ryzodeg Post Test Questions 2. According to JNC 8, what is the recommended target BP goal for patients with diabetes? <120/80 mm Hg <130/80 mm HG <140/90 mm Hg* <150/90 mm Hg Post Test Questions 3. Which of the following is NOT a moderate intensity statin? Pravastatin 40mg Rosuvastatin 5mg Simvastatin 20mg Atorvastatin 40mg* Post Test Questions 4. Which of the following is a sodium glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct therapy in patients with type 2 diabetes mellitus? Empagliflozin* Ryzodeg Dulaglutide Ideglira 9