Aprotinin—Are There Lessons Learned?

Ferguson, T. Bruce

doi:10.1001/jama.297.5.527

Cited by 22 publications

(13 citation statements)

References 13 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Both centers maintain a prospectively collected observational database of all patients undergoing OLT. It is increasingly recognized that such observational datasets and analyses can play a substantial role in postmarket surveillance and safety evaluation of drugs when adequate statistical methods are used to control for any selection bias in the use of medication (41,42). The most robust statistical method currently available to control for selection bias with respect to the use of specific medication is considered to be propensity score adjusted analysis (43,44).…”

Section: Discussionmentioning

confidence: 99%

The Impact of Aprotinin on Renal Function After Liver Transplantation: An Analysis of 1043 Patients

Warnaar

Mallett²,

Boer

et al. 2007

American Journal of Transplantation

View full text Add to dashboard Cite

Renal dysfunction is frequently seen after orthotopic liver transplantation (OLT).Aprotinin is an antifibrinolytic drug which reduces blood loss during OLT. Recent studies in cardiac surgery suggested a higher risk of postoperative renal complications when aprotinin is used. The impact of aprotinin on renal function after OLT, however, is unknown. In 1043 adults undergoing OLT, we compared postoperative renal function in patients who received aprotinin (n = 653) or not (n = 390). Using propensity score stratification (C-index 0.82) and multivariate regression analysis, aprotinin was identified as a risk factor for severe renal dysfunction within the first week, defined as increase in serum creatinine by ≥ 100% (OR = 1.97, 95% CI = 1.14-3.39; p = 0.02). No differences in renal function were noted at 30 and 365 days postoperatively. Moreover, no significant differences were found in the need for renal replacement therapy (OR = 1.52, 95% CI = 0.94-2.46; p = 0.11) or in 1-year patient survival rate (OR = 1.14, 95% CI = 0.73-1.77; p = 0.64) in patients who received aprotinin or not. In conclusion, aprotinin is associated with a higher risk of transient renal dysfunction in the first week after OLT, but not with a higher need for postoperative renal replacement therapy or an increased risk of mortality.

show abstract

Section: Discussionmentioning

confidence: 99%

The Impact of Aprotinin on Renal Function After Liver Transplantation: An Analysis of 1043 Patients

Warnaar

Mallett²,

Boer

et al. 2007

American Journal of Transplantation

View full text Add to dashboard Cite

show abstract

“…There has been considerable criticism of the perceived imperfections of these two papers in relation to aspects of study design, statistical analysis, and the relative risk profile of the aprotinin-treated patients. 4 It is important to remember that aprotinin use in cardiac surgery was initially directed toward patients considered to be at substantial risk of excessive bleeding. Furthermore, the Hammersmith regimen represented the recommended and approved dose in the early UK studies.…”

Section: Resultsmentioning

confidence: 99%

Does aprotinin increase the long-term risk of mortality in patients undergoing CABG surgery?

Taylor

2007

Nat Rev Cardiol

View full text Add to dashboard Cite

“…A recent editorial 33 praised the method used in the analysis of the large numbers of patients receiving aprotinin for rare side effects 4 that led the FDA to issue its warning regarding the use of aprotinin. 18 In fact, the author of that editorial suggested that the large review should be a model for future studies of drug safety and cited the admonition to ‘first, do no harm’ as the overriding consideration.…”

Section: Discussionmentioning

confidence: 99%

A possible association between aprotinin and improved survival after radical surgery for mesothelioma

Norman¹,

Thall²,

Purugganan³

et al. 2009

Cancer

View full text Add to dashboard Cite

Background Aprotinin has been used to decrease blood loss with complicated cardiac surgery but has not been investigated in extrapleural pneumonectomy, an operation that does not use cardiopulmonary bypass. In this prospective, randomized, placebo-controlled, double-blind trial, the authors investigated whether aprotinin decreased blood loss in patients who underwent this operation. Methods After appropriate statistical design and institutional review board approval, eligible patients who were scheduled for extrapleural pneumonectomy were randomized to receive either aprotinin or placebo during the operation. Blood loss and survival data were obtained from electronic medical records and surgical databases. Results Of 20 patients who were enrolled, 16 patients met criteria for blood loss analysis. Four patients were excluded from the blood loss analysis: Three patients were inoperable because of tumor spread and underwent limited surgery, and 1 patient died intraoperatively because of acute, massive hemorrhage. The mean blood loss was 769 mL with aprotinin versus 1832 mL with placebo (P = .05; Wilcoxon test). All 20 patients were included in survival analyses. All 9 patients who received placebo died. In contrast, 7 of 11 patients who received aprotinin remained alive at the time of the current report. Kaplan-Meier survival curves differed significantly between the 2 groups (P = .0004). A Bayesian multivariate survival analysis of 18 patients who had complete data available on 8 prognostic variables indicated a posterior probability of .99 that aprotinin was beneficial. Conclusions Aprotinin decreased blood loss. After accounting for covariate effects, there was a significant comparative benefit with aprotinin in postoperative survival. This finding was unexpected and could not be considered conclusive because of the small size of the current study. A confirmatory study may be warranted.

show abstract

Aprotinin—Are There Lessons Learned?

Cited by 22 publications

References 13 publications

The Impact of Aprotinin on Renal Function After Liver Transplantation: An Analysis of 1043 Patients

The Impact of Aprotinin on Renal Function After Liver Transplantation: An Analysis of 1043 Patients

Does aprotinin increase the long-term risk of mortality in patients undergoing CABG surgery?

A possible association between aprotinin and improved survival after radical surgery for mesothelioma

Contact Info

Product

Resources

About