Transcript Table 1. Top 5 most relevant reasons

PDB147
WHY PHYSICIANS DO NOT FOLLOW AACE/ACE GUIDELINES IN TREATING
QUALIFIED PATIENTS WITH T2DM: A SURVEY STUDY IN THE UNITED STATES
Ying Qiu1, Qiong Li1, Jackson Tang2, Chun-Po Steve Fan 2, Zhiyi Li2, Mercedes Apecechea3, Ruth Hegar3, Ravi
Shankar1, Samuel S. Engel1
1 Merck
2 Asclepius
Sharp & Dohme Corp., New Jersey, USA
3 Kantar
Analytics Ltd., Hong Kong, Hong Kong
Objective
The American Association of Clinical Endocrinologists (AACE) guidelines
recommend initiating dual therapy with anti-hyperglycemic agents in
untreated patients with type 2 diabetes mellitus (T2DM) and an HbA1c
between 7.6% and 9%. In practice physicians do not always adhere to
guidelines. This study assessed reasons why physicians do not follow
AACE guidelines when treating qualified patients.
Background
• The AACE pharmacologic recommendations are stratified by baseline
HbA1c:
‒ 6.5 ~ 7.5%: Initiate monotherapy
‒ 7.6 ~ 9.0%: Initiate dual therapy (i.e. metformin based dual
therapy)
‒ > 9.0%: Initiate triple therapy or initiate insulin
• A recent study using GE EMR database found that only 7.6% of
patients with T2DM patients with an initial HbA1c of 7.6% to 9.0%
received the recommended dual therapy within 30 days after diagnosis
(Qiu et al., results presented at ADA 2012).
• Many potential barriers exist preventing qualified patients from
receiving the recommended treatment, including physician, patient,
system, and drug related reasons.
PCP patients
(N=4,940)
N
%
Physician related reasons
1. I recommend monotherapy before considering dual
therapy
Irrelevant
Neutral
Relevant
2. Metformin monotherapy is sufficient to improve
glycemic control
Irrelevant
Neutral
Relevant
3. Monotherapy is easier to handle than dual therapy
Irrelevant
Neutral
Relevant
4. I believe that monotherapy and changes in lifestyle
(e.g. physical activity and dietary change) are enough
for hyperglycemia control
Irrelevant
Neutral
Relevant
Patient related reasons
5. Patient has mild hyperglycemia
Irrelevant
Neutral
Relevant
8 patient-related reasons (e.g. “Patient has mild hyperglycemia”).
‒
1 system-related reason (e.g. “Insurance of the patient does not
cover the dual therapy medications”).
1 drug-related reason(e.g. “Long term safety profile of dual therapy
is not clear”).
• Top 5 reasons (≥50% of physicians rating the reason with a 4 or 5)
were identified.
• Association of each reason with physician specialty and age was
conducted using mixed-effect model controlling for physician
and patient characteristics.
Results
• 1,235 PCPs and 290 specialists participated in the study and
provided reviews for 5,995 patients (3,009 young and 2,986
elderly patients).
• 4 relevant reasons were related to physicians attitudes and
beliefs toward metformin monotherapy and dual therapy.
• 1 relevant reason related to physicians’ perception of patients’
glycemic level. (Table 1)
14.5%
16.6%
68.9%
3.75
1.09
2.
Metformin monotherapy is sufficient
to improve glycemic control
17.8%
13.9%
68.3%
3.66
1.10
3.
Monotherapy is easier to handle
than dual therapy
4.
I believe that monotherapy and
changes in lifestyle (e.g. physical
activity and dietary change) are
enough for hyperglycemia control
20.6%
21.9%
57.4%
3.53
3.47
1.15
1.12
Patient related reason
5.
Patient has mild hyperglycemia
26.2%
21.1%
52.7%
3.27
1.11
Table 1. Top 5 most relevant reasons (≥50% physicians answered
relevant) for not initiating dual therapy when appropriate
Specialist patients
(N=1,055)
P-value
Mean
SD
Physician related reasons
1.
I recommend monotherapy before considering
dual therapy
3.81
1.06
3.43
1.19
<.001
2.
Metformin monotherapy is sufficient to improve
glycemic control
3.70
1.08
3.51
1.16
<.001
3.
Monotherapy is easier to handle than dual
therapy
3.59
1.14
3.25
1.19
<.001
4.
I believe that monotherapy and changes in
lifestyle (e.g. physical activity and dietary
change) are enough for hyperglycemia control
3.52
1.10
3.21
1.17
<.001
3.26
1.11
3.31
1.09
0.275
Patient related reason
5.
Patient has mild hyperglycemia
3.21
305
243
507
1.17 <0.01
28.9%
23.0%
48.1%
3.26
1,311
1,039
2,590
1.11
26.5%
21.0%
52.4%
3.31
259
225
571
1.09 0.402
24.5%
21.3%
54.1%
Elderly patients
(65+)
(N=2,986)
Mean
SD
P-value
1.13
<.001
2.
Metformin monotherapy is sufficient to improve
glycemic control
3.74
1.04
3.59
1.14
<.001
3.
Monotherapy is easier to handle than dual therapy
3.57
1.13
3.48
1.18
0.007
4.
I believe that monotherapy and changes in lifestyle
(e.g. physical activity and dietary change) are
enough for hyperglycemia control
3.50
1.09
3.43
1.15
0.039
3.24
1.11
3.30
1.10
0.061
Patient has mild hyperglycemia
Physician related reasons
1. I recommend monotherapy before considering dual
therapy
Irrelevant
Neutral
Relevant
2. Metformin monotherapy is sufficient to improve
glycemic control
Irrelevant
Neutral
Relevant
3. Monotherapy is easier to handle than dual therapy
Irrelevant
Neutral
Relevant
4. I believe that monotherapy and changes in lifestyle
(e.g. physical activity and dietary change) are enough
for hyperglycemia control
Irrelevant
Neutral
Relevant
Patient related reasons
5. Patient has mild hyperglycemia
Irrelevant
Neutral
Relevant
Elderly patients
(65+)
(N=2,986)
N
%
Overall
P-value
3.81
362
479
2,168
1.06
12.0%
15.9%
72.1%
3.43
506
515
1,965
1.19 <0.01
16.9%
17.2%
65.8%
3.70
459
399
2,151
3.59
522
575
1,912
1.08
15.3%
13.3%
71.5%
1.14
17.3%
19.1%
63.5%
3.51
608
433
1,945
3.25
628
549
1,809
1.16 <0.01
20.4%
14.5%
65.1%
1.19 <0.01
21.0%
18.4%
60.6%
3.52
577
669
1,763
1.10
19.2%
22.2%
58.6%
3.21
660
646
1,680
1.17 0.019
22.1%
21.6%
56.3%
3.26
832
606
1,571
1.11
27.7%
20.1%
52.2%
3.31
738
658
1,590
1.09 0.020
24.7%
22.0%
53.2%
Table 5. Top 5 most relevant reasons (Young vs. Elderly, rating distribution)
• Mixed linear model also demonstrated that physician related
reasons were more relevant to PCPs and when treating younger
patients, after controlling for covariates and the hierarchical data
structure. (Table 6)
Patient related
reason
Physician related reasons
I recommend
monotherapy
before
considering
dual therapy
Variable
Metformin
monotherapy
is sufficient to
improve
glycemic
control
Monotherapy
is easier to
handle than
dual therapy
Estimate P-value Estimate P-value Estimate
I believe that
monotherapy
and changes
in lifestyle are
enough for
hyperglycemia
control
Patient has
mild
hyperglycemia
PPEstimate P-value Estimate
value
value
PCPs (vs.
Specialists)
0.36
<.001
0.18
0.006
0.37
<.001
0.33
<.001
-0.06
0.296
Age
(as continuous
variable)
-0.06
<.001
-0.04
<.001
-0.03
<.001
-0.02
0.025
0.02
0.011
Table 6. Regression from mixed effect models
Other covariates included in the mixed model:
 Physician: sex, age, race, years in clinical practice, practice region, practice type, institution setting, % time spent in
direct patient care, A1C as the decisive factor for the choice, treatment guidelines followed, and awareness of AACE
guideline
• 4 out of 5 of the top reasons were more relevant for PCPs than for
specialists. (Table 2, 3)
PCP patients
(N=4,940)
Mean
SD
1.10
18.9%
21.7%
59.4%
3.65
std
I recommend monotherapy before
considering dual therapy
62.1%
3.52
932
1,072
2,936
1.04
Summary
Statistics
1.
18.7%
1.16 <0.01
23.7%
13.8%
62.5%
1.19 <0.01
28.1%
20.2%
51.8%
3.84
Physician related reasons
19.2%
3.51
250
146
659
3.25
296
213
546
Young patients
(18 – 64)
(N=3,009)
N
%
‒
mean
1.08
16.5%
13.9%
69.6%
1.14
17.3%
18.4%
64.3%
Table 4. Top 5 most relevant reasons (Young vs. Elderly, average rating)
12 physician-related reasons (e.g. “Metformin monotherapy is
sufficient to improve glycemic control”).
Relevant
(Score = 4, 5)
3.70
817
686
3,437
3.59
854
911
3,175
I recommend monotherapy before considering
dual therapy
5.
• Physicians rated 22 reasons on a 5-point Likert scale on how
relevant each reason was for them in treating each specific
patient (1-most irrelevant; 5-most relevant).
Neutral
(Score = 3)
1.19
23.8%
19.2%
57.0%
Patient related reason
‒ The final analysis sample included 1,525 physicians and 5,995
patient records.
Irrelevant
(Score = 1, 2)
3.43
251
203
601
1.
‒ Physician characteristics, key patient characteristics, and lab
measures were collected.
Distribution of Responses
N=5,995
1.06
12.5%
16.0%
71.5%
Physician related reasons
‒ Each physician provided medical chart reviews for 4 randomly
selected patients who were diagnosed with an HbA1c between 7.6%
and 9.0% after Jan 1, 2010 and initiated with metformin
monotherapy after diagnosis.
Reasons
<0.01
3.81
617
791
3,532
Young patients
(18 - 64)
(N=3,009)
Mean
SD
‒ Primary care physicians (PCPs) and specialists were randomly
selected to participate in a web-based survey.
Overall
P-value
• 4 out of 5 of the top reasons were more relevant to physicians
when treating younger patients compared to treating older
patients. (Table 4, 5)
• An internet-based survey of a panel of U.S. physicians was
conducted from Nov 2012 to Jan 2013
‒
Specialist patients
(N=1,055)
N
%
Table 3. Top 5 most relevant reasons (PCPs vs. Specialists, rating distribution)
Methods
‒
Health GmbH, Munich, Germany
Table 2. Top 5 most relevant reasons (PCPs vs. Specialists, average rating)
 Patient: sex, race, BMI, disease duration, A1C, number of comorbid conditions and if any concomitant medication uses
Conclusion
• This survey study demonstrated that physicians consider a complex set
of reasons when deciding to prescribe monotherapy instead of dual
therapy to qualified T2DM patients, despite recommendations by the
AACE.
• It also demonstrates that physicians face significant internal barriers that
lead them to prescribe monotherapy instead of dual therapy to qualified
T2DM patients.
• 5 reasons (4 physician related, 1 patient related) were identified as most
relevant when physicians’ decided to not initiate dual therapy for
qualified patients.
• Reasons, in particular those that were physician related, were more
relevant among primary care physicians than specialists, and when
treating younger patients compared to elderly patients.
• Further research in treatment patterns should be conducted to support
and confirm findings.
Presented at the ISPOR 19th Annual International Meeting; Montreal, Canada, May 31 – June 4, 2014