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
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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.
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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.
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04/06/2015
16
04/06/2015
If you’ve never heard of us… we may
have caused your memory loss.
Others
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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