Transcript Weight Loss Meds

J. Paul Martin, MD
Asheville, NC
*35 New Medications Approved in 2014
* 15 Orphan Drugs
*27 New Medications Approved in 2013
*
1. Weight Loss Meds
2. Meds for Diabetes
3. Hepatitis C
4. Sleep Meds / Pain Meds
5. Compounded Meds
1.
2.
3.
4.
5.
6.
7.
*Qsymia – phentermine/topiramate 2012
*Belviq – locaserin 2012
Contrave – bupropion/naltrexone 2014
Saxenda- liraglutide 2014
*Adipex - phentermine 1959
Xenical – orlistat - 1999
SGLT2 inhibitors – off label
*Schedule CIV
1.*Qsymia – phentermine/topiramate
2.*Belviq – locaserin
Neither have been approved by the European Medicines Agency
FDA approved in 2012
Phentermine HCl/topiramate
a.
b.
3.75/23; 7.5/46; 11.25/69; 15/92
start with low dose daily x 14 d then incr
to 7.5/46 daily; if wt loss<3% after 12 wk
consider increase dose or d/c
c. If wt loss <5% after 12 wk on max dos,
taper to qod x 1 wk & D/C
d. $240/mo
e. Pregnancy Category X
locaserin
a. 10 mg BID
b. 5-HT2C receptor agonist
c. If wt loss <5% after 12 wk D/C
d. $240/mo
e. Pregnancy Category X
3.
4.
Contrave – bupropion/naltrexone
Saxenda – liraglutide
Neither have been approved by the European Medicines Agency
Naltrexone ER 8mg/Bupropion ER 90mg
a.
b.
c.
d.
e.
Maintenance: 2 tabs BID (32/360 qd)
Begin with one tab daily x 1wk, then one bid
x 1 wk, then 2 tabs qAM & 1 qPM x1 wk, then
2 BID
$240/mo
Pregnancy Category C
Scale Down® – free digital wireless scale that
sends personalized text messages based on
weigh in.
subcutaneous injection
a.
b.
Victoza 1.2 – 1.8 mg daily
FDA approved 3mg Saxenda daily for
long term weight loss 12/24/14
c. Pregnancy Category C
5.
6.
7.
*Phentermine $30/mo - not approved for
long-term use Pregnancy Category X
Xenical (orlistat) $164/mo; Alli (OTC)
Pregnancy Category X. Approved 1999
Sodium-glucose Co-transporter 2 inhibitor
(SGLT2) – e.g. Invokana – off label
Pregnancy category C
*Schedule CIV
1. *Qsymia – phentermine/topiramate
2. *Belviq – locaserin
3. Contrave – bupropion/naltrexone
4. Liraglutide – Saxenda
5. *Phentermine
6. Xenical - orlistat
7. SGLT2 inhibitors off label
*Schedule CIV
 Weight Loss Meds
2. Meds for Diabetes
3. Hepatitis C
4. Sleep Meds / Pain Meds
5. Compounded Meds
1. GLP-1 agonists (like exenatide)
2. Specific sodium glucose Co-
transporter-2 (SGLT-2) inhibitors
3. Afrezza (insulin human [rDNA
origin]) Inhalation powder
1. GLP-1 agonists (like exenatide)
2. Specific sodium glucose Co-
transporter-2 (SGLT-2) inhibitors
3. Afrezza (insulin human [rDNA
origin]) Inhalation powder
1. Trulicity– dulaglutide sc 1 x weekly
– similar to Bydureon – exenatide.
2. Tanzeum – albiglutide sc 1 x weekly
1. Farxiga – dapagliflozin SGLT-2
inhibitor
1. Xigduo XR dapagliflozin/metformin
2. Invokamet – canagliflozin/metformin
3. Jardiance - empagliflozin
*Empagliflozin 10mg or 25mg/linagliptin 5 mg
*SGLT2 Inhibitor / DPP-4 Inhibitor
*Only for Type 2 Diabetes
*Add on to metformin
*Approved January 2015
*
 GLP-1 agonists (like exenatide)
 Specific sodium glucose Cotransporter-2 (SGLT-2) inhibitors
3. Afrezza (insulin human [rDNA
origin]) Inhalation powder
1.
Exubera 2006 – 2007 d/c’ed due to poor
sales (and high cost)
2. Afrezza (insulin human [rDNA origin])
Inhalation powder 6/14 ultra rapid acting
4 unit/8 unit cartridges
$270 - $330 (for 60)
(vs $80-$160 for Novolog
Flexpen)
Weight Loss Meds
 Meds for Diabetes
3. Hepatitis C
4. Sleep Meds / Pain Meds
5. Compounded Meds
1. Solvaldi - sofosbuvir
2. Olysio - simeprevir
3. Harvoni – ledipasvir/sofosbuvir
4. Viekira Pak -
ombitasvir/paritaprevir/ritonavir/dasabuvir
Six known Genotypes
1. Genotype 1 – 75% of cases in US
A. GT 1a – 50% B. GT 1 b 25%
2. GT2 a,b,c,d
3. GT3 a,b,c,d,e,f
4. GT4 a,b,c,d,e,f,g,h,i,j
5. GT5 a
6. GT6 a
Simeprivir 150 mg Caps
1. Olysio – Hepatitis C Genotype 1
2. NS3/4A Protease inhibitor
3. Must be used with peg-interferon
alpha and ribaviron
4.12-48 weeks depending on response
5. $750/pill
Sofosbuvir 400 mg Caps
1.
2.
3.
Sovaldi – Hepatitis C Genotype 1,2,3,4
Nucleotide analog inhibitor
Must be used with peg-interferon alpha
and ribavirin for 1,4 (although 24 week
course of Sovaldi and ribavirin can be used
off label for interferon intolerant patients)
4. May be used with ribavirin for types 2,3
5. $84,000 for 12 weeks
Ledipasvir/sofosbuvir
a.
Hepatitis C genotype 1 – 94% clearing of
virus
b. 12-week-course $95,000
c. 1 tab daily
d. No interferon or ribavirin
e. 24-week-course for prior treatment failure
f. Ledipasvir is a NS5A Protease inhibitor
ombitasvir/paritaprevir/ritonavir/dasabuvir
a.
b.
c.
d.
e.
f.
Hepatitis C genotype 1 > 90%
12- 24 week-course
Tablets BID – Blister Pack
Patients with GT 1a, cirrhosis or
liver transplant also receive ribavirin
24-week-course for GT1a w cirrhosis
$100,000 for 12 week course
*
* Cost for treating all with Harvoni =
$282,000,000,000
1. FDA approved combination Nov 2014
2. 12 – 24 Weeks
3. $1750 / day
4. $294,000 for 24 week course
5. 97% viral clearing with 24 weeks
*January – September 2014
*Pause for a moment
*
1.Belsomra – suvorexant 5-20 mg
Orexin receptor antagonist: orexin is a
nerotransmitter that regulates
wakefulness
20 mg dose resulted in next day impaired
driving.
*Tramadol (Ultram) Schedule
IV July 2014
*Hydrocodone Schedule II
Oct 2014
*
*Approved Dec 30, 2014
*37.5 mg administered by intravenous bolus
injection over 15 seconds q 6h not to
exceed 150mg/24hrs
*The most common adverse reactions in
controlled clinical trials with Dyloject
include nausea, constipation, headache,
infusion-site pain, dizziness, flatulence,
vomiting and insomnia
*
1. Targaniq - Oxycodone ER / Naloxone
2. 10/5, 20/10, 40/20
3. Potential interaction with all cytochrome
P450 3A4 inhibitors –
grapefruit/noni/pomegranate
clarithromycin, ketoconazole
1. Zohydro ER – abuse deterrent 1/2015
2. Hysingla ER (hydrocodone)
Once daily dosing
1.
2.
3.
4.
5.
Once a day oral tablet
Opioid – induced constipation
“Peripherally” acting mu-opioid receptor
antagonist
25mg 1 hour before meal
CYP 3A4 inhibitors increase risk of withdrawal
1. Nexium (esomeprazole) generic 1/15
2. Abilify (aripiprazole) generic 4/15
Weight Loss Meds
 Meds for Diabetes
 Hepatitis C
 Sleep Meds / Pain Meds
5. Compounded Meds
Alchemy
alkəmē
the ability to transmute
base metals into the
noble metals (gold or
silver); and development
of an elixir of life, which
would confer youth and
longevity..
Compounding Pharmacies
* Pharmacist mixes, combines, or
alters ingredients tailored to the
needs of an individual patient
E.g. if a patient has an allergy an needs a
medication without a specific dye.
Compounding Pharmacies
* May not be identical to a
patented drug
*
May not be prepared as a batch
for others
*October 2012
*Outbreak of fungal meningitis due to
contamination in epidural steroid
meds
*64 deaths / 750 persistent infections
Compounding Quality Act 2013
* May register with FDA as an
outsourcing facility – will be
inspected based on risk
* May not register – will not be
inspected
* Must be licensed pharmacist
* Must be prepared by prescription
Compounding Pharmacies
* Medications
are not
tested for effectiveness as
compounded
* No regulation regarding pricing
Compounding Pharmacies
*Diaper rash cream
*Combination muscle rub for pain
* Ketoprofen, Baclofen, Lidocaine, Ketamine,
* Neurontin, Robaxin
*If not covered by insurance, ½
strength alternative offered for cash
price of $40.
Compounding Pharmacies
*Diaper rash cream - $1600
*Combination muscle rub for pain
* Ketoprofen, Baclofen, Lidocaine, Ketamine,
* Neurontin, Robaxin - $2650
*If not covered by insurance, ½
strength alternative offered for cash
price of $40.
Express Scripts
*Spending on compounding products
grew from $28M in first quarter of
2012 to $171M in first quarter of
2014.
*August 2014 announced it will stop
paying for more than 1000
ingredients used in compounding
Crescent Health Solutions
*Has stopped paying for compounded
products unless supported by a medical
necessity and evidence-based research
supporting effectiveness and safety.
*Recognizes the value of legitimate need
for certain compounded preparations
Modern Alchemy …. JPM
the ability to transmute basic drugs
into the noble metals (gold or
silver), via development of an
embrocation, which may confer
comfort and soothing or may not.
1. Beta blockers
2. Codeine
3. Discontinued by manufacturer
*
Beta Blockers aka the “lols”
•Propranolol (Inderal)
•Atenolol (Tenormin)*
•Metoprolol (Lopressor)
•Carvedilol (Coreg)
Medications – Beta Blockers
*
Medications – Beta Blockers
*Cochrane Database Syst Rev 2007
* RCTs assessing the effectiveness of beta blockers
*compared to placebo, no therapy or other drug
classes,
*as monotherapy or first-line therapy for HTN, on
*morbidity and mortality endpoints
* 13 RCTs; 91,561 subjects
*Available evidence does not support the use
of beta blockers as first-line agents in HTN
treatment
Medications – Beta Blockers
*JAMA Oct 3, 2012 45,000 patient observation –
no lower risk of composite CV events with Beta
Blockers even in patients s/p MI (distant)
*2008 COMMIT Study 46,000 patients in China –
no improved outcome with metoprolol in Acute
MI
*Available evidence does not support the use of
beta blockers as first-line agents in HTN
treatment
*
Beta Blockers aka the “lols”
•Atenolol (Tenormin)*
Should be given BID not qd!
*
*
Ultra-rapid Metabolizers
FDA black box warning: no
codeine for kids <12 s/p
tonsillectomy/adenoidectomy &
none in kids<2 for any indication
1. Beta blockers
2. Codeine
3. Discontinued by manufacturer
*
*Ipecac 2010
*Chloral Hydrate 11/12
*Pediazole 7/14
*Tetanus toxoid 9/14
*Aridol(mannitol bronchial challenge caps)9/14
*Asacol 400 mg 11/14
*Neostigmine 12/14 (generic & tablets)
J. Paul Martin, MD
Asheville, NC