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Patient adherence in type 2 diabetes: What’s the issue and how to address it Anthony Barnett University of Birmingham and Heart of England NHS Foundation Trust, UK

Patient adherence in type 2 diabetes: What’s the issue and how to address it

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Patient adherence in type 2 diabetes: What’s the issue and how to address it. Anthony Barnett University of Birmingham and Heart of England NHS Foundation Trust, UK. Prescribed regimen for 12 months Fully compliant for 12 months Fully persistent for 12 months Partially compliant - PowerPoint PPT Presentation

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Page 1: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Patient adherence in type 2 diabetes: What’s the issue and how

to address itAnthony Barnett

University of Birmingham and Heart of England NHS Foundation Trust, UK

Page 2: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Prescribed regimen for 12 months

Fully compliant for 12 months

Fully persistent for 12 months

Partially compliant

Non-persistent (stopped therapy before

12 months)

Non-compliant and non-persistent

Non-acceptance (does not start therapy)

Definition of compliance and persistenceCompliance: extent to which a patient acts in accordance with the prescribed interval and dose of dosing regimenPersistence: accumulation of time from initiation to discontinuation of therapyAdherence: encompasses both

Page 3: Patient adherence in type 2 diabetes: What’s the issue and how to address it

US population 2002. J Int Med Res. 2002;30:71.US population 2002. J Int Med Res. 2002;30:71.

So what really happens when you fill a prescription? PERSISTENCE

0

20

40

60

80

100

120

0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 100 104

Metformin monotherapySulphonylurea monotherapyM+SU polytherapy

Study period

Study groupa nPersistence

(in days)b

SDPersistence

rate (%)c

1 year Metformin (M) 4,033 183.8 142.7 51.06(360 days) Sulphonylurea

(SU)11,234 183.1 141.8 50.86

M+SU 661 111.1 117.4 30.862 YEARS Metformin 915 296.7 285.1 41.21

(720 days) Sulphonylurea 2983 274.3 276.5 38.10M+SU 158 121.9 186.9 16.93

Pers

iste

nt

pati

ents

(%

)

Weeks of therapy

Page 4: Patient adherence in type 2 diabetes: What’s the issue and how to address it

So what really happens when you fill a prescription? COMPLIANCE

US population 2002. J Int Med Res. 2002;30:71.US population 2002. J Int Med Res. 2002;30:71.

65.06 64.64

44.42

63.07 60.54

35.76

0

20

40

60

80

100

Pati

ents

rem

ain

ing

com

plia

nt

to t

hera

py

(%)

1 Year (360 days) 2 Years (720 days)

Metformin Sulphonylurea Metformin + Sulphonylurea

Study period

Study groupa n

Compliance

(in days)b

SDPersistence

rate (%)c

1 year Metformin (M) 4033 234.2 110.8 65.06(360 days) Sulphonylure

a (SU)11,234 232.7 113.6 64.64

M+SU 661 159.9 115.3 44.422 YEARS Metformin 915 454.1 232.2 63.07

(720 days) Sulphonylurea

2983 435.9 232.6 60.54

M+SU 158 257.5 228.2 35.76

Page 5: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Diabetes Audit and Research in Tayside Study (DARTS)• Study population

– All people with Type 2 Diabetes living in Tayside, Scotland (~420,000)

– First prescription for oral anti-diabetes drug from 1 January 1993 onward

– Follow-up to 31 December 1995 with at least 12 months of prescriptions

Donnan PT et al. Diabet Med. 2002;19:279-284.Donnan PT et al. Diabet Med. 2002;19:279-284.

Total time drug prescribed

Total time of follow-up

Total time drug prescribed

Total time of follow-up

= Adherence index= Adherence index

Page 6: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Adherence index by type of therapy

Monotherapy Sulphonylurea 31Metformin 34

Polytherapy Sulphonylurea 19Metformin 13

Donnan PT et al. Diabet Med. 2002;19:279-284.Donnan PT et al. Diabet Med. 2002;19:279-284.

Page 7: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Retrospective, cohort study of community pharmacy records

(N=2,325)

Once the patient has ACCEPTED treatment, is everything fine?

Van Wijk et al. J Hypertens. 2005;23:2101-2107.Van Wijk et al. J Hypertens. 2005;23:2101-2107.

0 1 2 3 4 5 6 7 8 9 10

Years after first prescription

Con

tin

uou

s h

yp

ert

en

siv

e u

sers

(%

)

MenWomen

00

1010

2020

3030

4040

5050

6060

7070

8080

9090

100100

Page 8: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Sokol et al. Med Care. 2005;43:521-530.Sokol et al. Med Care. 2005;43:521-530.

Level of compliance (%)

All-c

au

se h

osp

italisati

on

ri

sk (

%)

44

3936

3027

0

10

20

30

40

1-19 20-39 40-59 60-79 80-100

Does it matter?Lessons from hypertension: improved outcome

Page 9: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Odds ratio = 1.45.*P = 0.026 (controlling for age, gender, and co-morbidities).

Does it matter?Lessons from hypertension: improved BP control

Bramley et al. J Manag Care Pharm. 2006;12:239-245.Bramley et al. J Manag Care Pharm. 2006;12:239-245.

10

40

30

20

Medium(50%–79%)

Low(< 50%)

Compliance (measured using MPR)

Pati

en

ts w

ith

BP

con

trol*

(%

)

0

**

42%42%

33%33%

32%32%

High(≥ 80%)

High(≥ 80%)

Page 10: Patient adherence in type 2 diabetes: What’s the issue and how to address it

BUT for type 2 diabetes it can be difficult

• Progressive disease• Multi-system disease with co-morbidities—

polypharmacy!• Complex guidelines• Unmet needs of pharmacotherapies

Page 11: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Progressively declining beta cell function in T2D‘waiting for failure’

Adapted from: Heine RJ et al. BMJ. 2006;333:1200-1204.Adapted from: Heine RJ et al. BMJ. 2006;333:1200-1204.

100

00

HbA1c

ß-cell function

Lifestyle Monotherapy Dualtherapy

Insulin ±oral drugs for lowering

blood glucose

Time (years)

ß-c

ell f

un

cti

on

(%

) Hb

A1

c (%

)

8

>15

5

6

7

9

0

10

Page 12: Patient adherence in type 2 diabetes: What’s the issue and how to address it

The treatment complexity in type 2 diabetes drives non-adherence to management strategiesMedication for Complex Diabetes

A 42-year-old woman’s regimen for treating complex diabetes includes…

• At least 15 types of oral medication• 2 over-the-counter products• 7 to 10 injections• 4 blood tests

…per day, costing over $1,800 a month retail

Source: Dr. John Buse, The New York TimesSource: Dr. John Buse, The New York Times

Page 13: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Mild to moderate hyperglycaemia (HbA1C <9.0%)

Overweight(BMI ≥ 25 kg/m2)

Non-overweight(BMI < 25 kg/m2)

Biguanide alone or incombination with 1 of:

•insulin sensitizer•insulin secretagogue

•insulin•alpha-glucosidase inhibitor

1 or 2 anti-hyperglycaemicagents from different classes

•biguanide•insulin sensitizer•insulin secretagogue•insulin•alpha-glucosidase

inhibitor

Add a drug from a different classor use insulin alone or in combination with:•biguanide•insulin

secretagogue•insulin sensitizer•alpha-glucosidase

inhibitor

Marked hyperglycaemia (HbA1C ≥9.0%)

2 anti-hyperglycaemic agentsfrom different classes

•biguanide•insulin sensitizer•insulin

secretagogue•insulin•alpha-glucosidase

inhibitor

Basal and/orpre-prandial insulin

Add an oralanti-hyperglycaemic agent

from a differentclass or insulin

Intensify insulinregimen or add

•biguanide•insulin

secretagogue•insulin sensitiser•alpha-glucosidase

inhibitor

If not at target

Timely adjustments to and/or additions of oral anti-hyperglycaemic agents and/or insulin should be made to attain target HbA1C within 6 to 12 months

Timely adjustments to and/or additions of oral anti-hyperglycaemic agents and/or insulin should be made to attain target HbA1C within 6 to 12 months

L

I

F

E

S

T

Y

L

E

Current treatment paradigms for type 2 diabetes are not “user-friendly”

If not at target If not at target If not at target

Page 14: Patient adherence in type 2 diabetes: What’s the issue and how to address it

*Physicians were asked to indicate key areas. †Patients were asked to choose top three most important areas.*Physicians were asked to indicate key areas. †Patients were asked to choose top three most important areas.

0

5

10

15

20

25

30

35

40

0 5 10 15 20 25 30

Patients’ Need for Improvement†

Percent

Weight loss

HbA1c

Hypoglycaemia

Ease of Use

Reasons for choice†

Percent

0

5

10

15

20

25

30

35

40

0 10 20 30 40 50 60 70 80 90 100

Physicians’ Need for Improvement*Percent

Reasons for choice*Percent

HbA1cPreserves beta cell function

Weight loss

Cost

GI side effect profile

Unmet patient & physician needs in the treatment of type 2 diabetes in Europe

Page 15: Patient adherence in type 2 diabetes: What’s the issue and how to address it

1. Xingbao C. Chinese Health Economics. 2003. Ling T. China Diabetic Journal. 2003. 2. Harris SB et al. Diabetes Res Clin Pract. 2005;70:90-97. 3. Lopez Stewart G et al. Rev Panam Salud Publica. 2007;22:12-20. 4. Saydah SH et al. JAMA. 2004;291:335-342. 5. Liebl A et al. Diabetologia. 2002;45:S23-S28.

1. Xingbao C. Chinese Health Economics. 2003. Ling T. China Diabetic Journal. 2003. 2. Harris SB et al. Diabetes Res Clin Pract. 2005;70:90-97. 3. Lopez Stewart G et al. Rev Panam Salud Publica. 2007;22:12-20. 4. Saydah SH et al. JAMA. 2004;291:335-342. 5. Liebl A et al. Diabetologia. 2002;45:S23-S28.

US(NHANES)4

HbA1c < 7%

37%

63%

Europe(CODE-2)5

HbA1c < 6.5%

31%

69%Canada(DICE)2

HbA1c < 7%

51%49%

China(CODIC-2)1

HbA1c < 7.5%

68%32%

Latin America(DEAL)3

HbA1c

<7%

43%57%

RESULT: Patients often fail to achieve glycaemic targets

Achieving glycaemic targetAchieving glycaemic target

Failed to achieve glycaemic targetFailed to achieve glycaemic target

Page 16: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Grant RW et al. Diabetes Care. 2003;26:1408-1412.Grant RW et al. Diabetes Care. 2003;26:1408-1412.

Side effectsDifficulty in rememberingdoses

Cost

Others*

Only 23% of patients who had side effects reported the problems to their primary care physician

Most common factors related to non-adherence in patients with type 2 diabetes

*Number of prescribed medications, patient characteristics

N=128 patients with Type 2 Diabetes.

Page 17: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Adherence to oral anti-diabetes agents

Literature search to determine extent of omitted oral anti-diabetes agentsLiterature search to determine extent of omitted oral anti-diabetes agents

Cramer J. Diabetes Care. 2004;27:1218-1224.Cramer J. Diabetes Care. 2004;27:1218-1224.

79.1

65.6

38.1

0

10

20

30

40

50

60

70

80

90

100

Perc

en

tage o

f pati

ents

re

main

ing

com

plia

nt

to

thera

py

Once-daily regimens

Twice-daily regimens

Three times daily

regimens

Page 18: Patient adherence in type 2 diabetes: What’s the issue and how to address it

UKPDS 34. Lancet. 1998:352:854-865. n=at baseline; Kahn et al (ADOPT).

N Engl J Med. 2006;355(23):2427-2443.

UKPDS 34. Lancet. 1998:352:854-865. n=at baseline; Kahn et al (ADOPT).

N Engl J Med. 2006;355(23):2427-2443.

Most current therapies promote weight gain

Years from randomization

Change in w

eig

ht

(kg)

0

1

5

8

7

6

4

3

2

UKPDS: up to 8 kg in 12 years

Glibenclamide (n=277)

Insulin (n=409)

Metformin (n=342)

0 3 6 9 12

Conventional treatment (n=411); diet initially then sulphonylureas, insulin, and/or metformin if FPG > 15 mmol/L

ADOPT: up to 4.8 kg in 5 years

Weig

ht

(kg)

Annualized slope (95% CI)Rosiglitazone, 0.7 (0.6 to 0.8)Metformin, -0.3 (-0.4 to -0.2)Glibenclamide, -0.2 (-0.3 to 0.0)

Years0 1 2 3 4 5

96

92

88

0

100 Treatment difference (95% CI)Rosiglitazone vs metformin 6.9 (6.3 tp 7.4); P<0.001Rosiglitazone vs glibenclamide, 2.5 (2.0 to 3.1); P<0.001

Glibenclamide (n=1,441)

Rosiglitazone (n=1,456)

Metformin (n=1,454)

Page 19: Patient adherence in type 2 diabetes: What’s the issue and how to address it

HypoglycaemiaThe major limiting factor to achieving intensive

glycaemic control for people with type 2 Diabetes

Briscoe VJ et al. Clin Diab. 2006;24:115-121.Briscoe VJ et al. Clin Diab. 2006;24:115-121.

Page 20: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Clinical consequences of hypoglycaemia

• Hospital admissions:– Prospective study1 of well-controlled elderly T2D patients

—25% of hospital admissions for diabetes for severe hypoglycaemia

• Increased mortality:– 9% in a study2 of severe SU-associated hypoglycaemia

• Road accidents caused by hypoglycaemia events3:– 45 serious events per month

1. Diab Nutr Metab. 2004;17:23-26. 2. Horm Metab Res Suppl. 1985;15:105-111. 3. BMJ. 2006;332:812.1. Diab Nutr Metab. 2004;17:23-26. 2. Horm Metab Res Suppl. 1985;15:105-111. 3. BMJ. 2006;332:812.

Page 21: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Multicentre study funded by Dept for Transport

Determine the frequency of hypoglycaemia in type 2 Diabetes treated with SUs and insulin for differing duration

Compare frequencies with type 1 Diabetes

Prospective study over 9-12 months of patients with good glycaemic control

Documented severe and mild hypoglycaemia prospectively, supplemented with CGM x 2

UK Hypoglycaemia Study Group. Diabetologia. 2007;50:1140-1147.UK Hypoglycaemia Study Group. Diabetologia. 2007;50:1140-1147.

Page 22: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Hypoglycaemia in type 2 diabetes:sulphonylureas vs insulin• In patients treated for < 2 years, no difference in

the proportion of patients experiencing:– severe hypoglycaemia (7% vs 7%)– mild symptomatic (39% vs 51%)– interstitial glucose < 2.2 mmol/L (22% vs 20%)

UK Hypoglycaemia Study Group. Diabetologia. 2007;50:1140-1147.UK Hypoglycaemia Study Group. Diabetologia. 2007;50:1140-1147.

Page 23: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Hypoglycaemia in type 2 diabetes

• Hypoglycaemia symptoms common in type 2 diabetes, occurring in up to 38% of patients1

• Hypoglycaemia is associated with : – Reduced “quality of life”– Reduced treatment satisfaction– Reduced therapy adherence– More common at HbA1c <7%

1. Diab Obes and Metab. 2008;Suppl 1:25-32.1. Diab Obes and Metab. 2008;Suppl 1:25-32.

Page 24: Patient adherence in type 2 diabetes: What’s the issue and how to address it

1. Asian-Pacific Type 2 Diabetes Policy Group. 4th Edition. 2005:1-58. 2. Henderson JN et al. Diabet Med. 2003;20:1016-1021. 3. Matyka K et al. Diabetes Care. 1997;20(2):135-141. 4. Miller CD et al. Arch Intern Med. 2001;161:1653-1659. 5. Wright et al. J Diabet Complicat. 2006;20:395-401. 6. Chico A et al. Diabetes Care. 2003;26(4):1153-1157. 7. Canadian Diabetes Association Clinical Practice Guidelines Expert Committee. Can J Diabet. 2008;32(suppl 1):S62-S64. 8. California Healthcare Foundation. J Am Ger Soc. 2003;51(Suppl 5):S265-S280. 9. Amiel SA et al. Diabet Med. 2008;25(3):245-254. 10. Salti L. Diabetes Care. 2004.

1. Asian-Pacific Type 2 Diabetes Policy Group. 4th Edition. 2005:1-58. 2. Henderson JN et al. Diabet Med. 2003;20:1016-1021. 3. Matyka K et al. Diabetes Care. 1997;20(2):135-141. 4. Miller CD et al. Arch Intern Med. 2001;161:1653-1659. 5. Wright et al. J Diabet Complicat. 2006;20:395-401. 6. Chico A et al. Diabetes Care. 2003;26(4):1153-1157. 7. Canadian Diabetes Association Clinical Practice Guidelines Expert Committee. Can J Diabet. 2008;32(suppl 1):S62-S64. 8. California Healthcare Foundation. J Am Ger Soc. 2003;51(Suppl 5):S265-S280. 9. Amiel SA et al. Diabet Med. 2008;25(3):245-254. 10. Salti L. Diabetes Care. 2004.

Type 2 diabetes: greatest risk of hypoglycaemia• Use of insulin and sulphonylureas1

• Older people2,3

• Long-duration diabetes2

• Irregular eating habits4 • Exercise4

• Periods of fasting4 (eg, Ramadan)• Have lower HbA1c5

• Prior hypoglycaemia6-8

• Hypoglycaemia unawareness9

• Excessive alcohol use10

Page 25: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Elderly Men Without Diabetes

Matyka K et al. Diabetes Care. 1997;20(2):135-14.Matyka K et al. Diabetes Care. 1997;20(2):135-14.

Hypoglycaemic clamp study of healthy men– symptom recognition is lower in older men

Time, min

Ch

an

ge in

Tota

l Sym

pto

m

Score

Pla

sm

a G

lucose,

mg

/dL

200–4036

54

72

90

108

0 40 80 120 1600

14

12

10

8

6

4

2

Glucose infusion

maintained at

5 mmol/L

Glucose infusion reduced

stepwise from 5 to 2.4 mmol/L

Glucose infusion

restored to

5 mmol/L

Young Men Without Diabetes

Page 26: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Wright et al. J Diabet Complicat. 2006;20:395-401.Wright et al. J Diabet Complicat. 2006;20:395-401.

Rates of hypoglycaemia increase as HbA1c levels decrease in patients with type 2 diabetes on OADs

0

10

20

30

40A

nn

ual ra

te,

%

0 4 5 6 7 8 9 10 11

Most recent HbA1c, %

Page 27: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Awareness of hypoglycaemia

• Recognition of warning symptoms fundamental for self-treatment and preventing progression to severe hypoglycaemia1

• Even mild hypoglycaemia induces defects in counter-regulatory responses and impaired awareness2

• Impaired awareness predisposes to 6-fold increase in the frequency of severe hypoglycaemia3

• Only 15% of type 2 diabetes patients who experienced a hypoglycaemic event reported the incident to their doctor1,4

1. McAulay V et al. Diabet Med. 2001;18:690-705. 2. Amiel SA et al. Diabetic Med. 2008;25:245-254. 3. Gold AE et al. Diabetes Carem. 1994;17:697-703. 4. Leiter LA et al. Can J Diabetes. 2005;29(3):186-192.

1. McAulay V et al. Diabet Med. 2001;18:690-705. 2. Amiel SA et al. Diabetic Med. 2008;25:245-254. 3. Gold AE et al. Diabetes Carem. 1994;17:697-703. 4. Leiter LA et al. Can J Diabetes. 2005;29(3):186-192.

Page 28: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Brain damage

Sweating, tremor

4

3

2

1

Blood glucose (mmol/L)

Start of brain dysfunction

Confusion/loss of concentration

Adrenaline release

Coma/seizure

Normal physiological response to hypoglycaemia

Page 29: Patient adherence in type 2 diabetes: What’s the issue and how to address it

4

3

2

1

Confusion/loss of concentration

Sweating, tremor

Start of brain dysfunction

Coma/seizure

Impaired physiological response and unawareness

Adrenaline release

Blood glucose (mmol/L)

Brain damage

Page 30: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Potential mechanisms of hypoglycaemia-induced mortality• Cardiac arrhythmias due to abnormal cardiac

repolarization in high-risk patients (IHD, cardiac autonomic neuropathy)

• Increased thrombotic tendency/decreased thrombolysis

• Cardiovascular changes induced by catecholamines– Increased heart rate– Silent myocardial ischaemia– Angina and myocardial infarction

Page 31: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Effect of experimental hypoglycaemia on QT interval

5.0 mM

QTc = 456 ms

HR = 66 bpm

A

2.5 mM

QTc = 610 ms

HR = 61 bpm

B

Page 32: Patient adherence in type 2 diabetes: What’s the issue and how to address it

What can we do?

• Progressive disease: need for therapies that influence natural history of the disease

• Polypharmacy: education, multi-disciplinary support, FDCs

• Simplify guidelines• Better tolerated drugs: low risk of hypoglycaemia/

weight neutral or weight loss

Page 33: Patient adherence in type 2 diabetes: What’s the issue and how to address it

The ‘ideal’ drug for type 2 diabetes

• Safe • Efficacious• Durable control• Well tolerated• Low risk of hypoglycaemia• Weight neutral or weight loss

Incretin based therapies come close to this but long-term safety and outcome

data are awaited

Incretin based therapies come close to this but long-term safety and outcome

data are awaited

Page 34: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Fixed-dose combination therapy meta-analysis of cardiovascular drugs and adherence

Amer J Med. 2007;120:713-719.Amer J Med. 2007;120:713-719.

.1.1 11 1010Risk ratioRisk ratio Publication Bias

(Egger’s) P=0.43Publication Bias

(Egger’s) P=0.43Favours Fixed Dose

CombinationsFavours Fixed Dose

CombinationsFavours Free Drug

CombinationsFavours Free Drug

CombinationsHeterogeneity chi2=14.49 (P=0.07)Heterogeneity chi2=14.49 (P=0.07)

Overall

0.74 (0.69, 0.80)

0.74 (0.67, 0.81)

0.89 (0.51, 1.57)

0.81 (0.77, 0.86)

0.47 (0.22, 1.01)

0.50 (0.35, 0.71)

0.88 (0.55, 1.42)

0.78 (0.55, 1.11)

0.71 (0.62, 0.80)

0.74 (0.65, 0.84)

Risk ratio(95% Cl)

100.0Overall

22.1Taylor AA et al, 2003

1.8Taylor AA et al, 2003

29.0NDC Dataset, 2003

1.0Melikian C et al, 2002

4.2Melikian C et al, 2002

2.5Geiter LJ et al, 1987

4.3Eron JJ et al, 2000

17.6Dezii CM et al, 2000

17.5Dezii CM et al, 2000

% WeightStudy

Page 35: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Compliance = days supplied/total days.Modified from Melikian C et al. Clin Ther. 2002;24:460-467.Modified from Melikian C et al. Clin Ther. 2002;24:460-467.

Compliance decreases when switching to non-FDC therapy

Monotherapy(n=33,567)

Switched toFDC

(Glyburide/Metformin)

Switched toNon-FDC

(Glyburide+ Metformin)

Com

plian

ce r

ate

(%

)

8277

54

0

20

40

60

80

100

(n = 105)

(n = 1,815)

(n = 33,567)

Page 36: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Fixed-dose combination therapy and diabetes:compliance with >6,000 US patients over 6 months

Clin Ther. 2002;24:3.Clin Ther. 2002;24:3.

Ad

here

nce r

ate

(%

)

Comparison of adjusted adherence rates in patients receiving metformin and glyburide combination therapy and those receiving fixed-dose glyburide/metformin combination therapy. *P = 0.001.

77

54

0

10

20

30

40

50

60

70

80

90

Metformin and Glyburide Glyburide/Metformin

**

Page 37: Patient adherence in type 2 diabetes: What’s the issue and how to address it

FDA on fixed-dose combination therapy (2005) – advantages• Advantages of fixed-dose combination drug

therapy:– Better adherence to a therapeutic regimen– Patient convenience– Economy (cost savings)– Generation of information regarding drug compatability

and drug interactions

Federal Register. 1971;36(33):3126-3127. Am J Cardiol. 2005;96:28K-33K.Federal Register. 1971;36(33):3126-3127. Am J Cardiol. 2005;96:28K-33K.

Page 38: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Fixed-dose combination therapy – conclusions• In many conditions, including diabetes,

combination therapy is inevitable• Poor adherence is common and significantly affects

outcome• FDC reduce non-adherence by ~25%• FDC may improve long-term outcomes and makes

life easier for the adherent

Page 39: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Improving adherence

• We have or will have:– Better tolerated drugs with low risk of hypoglycaemia and

weight gain, even weight loss!– Fixed-dose combinations for some– Possibility of once-weekly injectables coming through

The missing link:good rapport between patient, family, and healthcare professionals, including multi-

professional support

Page 40: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Diagnosis of Type 2 Diabetes = loss of patient’s accustomed state of health

Patient’s willpower and ability to improve outcomes depend on degree of acceptance of the serious nature of their condition

Relationship between patient and healthcareprofessionals critical in this process

Lacroix A et al. Schweiz Rundsch Med Prax. 1993;82:1370-1372.Lacroix A et al. Schweiz Rundsch Med Prax. 1993;82:1370-1372.

Helping patients to accept their condition andadhere to a management plan

Page 41: Patient adherence in type 2 diabetes: What’s the issue and how to address it

“I don’t really monitor my blood glucose levels. It doesn’t seem that important.

The physician never asks me my numbers or measurements, so why am I doing it?”

“My healthcare professional has helped me understand my blood glucose results and the importance of regular testing.

I feel more in control of my diabetes.”

The need for good patient-healthcare professional rapport is essential to driving treatment adherence

Page 42: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Motivating patients to achieve and maintain glycaemic control will drive treatment adherence

Heisler M et al. Diabetes Care. 2005;28:816-822.Heisler M et al. Diabetes Care. 2005;28:816-822.

“This is great news.Continue with the good

work and keep your blood sugar under control – you’ll feel better

for it!”

“I’ve reached my glucose target by eating properly,exercising more, and taking my medicine.”

Page 43: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Establish a partnership between the patient and the healthcare professional

Discuss importance of implementing

change

Build confidence that change is

possible

Establish rapport

Agree on mutual agenda

Work together to:

Reduceresistance to change

Exchangeinformation

Page 44: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Challenges in improving patient understanding

35% recalled receiving advice about their medication

15% knew the mechanism of action of their therapy

10% taking sulphonylureas knew that they could cause hypoglycaemia

20% taking metformin knew it could cause GI side effects

Patient knowledge of oral anti-diabetes agents

Browne DL et al. Diabet Med. 2000;17:528-531.Browne DL et al. Diabet Med. 2000;17:528-531.

Expectations regarding side effects should be appropriately managed

Page 45: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Outcome Weight (lbs) % Reduction

Initial consultationN = 60 Obese Women

218 0

Dream 135 38

Happy 150 31

Acceptable 163 25

Disappointed 180 17

Foster et al. J Consult Clin Psychol. 1997;65:79.Foster et al. J Consult Clin Psychol. 1997;65:79.

Treatment adherence can only be achieved by ensuring appropriate treatment goals

Unrealistic weight loss goals in obese patients seeking treatment

Page 46: Patient adherence in type 2 diabetes: What’s the issue and how to address it

A multi-disciplinary team has a significant impact on glycaemic control and hospital admissions

HbA1c

-1.4

-1.2

-1.0

-0.8

-0.6

-0.4

-0.2

0

Multi-disciplinary team

Control

Ch

an

ge in

Hb

A1

c f

rom

baselin

e (

%)

Sadur CN et al. Diabetes Care. 1999;22:2011-2017.Sadur CN et al. Diabetes Care. 1999;22:2011-2017.

Multi-disciplinary team

Control

30

25

20

15

10

5

0

Hosp

italiza

tion

s/1

,00

0 p

ers

on

-mon

ths

Hospitalizations

Page 47: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Variable Period of time after attending education courses

0 months 12 months

FPG (mmol/L) 10.2 8.7*

HbA1c (%) 8.9 7.8*

Body weight (kg) 83.0 81.0*

Systolic BP (mmHg) 154.0 143.0*

Diastolic BP (mmHg) 95.0 87.0*

Cholesterol (mmol/L) 6.2 5.4*

Triglycerides (mmol/L) 2.8 2.1*

Impact of implementing an educational program via a multi-disciplinary team

*Significant improvement versus 0 months.

Gagliardino JJ et al. Diabetes Care. 2001;24:1001-1007.Gagliardino JJ et al. Diabetes Care. 2001;24:1001-1007.

Page 48: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Clear benefits of a multi-disciplinary team approach in type 2 diabetes care

1. Codispoti C et al. J Okla State Med Assoc. 2004;97:201-204. 2. Gagliardino JJ et al. Diabetes Care. 2001;24:1001-1007.1. Codispoti C et al. J Okla State Med Assoc. 2004;97:201-204. 2. Gagliardino JJ et al. Diabetes Care. 2001;24:1001-1007.

Improvedglycaemic control1,2

Improved quality of life1

Improved patient follow-up1

Higher patient satisfaction1

Decreased healthcare costs2

Lower risk of complications2

Improved treatment adherence1,2

Decreased CV risk2

Page 49: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Personalized care is paramount

• When dealing with a complex chronic disease such as type 2 diabetes:

“. . . the guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer, and informed by the summary of product characteristics of any drug they are considering.”

NICE Clinical Guidelines for the Management of Type 2 Diabetes. May 2009.NICE Clinical Guidelines for the Management of Type 2 Diabetes. May 2009.

Page 50: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Need for personalized care: the benefits versus risks of diabetes therapy must be assessed for each patient

Tolerability/Side Effects Improved Outcomes

β-cell deterioration

CV riskGlycaemic Control

Hypo

Poor management/ inertia

Weight gain

Page 51: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Personalised care in type 2 diabetes

• The healthcare professional must agree with the individual patient on their glycaemic target, how this can be achieved, and measures of success

Guidelines are guidelines, not absolutes

Page 52: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Summary and conclusions• Patient adherence to agreed management plans is

the major challenge in type 2 diabetes• Poor adherence is due to many factors, including:

– tolerability issues, complexity of the disease and its co-morbidities,lack of knowledge and support

• Therapeutic advances can help with the problem of adherence:– modern drugs may be better tolerated with lower risk of

hypoglycaemia and weight gain– increasing availability of fixed-dose combination therapies

• Multi-disciplinary care and a good relationship between the patient and healthcare professionals can improve long-term outcomesPersonalized care should be the

cornerstone of good diabetes management

Page 53: Patient adherence in type 2 diabetes: What’s the issue and how to address it

Patient adherence in type 2 diabetes: What’s the issue and how

to addressAnthony Barnett

University of Birmingham and Heart of England NHS Foundation Trust, UK