Dana Staat, PharmD Clinical Pharmacy Lead-Internal Medicine
Spectrum Health, Grand Rapids, Michigan May 2015
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This speaker has no actual or potential conflicts of interest
to disclose in relation to this presentation
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Discuss the mechanism of distribution of the new medications
being developed and approved for the treatment of diabetes. List
the potential benefits of treating diabetes with the diabetes
medications in development. List the drawbacks to treating diabetes
with the diabetes medications in development.
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Almost 26 million Americans are affected by DM Seven million
Americans are unaware they have DM 79 million people may have
pre-diabetes Per the CDC, DM is the 7 th leading cause of death in
the US Over 75,000 deaths in the US per year Death rates have
fallen by up to 40% since 1997 New DM diagnosis has more than
tripled since 1980 National Diabetes Fact Sheet, 2011. US Centers
for Disease Control and Prevention (CDC). www.cdc.gov
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Cost of diabetes in 2012: $245 billion Direct medical costs:
$176 billion Reduced productivity: $69 billion Increase in 41%
since 2007 Average medical expenses are 2.3x higher in patients
with diabetes Economic costs of diabetes in the US in 2012,
American Diabetes Association (ADA), www. Diabetes.org
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Discovered in 1921 One of the most studied molecules in history
First hormone to be cloned and produced via DNA technology Made
insulin supply unlimited Full therapeutic potential is still not
optimized
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New medications in development for DM or related diseases: 180
128 for DM 52 for related diseases Clinical trials: 200 140
recruiting patients 60 active trials Medicines in Development-2014
report. Pharmaceutical Research and Manufacturers of America.
www.phrma.org/sites/default/files/pdf/diabetes 2014.pdf. Accessed
on 4/16/15.
Novel drug delivery First investigated in 1924 Large surface
tissue area Alveolar deposition
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Marketed in 2006 Removed from the market in 2007 Disappointing
profit margin Dosed in mg vs units Available in 2 strengths Large
device Small decrease in FEV1 FDA-warning regarding lung cancer
http://www.nature.com/nbt/journal/v2
5/n12/full/nbt1207-1331.html
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Approved July 2014 Dry powder, human, regular insulin Adsorbed
onto technosphere microparticles (TI-technosphere insulin) Carrier
is fumaryl diketopiperazine (FDKP) Inert excipient Dissolves
immediately when inhaled
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Ultra rapid acting insulin Peak-15 minutes Regular insulin
Bioavailability varies depending on inhaler technique (21-30% of
SubQ) Cartridges of 4 units or 8 units Afrezza(R) [package insert].
Danbury, CT: MannKind Corporation; 2014.
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Insulin nave 4 units Afrezza with each meal On mealtime insulin
Use chart Afrezzapro.com
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Affinity 1 DM1 Basal insulin present Compared to SubQ aspart
Verified efficacy of Dreamboat inhaler Change in A1C met
noninferiority, but favored aspart More patients in aspart group
achieved A1C