Hi Omar,
This assignment is precisely like the other ones you have been doing. The only difference here is that I will present the information you will write in the evaluation worksheet live to my peers, kind of like presenting the data to a group of pharmacists. So, if you can include a few more details (maybe in the notes section for each question, or somewhere) in those answers, especially concerning the scenario below, I would appreciate it.
Clinical Scenario (drug of choice is already established, which is dapagliflozin by the way):
“A 57-year-old woman with a history of hypertension, peripheral artery disease, and chronic kidney disease is newly hospitalized for systolic HF. She does not have any drug allergies or intolerances and does not drink alcohol. This patient does not have a family history of cardiovascular or kidney disease. Upon hospitalization, a transthoracic echocardiogram showed a left ventricular ejection fraction of 35%, an eGFR of 49 mL/min/1.73m, and an NT-proBNP of 1500 pg/mL. Her HR is 85 bpm, SBP at 95-100 mmHg, had no signs of lower extremity edema with clear lungs and regular heart sounds. The patient is currently on ASA 81 mg PO once daily, Rosuvastatin 40 mg PO once daily, Lasix 40 mg once daily, Lisinopril 2.5 mg once daily, Metoprolol 25 mg once daily, and spironolactone 25 mg once daily. The in-patient clinical pharmacist is asked to provide a recommendation to minimize the rate of hospitalization and reduce cardiovascular events for this patient at discharge.”
In addition, please come up with 3 clinically meaningful questions regarding the study and provide answers to them. Those questions can be about anything regarding the study, such as the results, or the exclusion or inclusion criteria.
As always, please let me know if you have any clarifying questions. I am compensating you a little more than usual since this assignment will take more work. I always appreciate you!
Thanks,
John
JAMAevidence USER’S GUIDE
CRITICAL APPRAISAL WORKSHEET FOR ARTICLES ABOUT THERAPY
Name:
Citation:
Study Question:
Are the results of this therapy study valid?
Did intervention and control groups start with the same prognosis?
o Were patients randomized?
o Was group allocation concealed?
o Were patients in the study groups
similar with respect to known
prognostic variables?
Was prognostic balance maintained as the study progressed?
o
To what extent was the study
blinded?
Were the groups prognostically balanced at the study’s completion?
o Was follow-up complete?
o Were patients analyzed in the
groups to which they were first
allocated?
o Was the trial stopped early?
1
JAMAevidence USER’S GUIDE
CRITICAL APPRAISAL WORKSHEET FOR ARTICLES ABOUT THERAPY
What are the results?
How large was the treatment effect?
o What was the relative risk reduction?
o What was the absolute risk
reduction?
How precise was the estimate of risk?
o What were the confidence intervals?
How can I apply the results to patient care?
Were the study patients similar to my population of interest?
o Does your population match the
study inclusion criteria?
o If not, are there compelling reasons
why the results should not apply to
your population?
2
JAMAevidence USER’S GUIDE
CRITICAL APPRAISAL WORKSHEET FOR ARTICLES ABOUT THERAPY
Were all clinically important outcomes considered?
o What were the primary and
secondary endpoints studied?
o Were surrogate endpoints used?
Are the likely treatment benefits worth the potential harm and costs?
o What is the number needed to treat
(NNT) to prevent 1 adverse outcome
or produce 1 positive outcome?
o Is the reduction of clinical endpoints
worth the increase of cost and risk of
harm?
3
JAMAevidence USER’S GUIDE
CRITICAL APPRAISAL WORKSHEET FOR ARTICLES ABOUT THERAPY
Name:
Citation:
Study Question: Do adult patients with systolic heart failure who receive dapagliflozin in
addition to ACEi or ARB, and BB compared with those who solely receive ACEi or ARB and BB
experience a lower risk of worsening heart failure or death from cardiovascular events? (Omar,
feel free to change this if you want)
Are the results of this therapy study valid?
Did intervention and control groups start with the same prognosis?
o Were patients randomized?
o Was group allocation concealed?
o Were patients in the study groups
similar with respect to known
prognostic variables?
Was prognostic balance maintained as the study progressed?
o
To what extent was the study
blinded?
Were the groups prognostically balanced at the study’s completion?
o Was follow-up complete?
o Were patients analyzed in the
groups to which they were first
allocated?
1
JAMAevidence USER’S GUIDE
CRITICAL APPRAISAL WORKSHEET FOR ARTICLES ABOUT THERAPY
o Was the trial stopped early?
What are the results?
How large was the treatment effect?
o What was the relative risk reduction?
o What was the absolute risk
reduction?
How precise was the estimate of risk?
o What were the confidence intervals?
How can I apply the results to patient care?
Were the study patients similar to my population of interest?
o Does your population match the
study inclusion criteria?
o If not, are there compelling reasons
why the results should not apply to
your population?
2
JAMAevidence USER’S GUIDE
CRITICAL APPRAISAL WORKSHEET FOR ARTICLES ABOUT THERAPY
Were all clinically important outcomes considered?
o What were the primary and
secondary endpoints studied?
o Were surrogate endpoints used?
Are the likely treatment benefits worth the potential harm and costs?
o What is the number needed to treat
(NNT) to prevent 1 adverse outcome
or produce 1 positive outcome?
o Is the reduction of clinical endpoints
worth the increase of cost and risk of
harm?
3
JAMAevidence USER’S GUIDE
CRITICAL APPRAISAL WORKSHEET FOR ARTICLES ABOUT THERAPY
Name:
Citation:
Study Question: Do adult patients with systolic heart failure who receive dapagliflozin in
addition to ACEi or ARB, and BB compared with those who solely receive ACEi or ARB and BB
experience a lower risk of worsening heart failure or death from cardiovascular events? (Omar,
feel free to change this if you want)
Are the results of this therapy study valid?
Did intervention and control groups start with the same prognosis?
o Were patients randomized?
o Was group allocation concealed?
o Were patients in the study groups
similar with respect to known
prognostic variables?
Was prognostic balance maintained as the study progressed?
o
To what extent was the study
blinded?
Were the groups prognostically balanced at the study’s completion?
o Was follow-up complete?
o Were patients analyzed in the
groups to which they were first
allocated?
1
JAMAevidence USER’S GUIDE
CRITICAL APPRAISAL WORKSHEET FOR ARTICLES ABOUT THERAPY
o Was the trial stopped early?
What are the results?
How large was the treatment effect?
o What was the relative risk reduction?
o What was the absolute risk
reduction?
How precise was the estimate of risk?
o What were the confidence intervals?
How can I apply the results to patient care?
Were the study patients similar to my population of interest?
o Does your population match the
study inclusion criteria?
o If not, are there compelling reasons
why the results should not apply to
your population?
2
JAMAevidence USER’S GUIDE
CRITICAL APPRAISAL WORKSHEET FOR ARTICLES ABOUT THERAPY
Were all clinically important outcomes considered?
o What were the primary and
secondary endpoints studied?
o Were surrogate endpoints used?
Are the likely treatment benefits worth the potential harm and costs?
o What is the number needed to treat
(NNT) to prevent 1 adverse outcome
or produce 1 positive outcome?
o Is the reduction of clinical endpoints
worth the increase of cost and risk of
harm?
3
new england
journal of medicine
The
established in 1812
November 21, 2019
vol. 381
no. 21
Dapagliflozin in Patients with Heart Failure and Reduced
Ejection Fraction
J.J.V. McMurray, S.D. Solomon, S.E. Inzucchi, L. Køber, M.N. Kosiborod, F.A. Martinez, P. Ponikowski,
M.S. Sabatine, I.S. Anand, J. Bělohlávek, M. Böhm, C.-E. Chiang, V.K. Chopra, R.A. de Boer, A.S. Desai, M. Diez,
J. Drozdz, A. Dukát, J. Ge, J.G. Howlett, T. Katova, M. Kitakaze, C.E.A. Ljungman, B. Merkely, J.C. Nicolau,
E. O’Meara, M.C. Petrie, P.N. Vinh, M. Schou, S. Tereshchenko, S. Verma, C. Held, D.L. DeMets, K.F. Docherty,
P.S. Jhund, O. Bengtsson, M. Sjöstrand, and A.-M. Langkilde, for the DAPA-HF Trial Committees and Investigators*
a bs t r ac t
BACKGROUND
In patients with type 2 diabetes, inhibitors of sodium–glucose cotransporter 2 (SGLT2)
reduce the risk of a first hospitalization for heart failure, possibly through glucoseindependent mechanisms. More data are needed regarding the effects of SGLT2 inhibitors in patients with established heart failure and a reduced ejection fraction,
regardless of the presence or absence of type 2 diabetes.
METHODS
In this phase 3, placebo-controlled trial, we randomly assigned 4744 patients with
New York Heart Association class II, III, or IV heart failure and an ejection fraction
of 40% or less to receive either dapagliflozin (at a dose of 10 mg once daily) or placebo, in addition to recommended therapy. The primary outcome was a composite
of worsening heart failure (hospitalization or an urgent visit resulting in intravenous
therapy for heart failure) or cardiovascular death.
RESULTS
Over a median of 18.2 months, the primary outcome occurred in 386 of 2373 patients (16.3%) in the dapagliflozin group and in 502 of 2371 patients (21.2%) in
the placebo group (hazard ratio, 0.74; 95% confidence interval [CI], 0.65 to 0.85;
P