New Drugs for the Primary Care Provider: What You Need to Know

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1 Presenter Disclosure Information 11:05 11:45am New Drugs for PCP: What You Need to Know SPEAKER Gerald Smetana, MD The following relationships exist related to this presentation: Gerald W. Smetana, MD: No financial relationships to disclose. Off-Label/Investigational Discussion In accordance with pmicme policy, faculty have been asked to disclose discussion of unlabeled or unapproved use(s) of drugs or devices during the course of their presentations. New Drugs for the Primary Care Provider: What You Need to Know Important New Drugs for 2014: What We Need to Know Novel Drugs? Gerald W. Smetana, M.D. Beth Israel Deaconess Medical Center Professor of Medicine Harvard Medical School Relevant for PCP No Me Too Drugs FDA New Drug Approvals in 2014: More Potentially Novel Drugs for Primary Care 2014: More Potentially Novel Drugs than Recent Years Me Too Drugs, 8 Novel Drugs, 5 Subspecialty Meds, 13 Biologicals, 8

2 Three Novel Drugs for Primary Care Practice Vorapaxar for secondary prevention of cardiovascular events Rivaroxaban for the treatment of DVT/PE Canagliflozin for the treatment of type 2 diabetes Historical Perspective Man has an inborn craving for medicine The desire to take medicine is one feature which distinguishes man, the animal, from his fellow creatures Even in minor ailments, which would yield to dieting or to simple home remedies, the doctor s visit is not thought to be complete without the prescription. William Osler 1895 Mr. Timi Vorapaxar (Zontivity )for Secondary Prevention of Cardiovascular Events 56 year old man NSTEMI 3 mos. Ago On ASA, statin, beta blocker Should he add vorapaxar to prevent 2 nd MI? FDA Approved May 8, 2014 Heart Disease is #1 Cause of Mortality and Morbidity in the U.S. Meta-Analysis of 195 Trials: Aspirin for Secondary Prevention of CV Events Events per Year in U.S. CV Death CHD Death MI Patient History Anti-platelet, percent Adjusted controls, percent Odds reduction, percent Prior MI ±4 Acute MI ±4 Prior stroke/tia ±4 Acute stroke ±3 Unstable angina ±7 Stable angina ±9 Peripheral arterial disease Outcomes were nonfatal MI, nonfatal stroke, and vascular death ±8 Antiplatelet Trialists' Collaboration, BMJ 1994; 308:81

3 Vorapaxar is a Novel PAR-1 Antagonist TRACER: Vorapaxar in Acute Coronary Syndromes Protease-activated receptor -1 (PAR-1) Primary thrombin receptor on platelets Vorapaxar blocks PAR-1 and inhibits thrombin mediated platelet aggregation Orally administered Half life 8 days N=12,944 ACS symptoms for < 24 hours At least one of: Troponin or CD elevation, or ST elevation or depression in 2 leads At least one of: 55 years old Prior MI, PCI, or CABG Diabetes PAD Randomly assigned Vorapaxar 40 mg, then 2.5 mg qd Or placebo NEJM 2012;366:20-33 Other Findings TRA 2 P-TIMI 50: Vorapaxar for Secondary Prevention Intracranial hemorrhage: 1.1% vs. 0.2% TIMI major bleeding: 4.0% vs. 2.5% Conclusion: Vorapaxar did not reduce secondary CV events but did increase bleeding rates N=26,449 Prior history of: MI Ischemic Stroke PAD Randomized to: Vorapaxar 2.5 mg qd Or Placebo Primary outcome Composite of CV death MI Stroke NEJM 2012;366:1403 Indirect Comparisons of Antiplatelet Agents for 2 Prevention Other Findings Relative Risk Reduction * P <0.05 Study Aspirin vs. Placebo ATC Meta analysis Clopidogrel plus ASA vs. ASA Vorapaxar vs. Placebo CHARISMA TRA 2 P All CV Events 19%* 7% 13%* MI 34%& 6% 17%* Stroke 22%* 21%* 3% Most patients in trial also on ASA Lower MI rates: 6.1% vs. 5.1% No effect on mortality or CV mortality Intracranial bleeding high in patient with prior h/o stroke: 2.4% vs. 0.9% At 2 years, safety committee terminated trial for patient subset with prior stroke AE s other than bleeding uncommon NEJM 2006;354:16 Lancet 1996;348:1329

4 Cost of Antiplatelet Agents Drug 30 Day Supply AWP Aspirin < $5 Clopidogrel 75 mg qd $193 Prasugrel 10 mg qd $270 Ticagrelor 90 mg bid $252 Vorapaxar 2.08 mg qd $268 Medical Letter Sept Key Points Single daily dose 2.08 mg qd No dose adjustment for CKD Multiple drug interactions Do not use in patients with h/o prior stroke or TIA (black box warning) FDA indications: prior MI or PAD Modestly reduces CV risk but increases risk of bleeding Unknown if offers advantage over clopidogrel as add-on to ASA What to Advise Mr. Timi? Continue ASA, statin, beta blocker Shared decision making Does he fear recurrent MI or bleeding more? Vorapaxar discretionary Ms. Virchow 28 year old woman Recent air travel from NRT to BOS Logan Developed LE DVT after the flight LENI s positive Doesn t want to hassle with warfarin How about rivaroxaban? Why Revisit Rivaroxaban? FDA approved July 2011 for VTE prophylaxis after orthopedic surgery Approved November 2011 for stroke prevention in AF New indication for the Rx of DVT and PE Desirable Attributes for the Ideal Anticoagulant Oral administration Predictable anticoagulant response No monitoring Rapid onset of action Rapid reversibility Safe antidote No major side effects

5 Rivaroxaban Inhibits Factor Xa X VIIa VIIIa Xa Va IXa Extrinsic Pathway Intrinsic Pathway Rivaroxaban Apixaban Rivaroxaban: Pharmacology Rapid onset after PO dose Half life of 5-9 hours Once daily dosing Predictable anticoagulant response No monitoring required Prothrombin (II) Fibrinogen Thrombin (IIa) Dabigatran Fibrin DVT and Pulmonary Embolus Are Morbid Events 300,000 to 600,00 cases / year in U.S % will die within one month of diagnosis 1/3 of patients will have recurrence within 10 years ½ of patients with DVT develop postphlebitic syndrome Outcomes for Rx of DVT/PE for 6 Months of Standard Therapy with LMWH and Warfarin DVT PE Mortality % % Major bleeding % Ann Intern Med 2010;578:589 EINSTEIN DVT Trial of Rivaroxaban vs. Standard Rx EINSTEIN Acute DVT Study: Random Rx Assignments N = 3449 Proximal DVT No PE GFR > 30 ml/min Exclusions Liver disease Active bleeding Bp > 180/110 Pregnancy Rivaroxaban 15 mg bid x 3 weeks, then 20 mg qd 3449 patients Enoxaparin 10 mg/kg bid until INR > 2 Primary Endpoint = Recurrent Symptomatic VTE NEJM 2010;363:2499 Rx for 3, 6, or 12 months Warfarin to INR 2-3. Rx for 3, 6, or 12 months

6 Safety Outcomes in Acute DVT Study: No Significant Differences Compared to Standard Rx Indirect Comparisons to Other Novel Anticoagulants for Rx DVT/PE Event Rivaroxaban % Enoxaparin / Warfarin % Rivaroxaban Dabigatran Apixaban Study EINSTEIN-DVT RE-COVER AMPLIFY Major bleeding Fatal bleeding < Non-major bleeding Fatal PE Study d/c # subjects Primary outcome Outcome vs. standard Rx 2.1% vs. 3.0% 2.4% vs. 2.1% 2.3% vs. 2.7% Major bleeding 0.8% vs. 1.2% 1.6% vs. 1.9% 0.6% vs. 1.8%* Outcomes comparable. Apixaban has marginally less bleeding Curr Cardiol Rep 2014;16:463 Indirect Comparisons to Other Novel Anticoagulants for Rx DVT/PE Indirect Comparisons to Other Novel Anticoagulants for Rx DVT/PE Rivaroxaban Dabigatran Apixaban Study EINSTEIN-DVT RE-COVER AMPLIFY # subjects Rivaroxaban Dabigatran Apixaban Study EINSTEIN-DVT RE-COVER AMPLIFY # subjects Primary outcome Primary outcome Outcome vs. standard Rx 2.1% vs. 3.0% 2.4% vs. 2.1% 2.3% vs. 2.7% Outcome vs. standard Rx 2.1% vs. 3.0% 2.4% vs. 2.1% 2.3% vs. 2.7% Major bleeding 0.8% vs. 1.2% 1.6% vs. 1.9% 0.6% vs. 1.8%* Outcomes comparable. Apixaban has marginally less bleeding Curr Cardiol Rep 2014;16:463 Major bleeding 0.8% vs. 1.2% 1.6% vs. 1.9% 0.6% vs. 1.8%* Outcomes comparable. Apixaban has marginally less bleeding Curr Cardiol Rep 2014;16:463 Other Considerations Drug interactions with CYP3A4 inhibitors Must be taken with food Contraindicated during pregnancy (C) Dose adjustment for moderate CKD Must instruct patients to not miss any doses No specific antidote for reversal Approach to bridging uncertain Monthly Cost of Outpatient Anticoagulation Item Cost Rivaroxaban 20 mg qd $295 Dabigatran 150 mg bid $323 Apixaban 5 mg bid $292 Warfarin 5 mg qd $15 INR measurement q 2 weeks $80 x 2 $160 Phlebotomy charge = $15 x 2 $30 Total cost of warfarin $205 plus? Rx Price Quotes.com Feb. 2014

7 Rivaroxaban: Key Points Single daily oral dose Non-inferior to warfarin in preventing recurrent VTE Bleeding rates comparable to standard therapy with LMWH and heparin No monitoring required No dietary restrictions No antidote if emergency surgery or major bleeding occurs An appropriate alternative to standard therapy What to Advise Ms. Virchow? LMWH followed by warfarin for at least 3-6 months is standard Rx Rivaroxaban is an acceptable alternative in order to avoid monitoring Mr. Sugarman Number and Percentage of U.S. Population with Diagnosed Diabetes year of history of type 2 diabetes PMHx hypertension, obesity A1c 8.5% on metformin alone What about this adding this new medication canagliflozin? Is this better than adding glyburide? Percentage with Diabetes Percentage with Diabetes Number with Diabetes Number with Diabetes (Millions) Year 0 CDC s Division of Diabetes Translation. National Diabetes Surveillance System available at History of Diabetes Medications Canagliflozin is a Novel SGL2 Inhibitor 1921 Insulin 1942 Sulfonylureas 1994 Metformin 1999 Rosiglitazone 2005 Exenatide 2006 Sitagliptin 2013 Canagliflozin Sodium-glucose co-transporter 2 = SGL2 Selective membrane protein expressed in in kidney Transports glucose from proximal tubular lumen to epithelial cells Canagliflozin blocks SGL2, prevents glucose reabsorption, and causes glucosuria Decreases blood glucose

8 Effect of Canagliflozin Monotherapy in Type 2 Diabetes Most Patients Achieved A1c Goal at 300 mg qd Dose N=584 A1c 7-10% at baseline Randomly assigned to: Canagliflozin 100 mg qd Canagliflozin 300 mg qd Placebo 26 week follow up Primary endpoint = change in A1c Diabetes Obes Metab 2013;15: Placebo Cana 100 mg Cana 300 mg A1c < 7% A1c < 6.5% Adverse Effects Among Pooled Studies Event Placebo Canagliflozin 100 mg qd % Canagliflozin 300 mg qd % Any Rx discontinuation Constipation UTI Polyuria Balanitis Vaginal candidiasis Orthostasis < Rash / urticaria NA < 2 < 2 Adverse Effects Among Pooled Studies Event Placebo Canagliflozin 100 mg qd % Canagliflozin 300 mg qd % Any Rx discontinuation Constipation UTI Polyuria Balanitis Vaginal candidiasis Orthostasis < Rash / urticaria NA < 2 < 2 Mean Change in A1c and Weight for Approved Drugs for Diabetes Cost: AWP for Selected Agents Agent A1c (%) Weight (kg) Insulin DCCT conventional Insulin DCCT intensive Sulfonylureas to Metformin to -0.8 Thiazolidinediones to +3.5 GLP-1 agonists 0.4 to to -2.8 DPP-4 inhibitors to -1.0 Canagliflozin to 3.3 Oral Monthly Cost (USD) Glipizide 10 mg qd 4 Metformin 1500 mg qd 30 Pioglitazone 15 mg qd 45 Sitagliptin 100 mg qd 246 Canagliflozin 100 mg qd 263 Injectable Exenatide 10 mcg bid 350 Insulin Glargine 2 pens 90 Medical Letter May 2013

9 Other Considerations Key Points Less A1c reduction (0.6%) for patients with CKD Reduces systolic bp by 4-8 mm Hg LDL increase 8 mg/dl Small increase in serum PO 4 and Mg Rarely may cause hyperkalemia, hypotension Does not cause hypoglycemia in monotherapy Small reduction in BMD Dapagliflozin, available in Europe, denied by FDA due to possible risk of breast and bladder cancer Dose 100 to 300 mg qd Adjust for CKD; contraindicated for GFR < 45 A1c reduction comparable to other agents Glucosuria causes weight loss More weight loss than any other Rx May cause polyuria and orthostasis Yeast and urinary tract infections? Potential for long term CA risk Very expensive Summary A Final Thought Vorapaxar reduces risk of second CV event but increases risk of bleeding Rivaroxaban is non-inferior to warfarin for the treatment of DVT/PE and requires no monitoring Canagliflozin reduces A1c and weight; though long term safety is unknown For some patients, though conscious that their condition is perilous, recover their health simply through contentment with the goodness of their physician. Hippocrates ( BC)

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