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Critical Appraisal of an Article on HARM

Critical Appraisal Is there potential harm after administering allopurinol in patients with gout and azotemia ? PUBMED Mesh Terms: Allopurinol Gout Adverse Events Kidney Function. Critical Appraisal of an Article on HARM. Catmaker. Validity Guidelines

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Critical Appraisal of an Article on HARM

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  1. Critical Appraisal Is there potential harm after administering allopurinol in patients with gout and azotemia? PUBMED Mesh Terms: Allopurinol Gout Adverse Events Kidney Function Critical Appraisal of an Article on HARM

  2. Catmaker

  3. Validity Guidelines Were there clearly identified comparison group? Yes. Group A (not exposed to high dose allopurinol) composed of patients whose allopurinol maintenance dose according to their creatinine clearance rate Group B (exposed to high dose allopurinol) composed of patients whose maintenance dose exceeded the dose recommended for their creatinine clearance rate Validity Guidelines Were the exposures and outcomes measured in the same way in the groups compared? Yes. Diligent and fair observation for the outcome was done in both groups. The study is a retrospective cohort which thoroughly reviewed the clinical records of patients. Validity Guidelines Was follow-up sufficiently long and complete? Yes. Drug intake = mean duration of 3.3 years Ample time for patients following up and physicians taking note of any adverse effects brought forth by allopurinol in both groups. Follow-up was complete Validity Guidelines Is the temporal relationship between the exposure and outcome correct and dose-response gradient present? Temporal relationship between the exposure (administration of high dose allopurinol) and outcome (development of adverse reaction) was shown; very minimal occurrences. 5/120 patients had adverse effects to allopurinol. 1. Rash (3/120; 2 grp A, 1 grp B) 2. Allopurinol hypersensitivity syndrome (1/120; 1 grp A) 3. Fixed pigmented drug eruption (1/120; 1 grp B) 4. Leukocytoclasticvasculitis (1/120; 1 grp B). Validity Guidelines OVERALL, IS THE STUDY VALID? Yes. The retrospective cohort study had a relatively good sample size (n=120), compared well 2 groups that had different exposures to allopurinol and determined the presence of very low prevalence of adverse reactions to the drug. Relevance Is the objective of the article on harm similar to your clinical dilemma? Yes. Objective: to determine the prevalence of adverse reactions attributable to allopurinol in patients with primary gout according to dose and creatinine clearance rate Critical Appraisal:Relation Between Adverse Events Associated with Allopurinol and Renal Function in Patients with GoutVasquez-Melladoet al.

  4. Results What is the magnitude of the association between exposure and outcome? The study showed that the frequency of adverse events was very low in both groups • Was the estimate of the risk precise? Yes. 95% CI as computed by the CATMAKER was 0.42 to 0.60. This is a narrow range and thus, the estimate of the risk is precise. RR of 0.51 stresses that exposure does not cause significant or potential harm to the population.

  5. Patient Care Are the study patients similar to my own? Not entirely, but yes. Patient: 50 y/o M, obese, with primary gout & azotemia Study patients: M (118/120, 98.3%), 52.7±12.4 y/o diagnosed with primary gout. 68/120 patients: creatinine clearance of 54.6 ml/min, a low creatinine clearance indicative of azotemia Similar to the profile of the patient involved in the case.

  6. Patient Care Should I attempt to stop the exposure? Harm risk is low. There is no increase in prevalence of potential harm to patients diagnosed with gout. It is important to monitor administration of higher than usual dose of allopurinol in patients with gout If drug is withdrawn, hyperuricemia persists → complications - Joint pains, inflamed tophi and kidney damage

  7. Resolution of the Problem What will I do to my patient? I will continue administering allopurinol to my patient. However, I will be cautious in management whenever I increase the drug dosage to be administered.

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