Questions Ans Page No: Statement

A 50-year old male, obese, hypertensive, dyslipidemic and a heavy smoker, is diagnosed
to have type 2 diabetes mellitus and ischemic heart disease. Latest blood work results are as
follows: FBS 160 mg/dl, A1c 8%, total cholesterol 280 mg/dl, HDL 28 mg/dl. He is on
Losartan, ASA and Atorvastatin, which he takes regularly.
A colleague of yours informs you about a new oral hypoglycemic agent, empagliflozin,
that claims to reduce the risk of cardiovascular mortality in diabetic patients. You search for
evidence if this claim is true.
Task 1:
Formulate the clinical question given this scenario.
Does empagliflozin reduces the risk of cardiovascular mortality in T2DM patients?
Task 2:
Appraise the attached article by answering the questions below with a YES or NO. For questions
on validity, indicate where in the article did you find the answer. Identify statement and page
number.
Questions Ans Page Statement

No:
a. Does the study provide a Yes 1 Empagliflozin, Cardiovascular Outcomes,
direct answer to your and Mortality in Type 2 Diabetes (Title)
clinical question in terms
of patient, exposure, and
outcome?
b.Were patients randomly Yes 3 Patients meeting the inclusion criteria were then
assigned to treatment randomly assigned in a 1:1:1 ratio to receive
groups? either 10 mg or 25 mg of empagliflozin or placebo
once daily.
c. Was allocation Yes 3 Performed with the use of a computer-generated
concealed? random-sequence and interactive voice- and
Web response system.
d.Were baseline Yes 7 At baseline, demographic and clinical
characteristics similar? characteristics were well balanced between the
placebo group and the empagliflozin group.
e. Were patients blinded to Yes 2 As described previously, this was a randomized,
treatment assignment? double-blind, placebo-controlled trial to assess
f. Were caregivers blinded the effect of once-daily empagliflozin
to treatment assignment?
g.Were outcome assessors No 2 The trial was designed and overseen by a steering
blinded to treatment committee that included academic investigators
assignment? and employees of Boehringer Ingelheim.
h.Were all patients Yes 34 From Figure S1 of Section G of Supplementary
analyzed in the groups to Appendix:
which they were
originally randomized?
i. Was follow-up rate Yes 7 A total of 7028 patients underwent randomization

adequate? from September 2010 through April 2013. Of
these patients, 7020 were treated and included
in the primary analysis.
Answer the following questions in NOT MORE THAN 2 lines:
j. What are the results (Indicate results and interpret)?
Patients who received empagliflozin had a lower rate of the primary composite cardiovascular
outcome and of death from any cause compared to the placebo group as seen in >0% RRR.
k. Are there biologic and socioeconomic issues that will affect applicability of treatment?
Issues
Sex Women have increased risk for genital mycotic infections (5.4-6.4%) compared
to male (1.6-3.1%)1
Co- Contraindicated for patients with severe renal impairment: eGFR <30
morbidities mL/min/1.73 m2, end-stage renal disease, or patients on dialysis1
Race Asian T2DM patients and established CV disease = overall trial population in
terms of reductions in the risk of CV outcomes and mortality with
empagliflozin2
Age Across age categories, empagliflozin AEs reflected its known safety profile3
Pathology Higher prevalence of insulin resistance in minority groups, even after correction
of disease for obesity and lifestyle factors; more aggressive approach for high-risk
patients4
Socio- EMPA-REG OUTCOME trial (Asian subpopulation), results: empagliflozin
economic added to SoC is highly cost-effective compared with SoC alone in Japan.5
Show steps in computation:

l. What is the patient’s treatment risk of mortality should he take empagliflozin? What is the
NNT?
Rc = 42.8% Based on the 2013 ACC/AHA Guideline on the Assessment of
Cardiovascular Risk; risk calculated for the patient is 42.8% for
a 10-year risk of heart disease or stroke
RR = 0.86 Based from Table 1: Death from cardiovascular causes, nonfatal
myocardial infarction, or nonfatal stroke, primary outcome has a
hazard ratio of 0.86 (0.74–0.99)
Rt = Rc x RR Number of patients needed to treat with empagliflozin is 17 to
42.8% x 0.86 prevent one negative outcome
36.81%
ARR = Rc – Rt
42.8% - 36.81%
5.99 or 6%
NNT = 100%/ARR
100%/6%
16.67
Task 3:
Create a face table depicting the patient’s baseline and treatment risk.
With Empagliflozin Without Empagliflozin
JJJJJJJJJJ JJJJJJJJJJ
JJJJJJJJJJ JJJJJJJLLL
JJJLLLLLLL LLLLLLLLLL
LLLLLLLLLL LLLLLLLLLL
Legend: L = Cardiovascular mortality
References
1
Empagliflozin (Rx). Copyright © 1994-2020 by WebMD LLC. Retrieved from
https://reference.medscape.com/drug/jardiance-empagliflozin-999907#4
2
Kaku, Kohei & Lee, Jisoo & Mattheus, Michaela & Kaspers, Stefan & George, Jyothis &
Woerle, Hans-Juergen. (2016). Empagliflozin and Cardiovascular Outcomes in Asian
Patients With Type 2 Diabetes and Established Cardiovascular Disease ― Results From
EMPA-REG OUTCOME® ―. Circulation Journal. 81. 10.1253/circj.CJ-16-1148.)
3
Monteiro, Pedro & Bergenstal, Richard & Toural, Elvira & Inzucchi, Silvio & Zinman,
Bernard & Hantel, Stefan & Kiš, Sanja & Kaspers, Stefan & George, Jyothis & Fitchett,
David. (2019). Efficacy and safety of empagliflozin in older patients in the EMPA-REG
OUTCOME® trial. Age and ageing. 48. 10.1093/ageing/afz096.
4
Dagogo-Jack S. (2003). Ethnic disparities in type 2 diabetes: pathophysiology and
implications for prevention and management. Journal of the National Medical
Association, 95(9), 774–789.
5
Kaku, Kohei & Haneda, Masakazu & Sakamaki, Hiroyuki & Yasui, Atsutaka & Murata,
Tatsunori & Ustyugova, Anastasia & Chin, Rina & Hirase, Tetsuaki & Shibahara, Tsunehisa
& Hayashi, Naoyuki & Kansal, Anuraag & Kaspers, Stefan & Okamura, Tomoo. (2019).
Cost-effectiveness Analysis of Empagliflozin in Japan Based on Results From the Asian
population in the EMPA-REG OUTCOME Trial. Clinical Therapeutics. 41.
10.1016/j.clinthera.2019.07.016.

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A 50-year old male, obese, hypertensive, dyslipidemic and a heavy smoker, is diagnosed

Does empagliflozin reduces the risk of cardiovascular mortality in T2DM patients?

Questions Ans Page Statement

i. Was follow-up rate Yes 7 A total of 7028 patients underwent randomization

Answer the following questions in NOT MORE THAN 2 lines:

j. What are the results (Indicate results and interpret)?

Show steps in computation:

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