Pharmacy & Therapeutics - February 2008 - (Page 104)

Antifibrinolytic Therapy in Cardiothoracic Surgery Only aprotinin appeared to be associated with a significantly increased risk of acute renal failure (odds ratio [OR] = 2.291; P < 0.0001). This risk remained significant when aprotinin patients were directly compared with AA Blood Transfusions: ICD-9-CM Odds 95% Confidence patients (OR = 2.056; P < 0.0001). Procedure Code 99.0x P Value Ratio Limits Within the CABG patient subgroup, a sigAll CTS Patients nificantly reduced risk against acute renal Aprotinin vs. aminocaproic acid P = 0.966 0.999 0.934 1.068 failure appeared to be conferred by AA use (2,747 of 6,855 vs. 3,858 of 9,751) (OR = 0.809; P = 0.0029). Aprotinin was still CABG Only associated with an increased risk of renal failAprotinin vs. aminocaproic acid P = 0.0288 0.906 0.830 0.990 ure within the CABG group (OR = 1.656; (1,181 of 3,066 vs. 2,804 of 7,064) P < 0.0001). The increased odds of acute renal CABG = coronary artery bypass graft; CTS = cardiothoracic surgery; failure with aprotinin, compared with AA, in ICD = International Classification of Diseases. both the larger CTS patient group and the CABG subgroup were similar (2.056 and 2.038, respectively). Relative comparisons are shown in Table 4. betes, diabetes with complications, hypertension, peripheral A secondary marker associated with new-onset acute renal vascular disease, and renal failure) in the subsequent comparfailure was the initiation of hemodialysis within the hospital. ative analysis. We evaluated the use of ACE-inhibitors to examWe used the ICD-9-CM procedure code 39.95 for new-onset ine their potential for increased renal failure when they were hemodialysis to determine the risk for both AA and aprotinin given in combination with aprotinin.8 in the CTS and CABG patients. To evaluate the relative efficacy of aprotinin and AA, we Table 5 depicts a significantly increased risk for new-onset assessed the total number of blood transfusions. All CTS hemodialysis in patients receiving aprotinin. Again, the risk of patients, as well as the CABG subgroup, were analyzed. As AA for producing hemodialysis in CTS patients was not sigshown in Table 3, there was no significant difference in the nificant. AA was associated with a significantly reduced risk in number of blood transfusions needed for all CTS patients, but CABG patients (OR = 0.693; P = 0.0008). for the CABG subgroup, aprotinin use was significantly more We also analyzed overall inpatient mortality rates in the likely to result in fewer blood transfusions than AA (P = 0.0288). CTS and CABG patient groups, comparing AA and aprotinin We compared the incidence of acute renal failure in CTSwith controls and then with each other. Again, we observed a patients receiving either AA or aprotinin with that in controls. significantly reduced risk for patients using AA in both the larger CTS group (OR = 0.801; Table 4 Acute Renal Failure in Cardiothoracic Surgery (CTS) P = 0.0041) and in the CABG subgroup (OR = and Coronary Artery Bypass Graft (CABG) Patients 0.766; P = 0.0206). Receiving Aprotinin or Aminocaproic Acid Aprotinin was associated with a significantly higher risk of death in both CTS Acute Renal Failure, patients (OR = 1.271; P < 0.0003) and in CABG Secondary: ICD-9-CM Odds 95% Confidence patients (OR = 1.496; P < 0.0005). A head-toDiagnostic Code 584.x P Value Ratio Limits head comparison of aprotinin and AA also All CTS Patients demonstrated a significantly increased risk Aminocaproic acid vs. controls P = 0.2055 1.069 0.964 1.187 of death in CTS patients (OR 1.633; P < 0.0001) (603 of 9,751 vs. 2,793 of 46,123) and in CABG patients (OR = 1.969; P < 0.0001). All CTS Patients Mortality rates are summarized in Table 6. Aprotinin vs. controls P < 0.0001 2.291 2.088 2.515 The literature on the risk for stroke with (748 of 6,855 vs. 2,793 of 46,123) aprotinin has been conflicting.9,12 The assessAll CTS Patients ment of secondar y stroke in our patient Aprotinin vs. aminocaproic acid P < 0.0001 2.056 1.827 2.313 groups was somewhat muddled. Both CTS (748 of 6,855 vs. 603 of 9,751) and CABG patients who received either AA or CABG Only aprotinin appeared to be at higher risk for Aminocaproic acid vs. controls P = 0.0029 0.809 0.703 0.930 postoperative strokes. Although the risk with (407 of 7,064 vs. 487 of 6,879) aprotinin was significantly greater when it CABG Only was compared directly with AA in all CTS Aprotinin vs. controls P < 0.0001 1.656 1.428 1.922 patients (OR = 1.506; P < 0.0006), this did not (351 of 3,066 vs. 487 of 6,879) remain true for the smaller CABG patient subCABG Only group (OR = 1.290; P = 0.1331). Results are Aprotinin vs. aminocaproic acid P < 0.0001 2.038 1.746 2.378 summarized in Table 7 (see page 106). (351 of 3,066 vs. 407 of 7,064) Only two cases (0.02%) of secondary acute MI were noted with AA. No MIs occurred ICD = International Classification of Diseases. with aprotinin, and 63 MIs (0.14%) were Table 3 Blood Transfusions Needed by Patients Receiving Aprotinin or Aminocaproic Acid 104 P&T® • February 2008 • Vol. 33 No. 2

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Pharmacy & Therapeutics - February 2008 Contents Editorial Medication Errors Prescription: Washington The Language of (Forgive Us) Change, As P&T Enters the Digital Age New Drugs/Drug News/New Medical Devices Drug Forecast Use and Outcomes of Antifibrinolytic Therapy in Patients Undergoing Cardiothoracic Surgery at 20 Academic Medical Centers in the United States Evaluation of the Management of Acute Venous Thromboembolism and Its Outcomes: One Institution's Experience American Society of Hematology, 49th Annual Meeting Pharmaceutical Approval Update

Pharmacy & Therapeutics - February 2008

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