Professional Documents
Culture Documents
2013
Dr. Erin Koepf, PharmD, BCACP
Assistant Professor, Ambulatory Care
University of New England College of Pharmacy
Maine Pharmacists Association, September 7, 2013
1
Objectives:
Based on the American Diabetes Association Standards of
Medical Care in Diabetes 2013:
Objectives:
Identify the class, mechanism of action, dosing, and administration
of new and common diabetes medications
Others?
Review: Diabetes
Pathogenesis
Insulin deficiency
Quantitative: decreased in production by the -cells of the
pancreas
Review: Diabetes
Pathogenesis
Excess secretion of glucagon by -cells of pancreas
Glucose overproduction by liver; underutilized by body
Gluconeogenesis (making glucose from glycerol and amino
acids)
Centers For Disease Control and Prevention. Diabetes Data and Trends.
9
.http://apps.nccd.cdc.gov/DDT_STRS2/NationalDiabetesPrevalenceEstimates.aspx?
mode=DBT
Diabetes Report Card 2012. Atlanta, GA: Centers for Disease Control
and Prevention, US Department of Health and Human Services; 2012.
Diabetes in the US
Incidence increases
with age
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Diabetes Report Card 2012. Atlanta, GA: Centers for Disease Control
and Prevention, US Department of Health and Human Services; 2012.
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Diabetes Report Card 2012. Atlanta, GA: Centers for Disease Control
and Prevention, US Department of Health and Human Services; 2012.
Rates of
Diabetes in
Maine have
been similar to
that of the US
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13
Prevalence Varies
throughout Maine
from 7% to 10.7%
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2009 in Maine, diabetes related deaths had incidence of 65.8 per 100,000
Leading cause of
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Diabetes Report Card 2012. Atlanta, GA: Centers for Disease Control
and Prevention, US Department of Health and Human Services; 2012.
Microvascular Complications:
Nephropathy
Retinopathy
Neuropathy
Foot ulcers/lesions
Numbness, pain
Sexual dysfunction
Gastroparesis
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http://www.mayomedicallaboratories.com/images/articles/communique/2009/09fig1.jp
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Macrovascular
Complications
Cardiovascular Diseases (CVD)
Coronary Artery Disease
(CAD)
Additional Concerns
Depression and other
mental disorders
Dental disease
Increased risk of infection
Can affect fertility
Severe hyper- or hypoglycemic events
http://diabeticradio.com/wp-content/uploads/2010/06/hypoglycemia.jpg
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Diabetes Preventative
Care
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Diabetes Report Card 2012. Atlanta, GA: Centers for Disease Control
and Prevention, US Department of Health and Human Services; 2012.
Preventative Care in
Maine
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Types
Diagnosis
Screening
Case
http://a.abcnews.com//images/Health/diabetes_Screening3_mn.jp
g
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Diabetes Classification
Type 1 Diabetes
Type 2 Diabetes
Gestational Diabetes (GDM)
Other types related to other causes
Exocrine diseases (i.e. cystic fibrosis)
Genetic defects affecting insulin action or production
Drug/chemically induced (i.e. HIV/AIDs treatments)
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American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes - 2013. Diabetes Care. 2013;36(1): S11S66.
Diagnosis of Diabetes:
Measurements that may be used
American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes - 2013. Diabetes Care. 2013;36(1): S11S66.
Diagnosis of Diabetes:
Symptoms/Presentation
Assessment for signs and symptoms of hyperglycemia
Excess thirst, urination, and/or hunger
Blurry vision or vision changes
In severe hyperglycemia (BG > 240 mg/dL)
Ketones may be present in urine
Ketoacidosis can occur when the body breaks down fat and other
molecules for energy
Diagnosis of Diabetes:
Values for Diabetes/Pre-Diabetes
Measurement
Criteria for
Diabetes
FPG
126 mg/dL
OGTT
200 mg/dL
A1C
6.5%
5.7 - 6.4%
Random PG
200 mg/dL
N/A
25
American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes - 2013. Diabetes Care. 2013;36(1): S11S66.
Pre-Diabetes Diagnosis
Plasma glucose and/or A1C level between normal range
and diabetes
American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes - 2013. Diabetes Care. 2013;36(1): S11S66.
Risk Factors*
Obesity/overweight (BMI 25 kg/m2)
History of CVD
Physical inactivity
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American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes - 2013. Diabetes Care. 2013;36(1): S11S66.
American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes - 2013. Diabetes Care. 2013;36(1): S11S66.
American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes - 2013. Diabetes Care. 2013;36(1): S11S66.
1.
diabetes today?
A.
50 year old Latina female who delivered a baby weighing 10 lbs when
she was 27, but had a negative diabetes screening test 24 months ago
B.
25 year old Caucasian female with a BMI of 28 kg/m2 who reports low
C. 40 year old African American male with a BMI of 24 kg/m2 and family
history significant for diabetes in his mother and maternal grandfather
D.
Patient: L. Labor
25 year old Caucasian Male who frequents your community pharmacy
and has just been to his doctors office (routine visit)
Webpage design and Watching games from the stands with snacks
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Patient: L. Labor
He mentions his doctor wants him to get lab work done to
check for diabetes
Diagnosis of Diabetes:
Values for Diabetes/PreDiabetes
Measurement
Criteria for
Diabetes
FPG
126 mg/dL
OGTT
200 mg/dL
A1C
6.5%
5.7 - 6.4%
Random PG
200 mg/dL
N/A
37
What else would you like to know about him or test for?
What should we recommend for him going forward?
38
Next Steps
To prevent/delay the onset of Type 2 Diabetes in patients who have
been diagnosed with Pre-diabetes, which of the following are
recommended as part of an ongoing support plan:
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40
http://www.diabetes-warrior.net/wp-content/uploads/2010/10/prediabetes1.jpg
American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes - 2013. Diabetes Care. 2013;36(1): S11S66.
American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes - 2013. Diabetes Care. 2013;36(1): S11S66.
American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes - 2013. Diabetes Care. 2013;36(1): S11S66.
Pharmacotherapy for
Pre-Diabetes
Which of the following answers lists medications that can help
prevent/delay the progress from pre-diabetes to diabetes?
45
American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes - 2013. Diabetes Care. 2013;36(1): S11S66.
Progress.
LL follows recommendations from you and his other health
care providers
Progress.
LL has tolerated Metformin therapy and is now
taking 1 gram BID
8 years later.
He comes into the pharmacy today for his Metformin
refill and reports bad news
His A1c has reached 8.1% and he has had two FPGs >
140 mg/dL drawn by the lab over 2 weeks
Adding on more
medications
Individually take 1 minute to list additional diabetes
therapies that could be added to LLs Metformin for
better glycemic control
Adding on Therapy
While metformin is still the preferred first line therapy for patients with diabetes, if
maximum doses of metformin do result in an A1C at goal, how should an additional
agent be chosen?
B. The second agent added on should be selected based on patient specific factors
with consideration of cost, potential side-effects, and comorbidities
C. The second agent should be insulin therapy with insulin glargine daily and
insulin aspart or lispro TID with meals
D. A second agent should not be added until diet and lifestyle goals have been
achieved to reduce insulin resistance
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A Patient Centered
Approach
American Diabetes Association (ADA) and the European
Association for the Study of Diabetes (EASD) 2012
recommendations
Factors to Consider
Think of each element as a continuous spectrum:
Patient attitude and expected treatment efforts
Risks of hypoglycemia and other adverse events
Disease duration
Life expectancy
Important comorbidities
Established vascular complications
Resources, support system available
Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 53
diabetes: a patientcentered approach, Position Statement by the ADA and the EASD. Diabetes Care. 2012;35:1364-79.
Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 54
diabetes: a patientcentered approach, Position Statement by the ADA and the EASD. Diabetes Care. 2012;35:1364-79.
Factors to Consider
Factors should also be considered in prescribing lifestyle
modifications
Adding on Therapy
While metformin is still the preferred first line therapy for patients with
diabetes, if maximum doses of metformin do result in an A1C at goal, how
should an additional agent be chosen?
B. The second agent should be insulin therapy with insulin glargine daily
and insulin aspart or lispro TID with meals
This strategy of starting insulin as first line (with or without metformin) may
be appropriate for patients with severe hyperglycemia at time of diagnosis or
therapy initiation
Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 56
diabetes: a patientcentered approach, Position Statement by the ADA and the EASD. Diabetes Care. 2012;35:1364-79.
Adding on Therapy
While metformin is still the preferred first line therapy for
patients with diabetes, if maximum doses of metformin do
result in an A1C at goal, how should an additional agent be
chosen?
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Canagliflozin (Invokana)
Moderate A1C reduction and weight reduction
Low incidence of hypoglycemia
Renal monitoring and dose adjustment
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Invokana (package insert). Janssen Pharmaceuticals, Inc. Titusville, NJ. March 2013; http://www.invokanahcp.com/. Accessed: 08/28/13.
Canagliflozin
(Invokana)
Can increase to 300 mg PO daily if eGFR 60 mL/min (if less max dose =
100 mg/day)
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Invokana (package insert). Janssen Pharmaceuticals, Inc. Titusville, NJ. March 2013; http://www.invokanahcp.com/. Accessed: 08/28/13.
Canagliflozin
(Invokana)
62
Invokana (package insert). Janssen Pharmaceuticals, Inc. Titusville, NJ. March 2013; http://www.invokanahcp.com/. Accessed: 08/28/13.
Injectable Medication
Options
Insulins
Exenatide, liraglutide
Amylin mimetics
Half-life ~ 42 hours
FDA declined to approve as of Feb 2013
Requested more long term cardiovascular safety data from
dedicated trial
Back to adding on
therapy
Any changes in what you would like to recommend for LL?
Comparative analysis of add-on therapy has indicated
that most 2 drug combinations have similar A1C lowering
effects
Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 67
diabetes: a patientcentered approach, Position Statement by the ADA and the EASD. Diabetes Care. 2012;35:1364-79.
UKPDS
ACCORD
ADVANCE
VADT
Values on both sides of the debate can not be ruled out by this
analysis
American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes - 2013. Diabetes Care. 2013;36(1): S11S66.
Daily monitoring is not required for most patients not taking insulin
Consider patient comfort, access to testing supplies, and risk of
hypoglycemia based on medication therapy
American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes - 2013. Diabetes Care. 2013;36(1): S11S66.
Saturated fat < 7 % of total calories (9 calories per gram of fat); limit trans
fats
Increase intake of whole grains to get recommended daily intake for fiber
Limit alcohol intake to moderate (1 drink per day women; 2 per day men)
American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes - 2013. Diabetes Care. 2013;36(1): S11S66.
Cardiovascular
Prevention
Hypertension
New goal option of systolic < 140 mmHg; Diastolic < 80 mmHg
Lower targets (< 130 mmHg) may be appropriate for specific
patients (younger)
Preferred treatment
DASH Diet and lifestyle modification
Angiotensin Converting Enzyme (ACE) Inhibitors or Angiotensin
Receptor Blocker (ARB) (monitor renal function and electrolytes)
American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes - 2013. Diabetes Care. 2013;36(1): S11S66.
Cardiovascular
Prevention
Hyperlipidemia
Monitor fasting lipids annually
Or every 2 years if at goal and stable
Lifestyle modifications recommended for all patients
Recommend addition of HMG-CoA Reductase Inhibitor (statin)
therapy regardless of baseline lipid values if patient has CVD
or
Cardiovascular
Prevention
Hyperlipidemia
For lower risk individuals add statin if
Lifestyle changes alone do not reduce LDL to < 100 mg/dL
Patient has multiple CVD risk factors
If patients do not meet goals (see next slide) on maximum
tolerated statin dosing
American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes - 2013. Diabetes Care. 2013;36(1): S11S66.
Cardiovascular
Prevention
Hyperlipidemia
LDL Goals (primary target of therapy)
< 100 mg/dL for patients without CVD
< 70 mg/dL for patients with CVD
Triglyceride goal < 150 mg/dL
HDL goal for men > 40 mg/dL
HDL goal for women > 50 mg/dL
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American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes - 2013. Diabetes Care. 2013;36(1): S11S66.
Cardiovascular
Prevention
Anti-platelet agents
Can use aspirin 81 mg daily as primary prevention in patients
with type 1 or type 2 DM at increased risk( 10 year risk > 10%)
Includes most men > 50, women > 60 with at least 1 risk
factor
For patients with lower risk (10 risk < 5%) with no risk factors therapy is not recommended
American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes - 2013. Diabetes Care. 2013;36(1): S11S66.
General Prevention
Monitoring of renal function
Treatment of elevated urinary albumin excretion with ACE
Inhibitors or ARBs
American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes - 2013. Diabetes Care. 2013;36(1): S11S66.
Prevention:
Immunizations
You are working with a 30 year old gentleman who has just
been diagnosed with type 2 Diabetes. Which vaccines would
you recommend he receive if he has not done had them
already?
A. Hepatitis B series
B. Influenza (to be repeated annually)
C. Pneumoccal Polysaccharide
D. Both B and C are correct
E. A, B, and C are all correct
82
Useful Abbreviations:
ADA
A1c or A1c
Hemoglobin A1c
FPG
OGTT
BG
Blood Glucose
IFG
IGT
DM
Diabetes Mellitus
HTN
Hypertension
HLD
Hyperlipidemia
MI
Myocardial Infarction
CAD
CVD
Cardiovascular Disease
PAD
TIA
References:
American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes - 2013. Diabetes Care.
2013;36(1): S11-S66.
Centers for Disease Control and Prevention. Diabetes Report Card 2012. Atlanta, GA: Centers for Disease Control and Prevention, US Department
of Health and Human Services; 2012. Available at: www.cdc.gov/diabetes/pubs/pdf/DiabetesReportCard.pdf
Centers for Disease Control and Prevention. National Diabetes Fact Sheet, 2011. Atlanta, GA: Centers for Disease Control and Prevention, US
Department of Health and Human Services; 2011. Available at: http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf.
Diabetes Surveillance Report, Maine 2012. Augusta, ME: Diabetes Prevention and Control Program, Maine Center for Disease Control and
Prevention; 2012. Available at: http://www.maine.gov/dhhs/mecdc/populationhealth/dcp/statistics.htm
Maine Center for Disease Control and Prevention. Maine Diabetes Prevention and Control Program, Health Fact Sheet: Diabetes in Maine. Maine
Center for Disease Control and Prevention, Maine Department of Health and Human Services; 2011.
Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach, Position Statement by
the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012;35:1364-79.
Invokana (package insert). Janssen Pharmaceuticals, Inc. Titusville, NJ. March 2013; http://www.invokanahcp.com/. Accessed: 08/28/13.
Stratton IM, Adler AI, Neil HAW, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS
35): prospective observational study. BMJ. 2000;321:405-12.
The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Group. Effects of intensive glucose lowering in type 2 diabetes. NEJM.
2008;358(24):2545-59.
The Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) Collaborative Group.
Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. NEJM. 2008;358(24):2560-72.
84
References (continued)
Duckworth W, Abraira C, Moritz T, et al. Glucose control and vascular complications in veterans with type 2 diabetes. NEJM. 2009;360(2):129-39.
Ray KK, Kondapally Seshasai S, Wijesuriya S, et al. Effect of intensive control of glucose on cardiovascular outcomes and death in patients with diabetes mellitus:
a meta-analysis of randomised controlled trials. Lancet. 2009;373:1765-72.
Boussageon R, Bejan-Angoulvant T, Saadatian-Elahi M, et al. Effect of intensive glucose lowering treatment on all cause mortality, cardiovascular death, and
microvascular events in type 2 diabetes: a meta-analysis of randomised control trials. BMJ. 2011;343:d4169 doi:10.1136/bmj.d4169.
Hemmingsen B, Lund SS, Gluud C, et al. Intensive glycaemic control for patients with type 2 diabetes: systemic review with meta analysis and trial sequence
analysis of randomised clinical trials. BMJ. 2011;343:d6898 Doi: 10.1136/bmj.d6898.
Ismail-Beigi F, Moghissi E, Tiktin M, et al. Individualizing glycemic targets in type 2 diabetes mellitis: implications of recent clinical trials. Ann Intern Med.
2011;154:554-9.
Bennett WL, Maruthur NM, Singh S, et al. Comparative effectiveness and safety of medications for type 2 diabetes: an update including new drugs and 2-drug
combinations. Ann Intern Med. 2011;154:602-13.
Matthews JE, Stewart MW, De Boever EH, et al. Pharmacodynamics, pharmacokinetics, safety, and tolerability of albiglutide, a long-acting glucagon-like peptide1 mimetic, in patients with type 2 diabetes. J Clin Endocrinol Metab. 2008;93:4810-4817.
Garber AJ, King AB, Del Prato SD, et al. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin
aspart in type 2 diabetes (BEGIN Basal-Bolus Type 2): a phase 3, randomized, open-label, treat-to-target non-inferiority trial. Lancet. 2012;379:1498-507.
Nisly SA, Kolanczyk DM, and Walton AM. Canagliflozin, a new sodium glucose cotransporter 2 inhibitor, in the treatment of diabetes. Am J Health-Syst
Pharm. 2013;70:311-9.
Tucker ME. FDA rejects Novo Nordisks Insulin Degludec. Medscape News. Accessed February 12, 2013. Available at:
http://www.medscape.com/viewarticle/779077
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