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Critical Appraisal
Treatment
Emmanuel D. Margate, Jr.
CASE SCENARIO
• 43/M
• Consult done with gastroenterologist due to abdominal pain
• Triple Contrast Enhanced CT was requested
• Found out to have increased creatinine at 3.36mg/dL with eGFR of
21ml/min
• Referred to a nephrologist and was then admitted as a Case of CKD
4 from Tubulointerstitial Nephropathy
Directness
• P : Patients undergoing Contrast Enhanced CT Scan
• I : Short Term High Dose Atorvastatin Therapy
• O : Prevention of Contrast-Induced Nephropathy
• M : Randomized controlled trial
Clinical Question:
Is short term high dose treatment of atorvastatin effective in
the prevention of contrast-induced nephropathy in patients
undergoing computed tomography with contrast in a
randomized controlled trial?
Relevance: Is the objective of the article
comparing therapeutic interventions similar to your
clinical dilemma?
STUDY CLINICAL QUESTION
Population Patients undergoing Angiography Patients undergoing Contrast Enhanced
CT
Intervention Atorvastatin 80mg Atorvastatin 80mg
Outcome Prevention of Contrast-Induced
Nephropathy
Prevention of Contrast-Induced
Nephropathy
Relevance: Is the objective of the article
comparing therapeutic interventions similar to your
clinical dilemma
• Objective of the article: To evaluate the
effectiveness of 80mg atorvastatin in the
prevention of contrast-induced nephropathy
in patients undergoing Angiography
• Clinical Question: Is short term high dose
treatment of atorvastatin effective in the
prevention of contrast-induced nephropathy
in patients undergoing computed tomography
with contrast?
Validity: Was the assignment of patients to
treatment randomized?
Validity: Was the Allocation concealed?
• No discussion about allocation concealment
Validity : Were patients, their clinicians,
and study personnel ”blind” to treatment?
Validity : Were the groups similar at the
start of the trial?
Validity : Were the patients analyzed in the groups to
which they were randomized? (intent–to-treat analysis)
Validity: Aside from the experimental
intervention, were the groups treated equally?
• No co-interventions mentioned
OVERALL, IS THE STUDY VALID?
• All validity guidelines were met
• Absolute Risk in Control (Rc) = 11/110 = 0.1
• Absolute Risk in Tx (Rt) = 3/110 = 0.027
• Absolute Risk Reduction (Rc-Rt) = 0.073
• Relative Risk (Rt/Rc) = 0.27
• Relative Risk Reduction (Rc-Rt/Rc) = 0.73
• NNT (1/ARR) = 13.69
WHAT ARE THE RESULTS?
• Decision (a= 0.05)
• Atorvastatin 80mg vs Placebo
• P value – 0.01
• p < a, indicates strong evidence against the null hypothesis, so null
hypothesis can be rejected. Therefore, a high dose of Atorvastatin
significantly reduces risk of CIN 24 hours after contrast medium
injection.
Can the results be applied to my patient?
INCLUSION CRITERIA (At LEAST 1) EXCLUSION CRITERIA
• Diabetes (fasting blood sugar > 126 mg/dL, random
blood sugar > 200 mg/dL, and glucose tolerance
test 200 mg/dL)
• Chronic renal failure (creatinine > 1.5 mg/dL or 15
< glomerular filtration rate [GFR] < 60
mls/min/1.73m2)
• Recent treatment with 80 mg of statin (not low-
dose atorvastatin) need for emergency
angiography
• Contraindications to statin prescription
• Previous contrast-media administration during the
preceding 10 days
• Chronic dialysis treatment
• Informed refusal of consent
Were all clinically important outcomes
considered?
RESOLUTION OF THE PROBLEM IN THE
SCENARIO
• Standard hydration and N-acetylcysteine and atorvastatin (80 mg)
reduced the incidence of CIN, and this regimen was more effective
than was the regimen of hydration and N-acetylcysteine (without
atorvastatin) in decreasing CIN. Accordingly, it is reasonable to
prescribe atorvastatin before angiography in high-risk patients.
Thank you!

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Cat therapy atorvastatin cin

  • 2. CASE SCENARIO • 43/M • Consult done with gastroenterologist due to abdominal pain • Triple Contrast Enhanced CT was requested • Found out to have increased creatinine at 3.36mg/dL with eGFR of 21ml/min • Referred to a nephrologist and was then admitted as a Case of CKD 4 from Tubulointerstitial Nephropathy
  • 3. Directness • P : Patients undergoing Contrast Enhanced CT Scan • I : Short Term High Dose Atorvastatin Therapy • O : Prevention of Contrast-Induced Nephropathy • M : Randomized controlled trial Clinical Question: Is short term high dose treatment of atorvastatin effective in the prevention of contrast-induced nephropathy in patients undergoing computed tomography with contrast in a randomized controlled trial?
  • 4.
  • 5.
  • 6.
  • 7. Relevance: Is the objective of the article comparing therapeutic interventions similar to your clinical dilemma? STUDY CLINICAL QUESTION Population Patients undergoing Angiography Patients undergoing Contrast Enhanced CT Intervention Atorvastatin 80mg Atorvastatin 80mg Outcome Prevention of Contrast-Induced Nephropathy Prevention of Contrast-Induced Nephropathy
  • 8. Relevance: Is the objective of the article comparing therapeutic interventions similar to your clinical dilemma • Objective of the article: To evaluate the effectiveness of 80mg atorvastatin in the prevention of contrast-induced nephropathy in patients undergoing Angiography • Clinical Question: Is short term high dose treatment of atorvastatin effective in the prevention of contrast-induced nephropathy in patients undergoing computed tomography with contrast?
  • 9. Validity: Was the assignment of patients to treatment randomized?
  • 10. Validity: Was the Allocation concealed? • No discussion about allocation concealment
  • 11. Validity : Were patients, their clinicians, and study personnel ”blind” to treatment?
  • 12. Validity : Were the groups similar at the start of the trial?
  • 13. Validity : Were the patients analyzed in the groups to which they were randomized? (intent–to-treat analysis)
  • 14. Validity: Aside from the experimental intervention, were the groups treated equally? • No co-interventions mentioned
  • 15. OVERALL, IS THE STUDY VALID? • All validity guidelines were met
  • 16. • Absolute Risk in Control (Rc) = 11/110 = 0.1 • Absolute Risk in Tx (Rt) = 3/110 = 0.027 • Absolute Risk Reduction (Rc-Rt) = 0.073 • Relative Risk (Rt/Rc) = 0.27 • Relative Risk Reduction (Rc-Rt/Rc) = 0.73 • NNT (1/ARR) = 13.69
  • 17. WHAT ARE THE RESULTS? • Decision (a= 0.05) • Atorvastatin 80mg vs Placebo • P value – 0.01 • p < a, indicates strong evidence against the null hypothesis, so null hypothesis can be rejected. Therefore, a high dose of Atorvastatin significantly reduces risk of CIN 24 hours after contrast medium injection.
  • 18. Can the results be applied to my patient? INCLUSION CRITERIA (At LEAST 1) EXCLUSION CRITERIA • Diabetes (fasting blood sugar > 126 mg/dL, random blood sugar > 200 mg/dL, and glucose tolerance test 200 mg/dL) • Chronic renal failure (creatinine > 1.5 mg/dL or 15 < glomerular filtration rate [GFR] < 60 mls/min/1.73m2) • Recent treatment with 80 mg of statin (not low- dose atorvastatin) need for emergency angiography • Contraindications to statin prescription • Previous contrast-media administration during the preceding 10 days • Chronic dialysis treatment • Informed refusal of consent
  • 19. Were all clinically important outcomes considered?
  • 20. RESOLUTION OF THE PROBLEM IN THE SCENARIO • Standard hydration and N-acetylcysteine and atorvastatin (80 mg) reduced the incidence of CIN, and this regimen was more effective than was the regimen of hydration and N-acetylcysteine (without atorvastatin) in decreasing CIN. Accordingly, it is reasonable to prescribe atorvastatin before angiography in high-risk patients.

Editor's Notes

  1. Patient was then started on Colchicine 0.5mg OD
  2. Yes, because
  3. Yes. Randomization was mentioned at 2498 and page 2499
  4. The study was able to meet all the validity guidelines Randomization, allocation concealment, baselin data wer similar, double blinding was done, there was adequate follow up
  5. RRR - >0% Treatment is beneficial ARR - >0% Treatment is beneficial RR - <1.0 Treatment is beneficial