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10/26/2012
Diabetes Pharmacotherapy
Update: What’s the News?
3rd Annual Regional Healthcare Symposium
L. Brian Cross, PharmD, BCACP, CDE
October 27, 2012
Objectives
At the completion of this presentation
the participant will be able to:
• Describe recent changes to national diabetes
treatment guidelines.
• Describe newer evidence concerning various
approved medication classes for the treatment of
diabetes.
• Describe recently approved and yet-to-beapproved pharmacotherapy agents for the
treatment of diabetes.
• Describe new technology issues related to the
treatment of diabetes.
RECENT DIABETES
GUIDELINE CHANGES
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DM Disease Related Issues
• Intensive A1C lowering in trials offers
modest benefit, mostly microvascular over
5+ yrs. There is some evidence for
macrovascular benefit over the long
long‐term
term
(>10‐20yrs).
• Intensive A1C lowering may increase risk of
harm including major hypoglycemia &
increased all‐cause death in some.
Cochrane Database Syst Rev. 2011 Jun 15;(6):CD008143.9
N EnglJ Med. 2008 Jun 12;358(24):2545‐59.
Diabetes Care. 2008;31:1913-19.
DM Disease Related Issues
• In studies with A1Cs as high as 7.9% and
8.4% in the less intensive Tx arms, there
were only marginal clinical outcome
differences, but much less hypoglycemia in
the less intensive Tx arms.
arms Since frail elderly
patients are even more likely to experience
potential harms, these A1Cs provide some
insight as to potentially reasonable A1C
targets/ranges.
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IS THERE A J-CURVE
IN BLOOD GLUCOSE?
GPRD Retrospective
Cohort Analysis
Lancet. 2010;375:481-9.
DM Disease Related Issues
• The cohort study in aging found that the mortality
risk is a U‐ shaped curve which increases for A1Cs
<6% and >9%. Risk of any complication increased
with A1Cs >8%. A similar study of patients with
diabetes and CKD found a similar U‐curve where
mortality was increased with A1C <6.5% and
>8.0%.
• Some guidelines have provided specific
recommendations on how to individualize glycemic
control in the elderly.
Diabetes Care. 2011Jun;34(6):1329‐36.
Arch Intern Med. 2011 Nov 28;171(21):1920‐7
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Endocrine Practice. 2011;17(suppl2):1-53.
PT CENTERED APPROACH!!!
TREAT THE PT NOT THE TARGET
Diabetes Care. 2012;35:1364-79.
Less stringent A1C goals (such as <8% or even
slightly higher) may be appropriate for patients with
a history of severe hypoglycemia, limited life
expectancy, advanced microvascular or
macrovascular complications, and extensive
comorbid conditions and for those with
longstanding diabetes in whom the general goal is
difficult to attain despite diabetes self‐management
education, appropriate glucose monitoring, and
effective doses of multiple glucose‐lowering agents
including insulin.
Diabetes Care. 2012;35:1364-79.
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Diabetes Care. 2012;35:1364-79.
Diabetes Care. 2009;32:193-203.
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TIER 1
Lifestyle + Metformin
+
Basal insulin
Lifestyle + Metformin
+
Intensive insulin
Lifestyle
+
Metformin
Lifestyle + Metformin
+
Sulfonylurea
Step 1
Step 2
Lifestyle + Metformin
+
Pioglitazone
No hypoglycemia
Edema, CHF, Bone loss
Lifestyle + Metformin
+
GLP-1 agonistb
TIER 2
Diabetes Care 2009;32:193-203.
No hypoglycemia; Weight loss,
Nausea/vomiting
Step 3
Lifestyle + Metformin
+
Pioglitazone
+
Sulfonylurea
Lifestyle + Metformin
+
Basal insulin
NEWER EVIDENCE FOR
APPROVED
PHARMACOTHERAPIES
DM Medication Related
Issues
• Metformin – still foundational therapy, more
debate on dose adjustments with renal function
(GFR < 30 = D/C; 30 = <850mg/day; 60 =
<1700mg/day), GI issues & elderly may be more
difficult in some, lactic acidosis risk unclear
• SU’s – ↑hypoglycemia,
↑h pogl cemia esp with
ith decreased
dec eased renal
enal
function, ? CV events, repaglinide (Prandin®) might
be useful for pts with varying appetites
• TZD’s – less useful due to concerns (HF, edema,
weight gain, fractures), cost
• DPP-4’s/GLP-1’s – limited beta-cell function?,
cost, less hypoglycemia vs. SU’s & insulin
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DM Medication Related
Issues
• Insulin – basal & premix sometimes helpful if
mealtimes / activity times are predictable, MDI OK
in some but need to assess pt & caregiver ability,
glargine & detemir may have less hypos, AVOID
sliding scales,
• FIX LOW’s
LOW’ FIRST,
FIRST THEN HIGH’S
• SMBG – growing controversial data on utility
Am Health Drug Benefits. 2011;4(5):303-11.
Am Health Drug Benefits. 2011;4(5):303-11.
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YET-TO-BE APPROVED
PHARMACOTHERAPIES
Am Health Drug Benefits. 2011;4(5):303-11.
NEW TECHNOLOGY
ISSUES FOR DIABETES
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