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1
Accreditation Information
The American Pharmacists Association is accredited by the
Accreditation Council for Pharmacy Education as a provider of
continuing pharmacy education.
The self-study learning portion of The Pharmacist & Patient-Centered
Diabetes Care is approved for 15 contact hours (1.5 CEUs) of continuing
pharmacy education credit (UAN 202-999-12-108-H04-P). The seminar is
approved for 8 contact hours (0.8 CEUs) of continuing pharmacy
education credit (UAN 202-999-12-107-L04-P).
The live seminar is a required component of the certificate training
program. This practice-based activity was developed by the American
Pharmacists Association in co-sponsorship with the American Association
of Diabetes Educators.
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Speakers
[insert session speakers]
3
Advisory Board
•
•
•
•
•
•
Tommy Johnson, PharmD, CDE, BC-ADM
Jonathan Marquess, PharmD, CDE, CPT
Staci-Marie Norman, PharmD, CDE
Charles Ponte, PharmD, CDE, BCPS
Philip Rodgers, PharmD, BCPS, CPP, FCCP
Jennifer Smith, PharmD, CDE
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Disclosures
Jonathan Marquess serves on the Speakers’ Bureaus for Abbott Diabetes
Care, Novo Nordisk, and Sanofi.
Staci-Marie Norman is a speaker for Eli Lilly and Company and LifeScan,
Inc. Dr. Norman’s spouse is employed by Takeda Pharmaceutical Company.
Philip Rodgers holds stock in Novo Nordisk.
All other individuals involved in the development of this material
declare no conflicts of interest or financial interests in any product or
service mentioned in this activity, including grants, employment, gifts,
stock holdings, and honoraria.
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6
Section 1
Comprehensive Diabetes Care
Treating Type 2 Diabetes
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Patient Case
Leroy Davis
8
Leroy Davis (Part 1)
• Assess Leroy’s status
relative to
comprehensive
diabetes care goals
and
recommendations
9
Leroy Davis (Part 1)
• What are your initial impressions of Leroy?
10
Leroy Davis (Part 1)
• Is Leroy meeting the goals for glycemic control?
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Goals for Glycemic Control
A1C (%)
Fasting/preprandial
glucose
Peak postprandial
glucose
ADA1
AACE2
<7a
≤6.5
70–130 mg/dL
<110 mg/dL
<180 mg/dL
<140 mg/dLb
aGoal
for most adult patients. Goal for individual patients is A1C as close to normal (<6%) as possible without
significant hypoglycemia.
b2-hour
postprandial.
Abbreviations: AACE, American Academy of Clinical Endocrinologists; ADA, American Diabetes Association.
1. ADA Position Statement 2012. Available at: http://care.diabetesjournals.org/content/35/Supplement_1/S11.full.pdf+html.
2. AACE Guidelines 2011. Available at: https://www.aace.com/sites/default/files/DMGuidelinesCCP.pdf.
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Leroy Davis (Part 1)
• Is Leroy meeting the goals for blood
pressure management?
• Recommendations related to
antihypertensive therapy?
13
Hypertension Goals
ADA
JNC 8
• <140/80 for most
• <130/80 for younger
individuals
• <150/90 for >60 w/o DM
or kidney disease
• <140/90 for 18-59 w/o
comorbidity or >60
w/comorbidity
Diabetes Care Vol 37, Supp 1, January 2014
JNC 8: http://jama.jamanetwork.com 1/12/2014
Hypertension Treatment
ADA
JNC 8
• First-line agents:
• BP >120/80: life-style
– thiazide diuretics
modification
– calcium channel blockers
– ACE Inhibitors
• BP >140/80 life-style and
– ARBs
appropriate drug therapy • Second and third-line
– ACE or ARBs
– Multiple-drug therapy will
probably be needed
– One dose administered at
bedtime
Diabetes Care Vol 37, Supp 1, January 2014
JNC 8: http://jama.jamanetwork.com 1/12/2014
agents: high dose first line
agents
• Later-line alternatives
include: the rest of the
antihypertensive
medications
JNC 8 Hypertension Guidelines
• Initial therapy in African-Americans is CCBs and
thiazides instead of ACEIs
• ACEIs and ARBs is recommended in all patients
with chronic kidney disease regardless of ethnic
decent
• ACEIs and ARBs should not be used together
• CCBs and thiazide diuretics should be used instead
of ACEIs and ARBs in patients >75 with impaired
kidney function
JNC 8: http://jama.jamanetwork.com 1/12/2014
Leroy Davis (Part 1)
• Is Leroy meeting the goals for
cholesterol management?
• Recommendations related to lipidmodifying therapy?
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Cholesterol Goals
Lipid
Goal
Low-density lipoprotein (LDL)
cholesterol
<100 mg/dLa
High-density lipoprotein (HDL)
cholesterol
>40 mg/dL men
>50 mg/dL women
Triglycerides
<150 mg/dL
aLDL
<70 mg/dL is an option in some patients.
American Diabetes Association Standards of Medical Care in Diabetes—2012
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Cholesterol Goals
• Statin therapy + lifestyle
modification for
patients:
– With overt
cardiovascular disease
(CVD)
– >40 years of age with at
least one other CVD risk
factor
• For other patients,
consider adding statin
therapy to lifestyle
modification if:
– LDL cholesterol remains
>100 mg/dL
– Multiple CVD risk factors
are present
American Diabetes Association Standards of Medical Care in Diabetes—2012
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2013 ACC/AHA Guideline on the
Treatment of Blood Cholesterol
• Changed the paradigm for goals and therapy
– Focuses on those most likely to benefit
• 4 Statin Benefit Groups:
– Individuals with clinical CVD
– Individuals with primary elevated LDL ≥ 190mg/dL
– Individuals 40-75 with diabetes and LDL 70-189 mg/dL
– Individuals 40-75 without CVD or diabetes with LDL 70189 mg/dL with 10-year risk of CVD ≥ 7.5%
• Statin therapy goal is maximum tolerated intensity
– Not focused on LDL of <100 or <70mg/dL
2013 ACC/AHA Blood Cholesterol Guidelines
http://circ.ahajournals.org 1/12/13
Leroy Davis (Part 1)
• What additional care might Leroy need?
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Comprehensive Care Needs
•
•
•
•
Aspirin therapy
Dental/oral examination
Depression screening
Diabetes selfmanagement education
• Dilated eye examination
• Foot examination
• Annual influenza
vaccination
• Pneumococcal
vaccination
• Hepatitis B vaccination
• Serum creatinine
measurement
• Smoking cessation
counseling
• Urine test for albuminto-creatinine ratio
22
Leroy Davis (Part 1)
• What about self-monitoring of blood glucose
(SMBG)?
23
SBGM with Intensive Insulin Regimen
At least prior to meals and snacks
•
•
•
•
•
•
Occasionally postprandial
At bedtime
Prior to exercise
When suspect low blood glucose
After treatment of low blood glucose
Prior to critical tasks – such as driving
Continuous Blood Glucose Monitoring
• May be useful in helping lower A1c
• May be a supplemental tool to SMBG in those with
hypoglycemia unawareness or frequent hypo episodes
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Continuous Blood Glucose Monitoring
When and Why would we use this:
• May be useful in helping lower A1c
• May be a supplemental tool to SMBG in those with
hypoglycemia unawareness or frequent hypo episodes
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“For patients using less-frequent insulin
injections, noninsulin therapies, or medical
nutrition therapy alone, SBGM may be
useful as a guide to management.”
American Diabetes Association Standards of Medical Care in Diabetes—2012
26
SBGM with Non-Insulin Type 2 Regimens
For patients not using insulin the recommendations are open and
geared to individualizing the regimen to the patient’s needs.
Reasons to Use
• Improve patient awareness
of effects of lifestyle habits
(e.g., food, exercise)
• Identify variability of
glucose levels
• Aid in treating to target
• Help patients recognize
episodes of hypoglycemia
Factors to Consider
• Cost
• Patient motivation
• How will results be used?
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Leroy Davis (Part 1)
• Which of Leroy’s care needs will you address first?
• How will you ensure that all of Leroy’s care needs
are addressed?
28
Leroy Davis (Part 2)
• Recommend
possible changes to
Leroy’s diabetes
medication regimen
to meet glycemic
goals
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Leroy Davis (Part 2)
• What are the possible options for intensifying
Leroy’s antihyperglycemic regimen?
• What specific change would you recommend?
Why?
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Treatment Intensification
• Based on adding another agent from a
different class
– Second oral agent
– Glucagon-like peptide-1 (GLP-1) receptor agonist
– Insulin
• Each new class of noninsulin agents added to
initial therapy lowers A1C ~0.9%–1.1%
31
Drug Selection Considerations
• Efficacy (A1C-lowering
capacity)
• Effect on fasting plasma
glucose and postprandial
plasma glucose
• Mechanism of action
• Route of administration
• Ease of use
• Contraindications in
hepatic or renal failure
• Impact on weight
• Impact on nonglycemic
factors (e.g., serum lipids)
• Adverse effects/
tolerability
• Risk of hypoglycemia
• Likely adherence
• Cost
32
T2DM Anti-hyperglycemic Therapy: General Recommendations
Diabetes Care, Diabetologia. 19 April 2012
[Epub ahead of print]
33
Benefits are classified according to major effects on fasting glucose, postprandial glucose, and nonalcoholic fatty liver disease (NAFLD). Eight
broad categories of risks are summarized. The intensity of the background shading of the cells reflects relative importance of the benefit or risk.*
* The abbreviations used here correspond to those used on the algorithm (Fig. 1).
** The term ‘glinide’ includes both repaglinide and nateglinide.
AACE/ACE Consensus Statement Algorithm 2009. Available at: www.aace.com/pub.
© AACE December 2009 Update. May not be reproduced in any form without express written permission from AACE.
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Drug Therapy Updates
36
Emerging Agents
SGLT2 Inhibitors
• Empagliflozin (BI10773) :filed by Eli Lilly (+) Boehringer
Ingelheim
• Ertugliflozin (MK-8835; PF-04971729): Phase II, Merck +
Pfizer
GLP1 Agonists (once weekly SQ formulations)
• Albiglutide BLA (formerly Syncria): filed by GSK
• Dulaglutide (LY2189265): filed by Eli Lilly
• Semaglutide (NN9535): Phase III; Novo Nordisk
Emerging Agents
DPP4 Inhibitors
• Trelagliptin (SYR-472): Phase III, Takeda
• Omarigliptin: once weekly oral; Phase III, Merck
Inhaled Insulin
• Afrezza: Ultra-rapid-acting bolus insulin using
Dreamboat™ inhaler; NDA submitted October 2013
GPR 40 Agonist
• Fasiglifam (TAK-875): Development terminated due to
concerns of liver safety
Questions?
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