Read the article and make a powerpoint

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Read the article and make a power point addressing all the points in the grading evaluation and use the presentation I had started and answer all the questions posted for the evaluation.

PHAR 9942 / PSCI 6602 JOURNAL CLUB ACTIVITY GRADING EVALUATION
Presenter:_______________________________________________
Date:_____________
Reviewer:_______________________________________________
STYLE / PRESENTATION
2 points
Presentation
Exhibited professional appearance and
demeanor, and spoke clearly throughout
the presentation
Mannerisms
Eye Contact
Slides
Handout
TOTAL
Comments
Adapted from Am J Pharm Educ. 2007;71(4):Article 63.
1 point
SOMEWHAT exhibited professional
appearance and demeanor, was difficult
to hear or understand SOME things
spoken
Few (or no) distracting mannerisms
(e.g., um)
Maintained eye contact throughout the
presentation
Slides were organized, easy to read, and
aesthetically pleasing
Handout was organized, easy to read,
and aesthetically pleasing
0 points
Did NOT exhibit professional
appearance and demeanor, was difficult
to hear or understand MOST things
spoken
Score
/2
Had distracting mannerisms
/1
Did NOT maintain eye contact
/1
Slides were NOT organized and difficult
to read
Handout was NOT organized and
difficult to read
/1
/1
/6
PHAR 9942 / PSCI 6602 JOURNAL CLUB ACTIVITY GRADING EVALUATION
CONTENT / CRITICAL EVALUATION
Study Overview
Introduction
– Authors’ affiliations/study support
– Study objective(s) & rationale
Methods – Design
– Case-control, cohort, controlled experiment, etc.
– Type of design (cross-over, parallel, etc.)
– Type of assignment used
– Blinding
Methods – Patients/Subjects
– How enrolled/from where?
– Inclusion/exclusion criteria
– # enrolled per group
Methods – Treatment Regimen
– Treatments used
– Dosages/administration
– Therapy duration
Methods – Outcome Measures
– Primary measures
– Secondary measures
Methods – Data Handling
– Intention to treat, per protocol, etc.
– # lost to follow-up
– Reasons for dropouts
Methods – Statistics
– Tests used
– Power of study
Results
– Results for each outcome measure
– Confidence intervals
– P-values
– Compliance
– Adverse effects
Conclusion – Authors’ conclusion
Adapted from Am J Pharm Educ. 2007;71(4):Article 63.
2 points
1 point
0 points
Score
Accurately and completely
reported ALL relevant
introduction, study design,
and patients/subject
components
Accurately and completely
reported MOST of the
relevant introduction, study
design, and patients/subject
components
Did NOT accurately and
completely report most of
the relevant introduction,
study design, and
patients/subject
components
/2
Accurately and completely
reported ALL relevant
treatment regimens,
outcome measures, and
data handling components
Accurately and completely
reported MOST of the
relevant treatment
regimens, outcome
measures, and data
handling components
Did NOT accurately and
completely most of the
relevant treatment
regimens, outcome
measures, and data
handling components
/2
Accurately and completely
reported ALL relevant
statistics, results, and
authors’ conclusion
components
Accurately and completely
reported MOST of the
relevant statistics, results,
and authors’ conclusion
components
Did NOT accurately and
completely most of the
relevant statistics, results,
and authors’ conclusion
components
/2
PHAR 9942 / PSCI 6602 JOURNAL CLUB ACTIVITY GRADING EVALUATION
STUDY OVERVIEW TOTAL
/6
Comments
Analysis
Analyzed
all parts of
study
4 points
ALL parts
appropriately
critiqued with ALL
relevant questions
accurately addressed
with strengths,
weaknesses and their
impact described
3 points
Missed only ONE or
TWO considerations
or relevant questions
in critique, with the
rest appropriately
addressed with
strengths,
weaknesses, and their
impact described
TOTAL
Comments
Adapted from Am J Pharm Educ. 2007;71(4):Article 63.
2 points
1 point
0 points
MOST parts
appropriately
critiqued, some
relevant questions
with strengths,
weaknesses, and their
impact overlooked or
inaccurate
Only SOME parts
appropriately
critiqued, most
relevant questions
with strengths,
weaknesses, and their
impact overlooked or
inaccurate
Failed to
appropriately critique
any part, all relevant
questions with
strengths,
weaknesses, and their
impact overlooked or
inaccurate
Score
/4
PHAR 9942 / PSCI 6602 JOURNAL CLUB ACTIVITY GRADING EVALUATION
Conclusion
Clear, concise
conclusion stated
1 point
Summarized accurately & completely: key points to
be taken from study (which reflected limitations),
drug’s role in therapy or clinical practice implications,
and need for any further research in area
0 points
Did NOT summarize accurately & completely a
conclusion OR conclusion completely inaccurate
TOTAL
Comments
Preparedness
Response to
questions
TOTAL
Comments
Score
/1
/1
1 point
Correctly answered questions in a confident manner
STYLE / PRESENTATION TOTAL POINTS:
Score
/1
/1
______/6
CONTENT / CRITICAL EVALUATION TOTAL POINTS: ______/12
Adapted from Am J Pharm Educ. 2007;71(4):Article 63.
0 points
Did NOT correctly answer questions OR handled
questions unprofessionally
DIABETICMedicine
DOI: 10.1111/dme.13003
Research: Treatment
Open-label randomized non-inferiority trial of a
fixed-dose combination of glimepiride and atorvastatin
for the treatment of people whose Type 2 diabetes is
uncontrolled on metformin
P. Ambery1, A. Stylianou2, G. Atkinson3, C. Dott3, L. Baylor Curtis3, N. Haque3, K. LaCroix4
and K. W. Min5 on behalf of the Glimepiride/Atorvastatin Investigational Team
1
Department of Medicine, Addenbrooke’s Hospital, Cambridge, 2Clinical Statistics, GlaxoSmithKline, Stevenage, 3Alternative Discovery and Development,
GlaxoSmithKline, Brentford, UK, 4Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Research Triangle Park, NC, USA and 5Diabetes Centre, Eulji
Hospital, Eulji University School of Medicine, Seoul, Republic of Korea
Accepted 15 October 2015
Abstract
Aims To evaluate, in a randomized, open-label study, the non-inferiority of a bioequivalent fixed-dose combination of
glimepiride and atorvastatin vs. separately co-administered tablets in people with Type 2 diabetes mellitus.
Methods Participants with HbA1c ≥ 53 to < 80 mmol/mol (≥ 7.0 to < 9.5%), average fasting blood glucose
> 7.0 mmol/l, who were on metformin for ≥ 3 months, were randomized to combination (n = 215) or co-administered
glimepiride and atorvastatin (n = 212) once daily for 20 weeks. Up-titration of glimepiride (1–4 mg) and atorvastatin
(10–20 mg) were based on average fasting blood glucose and LDL cholesterol, respectively. Co-primary endpoints were
change from baseline to week 20 in HbA1c and LDL cholesterol.
Non-inferiority was demonstrated for both co-primary endpoints: the upper limits of 95% CIs for differences
(combination-reference) were less than the prespecified margins of 3.3 mmol/mol (0.3%) for change from baseline in
HbA1c [difference 0.1 mmol/mol (95% CI 1.6, 1.9); 0.01% (95% CI 0.15, 0.17)] and 6% for percentage change
from baseline in LDL cholesterol [difference 0.87% (95% CI 2.47, 4.21)]. Similar proportions of participants on
combination and reference had treatment-emergent adverse events (64 vs. 61%). More participants on combination had
hypoglycaemia (21 vs. 13%); most events were considered by the treating physician to be unrelated to study drug.
Results
Conclusions The combination was non-inferior to separately co-administered tablets and the safety profile was
consistent with the known profiles of glimepiride and atorvastatin. The observed increase in hypoglycaemia on the
combination cannot be explained, but may be attributable to non-systematic collectiof glucose readings and may have
been influenced by reporting bias in this open-label trial.
Diabet. Med. 33, 1084–1093 (2016)
Introduction
Type 2 diabetes mellitus is a chronic illness that requires
continuing medical care, self-management and support. A
stepwise approach to management is recommended, starting
with advice concerning diet, exercise and weight reduction
[1]. If glucose targets are not met by lifestyle interventions,
treatment with metformin is recommended [1]. Other
glucose-lowering therapies, such as a sulphonylurea, may
then be added if glycaemic control is not achieved [1]. As
Correspondence to: Anastasia Stylianou.
E-mail: anastasia.2.stylianou@gsk.com
1084
people with Type 2 diabetes have an increased risk of
cardiovascular disease [2], predominantly driven by risk
factors such as dyslipidaemia and hypertension [3], multifactorial risk reduction strategies beyond glycaemic control
are required; therefore, consensus treatment guidelines now
recommend antihypertensives and lipid-lowering therapy for
most people with Type 2 diabetes [1,4,5].
Persistence and adherence to therapy are critical in improving outcomes in Type 2 diabetes, but many people do not meet
their personalized targets; for example, almost half of the
surveyed adults with diagnosed diabetes participating in a
national surveillance programme in the USA did not meet the
ª 2015 Diabetes UK
Research article
What’s new?
• We evaluated a bioequivalent fixed-dose combination
of glimepiride plus atorvastatin versus separately coadministered tablets in people with Type 2 diabetes
mellitus on metformin.
• The combination was non-inferior to separately coadministered tablets with respect to reductions in
HbA1c and LDL cholesterol after 20 weeks.
• The safety profile of the combination was consistent
with the known profiles of glimepiride and atorvastatin.
• More participants on the combination reported hypoglycaemia. This cannot be explained but may be
attributable to non-systematic collection of glucose
readings and may have been influenced by reporting
bias in this open-label trial.
recommended goals for glycaemic control, blood pressure and
lipids [6]. Simplification of dosage regimens, by combining
medications in a single dosage form, is likely to improve
compliance [7–9], thereby improving clinical outcomes.
The aim of the present study was to demonstrate the noninferiority of a fixed-dose combination of glimepiride plus
atorvastatin, compared with both agents taken concomitantly as separate tablets, in improving glucose control and
lipid profiles in Type 2 diabetes. Glimepiride and atorvastatin are well-established medicines, with substantial clinical
trials and post-marketing experience [10–12]. In a previous
trial in healthy people, the glimepiride-atorvastatin formulation was shown to be bioequivalent to separately administered glimepiride and atorvastatin tablets, in terms of rate
and extent of exposure (data on file).
Participants and methods
Study design and ethics
This was an open-label, randomized, two-arm, parallel group
study conducted at 33 centres in six countries (Malaysia,
Mexico, Philippines, Russia, South Korea and Thailand)
between December 2011 and September 2013. The study
protocol (ATG115317) was approved by the relevant independent ethics committee for each centre and written
informed consent was obtained from each participant. The
procedures followed were in accordance with guidelines for
good clinical practice and the Declaration of Helsinki. The
trial was registered with ClinicalTrials.gov (NCT01495013).
Participants
Men and women aged ≥ 18 years with Type 2 diabetes on a
stable dose of metformin for ≥ 3 months, with HbA1c ≥ 53
ª 2015 Diabetes UK
DIABETICMedicine
to < 80 mmol/mol (≥ 7.0 to < 9.5%) and average fasting
blood glucose > 7.0 mmol/l, taken on 4 days in the week
before enrolment, were eligible. Participants had to be statinna€ıve or have no statin use for 2 months before screening and
be eligible for statin therapy (history of cardiovascular
disease; ≥ 40 years with a cardiovascular risk factor;
< 40 years with LDL cholesterol > 100 mg/dl).
Exclusions were: other lipid-lowering or antidiabetic
agents; Type 1 diabetes or current need for insulin therapy;
concurrent myalgia; symptomatic hyperglycaemia requiring
therapy; hypertriglyceridaemia; clinically significant cardiovascular disease; end-stage renal disease; cancer in the past
3 years; a clinically significant abnormality on physical
examination or laboratory tests; receiving drug therapy to
treat liver disease; antiviral or immunosuppressive therapy;
haemoglobinopathy that could interfere with the assessment
of HbA1c; and hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption.
Interventions
Participants were randomly assigned (1:1) using an interactive web response system to receive glimepiride-atorvastatin
fixed-dose combination or co-administration of glimepiride
and atorvastatin (reference) once daily for 20 weeks. Block
randomization was used and the randomization list was
computer-generated using statistical software.
The combination tablets (1/10, 2/10, 3/10, 4/10, 1/20, 2/20,
3/20 and 4/20 mg of glimepiride/atorvastatin, respectively)
were manufactured by Dr Reddy’s Laboratories (Hyderabad,
India). Glimepiride (1, 2, 3 and 4 mg) and atorvastatin (10 and
20 mg) tablets were sourced from commercial supplies
(Amaryl ; Sanofi Aventis, Anagni, Italy; Lipitor ; Pfizer,
Berlin, Germany).
All participants started on 10 mg atorvastatin and 1 mg
glimepiride, either as combination or separate tablets.
Participants were advised to take study drug(s) shortly
before or during a substantial breakfast or the first main
meal. Glimepiride was up-titrated at weeks 2, 4, 6 and 10 if
average fasting blood glucose was > 7 mmol/l in the preceding week and no individual value was < 4.5 mmol/l. Atorvastatin was up-titrated at weeks 6 or 12 if LDL cholesterol
at the preceding visit was > 2.6 mmol/l. The study was
designed to achieve rapid titration to enable participants to
have exposure at the higher doses; thus, participants who
required down-titration were to be withdrawn.
Assessments
The co-primary efficacy endpoints were change from baseline
to week 20 in HbA1c and percent change from baseline to
week 20 in LDL cholesterol. Secondary efficacy endpoints
were change from baseline to week 12 in HbA1c and percent
change from baseline to weeks 4 and 10 in LDL cholesterol.
1085
DIABETICMedicine
Fixed-dose combination of glimepiride and atorvastatin for type 2 diabetes P. Ambery et al.
Safety assessments included monitoring of adverse events
(AEs), hypoglycaemia and liver function tests.
Blood samples were taken at screening, baseline and
during the treatment period for measurement of HbA1c
(weeks 12 and 20), lipids (weeks 4, 10 and 20) and liver
function tests (weeks 2, 6, 16 and 20). HbA1c and lipids were
measured at a central laboratory. Liver function tests were
measured at each centre’s laboratory.
Participants were assigned a glucometer to measure blood
glucose. They were trained to identify symptoms of hypoglycaemia and to document these in a diary card, together
with the accompanying blood glucose reading. Participants
also recorded their fasting blood glucose for at least 4 days in
the week preceding a potential up-titration visit. Glucometer
readings were examined by investigators and categorized
using American Diabetes Association working group criteria
for hypoglycaemia [13]. All values ≤ 3.9 mmol/l were
recorded as hypoglycaemia, regardless of symptoms.
The AE information was collected from the start of
treatment until the last follow-up contact. Drug compliance
was determined by counting returned tablets.
Change from baseline in HbA1c and percentage change
from baseline in LDL cholesterol were separately analysed
for the observed case dataset using a mixed model for
repeated measures with restricted maximum likelihood
estimation. The baseline values for HbA1c and LDL cholesterol were included as covariates in the respective models. In
case of drop-out, HbA1c and LDL cholesterol values at the
early withdrawal visit were included in the analysis. Analyses
were performed using SAS v. 9.2 or later.
HbA1c results were reported as percentages and converted
to mmol/mol as follows: HbA1c (mmol/mol)=[HbA1c (%)
2.15]910.93. Standard deviation and change from baseline
values in mmol/mol were calculated by multiplying the
percentage value by 10.93.
Safety variables were summarized descriptively.
Compliance was defined as: 100 9 total number of tablets
consumed/(days of study drug exposure)*(number of tablets
prescribed per day).
Results
Study population
Statistical methods
A non-inferiority hypothesis was used to show that participants taking the combination were not disadvantaged
compared with participants taking the separate agents.
Assessment of non-inferiority was based on the two-sided
95% CI for the difference between groups for each coprimary endpoint. If the upper limit of the 95% CI for the
difference in change from baseline to week 20 for HbA1c was
< 3.3 mmol/mol (< 0.3%), and percentage change from
baseline to week 20 in LDL cholesterol was < 6%, then
non-inferiority was to be concluded. Non-inferiority margins
were selected based on regulatory guidance for diabetes [14]
and previous lipid studies [15].
A sample size of 191 evaluable participants in each group
provided 90% power for the comparison between groups for
change from baseline in HbA1c (based on a non-inferiority
margin of 0.3% assuming standard deviation of 0.9%) and
83% power for the comparison between groups for percentage change from baseline in LDL cholesterol (based on a
non-inferiority margin of 6% assuming standard deviation of
20%) and a one-sided test with 2.5% significance level.
Assuming up to 10% of participants would be nonevaluable, 424 participants were to be randomized (212
per group).
The primary non-inferiority analysis was conducted on the
per-protocol population (all participants without major
protocol deviations). Analysis of the intention-to-treat population (all randomized participants with at least one postbaseline HbA1c or LDL cholesterol value) was conducted as a
sensitivity analysis. The safety population comprised all
participants who took at least one dose of study drug.
1086
A total of 427 participants were randomized (215 and 212
in combination and reference groups, respectively) and 393
(92%) participants completed the study (Fig. 1). Over 90%
of participants were included in the per-protocol populations for the analysis of HbA1c (391/427, 92%) and LDL
cholesterol (393/427, 92%). The most common reasons for
exclusion from per-protocol populations were incorrect
dose titration (six and seven participants in the combination and reference groups, respectively) and inadequate
treatment compliance (four and six participants, respectively; Fig. 1). The two groups were well matched with
regard to demographic and baseline characteristics
(Table 1). In both groups, mean age was 57–58 years and
there was a predominance of women (59 and 64%,
respectively).
Exposure and treatment compliance
At the end of the 20-week treatment period or at premature
discontinuation, 19 and 20% of participants in the combination and reference groups, respectively, remained on the
lowest combination of glimepiride/atorvastatin 1/10 mg and
10% of participants in each group were on the highest
combination of 4/20 mg (Table S1). Glimepiride 4 mg,
irrespective of atorvastatin dose, was received by 42 and
44% of participants, respectively, with 34 and 35% of
participants titrated to this dose at week 6. Atorvastatin
20 mg was received by 19 and 21% of participants,
respectively, with 10 and 14% of participants titrated to
this dose at week 6. Compliance with study drug was 98% in
each group.
ª 2015 Diabetes UK
768 assessed for eligibility
427 randomised
Analysis
Follow-up
Enrollment
DIABETICMedicine
Allocation
Research article
341 excluded
• 327 did not meet eligibility criteria
• 11 withdrew consent
• 3 other reasons
215 allocated to combination group
• 215 received allocated intervention
212 allocated to reference group
• 212 received allocated intervention
199 completed the study to Week 20
16 discontinued prematurely:
• 1 down-titration of study drug
• 1 change in treatment for underlying
disease
• 2 sponsor discretion due to
unacceptable visit window deviations
• 4 withdrew consent
• 1 lost to follow-up
• 2 non-serious adverse events
• 5 protocol violations
194 completed the study to Week 20
18 discontinued prematurely:
• 5 withdrew consent
• 2 non-serious adverse events
• 3 serious adverse events
• 8 protocol violations
213 in ITT population
2 excluded (did not have post-baseline
HbA1c and LDL cholesterol value)
211 in ITT population
1 excluded (did not have post-baseline
HbA1c and LDL cholesterol value)
200 in PP population
13 excluded from ITT due to major
protocol deviation:
• 6 incorrect titration
• 4 inadequate study drug compliance
• 2 violation of inclusion/exclusion criteria
• 1 prohibited medication
193 in PP population
18 excluded from ITT due to major
protocol deviation:
• 7 incorrect titration
• 6 inadequate study drug compliance
• 2 violation of inclusion/exclusion criteria
• 2 prohibited medication
• 1 metformin dose change
1 additional patient excluded from PP
analysis of HbA1c as did not have a
post-baseline HbA1c value
1 additional patient excluded from PP
analysis of HbA1c as did not have a
post-baseline HbA1c value
FIGURE 1 Enrolment, randomization and follow-up of study participants. Combination, fixed-dose combination of glimepiride-atorvastatin; ITT,
intention-to-treat; PP, per-protocol; Reference: co-administered glimepiride and atorvastatin tablets.
Efficacy
Decreases in HbA1c and LDL cholesterol from baseline to
week 20 were observed in both groups (Fig. 2).The combination was non-inferior to co-administered glimepiride and
atorvastatin for both co-primary endpoints at week 20. In the
per-protocol population, the least squares (LS) mean change
from baseline to week 20 in HbA1c was 7.4 (95% CI 8.7,
6.2) mmol/mol [ 0.68 (95% CI 0.80, 0.57) %] vs.
ª 2015 Diabetes UK
7.5 (95% CI 8.7, 6.2) mmol/mol [ 0.69 (95% CI
0.80, 0.57)%] for the combination and reference group,
respectively. The upper limit of the two-sided 95% CI for the
between-group difference was less than the prespecified noninferiority margin of 3.3 mmol/mol (0.3%) [difference
0.1 mmol/mol (95% CI 1.6, 1.9); 0.01% (95% CI 0.15,
0.17)]. The LS mean percentage change in LDL cholesterol
from baseline to week 20 was 38.38% (95% CI 40.72,
36.03) vs.
39.25% (95% CI
41.62,
36.88) for
1087
DIABETICMedicine
Fixed-dose combination of glimepiride and atorvastatin for type 2 diabetes P. Ambery et al.
Table 1 Demographic and baseline characteristics
Combination
N = 215
Mean (SD) age, years
57.3 (8.8)
Gender, n (%)
Men
89 (41.4)
Women
126 (58.6)
Geographic ancestry, n (%)
East Asian
50 (23.3)
South-East Asian
65 (30.2)
White/Caucasian/European
24 (11.2)
Hispanic-Latino
76 (35.3)
Mean (SD) vital statistics
Weight, kg
71.9 (17.5)
Hip circumference, cm
100.9 (12.4)
Hip–waist ratio
1.1 (0.1)
Family history of cardiovascular disease, n (%)
Premature coronary artery
22 (10.2)
disease
Peripheral artery disease or
13 (6.0)
stroke
Smoking history, n (%)
Current smoker
36 (16.7)
Past smoker
33 (15.3)
Mean (SD) blood pressure, mmHg
Systolic blood pressure
129.9 (14.6)
Diastolic blood pressure
78.5 (8.3)
Mean (SD) HbA1c, mmol/mol
63 (7.8)
Mean (SD) HbA1c, %
7.9 (0.71)
Mean (SD) LDL cholesterol,
3.12 (0.91)
mmol/l
Reference
N = 212
57.9 (10.7)
77 (36.3)
135 (63.7)
48
66
24
74
(22.6)
(31.1)
(11.3)
(34.9)
71.4 (15.4)
101.2 (12.7)
1.1 (0.1)
17 (8.0)
16 (7.5)
30 (14.2)
30 (14.2)
129.2
77.2
63
7.9
3.28
(13.9)
(8.6)
(7.2)
(0.66)
(0.90)
Combination: fixed-dose combination of glimepiride-atorvastatin; Reference; co-administered glimepiride and atorvastatin
tablets.
combination and reference. The upper limit of the two-sided
95% CI for the between-group difference was less than the
prespecified non-inferiority margin of 6% [difference 0.87%
(95% CI 2.47 to 4.21)].
Intention-to-treat analyses supported the primary perprotocol analyses. In the intention-to-treat population, LS
mean differences between groups were 0.2 (95% CI 1.4,
1.7) mmol/mol [0.02 (95% CI 0.13, 0.16)%] for change
from baseline in HbA1c at week 20 and 1.29% (95% CI
1.98, 4.57)] for percentage change in LDL cholesterol at
week 20.
Changes in HbA1c and LDL cholesterol at other time
points for the per-protocol population were similar to those
observed at week 20 (Fig. 2). LS mean differences between
groups were 0.1 (95% CI 1.4, 1.6) mmol/mol [0.01 (95%
CI 0.13, 0.15)%] for change from baseline in HbA1c at
week 12, and 0.85% (95% CI 3.98, 2.28) and 0.92%
(95% CI 4.20, 2.36) for percent change in LDL cholesterol
at weeks 4 and 10, respectively.
Safety
Similar proportions of participants in the combination and
reference groups had treatment-emergent AEs [64% (138/
1088
215) vs. 61% (130/212)], AEs assessed as drug-related [9%
(20/215) vs. 11% (24/212)] and non-serious AEs leading to
discontinuation [1% (2/215) vs. 1% (2/212)]. Non-fatal
serious adverse events (SAEs) were experienced by 1%
(3/215) and 3% (7/212) of participants in the combination
and reference groups, respectively. One additional participant in the reference group died from pancreatic carcinoma.
None of the SAEs was assessed by the investigator as related
to study drug.
The most common AEs were abnormalities in liver
function tests (Fig. 3). Investigators were instructed to report
all out of range transaminase and bilirubin levels as AEs,
regardless of clinical significance. At least one liver function
test AE was reported for 39% (83/215) and 29% (61/212) of
participants in combination and reference groups, respectively. All of the liver function test AEs were of mild
intensity, except for one moderate liver function test AE in
the reference group. None of the liver function test AEs was
assessed as serious or severe, or led to discontinuation. There
were no events of possible drug-induced liver injury with
hyperbilirubinaemia. A review of maximum normalized liver
function test values, and maximum relative change from
baseline in liver function test values, showed no differences
between the groups (Fig. 4).
Hypoglycaemia was reported more frequently in the
combination group [88 events for 45/215 (21%) participants] than the reference group [54 events for 27/212 (13%)
participants]. Most events (> 95%) were classified as mild
and none led to discontinuation of study drug (Table 2). All
events resolved within a day without medical intervention.
Similar numbers of participants in the combination and
reference groups had glucometer readings considered to be
potentially severe (< 2.8 mmol/l; four and three participants,
respectively). The majority of participants who experienced
hypoglycaemia had a single occurrence; few participants had
≥ 5 events (five and three participants, respectively) and none
had > 9 events over the 20-week study. Most hypoglycaemic
events were considered by the investigators to be unrelated to
study drug [64/88 (73%) and 37/54 (69%) events].
Discusssion
This is, to our knowledge, the first trial of a fixed-dose
combination of glimepiride-atorvastatin. We showed that the
combination was non-inferior to the two agents taken
concomitantly in lowering HbA1c and LDL cholesterol at
20 weeks. The predefined non-inferiority criteria were met
for both variables for the per-protocol population (primary
analysis) and intention-to-treat population. The observed
improvements in glycaemic control and LDL cholesterol are
consistent with the effects of glimepiride [9–13 mmol/mol
(0.8–1.2%) reduction] and atorvastatin (37–39% reduction)
reported in other studies [16–20].
The study duration of 20 weeks was considered adequate
to assess change from baseline in efficacy variables [16–18];
ª 2015 Diabetes UK
Research article
DIABETICMedicine
Change in HbA1c (mmol/mol) from baseline
Week 20
22
2
0
0
-22
-2
-44
-4
Combination
Week 4
Percentage change in LDL cholesterol from baseline
(b)
Reference
Combination
Week 10
Change in HbA1c (%) from baseline
Week 12
(a)
Reference
Week 20
50
0
-50
-100
Combination Reference Combination Reference
Combination Reference
FIGURE 2 Box plots of (a) change from baseline in HbA1c and (b) percentage change from baseline in LDL cholesterol by visit for the per-protocol
population. For each plot, the bottom and top of each box are the lower and upper quartiles, respectively; the band inside the box is the median; the
open diamond is the mean; the whiskers represent the non-outlier minimum and maximum values (Q1-1.5*IQR and Q3 + 1.5*IQR, where IQR is
interquartile range); open circles are outliers. Combination: fixed-dose combination of glimepiride-atorvastatin; Reference: co-administered
glimepiride and atorvastatin tablets.
however, to allow a stable maintenance period before the
final evaluation, the titration schedule for glimepiride was
more rapid than typically seen in clinical practice. Incremental increases of glimepiride dose were permitted at 2-weekly
intervals up to week 10 if clinically indicated, based on
average fasting blood glucose values recorded in the week
before the up-titration visit. Approximately 40% of participants in each group were titrated to the highest glimepiride
dose of 4 mg, with most receiving this dose from week 6
onwards. Atorvastatin was up-titrated in line with the
labelling instructions, with increases at weeks 6 and 12
based on LDL cholesterol levels.
ª 2015 Diabetes UK
The overall safety profile was generally similar across
groups, except that hypoglycaemia was reported more
frequently for the combination than for the reference group.
Blood glucose was not monitored and recorded systematically in this study. Instead, hypoglycaemic events were selfreported by participants who were trained to perform home
blood glucose monitoring and educated to recognize and
record the symptoms of such events, or were recorded by
investigators when reviewing glucometer readings. Nonetheless, the overall incidence of hypoglycaemia was generally
consistent with findings from other recent studies with
glimepiride (8–17%) [18,21].
1089
DIABETICMedicine
Fixed-dose combination of glimepiride and atorvastatin for type 2 diabetes P. Ambery et al.
▲●
Hypertension
Hypoglycaemia
Alanine aminotransferase increased
Blood bilirubin increased
Aspartate aminotransferase increased
Headache
Myalgia
Bilirubin conjugated increased
Upper respiratory tract infection
Diarrhoea
Nasopharyngitis
Pharyngitis








▲●




●▲
●▲
●▲

0

5
10
15
20
25
Percentage of participants
● Combination (n=215)












.25 1 2 4 8
32
Relative risk with 95% CI
▲ Reference (n=212)
FIGURE 3 Percentage of participants with the most frequent treatment-emergent adverse events (≥ 3% total incidence) sorted by relative risk for
fixed-dose combination vs. reference. Combination: fixed-dose combination of glimepiride-atorvastatin; Reference: coadministered glimepiride and
atorvastatin tablets. A relative risk > 1 means that the adverse event occurred more frequently in the combination group and relative risk < 1 means
that the adverse event occurred more frequently in the reference group (post hoc analysis).
There is no reason to believe that the pharmacokinetics of
glimepiride may have influenced the differential rates of
hypoglycaemia between the two groups, since the fixed-dose
combination has been shown to be bioequivalent to coadministered glimepiride and atorvastatin tablets. Preclinical
studies suggest that atorvastatin may increase the bioavailability of glimepiride [22], but if such an interaction occurs in
humans it would be expected to affect both groups similarly.
Most of the participants with hypoglycaemia had single
episodes that were classified as mild, required no pharmacological intervention or change in dosing, and were assessed as
unrelated to study drug. Only a small number of participants
(four and three in combination and reference groups,
respectively) had a blood glucose reading considered to be
of potential clinical concern (≤ 2.8 mmol/l). Hypoglycaemic
events might be expected after up-titration of glimepiride as a
result of increased endogenous insulin production; however,
there was no evidence of a dose-related increase in incidence
in either group. The observed pattern of single events, or
intermittent events days or weeks apart, is more likely to
reflect the timing of food intake relative to the glucoselowering effect of glimepiride.
Given equivalence on objective measures of glucose and
LDL cholesterol control for the combination versus separate
tablets, reporting bias with respect to hypoglycaemia is a
possibility. Patients instructed to take the combination tablet
in this open-label study may well have perceived increased risk
of hypoglycaemia, affecting both symptoms of low blood
glucose and frequency of monitoring. Unfortunately, frequency of monitoring (use of home blood glucose testing
strips) was not recorded. In retrospect, such measurements
could have provided important data on the objectivity of home
1090
glucose monitoring. The frequency of monitoring is already
well recognized to be a confounder in blood pressure studies,
and in cardiac rhythm monitoring in phase I/II clinical trials
[23]. Without these data, the assumption of reporting bias
(excess recording of hypoglycaemia symptoms, and excess
home blood glucose monitoring) cannot be confirmed.
The known safety profile of atorvastatin includes skeletal
muscle-related effects and liver injury [24,25]. Myalgia was
reported with similar incidence in the two groups, and no
serious skeletal muscle AEs were reported. Increases in liver
transaminases are also reported with statin use. To monitor
the effect of atorvastatin, all out of range liver function tests
were reported as AEs during the study, irrespective of their
clinical significance. Although a higher incidence of liver
function test AEs was reported in the combination group than
the reference group, a review of the change in liver function
tests from baseline showed no difference between groups with
respect to clinically significant measurements during the study.
A limitation of the study is the open-label design, such that
both participants and investigators were aware of the treatment allocation. Whilst this was unlikely to influence the
primary efficacy variables, which were objective laboratory
assessments, it may have biased subjective assessments such as
AE reporting or glucose monitoring by participants [26]. Other
limitations are that data are restricted to people with HbA1c of
< 80 mmol/mol (< 9.5%); therefore, no inferences can be
made for those with severe hyperglycaemia. Additionally, the
study was of relatively short duration and not designed to
provide long-term data regarding cardiovascular outcomes.
Treatment regimens for Type 2 diabetes are becoming
more complex with respect to multiple therapies targeting
glucose, lipids and blood pressure [1]. Many people with
ª 2015 Diabetes UK
Research article
DIABETICMedicine
Maximum normalised value LFTs excluding baseline
(a)
Combination
Reference
4
3
2
1
0
ALT
(b)
AST
Total bilirubin
ALT
Combination
AST
Total bilirubin
Reference
LFTs maximum relative change from baseline
6
5
4
3
2
1
ALT
AST
Total bilirubin
ALT
AST
Total bilirubin
FIGURE 4 Box plots of (a) maximum normalized values for liver function tests, excluding baseline values, by treatment and (b) maximum relative
change in liver function tests by treatment. The normalized value is the ratio of the observed value to the upper limit of the normal reference range
for that particular local laboratory (e.g. a normalized value of 2 represents an observed value that was twice the upper limit of the normal range).
The relative change from baseline was calculated as the ratio of the normalized value at a particular visit/normalized value at baseline. For each plot,
the bottom and top of each box are the lower and upper quartiles, respectively; the band inside the box is the median; the open diamond is the mean;
the whiskers represent the non-outlier minimum and maximum values (Q1-1.5*IQR and Q3 + 1.5*IQR, where IQR is interquartile range); open
circles are outliers. ALT, alanine aminotransferase; AST, aspartate aminotransferase; LFT, liver function test. Combination: fixed-dose combination
of glimepiride-atorvastatin; Reference: co-administered glimepiride and atorvastatin tablets.
Type 2 diabetes miss their treatment targets [6] and combination therapies offer the potential to improve outcomes by
simplifying dosing regimens. Traditionally, cross-indication
combination therapies, such as glucose- and lipid-lowering
agents, have not featured in regimens for treatment simplification. More studies investigating cross-indication combination products should be encouraged, but where possible
they should be blinded.
ª 2015 Diabetes UK
Funding sources
GlaxoSmithKline sponsored the study and provided the
funding for the study, development and publishing of the
present manuscript. All authors of the study were involved in
all stages of study conduct, analysis and interpretation,
approved the final version of the manuscript and all agreed to
publish the findings of this study.
1091
Fixed-dose combination of glimepiride and atorvastatin for type 2 diabetes P. Ambery et al.
DIABETICMedicine
Table 2 Summary of hypoglycaemic events
A. Number of participants
Combination
N = 215
Reference
N = 212
Participants reporting at least one 45 (20.9)
27
hypoglycaemic event
Serious event
0
0
Drug-related event
12 (5.6)
9
Event with glucometer reading
4 (1.9)
3
≤ 2.8 mmol/l*
Participants with the specified number of events*
1
26 (12.1)
17
2-4
14 (6.5)
7
5-9
5 (2.3)
3

Participants with at least one event in specified period
Within first 4 weeks of
15 (7.0)
14
treatment
4-8 weeks of treatment
10 (4.7)
7
8-12 weeks of treatment
13 (6.0)
8
≥ 12 weeks of treatment
20 (9.3)
8
B. Number of hypoglycaemic events
n = 88
Maximum intensity
Mild
84 (95.5)
Moderate
4 (4.5)
Severe
0
Causality
Related
24 (27.3)
Not related
64 (72.7)
American Diabetes Association Workgroup category
Documented symptomatic
37 (42.0)
hypoglycaemia
Asymptomatic hypoglycaemia
30 (34.1)
Probable symptomatic
9 (10.2)
hypoglycaemia
Relative hypoglycaemia
12 (13.6)
Action taken with regard to study drug
Study drug withdrawn
0
Dose reduced‡
0
Dose not changed
88 (100)
Dose interrupted
0
(12.7)
(4.2)
(1.4)
(8.0)
(3.3)
(1.4)
(6.6)
(3.3)
(3.8)
(3.8)
n = 54
52 (96.3)
2 (3.7)
0
17 (31.5)
37 (68.5)
18 (33.3)
20 (37.0)
4 (7.4)
12 (22.2)
0
5 (9.3)
48 (88.9)
1 (1.9)
Data in part A of the table are number and percentage of
participants with the event (denominator is total number of
participants in each group). Data in part B of the table are
number and percentage of events in given category (denominator is total number of hypoglycaemic events in each group).
Combination: fixed-dose combination of glimepiride-atorvastatin; Reference: coadministered glimepiride and atorvastatin
tablets.
*Post hoc analysis.

Subjects are counted in each period within which they had at
least one event; if a subject had more than one hypoglycaemic
event in a specified period then the subject is counted only once
within that period.

One participant in the reference group had five episodes of
hypoglycaemia with action of ‘dose reduced’. Dose reductions
were not allowed and this participant was excluded from the
per protocol population.
Competing interests
G.A., C.D., L.B.C., A.S., N.H. and K.L. are employees and
hold stock/stock options in GlaxoSmithKline. At the time
this study was conducted, P.A. was an employee of
GlaxoSmithKline; he is now an employee of MedImmune
1092
Ltd and has an honorary contract with Cambridge University
Hospitals Trust. K.W.M. has no conflict of interest to
disclose.
Acknowledgements
We thank and acknowledge the participants, investigators
and other site personnel who participated in this clinical trial.
We thank colleagues at GlaxoSmithKline and Dr Reddy’s
Laboratories who supported the development of the glimepiride-atorvastatin fixed-dose combination and DiagnoSearch Life Sciences Pvt. Ltd, Mumbai, India for project
management, clinical data management, statistical analysis
and writing the clinical study report. Writing assistance for
this manuscript was provided by Julie Taylor of Peak
Biomedical Ltd, paid for and on behalf of GlaxoSmithKline.
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EW. Achievement of goals in U.S. diabetes care, 1999-2010. N Engl
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9 Thayer S, Arondekar B, Harley C, Darkow TE. Adherence to a
fixed dose combination of rosiglitazone glimepiride in subjects
switching from monotherapy or dual therapy with a thiazolidinedione and or a sulfonylurea. Ann Pharmacother 2010; 44: 791–
799.
10 Langtry HD, Balfour JA. Glimepiride. A review of its use in the
management of type 2 diabetes mellitus. Drugs 1998; 55: 563–584.
11 Colhoun HM, Betteridge DJ, Durrington PN, Hitman GA, Neil
HA, Livingstone SJ et al. Primary prevention of cardiovascular
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Sever PS, Dahl€
of B, Poulter NR, Wedel H, Beevers G, Caulfield M
et al. Prevention of coronary and stroke events with atorvastatin in
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Supporting Information
Additional Supporting Information may be found in the
online version of this article:
Table S1. Dose at the end of the 20-week treatment period
or the time of premature discontinuation.
1093
introduction
Study objective
Authors affiliation/study support
Method/study design
Methods – Patients/Subjects -How enrolled/from
where? -Inclusion/exclusion criteria -# enrolled
per group
-Inclusion/exclusion criteria -# enrolled per
group
Methods – Treatment Regimen -Treatments used Dosages/administration -Therapy duration
Methods – Outcome Measures -Primary
measures -Secondary measures
Methods – Data Handling -Intention to treat, per
protocol, etc. -# lost to follow-up -Reasons for
dropouts
Methods – Statistics -Tests used -Power of
study
• Confidence interval measures
• What is needed to be seen to be considered non inferior
• Can be considered non inferior because 1.9 is less than 3.3
• Based analysis on the people that obeyed the rules of the study
• Sensitivity analysis to look at are the reults still the same
• Intent to treat also done
Results -Results for each outcome measure Confidence intervals -P-values -Compliance Adverse effects
Conclusion – Authors’ conclusion
Study strengths
Study weaknesses
My conclusion
is this study a good study?
Clinical applicability
PHAR 9942 / PSCI 6602 JOURNAL CLUB ACTIVITY GRADING EVALUATION
Presenter:_______________________________________________
Date:_____________
Reviewer:_______________________________________________
STYLE / PRESENTATION
2 points
Presentation
Exhibited professional appearance and
demeanor, and spoke clearly throughout
the presentation
Mannerisms
Eye Contact
Slides
Handout
TOTAL
Comments
Adapted from Am J Pharm Educ. 2007;71(4):Article 63.
1 point
SOMEWHAT exhibited professional
appearance and demeanor, was difficult
to hear or understand SOME things
spoken
Few (or no) distracting mannerisms
(e.g., um)
Maintained eye contact throughout the
presentation
Slides were organized, easy to read, and
aesthetically pleasing
Handout was organized, easy to read,
and aesthetically pleasing
0 points
Did NOT exhibit professional
appearance and demeanor, was difficult
to hear or understand MOST things
spoken
Score
/2
Had distracting mannerisms
/1
Did NOT maintain eye contact
/1
Slides were NOT organized and difficult
to read
Handout was NOT organized and
difficult to read
/1
/1
/6
PHAR 9942 / PSCI 6602 JOURNAL CLUB ACTIVITY GRADING EVALUATION
CONTENT / CRITICAL EVALUATION
Study Overview
Introduction
– Authors’ affiliations/study support
– Study objective(s) & rationale
Methods – Design
– Case-control, cohort, controlled experiment, etc.
– Type of design (cross-over, parallel, etc.)
– Type of assignment used
– Blinding
Methods – Patients/Subjects
– How enrolled/from where?
– Inclusion/exclusion criteria
– # enrolled per group
Methods – Treatment Regimen
– Treatments used
– Dosages/administration
– Therapy duration
Methods – Outcome Measures
– Primary measures
– Secondary measures
Methods – Data Handling
– Intention to treat, per protocol, etc.
– # lost to follow-up
– Reasons for dropouts
Methods – Statistics
– Tests used
– Power of study
Results
– Results for each outcome measure
– Confidence intervals
– P-values
– Compliance
– Adverse effects
Conclusion – Authors’ conclusion
Adapted from Am J Pharm Educ. 2007;71(4):Article 63.
2 points
1 point
0 points
Score
Accurately and completely
reported ALL relevant
introduction, study design,
and patients/subject
components
Accurately and completely
reported MOST of the
relevant introduction, study
design, and patients/subject
components
Did NOT accurately and
completely report most of
the relevant introduction,
study design, and
patients/subject
components
/2
Accurately and completely
reported ALL relevant
treatment regimens,
outcome measures, and
data handling components
Accurately and completely
reported MOST of the
relevant treatment
regimens, outcome
measures, and data
handling components
Did NOT accurately and
completely most of the
relevant treatment
regimens, outcome
measures, and data
handling components
/2
Accurately and completely
reported ALL relevant
statistics, results, and
authors’ conclusion
components
Accurately and completely
reported MOST of the
relevant statistics, results,
and authors’ conclusion
components
Did NOT accurately and
completely most of the
relevant statistics, results,
and authors’ conclusion
components
/2
PHAR 9942 / PSCI 6602 JOURNAL CLUB ACTIVITY GRADING EVALUATION
STUDY OVERVIEW TOTAL
/6
Comments
Analysis
Analyzed
all parts of
study
4 points
ALL parts
appropriately
critiqued with ALL
relevant questions
accurately addressed
with strengths,
weaknesses and their
impact described
3 points
Missed only ONE or
TWO considerations
or relevant questions
in critique, with the
rest appropriately
addressed with
strengths,
weaknesses, and their
impact described
TOTAL
Comments
Adapted from Am J Pharm Educ. 2007;71(4):Article 63.
2 points
1 point
0 points
MOST parts
appropriately
critiqued, some
relevant questions
with strengths,
weaknesses, and their
impact overlooked or
inaccurate
Only SOME parts
appropriately
critiqued, most
relevant questions
with strengths,
weaknesses, and their
impact overlooked or
inaccurate
Failed to
appropriately critique
any part, all relevant
questions with
strengths,
weaknesses, and their
impact overlooked or
inaccurate
Score
/4
PHAR 9942 / PSCI 6602 JOURNAL CLUB ACTIVITY GRADING EVALUATION
Conclusion
Clear, concise
conclusion stated
1 point
Summarized accurately & completely: key points to
be taken from study (which reflected limitations),
drug’s role in therapy or clinical practice implications,
and need for any further research in area
0 points
Did NOT summarize accurately & completely a
conclusion OR conclusion completely inaccurate
TOTAL
Comments
Preparedness
Response to
questions
TOTAL
Comments
Score
/1
/1
1 point
Correctly answered questions in a confident manner
STYLE / PRESENTATION TOTAL POINTS:
Score
/1
/1
______/6
CONTENT / CRITICAL EVALUATION TOTAL POINTS: ______/12
Adapted from Am J Pharm Educ. 2007;71(4):Article 63.
0 points
Did NOT correctly answer questions OR handled
questions unprofessionally

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