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Section 6 - Gp 11 - Pharma Journal

Pharmacology Journal Club - Paper Review
by

Amr Ehab Kamel

on 9 November 2015

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Transcript of Section 6 - Gp 11 - Pharma Journal

Section 6
Group 11
Chronic Kidney Disease
What is CKD?
Chronic Kidney Disease is a disease that occurs when one suffers from gradual and usually permanent loss of kidney function over time
5 stages
Complications
Cardiovascular Disease
Metabolic acidosis
Anemia
Inflammation
Fluid overload
Protien in urine
Hypertension
Reduced GFR
Renal failure
And then..
We'll focus on..
Cardiovascular Disease
CABG
No dialysis..
No off-pump CABG..
The Study
Nihon University Itabashi Hospital
The purpose of this comparative study is to prove the efficacy of the human atrial natriuretic peptide (hANP) in patients with chronic kidney disease (CKD) undergoing coronary artery bypass graft surgery (CABG).
Method
This was a randomized controlled study of 303 patients with CKD who underwent CABG, and were divided into a group who received carperitide infusion and another group without carperitide (placebo group).

The study was double-blinded, placebo-controlled, parellel and randomized by lottery method.
Endpoints?
The primary endpoints were:

1) the post-operative dialysis-free rate.
2) serum creatinine (sCr) and estimated glomerular filtration rate (eGFR).
&
The secondary endpoints were:

1) the early post-operative outcome.
2) outcome at 1 year post-operatively.
3) the maximum sCr, the rate of increase of sCr, and an increase of sCr by 0.3 mg/dl compared with the pre-operative value.
4) ANP and cyclic-guanosine monophosphate levels.
Inclusion Criteria

1- Non dialysis CKD. 2-Undergoing On-pump CABG.
Exclusion Criteria
Dialysis. Cardiogenic shock. Off-pump CABG.
Intro
Case
Limitations
Strengths
Results
Study
Outlines
Results
The
post-operative sCr was significantly lower
in the hANP group not only in the post-operative acute stage but also in the first year. The
maximum Cr and Cr increase rate were significantly lower
in the hANP group (p 0.00665, p 0.0001).

There was no difference in mortality rate in the first year post-operatively, and fewer cardiac events and patients going on dialysis were found in the hANP group (p 0.0001 and p 0.0014, respectively).
The paper was published in:
American College of Cardiology.
Sciencedirect
Pubmed.
Alsevier
Reliable & significant statistical results.
Highly relevant to references.
Appropriate study design (Selection, randomization, primary and secondary end points and minimum inclusion criteria).
Clear objectives, aim and informative background.
Unbiased discussion and conclusions and reasoning by results of similar trials.
Funding is by grant from three NGOs.
Cardiac markers
not
assessed e.g, AST,CK,hs-CRP,TAG & LDL, tropnin, myoglobim, LDH.

Although cGMP & ANP were assessed but they are
neither tabulated nor plotted
.

Mode of action of cGMP isn't mentioned
& what's its relation to hANP in our study ?
We found 2 points of confections:

"In the present study, carperitide or saline administration was discontinued only when the systolic blood pressure could not be maintained at 90 mm Hg using intra-aortic balloon pump."
VS saying
"......and administration was not discontinued for reasons such as hypotension in any of the patients."

eGFR results show significant decrease in hANP gp but he said:"the hANP group showed significantly lower values than the placebo group (p 0.01)."
Method of measurment : not mentioned in all biomarkers (just eGFR & delta % sCr )
Confounding factors are not mentioned (e.g., life style, medical history, other treatment, etc..).
Facilities at site of performance aren't mentioned in this paper.
PHARMACOLOGY
Thank You!
Principle
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