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Diabetes Update 2013

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Dr. Erin Koepf, PharmD, BCACP Assistant Professor, Ambulatory Care University of New England College of Pharmacy Maine Pharmacists Association, September 7, 2013 – PowerPoint PPT presentation

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Title: Diabetes Update 2013


1
Diabetes Update 2013
  • Dr. Erin Koepf, PharmD, BCACP
  • Assistant Professor, Ambulatory Care
  • University of New England College of Pharmacy
  • Maine Pharmacists Association, September 7, 2013

2
Objectives
  • Based on the American Diabetes Association
    Standards of Medical Care in Diabetes 2013
  • Identify the classification, risk factors,
    diagnosis, and screening criteria for diabetes
  • Explain pharmacologic and non-pharmacologic
    treatments options for patients with diabetes or
    pre-diabetes
  • Describe measures that can be taken to prevent
    diabetes progression and complications including
    immunization recommendations

3
Objectives
  • Identify the class, mechanism of action, dosing,
    and administration of new and common diabetes
    medications
  • Discuss with patients and other health care
    practitioners diabetes treatment options,
    monitoring, and the goals for therapy
  • Compare and contrast medication therapies
    available for the treatment of diabetes and
    select appropriate options for a given patient
  • Develop a comprehensive care plan for a given
    patient with diabetes which included
    pharmacologic and non-pharmacologic measures,
    monitoring, and preventative measures

4
What is Diabetes? Warm-up
  • Spend 60 seconds thinking about and writing down
    a description of Diabetes
  • Spend the next 2 minutes sharing your description
    with someone next to you
  • Write down some of the concepts you come up with

5
What is Diabetes? Warm-up
  • Endocrine condition that increases risks of
    Cardiovascular events v.
  • Cardiovascular disease with abnormal processing
    and distribution of glucose
  • Others?

6
Review Diabetes Pathogenesis
  • Insulin deficiency
  • Quantitative decreased in production by the
    ß-cells of the pancreas
  • Qualitative insulin resistance especially
    muscle, liver, adipose, myocardial
  • Improvements in insulin function
  • Weight loss to decrease insulin resistance
  • Can in turn improve ß-cell function

7
Review Diabetes Pathogenesis
  • Excess secretion of glucagon by a-cells of
    pancreas
  • Glucose overproduction by liver underutilized by
    body
  • Gluconeogenesis (making glucose from glycerol and
    amino acids)
  • Renal tubular transport of glucose to the urine
    due to hyperglycemia
  • Incretin system deviations (relationship to DM
    still not fully clear)
  • Glucagon-like peptide 1 (GLP-1)
  • Glucose dependent insulinotropic peptide (GIP)

8
Who has Diabetes?
  • Incidence of diabetes is rising (about 25 million
    adults in the US)
  • Incidence is higher in certain populations
  • Many risk factors/associated conditions are also
    rising in prevalence
  • About 2/3 of patients with diabetes in the US
    also have hypertension (HTN)
  • How does Maine compare to the US when it comes to
    incidence of Diabetes?

9
Incidence of Diabetes in the US
Diabetes Report Card 2012. Atlanta, GA Centers
for Disease Control and Prevention, US Department
of Health and Human Services 2012.
Centers For Disease Control and Prevention.
Diabetes Data and Trends. .http//apps.nccd.cdc.g
ov/DDT_STRS2/NationalDiabetesPrevalenceEstimates.a
spx?modeDBT
10
Diabetes in the US
  • Incidence increases with age
  • Incidence ranges from 7.1 - 16.1 between
    different racial/ethnic groups

Diabetes Report Card 2012. Atlanta, GA Centers
for Disease Control and Prevention, US Department
of Health and Human Services 2012.
11
New Cases of Diabetes
Diabetes Report Card 2012. Atlanta, GA Centers
for Disease Control and Prevention, US Department
of Health and Human Services 2012.
12
Rates of Diabetes in Maine have been similar to
that of the US
Diabetes Surveillance Report, Maine 2012.
Augusta, ME Diabetes Prevention and Control
Program, Maine Center for Disease Control and
Prevention 2012.
13
Diabetes Incidence in Maine
Diabetes Surveillance Report, Maine 2012.
Augusta, ME Diabetes Prevention and Control
Program, Maine Center for Disease Control and
Prevention 2012.
14
Prevalence Varies throughout Maine from 7 to
10.7
Diabetes Surveillance Report, Maine 2012.
Augusta, ME Diabetes Prevention and Control
Program, Maine Center for Disease Control and
Prevention 2012.
15
Diabetes Disease Burden
  • 2009 in Maine, diabetes related deaths had
    incidence of 65.8 per 100,000
  • Decreased from 81.5 per 100,000
  • US 2008 incidence was 72.2 per 100,000
  • Significantly increased risk of cardiovascular
    diseases
  • Including stroke and myocardial infarction (MI)
  • Leading cause of
  • Non-traumatic lower extremity amputations,
    blindness, and kidney failure
  • Medical expenditures are on average 2.3 times
    higher in patients with diabetes than those
    without ( 174 billion in direct indirect
    costs in 2007)

Diabetes Surveillance Report, Maine 2012.
Augusta, ME Diabetes Prevention and Control
Program, Maine Center for Disease Control and
Prevention 2012.
Diabetes Report Card 2012. Atlanta, GA Centers
for Disease Control and Prevention, US Department
of Health and Human Services 2012.
16
Microvascular Complications
  • Nephropathy
  • Retinopathy
  • Neuropathy
  • Foot ulcers/lesions
  • Numbness, pain
  • Sexual dysfunction
  • Gastroparesis

http//www.mayomedicallaboratories.com/images/arti
cles/communique/2009/09fig1.jpg
17
Macrovascular Complications
  • Cardiovascular Diseases (CVD)
  • Coronary Artery Disease (CAD)
  • Myocardial Infarction (MI)
  • Stroke or transient ischemic attack (TIA)
  • Peripheral Artery Disease (PAD)

http//womenshealth.gov/heart-health-stroke/images
/heart-attack-signs.gif
18
Additional Concerns
  • Depression and other mental disorders
  • Dental disease
  • Increased risk of infection
  • Can affect fertility
  • Severe hyper- or hypo- glycemic events

http//diabeticradio.com/wp-content/uploads/2010/0
6/hypoglycemia.jpg
19
Diabetes Preventative Care
Diabetes Report Card 2012. Atlanta, GA Centers
for Disease Control and Prevention, US Department
of Health and Human Services 2012.
20
Preventative Care in Maine
Diabetes Surveillance Report, Maine 2012.
Augusta, ME Diabetes Prevention and Control
Program, Maine Center for Disease Control and
Prevention 2012.
21
How do we classify and diagnose diabetes?
  • Types
  • Diagnosis
  • Screening
  • Case

http//a.abcnews.com//images/Health/diabetes_Scree
ning3_mn.jpg
22
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)

American Diabetes Association (ADA) Professional
Practice Committee. Standards of medical care in
diabetes - 2013. Diabetes Care. 201336(1)
S11-S66.
23
Diagnosis of DiabetesMeasurements that may be
used
  • Fasting Plasma Glucose (FPG)
  • Blood glucose measured after 8 hours fasting
  • Oral Glucose Tolerance test (OGTT)
  • Blood glucose measured 2 hours after 75 gram
    glucose load (use of anhydrous glucose solution)
  • Glycosylated hemoglobin or Hemoglobin A1c (A1C)
  • Test without regard to meals, provides 3 month
    mean glucose
  • Random plasma glucose (PG)
  • For use in patients with symptoms of
    hyperglycemia/hyperglycemic crisis

American Diabetes Association (ADA) Professional
Practice Committee. Standards of medical care in
diabetes - 2013. Diabetes Care. 201336(1)
S11-S66.
24
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 gt 240 mg/dL)
  • Ketones may be present in urine
  • Ketoacidosis can occur when the body breaks down
    fat and other molecules for energy
  • Can not use glucose for energy without insulin

25
Diagnosis of DiabetesValues for
Diabetes/Pre-Diabetes
Measurement Criteria for Diabetes Criteria for Pre-Diabetes
FPG 126 mg/dL 100 - 125 mg/dL
OGTT 200 mg/dL 140 - 199 mg/dL
A1C 6.5 5.7 - 6.4
Random PG 200 mg/dL N/A
American Diabetes Association (ADA) Professional
Practice Committee. Standards of medical care in
diabetes - 2013. Diabetes Care. 201336(1)
S11-S66.
26
Pre-Diabetes Diagnosis
  • Plasma glucose and/or A1C level between normal
    range and diabetes
  • Risk for developing DM and CVD
  • Estimates for developing diabetes over 5 years
    range from 9 - 50
  • Evaluate and treat other risk factors
  • Obesity/overweight, dyslipidemia, and
    hypertension

American Diabetes Association (ADA) Professional
Practice Committee. Standards of medical care in
diabetes - 2013. Diabetes Care. 201336(1)
S11-S66.
27
Who to Test/Screen for Diabetes?
  • For which patients should you be recommending
    testing/screening for Diabetes?
  • When/How often should they be screened?
  • Evaluate individual patient risk
  • Assess previous screening results
  • What risk factors can you name?

28
Risk Factors
Obesity/overweight (BMI 25 kg/m2) History of CVD
Physical inactivity Prior diagnosis of pre-diabetes
First degree relative with DM HDL cholesterol lt 35 mg/dL
High risk ethnicity/race African American Latino Native American Asian Amerian Pacific Islander Triglycerides gt 250 mg/dL
High risk ethnicity/race African American Latino Native American Asian Amerian Pacific Islander Hypertension BP 140/90 mmHg or on treatment
High risk ethnicity/race African American Latino Native American Asian Amerian Pacific Islander Conditions associated with insulin resistance Severe obesity (BMI 40 kg/m2) Acanthosis Nigrans
Women with history of GDM or delivering a baby weighing gt 9 lbs Conditions associated with insulin resistance Severe obesity (BMI 40 kg/m2) Acanthosis Nigrans
Women with Polycystic Ovarian Syndrome (PCOS) Conditions associated with insulin resistance Severe obesity (BMI 40 kg/m2) Acanthosis Nigrans
29
Who to Screen for Diabetes?
  • All adults ( 18 years old) with BMI 25 kg/m2
    and 1 or more additional risk factors
  • In adults without additional risk factors
  • Screening should start at age 45
  • If results of screening are normal repeat in 3
    years
  • Repeat yearly in those with Pre-diabetes values
  • For diagnosis screening test must be repeated
  • Is better to use same test (i.e. A1C, FPG, etc)
    for repeat

American Diabetes Association (ADA) Professional
Practice Committee. Standards of medical care in
diabetes - 2013. Diabetes Care. 201336(1)
S11-S66.
30
Screening in Children and Adolescents
  • Test for type 2 diabetes and pre-diabetes in
    children/adolescents
  • Overweight (BMI gt 85th percentile for age and
    gender or gt 120 of ideal weight for height)
  • Plus 2 risk factors
  • Family history in 1st or 2nd degree relative
  • Race/ethnicity (same as in adults)
  • Signs of insulin resistance or associated
    conditions
  • Gestational DM in mother while child was in utero

American Diabetes Association (ADA) Professional
Practice Committee. Standards of medical care in
diabetes - 2013. Diabetes Care. 201336(1)
S11-S66.
31
Screening for Gestational Diabetes
  • Screen at first pre-natal visit for those with
    risk factors
  • Without risk factors screen at 24-28 weeks
  • Use OGTT for diagnosis (fasting, 1 hour, and 2
    hour)
  • FPG 92 mg/dL
  • 1 hour 180 mg/dL
  • 2 hour 153 mg/dL
  • In women with gestational DM, screen for type 2
    DM at 6-12 weeks post-delivery then every 3 years

American Diabetes Association (ADA) Professional
Practice Committee. Standards of medical care in
diabetes - 2013. Diabetes Care. 201336(1)
S11-S66.
32
Who to screen for Diabetes?
  • 1. Which of the following symptom-free patients
    is due to be screened for 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 to no physical activity and
    is taking medication to treat his hypertension
  • 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. 42 year old Caucasian male with a BMI of 26
    kg/m2 who has no comorbidities and is physically
    active, but has never been screened

33
Meet Mr. L. Labor
34
Patient L. Labor
  • 25 year old Caucasian Male who frequents your
    community pharmacy and has just been to his
    doctors office (routine visit)
  • Claims he is generally healthy (admits his diet
    could be better)
  • BMI 28 kg/m2 (height 73 inches weight 215
    lbs)
  • Has a wife and daughter ( 1 year old)
  • Previously had a very physically active job, but
    now spends most of his time sitting at a computer
    both at work and at home
  • Carpentry and Coaching little league v.
  • Webpage design and Watching games from the
    stands with snacks

35
Patient L. Labor
  • He mentions his doctor wants him to get lab work
    done to check for diabetes
  • He does not understand why
  • He feels he is young and healthy
  • How can you explain to him the importance and
    potential benefit to having the tests done?
  • Can you explain to him what diabetes is and what
    it means for his health?

36
Interpreting test results
  • Which of the following values is one of the
    criteria for the diagnosis of pre-diabetes?
  • A. Glycosylated Hemoglogbin (A1C) 6.2
  • B. Fasting Plasma Glucose (FPG) 90 mg/dL
  • C. Plasma Glucose 2 hours after a 75 grams
    glucose load 130 mg/dL
  • D. Glycosylated Hemoglogbin (A1C) 5.7

37
Diagnosis of DiabetesValues for
Diabetes/Pre-Diabetes
Measurement Criteria for Diabetes Criteria for Pre-Diabetes
FPG 126 mg/dL 100 - 125 mg/dL
OGTT 200 mg/dL 140 - 199 mg/dL
A1C 6.5 5.7 - 6.4
Random PG 200 mg/dL N/A
38
Interpreting test results
  • What does it mean if LLs lab test shows
  • Glycosylated Hemoglogbin (A1C) 6.0
  • And
  • Fasting Plasma Glucose (FPG) 110 mg/dL
  • What else would you like to know about him or
    test for?
  • What should we recommend for him going forward?

39
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
  • A. Weight loss of 7 of the patients initial
    body weight
  • B. Moderate physical activity for a minimum of
    150 minutes/week
  • C. Initiation of canagliflozin therapy
  • D. A and B are correct
  • E. A, B, and C are all correct

40
Treatment for Pre-Diabetes
http//www.diabetes-warrior.net/wp-content/uploads
/2010/10/pre-diabetes1.jpg
41
Lifestyle Modifications for Pre-Diabetes and
Diabetes
  • Medical Nutrition Therapy (MNT)
  • Moderation, variety of carbohydrates
  • Increased physical activity
  • Minimum 150 minutes/week moderate level
  • Weight loss/maintenance
  • Initial 7 of body weight and maintenance of
    weight loss
  • Smoking cessation
  • Encourage and support with counseling and/or
    pharmacotherapy

American Diabetes Association (ADA) Professional
Practice Committee. Standards of medical care in
diabetes - 2013. Diabetes Care. 201336(1)
S11-S66.
42
Lifestyle Modifications for Pre-Diabetes and
Diabetes
  • Can decrease progression from pre-DM to DM
  • Group and individual delivery methods have both
    been found to be effective
  • Monitoring for and managing other CVD risk
    factors
  • Hypertension (HTN)
  • Hyperlipidemia (HLD)
  • Overweight/obesity (especially excessive
    abdominal fat)
  • Tobacco use

American Diabetes Association (ADA) Professional
Practice Committee. Standards of medical care in
diabetes - 2013. Diabetes Care. 201336(1)
S11-S66.
43
Lifestyle Modifications for Pre-Diabetes and
Diabetes
  • What specifically could you recommend for LL?
  • Work with 1 -2 others for 2-3 minutes writing
    down specific recommendations for LL

44
Specific Recommendations for LL
  • Smoking cessation (assessment of readiness to
    quit)
  • Healthful diet and exercise plan with goal of 15
    lbs weight loss
  • Limit intake of high sugar beverages
  • Increase intake of whole grains to obtain
    recommended intake of fiber
  • Recheck BP, recommend treatment if it continues
    to be elevated
  • Check fasting lipid panel, recommend treatment if
    levels are elevated
  • Annual monitoring for development of DM
  • Medication therapy for Pre-Diabetes?

American Diabetes Association (ADA) Professional
Practice Committee. Standards of medical care in
diabetes - 2013. Diabetes Care. 201336(1)
S11-S66.
45
Pharmacotherapy for Pre-Diabetes
  • Which of the following answers lists medications
    that can help prevent/delay the progress from
    pre-diabetes to diabetes?
  • A. Pioglitazone and Glipizide
  • B. Orlistat and Sitagliptin
  • C. Acarbose and Pioglitazone
  • D. Any of the above

46
Metformin for Pre-Diabetes
  • Can be considered for all patients with
    Pre-diabetes as adjunct to lifestyle modification
  • Especially recommend for patients with
  • Elevated FPG ( gt 100 mg/dL)
  • BMI gt 35 kg/m2
  • Aged lt 60 years old
  • History of GDM (women)

American Diabetes Association (ADA) Professional
Practice Committee. Standards of medical care in
diabetes - 2013. Diabetes Care. 201336(1)
S11-S66.
47
Progress.
  • LL follows recommendations from you and his other
    health care providers
  • He is able to quit smoking with nicotine patches
    and counseling, but during this time his weight
    goes up 2.5 kg
  • About 6 months later he begins a diet and
    exercise program for patients with Pre-Diabetes
  • He is able to loose 20 lbs but has been
    struggling to keep from gaining it back

48
Progress.
  • LL has tolerated Metformin therapy and is now
    taking 1 gram BID
  • He is exercising more, but he is still having
    difficulties balancing his diet
  • He was diagnosed with high blood pressure
  • Not currently on therapy - improved with smoking
    cessation and weight loss

49
8 years later.
  • He comes into the pharmacy today for his
    Metformin refill and reports bad news
  • Despite his lifestyle changes he has been
    diagnosed with type 2 diabetes
  • His A1c has reached 8.1 and he has had two FPGs
    gt 140 mg/dL drawn by the lab over 2 weeks
  • He is motivated to continue with his lifestyle
    changes, but wants to know more about additional
    medications

50
Adding on more medications
  • Individually take 1 minute to list additional
    diabetes therapies that could be added to LLs
    Metformin for better glycemic control
  • In pairs take a few minutes to discuss your
    options
  • Select and write down one agent/class that you
    would recommend for him based on his current
    status
  • Write down why you think it is a good choice for
    him

51
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?
  • A. The second agent added on should be a
    Glucagon-Like-Peptide-1 (GLP-1) receptor agonist
  • 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

52
A Patient Centered Approach
  • American Diabetes Association (ADA) and the
    European Association for the Study of Diabetes
    (EASD) 2012 recommendations
  • Patient be involvement in decision making
  • Patient factors be considered in selecting
    treatments and goals of therapy
  • Most add-on therapy will offer similar glycemic
    benefit, but compliance and risk of adverse
    events varies

Inzucchi SE, Bergenstal RM, Buse JB, et al.
Management of hyperglycemia in type 2 diabetes a
patient-centered approach, Position Statement by
the ADA and the EASD. Diabetes Care.
2012351364-79.
53
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 diabetes a
patient-centered approach, Position Statement by
the ADA and the EASD. Diabetes Care.
2012351364-79.
54
Inzucchi SE, Bergenstal RM, Buse JB, et al.
Management of hyperglycemia in type 2 diabetes a
patient-centered approach, Position Statement by
the ADA and the EASD. Diabetes Care.
2012351364-79.
55
Factors to Consider
  • Factors should also be considered in prescribing
    lifestyle modifications
  • Setting goals that are realistic
  • Adapting to patient situations
  • These may include
  • Access to healthful foods
  • Access to a safe environment for exercise
  • Patients physical ability (i.e. Fall risk,
    respiratory conditions)

56
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
  • A1C 10 or Blood glucose gt 300 mg/dL

Inzucchi SE, Bergenstal RM, Buse JB, et al.
Management of hyperglycemia in type 2 diabetes a
patient-centered approach, Position Statement by
the ADA and the EASD. Diabetes Care.
2012351364-79.
57
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?
  • A. The second agent added on should be a
    Glucagon-Like-Peptide-1 (GLP-1) receptor agonist
  • This may be appropriate for patients in whom
    weight gain is desirable, patient has insurance
    that will cover cost (reasonable copay), and
    patient feels comfortable with injectable therapy

Inzucchi SE, Bergenstal RM, Buse JB, et al.
Management of hyperglycemia in type 2 diabetes a
patient-centered approach, Position Statement by
the ADA and the EASD. Diabetes Care.
2012351364-79.
58
Oral Medication Options
  • Biguanides (metformin)
  • Sulfonylureas
  • Dipeptidyl peptidase IV (DPP-IV) inhibitor
  • Sitagliptin
  • Saxagliptin
  • Linagliptin
  • Alogliptin
  • Meglitinides
  • Thiazolidinediones (TZDs)
  • Only Pioglitazone
  • a-Glucosidase inhibitors
  • Acarbose, Miglitol,
  • Bile acid sequesterants
  • Colesevelam
  • Dopamine-2 agonists
  • Bromocriptine

59
New Oral Options
  • Sodium-Glucose Cotransporter 2 (SGLT2) inhibitors
  • Dapagliflozin (Forxgia)
  • 2011, FDA declined approval (concerns over risk
    of breast and bladder cancer)
  • July 2012 NDA resubmitted to FDA with new data
  • Has been approved in the EU, Australia, New
    Zealand, Mexico, and Brazil
  • Canagliflozin (Invokana) - approved earlier this
    year

60
New Oral Options
  • Sodium-Glucose cotransporter 2 (SGLT2) inhibitors
  • Lowers blood glucose by decreasing the amount of
    glucose re-absorbed by the kidneys
  • Canagliflozin (Invokana)
  • Moderate A1C reduction and weight reduction
  • Low incidence of hypoglycemia
  • Renal monitoring and dose adjustment

Invokana (package insert). Janssen
Pharmaceuticals, Inc. Titusville, NJ. March
2013 http//www.invokanahcp.com/. Accessed
08/28/13.
61
Canagliflozin (Invokana)
  • Approved for treatment of adults with type 2
    Diabetes in conjunction with lifestyle
    interventions
  • Initiate at 100 mg PO daily, before first meal of
    the day
  • Can increase to 300 mg PO daily if eGFR 60
    mL/min (if less max dose 100 mg/day)
  • Contraindicated with hypersensitivity, ESRD,
    dialysis
  • Avoid or discontinue if eGFR lt 45 mL/min
  • Additional Warnings include
  • Hypotension, hyperkalemia, hypoglycemia, mycotic
    genital infections, and increased LDL cholesterol

Invokana (package insert). Janssen
Pharmaceuticals, Inc. Titusville, NJ. March
2013 http//www.invokanahcp.com/. Accessed
08/28/13.
62
Canagliflozin (Invokana)
  • Significant Interactions
  • Rifampin (UGT inducers)
  • 50 decrease in AUC
  • Increased digoxin Cmax and AUC
  • Pharmacokinetics
  • 65 absorption
  • 99 protein bound in plasma
  • O-glucuronidation via UGT1A9 and UGT2B4 to
    inactive metabolites
  • 33 excreted in urine
  • 40 excreted unchanged in feces
  • Common Adverse Events ( 5)
  • Urinary track infections (UTIs)
  • Mycotic genital infections
  • Increased frequency and/or volume of urination
    and nocturia
  • Less common include
  • Hypersensitivity reaction
  • Constipation
  • Thirst

Invokana (package insert). Janssen
Pharmaceuticals, Inc. Titusville, NJ. March
2013 http//www.invokanahcp.com/. Accessed
08/28/13.
63
Injectable Medication Options
  • Insulins
  • Long acting, short acting, rapid acting, and
    premixes
  • Insulin Degludec - FDA declined approval
    requesting more data
  • Glucagon-like peptide - 1 receptor agonists
  • Exenatide, liraglutide
  • Albiglutide - may be next agent in class (FDA
    petition submitted by GlaxoSmithKline Jan 2013)
    proposed for once weekly injection
  • Amylin mimetics
  • Pramlintide - use with insulin mostly in
    patients with type 1 DM

64
Ultra-long Acting Insulin?
  • Insulin Degludec
  • Proposed to have gt 24 hour activity to give
    better once daily dose coverage than other
    products
  • Half-life 42 hours
  • FDA declined to approve as of Feb 2013
  • Requested more long term cardiovascular safety
    data from dedicated trial
  • Has been approved in the European Union

Tucker ME. FDA rejects Novo Nordisks Insulin
Degludec. Medscape News. Available at
http//www.medscape.com/viewarticle/779077
65
Injectable Agent Dosing
  • Which of the following answers correctly lists
    medication name, strength, and starting dose for
    a Glucagon-Like Peptide-1 (GLP-1) receptor
    agonist?
  • A. Liraglutide (Victoza) 0.6 mg injected SubQ
    once daily without regard to meals
  • B. Exenatide (Byetta) 5 mg injected SubQ BID 60
    minutes or less before a meal
  • C. Exenatide (Bydureon) 2 mg injected SubQ once
    weekly, must be with a meal
  • D. Both A and C are correct
  • E. A, B, and C are all correct

66
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
  • Variance is greater in incidence of hypoglycemia
    and other side-effects
  • For each patient must consider risk v. benefit of
    each medications positive and negative effects

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. 2011154602-13.
67
Inzucchi SE, Bergenstal RM, Buse JB, et al.
Management of hyperglycemia in type 2 diabetes a
patient-centered approach, Position Statement by
the ADA and the EASD. Diabetes Care.
2012351364-79.
68
Goals for therapy
  • Choosing an A1C goal for a patient should be
    individualized just like the therapy selected
  • Guidelines recommend lowering A1C to below or
    around 7 to reduce microvascular complications
    (range 6.5 - 8)
  • May also reduce macrovascular complications in
    some patients if implemented soon after diagnosis
  • For other patients, older, greater duration of
    disease, benefit of lower A1C may not outweigh
    risk of hypoglycemia
  • Variance in cardiovascular outcomes between large
    trials

Inzucchi SE, Bergenstal RM, Buse JB, et al.
Management of hyperglycemia in type 2 diabetes a
patient-centered approach, Position Statement by
the ADA and the EASD. Diabetes Care.
2012351364-79.
69
Brief on Trials for Tight Glycemic Control
  • UKPDS
  • Intensive Control associated with improved
    microvascular outcomes
  • ACCORD
  • Intensive therapy/targets increased mortality
    without significantly reducing cardiovascular
    events
  • ADVANCE
  • Intensive control resulted in relative reduction
    of combined major cardiovascular events and
    microvascular events
  • VADT
  • No significant effect on rates of major
    cardiovascular events, death, or microvascular
    complications

The Action in Diabetes and Vascular Disease
Preterax and Diamicron Modified Release
Controlled Evaluation (ADVANCE) Collaborative
Group. NEJM. 2008358(24)2560-72. Duckworth
W, Abraira C, Moritz T, et al. NEJM.
2009360(2)129-39.
Stratton IM, Adler AI, Neil HAW, et al. BMJ.
2000321405-12. The Action to Control
Cardiovascular Risk in Diabetes (ACCORD) Study
Group. NEJM. 2008358(24)2545-59.
70
Meta-analysis on tight glycemic control
  • Lancet 2009 based on 5 randomised trials
  • Intensive therapy reduces coronary events without
    an increased risk of death
  • Notes variance between populations and rate of
    A1C reduction
  • BMJ 2011 based on 14 randomised trials (used
    trial sequence analysis)
  • Intensive control has not been proven to reduce
    all cause mortality
  • Increase in relative risk of hypoglycemia by 30
  • Evidence insufficient to draw conclusions on
    cardiovascular mortality, non-fatal MI, composite
    microvascular complications, or retinopathy

Ray KK, Kondapally Seshasai S, Wijesuriya S, et
al. Lancet. 20093731765-72. Hemmingsen B, Lund
SS, Gluud C, et al. BMJ. 2011343d6898 Doi
10.1136/bmj.d6898.
71
Meta-analysis on tight glycemic control
  • BMJ 2011 based on 13 studies
  • Limited benefits to all cause mortality and
    cardiovascular-related death
  • Values on both sides of the debate can not be
    ruled out by this analysis
  • Risk and benefit for microvascular and
    macrovascular complications - inconclusive
  • Risk of harm with hypoglycemia noted
  • Need for more trials

Boussageon R, Bejan-Angoulvant T, Saadatian-Elahi
M, et al. BMJ. 2011343d4169 doi10.1136/bmj.d41
69.
72
What should be goal for LL?
  • What do you think we should set at LLs A1C goal?
  • How about other goals/plans?
  • Self-monitoring of blood glucose (SMBG)
  • Preventative Care
  • Cardiovascular risk reduction
  • Medical Nutrition Therapy (MNT)

73
Potential Plans for LL
  • A1C 7 (depending on response to therapy)
  • Check A1C at least twice per year
  • Check more often when changing therapies or above
    goal
  • Diabetes Self-Management Education (DSME) and
    support
  • Initial education plus follow-up
  • Education should address quality of life and
    psychosocial issues
  • May be recommended for patients with Pre-Diabetes
    as well

American Diabetes Association (ADA) Professional
Practice Committee. Standards of medical care in
diabetes - 2013. Diabetes Care. 201336(1)
S11-S66.
74
Potential Plans for LL
  • SMBG
  • Part of comprehensive DM education and care
    discussion with patient
  • 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
  • Goals and frequency should be individualized can
    consider
  • Fasting BG range 70 - 130 mg/dL
  • Peak Post-prandial BG lt 180 mg/dL (taken 1-2
    hours after meal)

American Diabetes Association (ADA) Professional
Practice Committee. Standards of medical care in
diabetes - 2013. Diabetes Care. 201336(1)
S11-S66.
75
Medical Nutrition Therapy
  • Weight loss (overweight/obese) and weight
    maintenance
  • Use of low carbohydrate, low fat
    calorie-restricted, or Mediterranean diet
  • Monitor lipids, renal function, and protein
    intake
  • Individual diet plan for intake of carbohydrates,
    proteins, and fats
  • Saturated fat lt 7 of total calories (9 calories
    per gram of fat) limit trans fats
  • Addition of physical activity (design to meet
    patients ability)
  • 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)
  • Specific vitamin supplementation not currently
    supported by evidence

American Diabetes Association (ADA) Professional
Practice Committee. Standards of medical care in
diabetes - 2013. Diabetes Care. 201336(1)
S11-S66.
76
Cardiovascular Prevention
  • Hypertension
  • New goal option of systolic lt 140 mmHg Diastolic
    lt 80 mmHg
  • Lower targets (lt 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)
  • Addition of diurectics or other agents may be
    required to reach goal

American Diabetes Association (ADA) Professional
Practice Committee. Standards of medical care in
diabetes - 2013. Diabetes Care. 201336(1)
S11-S66.
77
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
  • Over the age of 40 with 1 or more CVD risk
    factors
  • Family history of CVD, HTN, smoking, albuminuria,
    dyslipidemia

78
Cardiovascular Prevention
  • Hyperlipidemia
  • For lower risk individuals add statin if
  • Lifestyle changes alone do not reduce LDL to lt
    100 mg/dL
  • Patient has multiple CVD risk factors
  • If patients do not meet goals (see next slide) on
    maximum tolerated statin dosing
  • Alternative goal LDL reduction by 30 - 40 from
    baseline
  • Combination therapy has not been shown to have
    additional cardiovascular benefit

American Diabetes Association (ADA) Professional
Practice Committee. Standards of medical care in
diabetes - 2013. Diabetes Care. 201336(1)
S11-S66.
79
Cardiovascular Prevention
  • Hyperlipidemia
  • LDL Goals (primary target of therapy)
  • lt 100 mg/dL for patients without CVD
  • lt 70 mg/dL for patients with CVD
  • Triglyceride goal lt 150 mg/dL
  • HDL goal for men gt 40 mg/dL
  • HDL goal for women gt 50 mg/dL

American Diabetes Association (ADA) Professional
Practice Committee. Standards of medical care in
diabetes - 2013. Diabetes Care. 201336(1)
S11-S66.
80
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 gt 10)
  • Includes most men gt 50, women gt 60 with at least
    1 risk factor
  • For patients with lower risk (10 risk lt 5) with
    no risk factors - therapy is not recommended
  • For patients at moderate risk, must weigh risks
    and benefits
  • For secondary prevention, aspirin 81 mg is
    recommended
  • May use clopidogrel with documented aspirin
    allergy

American Diabetes Association (ADA) Professional
Practice Committee. Standards of medical care in
diabetes - 2013. Diabetes Care. 201336(1)
S11-S66.
81
General Prevention
  • Monitoring of renal function
  • Treatment of elevated urinary albumin excretion
    with ACE Inhibitors or ARBs
  • Eye exams yearly
  • Foot care and exams
  • Skin care
  • Vaccinations
  • Social support

American Diabetes Association (ADA) Professional
Practice Committee. Standards of medical care in
diabetes - 2013. Diabetes Care. 201336(1)
S11-S66.
82
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

83
Useful Abbreviations
ADA American Diabetes Association
A1c or A1c Hemoglobin A1c
FPG Fasting Plasma Glucose
OGTT Oral Glucose Tolerance Test
BG Blood Glucose
IFG Impaired Fasting Glucose
IGT Impaired Glucose Tolerance
DM Diabetes Mellitus
HTN Hypertension
HLD Hyperlipidemia
MI Myocardial Infarction
CAD Coronary Artery Disease
CVD Cardiovascular Disease
PAD Peripheral Artery Disease
TIA Transient Ischemic Attack
84
References
  • American Diabetes Association (ADA) Professional
    Practice Committee. Standards of medical care in
    diabetes - 2013. Diabetes Care. 201336(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/DiabetesReportCa
    rd.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/population-health/
    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. 2012351364-79.
  • 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. 2000321405-12.
  • The Action to Control Cardiovascular Risk in
    Diabetes (ACCORD) Study Group. Effects of
    intensive glucose lowering in type 2 diabetes.
    NEJM. 2008358(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. 2008358(24)2560-72.

85
References (continued)
  • Duckworth W, Abraira C, Moritz T, et al. Glucose
    control and vascular complications in veterans
    with type 2 diabetes. NEJM. 2009360(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.
    20093731765-72.
  • 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. 2011343d4169 doi10.1136/bmj.d416
    9.
  • 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. 2011343d6898 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.
    2011154554-9.
  • 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. 2011154602-13.
  • Matthews JE, Stewart MW, De Boever EH, et al.
    Pharmacodynamics, pharmacokinetics, safety, and
    tolerability of albiglutide, a long-acting
    glucagon-like peptide-1 mimetic, in patients with
    type 2 diabetes. J Clin Endocrinol Metab.
    2008934810-4817.
  • 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.
    20123791498-507.
  • 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. 201370311-9.
  • Tucker ME. FDA rejects Novo Nordisks Insulin
    Degludec. Medscape News. Accessed February 12,
    2013. Available at http//www.medscape.com/viewa
    rticle/779077
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