Drug Update 2015: What`s New. Objectives
04/06/2015 Drug Update 2015: What’s New. Peter Koopman, MD Associate Professor MU Dept. Family and Community Medicine Family Medicine Update 4/10/2015 Objectives At the completion of this lecture, the participant should be able to: 1. Discuss the new drugs presented with respect to their pharmacology, and approved indications. 2. Describe adverse effects and drug interactions that may affect patient compliance and safety. 3. Compare efficacy, dosage and cost to existing agents. 1 04/06/2015 Thanks To Our Sponsors Prescott Pharmaceuticals: Go Toward The Light. Seriously I have no conflicts 2 04/06/2015 Weight Loss Saxenda (liraglutide) • GLP-1 agonist Victoza now marketed for weight loss. • Weight loss seen for diabetics so they studied in nondiabetics. • Approved for use with BMI>30 in all or >27 in those with weight related condition. • Weight loss at 1 year 10 pounds more than placebo. • 3 mg instead of 1.8 mg. • $20 a day. Other new meds cheaper. • Nausea most common side effect for discontinuation. 3 04/06/2015 Contrave (naltrexone/bupropion) • Combination opioid antagonist/aminoketone for weight loss • Appetite suppression with naltrexone and craving control with bupropion. • 9 pound weight loss at 1 year. • Should see 5% weight loss after 12 weeks or stop. • 15 weeks with Contrave to reach maximum or maintenance dose. • $7 a day. 12% stop due to adverse events. Most of the new pills. • Do not use with opioids as will decrease effectiveness. Belviq (lorcaserin) • First Serotonin 2C agonist marketed for weight loss. • 47% achieve 5% or more weight loss in one year. 7 pound weight loss average at 1 year • Should not effect heart valves as works at different receptor • Can cause serotonin syndrome. Careful with use with serotonin agents. • $7 a day. • Controlled CIV similar to Ambien 4 04/06/2015 Qsymia (phentermine/topiramate) • Combination of two older meds found to work well together. • 5 dose strengths from 3.75 mg/23 mg to 15/92 • Average 20 pound loss in one year. The highest of all. • Works better than either component alone (8-13 pounds) • $7 a day. Have coupon programs. • Topiramate can cause birth defects and cognitive impairment and paresthesias. 9% discontinuation. • Phentermine is controlled and has cardiovascular effects. • Can take 28 weeks to titrate and have 12 weeks on maintenance dose to determine 5% goal. Prescott: If you have a problem, we have a pill for that. If you don't have a problem, we have a pill for that too! 5 04/06/2015 DIABETES Invokana (canagliflozin) • Is a new class. SGLT2 inhibitor for Type 2 Diabetes • Inhibits NA-glucose co-transporter 2 in kidneys-more glucose in urine • Causes osmotic diuresis • May cause modest weight loss • Increases risk UTI and fungus • Increase LDL by 8% • $9 a day 6 04/06/2015 Farxiga (dapagliflozin) • • • • The second SGLT2 inhibitor. Weight loss 4-7 pounds. Lower A1C by 1%. Farxiga has a slight association with bladder cancer. Not true for Invokana. • $9 a day • Avoid if eGFR < 60 Jardiance (empagliflozin) • Third SGLT2 inhibitor • Same benefit • Same weight loss and risk • No cancer association • Avoid if eGFR < 45 • $9 a day 7 04/06/2015 Bydureon (exenatide) • A GLP-1 agonist. Third on the US Market. • Long acting Byetta for once weekly injection • Less nausea than Byetta or Victoza and still weight loss a possibility. • Pancreatitis risk. • Needs to be reconstituted-not a pen • $325 a month Tanzeum (albiglutide) • Fourth GLP1 agonist. • Also once weekly. • Needs reconstitution • Less weight loss than previous. • Nausea is most common side effect. • $325 a month 8 04/06/2015 Trulicity (dulaglutide) • Fifth GLP1 agonist • Once weekly • 1.5% A1C decrease. • Does not need reconstitution. • Weight loss similar to Byetta • $500 a month. • No renal adjustment. Toujeo (Insulin Glargine) • Concentrated Lantus-U300. • 300 Units of Insulin per ml versus 100. • Stated for people who need a little more time out of long acting insulin dose. • Same cost as Lantus • Switch at same dosing of Lantus but may take more. 9 04/06/2015 Afreeza (Inhaled Insulin) • Easier to use than Exubera and about the size of a whistle. • Replacement for short acting mealtime dosing but still need basal dosing so still needle. • Dry powder inhaler in 4 or 8 unit dosing. • Costs about twice injectable 10 04/06/2015 New Combinations • Xigduo XR- SGLT2/biguanide-Farxiga (dapagliflozin)/metformin extended release. • Glyxambi- SGLT2 inhibitor/DPP4 inhibitor- empagliflozin/linagliptinJardiance/Tradjenta. All our products are made with TLC * *Tetra-lysine-chlorafluoride, not a proven carcinogen 11 04/06/2015 COPD Spiriva Respimat (tiotropium) • New inhaler device for mist spray versus dry inhaler for tiotropium. • Once daily long acting anticholinergic. • 2 puffs once a day same as once a day for Spiriva egg. • $300 per inhaler for either form. 12 04/06/2015 Striverdi Respimat (olodaterol) • Long acting beta-agonist in respimat inhaler device. • Once daily two puffs unlike Serevent. • Respimat device often reported as easier to use. • Slightly cheaper than alternatives at $155 per inhaler. 13 04/06/2015 Incruse Ellipta (umeclidinium) • Another long acting anticholinergic with a different device. • Dry powder inhaler similar to Advair. • Choice based on cost and patient preference and symptom control. • Tiotropium only long acting med shown to reduce COPD exacerbations. • $225/inhaler 14 04/06/2015 Anoro Ellipta • Combo long acting beta agonist and long acting anticholinergicumeclidinium/vilanterol. • Like once daily Combivent. Only combo on the market. • Costs less than any combo of current single med long acting inhalers. • $280/inhaler. 15 04/06/2015 16 04/06/2015 If you’ve never heard of us… we may have caused your memory loss. Others 17 04/06/2015 Savaysa (edoxaban) • A new (now fourth) anticoagulant. • Direct factor Xa inhibitor like Xarelto. • Approved for Atrial Fibrillation and venous thromboembolism. • Less effective for afib then warfarin if Cr Cl >95. Dosing issue • Once a day. $280 a month Belsomra (suvorexant) • Novel sleep agent- orexin receptor antagonist. • Hoped to be better with less side effects than zolpidem. • In actuality same side effects and sleep paralysis worse. • On average, 10 minute faster to sleep, 22 minutes longer sleep. • $300 a month 18 04/06/2015 Zontivity (vorapaxar) • First protease-activated receptor-1 (PAR-1) antagonist- inhibits platelet aggregation for 4 weeks. • Approved for use with Plavix or low dose aspirin post MI to reduce CV risk. • Risk in patients with stroke or TIA or < 60 Kg. • Limited use. $260 a month. Rapivab (peramivir) • New IV single dose neuraminidase inhibitor for acute uncomplicated influenza. • Similar to others should be used with less than 2 days. Reserved currently for hospitalized patients • $950 dollars a dose. 19 04/06/2015 Evzio (naloxone) • Home auto injector for opioid overdose. • One person dies every 36 minutes from an opioid overdose in USA. • Consider if on more than 100 mg morphine equivalent or using opioid with other sedating drugs. • If unusually sedated or unresponsive give dose and seek emergency care. • Has voice instructions. • $300 mg per dose. 20 04/06/2015 Sure, mortality is important, but... What doesn’t kill you makes you part of our class-action settlement. And Now… The Colwill Rule 21 04/06/2015 The Colwill Rule Let other folks use new medications for five years and sort out the bad players -Jack Colwill, MD Reasons to Heed the Colwill Rule Greater than expected toxicity • Baychol, Rezulin, Ketek, Duract • "How does one justify balancing the risk of fatal liver failure against one day less of ear pain?" –FDA official criticizing Ketek approval 22 04/06/2015 Reasons to Heed the Colwill Rule Fatal anaphylaxis is a bummer • Lesson from the 80s: Zomax • Lesson from now: Saphris Reasons to Heed the Colwill Rule Heart valves are touchy • Permax, phen-fen 23 04/06/2015 Reasons to Heed the Colwill Rule Other unanticipated cardiovascular badness • Zelnorm, Vioxx, Raxar, Avandia, Spiriva • Celexa over 20 mg • Multaq (dronedarone) in permanent a fib Reasons to Heed the Colwill Rule Unwelcome surprises not limited to heart and liver Bad few years for PPIs (pneumonia, fractures, hypomag, C diff…) 24 04/06/2015 Patient Safety is a Prescott Priority You probably went blind even without our products Reasons to Heed the Colwill Rule This just in: new meds are expensive 25 04/06/2015 Reasons to Heed the Colwill Rule Beware the intermediate “disease-oriented” outcomes • New antihypertensives, cholesterol meds, diabetes meds, antiarrhythmics, estrogen replacement Reasons to Heed the Colwill Rule Rare but serious loopiness • Chantix 26 04/06/2015 Reasons to Heed the Colwill Rule Is it just an isomer, metabolite, or combo “patent extender”? • Vynase, Lexapro, Nuvigil, Xyzal, Invega, Nexium, Pristiq, Caduet Reasons to Heed the Colwill Rule • • • • • • • • Going generic 2014-2015: Abilify (aripiprazole) Androgel (testosterone gel) Celebrex (celecoxib) Nexium (esomeprazole) Micardis (telmisartan) Patanol (olopatadine) Lunesta (eszopiclone) Nasonex (mometasone nasal) 27 04/06/2015 Reasons to Heed the Colwill Rule Unanticipated Name Mixups • Kapidex (dexlansoprazole) now Dexilant Some received Casodex (anti-androgen) or Kadian (that’s morphine) • Reminyl (galantamine) now Razadyne Remeron, Amaryl Reasons to Heed the Colwill Rule Age Isn’t Just a Number • Kiddos and cold medicine • “Old ” and…potentially anything 28 04/06/2015 Reasons to Heed the Colwill Rule Has it been studied and/or approved for what you are prescribing it for? • Speaking of cold medicine – 500 pulled over last few years. http://www.fda.gov/NewsEvents/Newsroom/PressAnno uncements/ucm245048.htm • Quiz: How many conditions is Neurontin approved for? Hint: It’s not 12. Reasons to Heed the Colwill Rule The Pregnancy Corollary • Double the waiting period? Triple? • ACE inhibitors, Topamax 29 04/06/2015 Reasons to Heed the Colwill Ruleinteractions Other unforeseen • Simvastatin and amlodipine (inhibition of liver transport proteins? • Requip and… 30 04/06/2015 Exception to the Colwill Rule Severe illness with poor prognosis • Dramatic improvement in life expectancy with HIV infection, CF, some malignancies due to rapid dissemination and adoption of new therapies Chronic Non-Heeders of the Colwill Rule Specialists (Partialists?) • Tend to be early adopters, for better or for worse • Don’t be guilted into being “cutting-edge”! 31 04/06/2015 What can we do? • Speak up! Blow the whistle on bad ads and misleading marketing, & receive alerts: www.fda.gov/BadAd Thanks To Our Sponsor We sincerely apologize about that whole zombie thing. 32 04/06/2015 Precautions Products from Prescott Pharmaceuticals have been associated with: Nausea Headache Tumors Threemors Restless Leg Syndrome Restless Arm Syndrome Restless Torso Syndrome Legless Leg Syndrome Wandering Genital Syndrome Precautions Products from Prescott Pharmaceuticals have been associated with: Severe Weight Loss Massive Weight Gain Bilious D. Williams Mao Tse Tongue Labias Corpus Vapor Bone Stress Balls Occasional bouts of waking up while driving an Oldsmobile through a cornfield 33 04/06/2015 Precautions Products from Prescott Pharmaceuticals have been associated with: Deviated Rectum Chubbywumbas Elbow Baggins Abdominal Foosball The Humpty Hump Tongue depression Intracranial nougat Admiral’s Club Foot Precautions Products from Prescott Pharmaceuticals have been associated with: Shortness of Breath Stoppedness of Breath Mild Kidney Explosions Conjunction Junctivitis Pork Shoulder Ankle Remus Scrotal Eclipse of the Heart Auto-Not-At-All-Erotic Asphyxiation 34 04/06/2015 Precautions Products from Prescott Pharmaceuticals have been associated with: Asperger Helper Cranial Biebering Norwegian Wood Shin Squints Honey Nut Areolas Jameson’s Irish Whiskers Pituitary Ferning Intermittent Albino Features Precautions Products from Prescott Pharmaceuticals have been associated with: Involuntary Narnia Adventure Reemerging Umbilical Cord Mock Turtleneck Delusions of Grandma Pez Neck Vigilant Kidney Hepatitis Bees Irritating Bowel Syndrome 35 04/06/2015 Precautions Products from Prescott Pharmaceuticals have been associated with: Vein Seizures Autonomous Nipple Rectal Departure Opposable Spleens Mahmoud Ahmadinejaw Verizon Guy Syndrome Hair Swelling Bone Sporking Precautions Products from Prescott Pharmaceuticals have been associated with: Testicular Testicularization Fallopian Tapeworm Adult Onset Infancy Ventricular Funk Navel Decongestion Insidious Mer-Tail Gastric Thigh Pass Osteoperogies 36 04/06/2015 Precautions Products from Prescott Pharmaceuticals have been associated with: Spontaneous Blowhole Esophageal Pringle Canning Subcutaneous Funyuns Angina Monologues Lung Badgers Acid Reflux Capacitor Hairy Bellafontanelle Tracheal Meerkat Colonies Precautions Products from Prescott Pharmaceuticals have been associated with: Skeletal Xylophoning Prehensile Nose Barry Manilobes Jack Russell Derriere Mid-Liver Crisis Genital Slurpees Deskullification Vivid Dreams of Self-Cannibalism 37 04/06/2015 Precautions • In case you missed any of those, to repeat… Precautions Products from Prescott Pharmaceuticals have been associated with: Nausea Headache Tumors Threemors Restless Leg Syndrome Restless Arm Syndrome Restless Torso Syndrome Legless Leg Syndrome Wandering Genital Syndrome 38 04/06/2015 Precautions Products from Prescott Pharmaceuticals have been associated with: Severe Weight Loss Massive Weight Gain Bilious D. Williams Mao Tse Tongue Labias Corpus Vapor Bone Stress Balls Occasional bouts of waking up while driving an Oldsmobile through a cornfield Precautions Products from Prescott Pharmaceuticals have been associated with: Deviated Rectum Chubbywumbas Elbow Baggins Abdominal Foosball The Humpty Hump Tongue depression Intracranial nougat Admiral’s Club Foot 39 04/06/2015 Precautions Products from Prescott Pharmaceuticals have been associated with: Shortness of Breath Stoppedness of Breath Mild Kidney Explosions Conjunction Junctivitis Pork Shoulder Ankle Remus Scrotal Eclipse of the Heart Auto-Not-At-All-Erotic Asphyxiation Precautions Products from Prescott Pharmaceuticals have been associated with: Asperger Helper Cranial Biebering Norwegian Wood Shin Squints Honey Nut Areolas Jameson’s Irish Whiskers Pituitary Ferning Intermittent Albino Features 40 04/06/2015 Precautions Products from Prescott Pharmaceuticals have been associated with: Involuntary Narnia Adventure Reemerging Umbilical Cord Mock Turtleneck Delusions of Grandma Pez Neck Vigilant Kidney Hepatitis Bees Irritating Bowel Syndrome Precautions Products from Prescott Pharmaceuticals have been associated with: Vein Seizures Autonomous Nipple Rectal Departure Opposable Spleens Mahmoud Ahmadinejaw Verizon Guy Syndrome Hair Swelling Bone Sporking 41 04/06/2015 Precautions Products from Prescott Pharmaceuticals have been associated with: Testicular Testicularization Fallopian Tapeworm Adult Onset Infancy Ventricular Funk Navel Decongestion Insidious Mer-Tail Gastric Thigh Pass Osteoperogies Precautions Products from Prescott Pharmaceuticals have been associated with: Spontaneous Blowhole Esophageal Pringle Canning Subcutaneous Funyuns Angina Monologues Lung Badgers Acid Reflux Capacitor Hairy Bellafontanelle Tracheal Meerkat Colonies 42 04/06/2015 Precautions Products from Prescott Pharmaceuticals have been associated with: Skeletal Xylophoning Prehensile Nose Barry Manilobes Jack Russell Derriere Mid-Liver Crisis Genital Slurpees Deskullification Vivid Dreams of Self-Cannibalism 43
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