Surgery News - April 2008 - (Page 23)

APRIL 2008 • SURGERY NEWS TRANSPLANT BiLE Tops Other Liver Transplant Scoring Methods BY ROBERT FINN Else vier Global Medical Ne ws scoring method that combines bilirubin and lactate values with the specific etiology of acute liver failure better predicts death or the need for transplant than do existing methods, Dr. Johannes Hadem and colleagues reported. The new scoring method, known as the bilirubin-lactate-etiology (BiLE) measure, has a sensitivity of 79% and a specificity of 84% for predicting death or the need for transplant if the patient’s score is above 6.9. These sensitivity and specificity values are significantly better than other measures, including the Model for End-Stage Liver Disease (MELD) and the Simplified Acute Physiology Score III (SAPS-III), according to Dr. Hadem of Hannover (Germany) Medical School, and his colleagues (Clin. Gastroenterol. Hepatol. 2008;6:339-45). But because of the diversity of acute liver failure etiologies in different regions of death group. Similarly, patients who survived without transplantation had a mean lactate level of 2.9 mmol/L, compared with 4.7 mmol/L in the liver transplantation or death group. The investigators designed the BiLE score empirically. To bring bilirubin and lactate into the same range of values, the equation calls for dividing bilirubin concentrations in micromol/L by 100. To this figure, one adds the lactate concentration in mmol/L and then adds or subtracts a value depending on the etiology. With a cutoff of 6.9 to predict death or the need for transplant, the BiLE score achieved a sensitivity of 79%, a specificity of 84%, a positive predictive value of 89%, and a negative predictive value of 71%. The sensitivity of the BiLE score was 100% in patients with cryptogenic acute liver failure. In contrast, lactate alone with a cutoff of 3.5 mmol/L achieved a sensitivity and specificity of 59% and 66%, respectively. The MELD score with a cutoff of 32 achieved a sensitivity and specificity of 65% and 69%, respectively, and the King’s College Criteria achieved a sensitivity and specificity of 58% and 82%, respectively. “The investigators looked at the composite risk of death or transplant. I think it would have been more appropriate to look at mortality risk and censor the analysis at transplantation. What we need to know is when to do a transplant,” said Dr. Jeffrey Punch, an ACS Fellow and associate professor of surgery at the University of Michigan, who commented on the study. The investigators stated that they had no conflicts of interest to report. THE BILE SCORE ACHIEVED A SENSITIVITY OF 79% AND A SPECIFICITY OF 84% FOR PREDICTING DEATH OR THE NEED FOR TRANSPLANT. the world, the BiLE score will need to be validated in other patient cohorts. To develop the score, they conducted a retrospective analysis of 102 ICU patients from a single institution who fulfilled the diagnostic criteria for acute liver failure. Of those, 39 survived for at least 8 weeks without the need for orthotopic liver transplant (OLT), 18 died without OLT, 5 died following OLT, and 40 survived following OLT. In all, 79 of the patients (77%) survived to week 8. For the purposes of the study, patients with hepatic dysfunction were diagnosed with acute liver failure if they had hepatic encephalopathy, acute-onset increase of the International Normalized Ratio (INR) above 1.5, and the absence of signs of chronic liver disease during the clinical and ultrasound examinations. There was no predominant etiology for acute liver failure among the patients in the study. Cryptogenic acute liver failure was the etiology in 21 patients, acute hepatitis B in 18, acetaminophen ingestion in 16, Budd-Chiari syndrome in 9, phenprocoumon toxicity in 7, idiosyncratic drug reactions in 5, Amanita phalloides ingestion in 5, Wilson’s disease in 5, hepatitis A in 4, ischemic hepatitis in 4, and halothane reaction in 3; the remaining 5 patients had etiologies classified as “other.” In comparing patients who survived with those who died or required OLT, the investigators found that 15 different laboratory values and other characteristics showed statistically significant differences. Analysis revealed that bilirubin and lactate levels were the most predictive of survival. Patients who survived without transplantation had a mean bilirubin level of 103 micromol/L, compared with 263 micromol/L in the liver transplantation or TYGACIL® (tigecycline) Brief Summary See package insert for full Prescribing Information. For further product information and current package insert, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556. CONTRAINDICATIONS TYGACIL is contraindicated for use in patients who have known hypersensitivity to tigecycline. WARNINGS Anaphylaxis/anaphylactoid reactions have been reported with nearly all antibacterial agents, including tigecycline, and may be life-threatening. Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics and may have similar adverse effects. TYGACIL should be administered with caution in patients with known hypersensitivity to tetracycline class antibiotics. TYGACIL may cause fetal harm when administered to a pregnant woman. If the patient becomes pregnant while taking tigecycline, the patient should be apprised of the potential hazard to the fetus. Results of animal studies indicate that tigecycline crosses the placenta and is found in fetal tissues. Decreased fetal weights in rats and rabbits (with associated delays in ossification) and fetal loss in rabbits have been observed with tigecycline. (See PRECAUTIONS, Pregnancy.) The use of TYGACIL during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). Results of studies in rats with TYGACIL have shown bone discoloration. TYGACIL should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including TYGACIL, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. PRECAUTIONS General Caution should be exercised when considering TYGACIL monotherapy in patients with complicated intra-abdominal infections (cIAI) secondary to clinically apparent intestinal perforation. (See ADVERSE REACTIONS.) In Phase 3 cIAI studies (n=1642), 6 patients treated with TYGACIL and 2 patients treated with imipenem/cilastatin presented with intestinal perforations and developed sepsis/septic shock. The 6 patients treated with TYGACIL had higher APACHE II scores (median = 13) vs the 2 patients treated with imipenem/cilastatin (APACHE II scores = 4 and 6). Due to differences in baseline APACHE II scores between treatment groups and small overall numbers, the relationship of this outcome to treatment cannot be established. Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics and may have similar adverse effects. Such effects may include: photosensitivity, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, and hyperphosphatemia). As with tetracyclines, pancreatitis has been reported with the use of TYGACIL. The safety and efficacy of TYGACIL in patients with hospital acquired pneumonia have not been established. In a study of patients with hospital acquired pneumonia, patients were randomized to receive TYGACIL (100 mg initially, then 50 mg every 12 hours) or a comparator. In addition, patients were allowed to receive specified adjunctive therapies. The sub-group of patients with ventilator-associated pneumonia who received TYGACIL had lower cure rates (47.9% versus 70.1% for the clinically evaluable population) and greater mortality (25/131 [19.1%] versus 15/122 [12.3%]) than the comparator. As with other antibacterial drugs, use of TYGACIL may result in overgrowth of non-susceptible organisms, including fungi. Patients should be carefully monitored during therapy. If superinfection occurs, appropriate measures should be taken. Prescribing TYGACIL in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Information for Patients Patients should be counseled that antibacterial drugs including TYGACIL should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When TYGACIL is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by TYGACIL or other antibacterial drugs in the future. Diarrhea i http://www.wyeth.com http://www.wyeth.com

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Surgery News - April 2008 Contents Comorbidities Sway Bariatric Outcomes Database Finds Gap in Dissection For Melanoma Future Surgeon Shortage Predicted Dexterity Demo Best for Bile? Health Policy Scan Plan

Surgery News - April 2008

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