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Oral ciprofloxacin versus intravenous cefotaxime and ceftriaxone in the treatment of spontaneous bacterial peritonitis |
Tuncer I, Topcu N, Durmus A, Turkdogan M K |
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Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology Cirrhotic patients with spontaneous bacterial peritonitis (SBP) were given 500 mg ciprofloxacin (Cipro; Biofarma) orally, every 12 hours for 5 days (group A). The comparators were 2 g intravenous cefotaxime (Sefotak; Eczacibasi) given every 8 hours for 5 days (group B), and 2 g intravenous ceftriaxone (Rocephin; Roche) given daily for 5 days (group C).
Economic study type Cost-effectiveness analysis.
Study population The study population comprised cirrhotic patients with SBP. A diagnosis of SBP was considered if the ascitic fluid polymorphonuclear (PMN) count was greater than 250/mm3, with and without positive culture, and if there was no evidence of secondary peritonitis. Patients were excluded if they were hypersensitive to fluoroquinolones and cephalosporins. They were also excluded if they had received antibiotic treatment in the two weeks preceding the study, and if they were suffering from systemic infections such as pneumonia which usually require antibiotic treatment with a broader antimicrobial spectrum.
Setting The setting was secondary care. The economic study was carried out in Turkey.
Dates to which data relate No dates for the effectiveness and resource evidence were given. No price year was reported.
Source of effectiveness data The effectiveness data were derived from a single study.
Link between effectiveness and cost data The costing was carried out retrospectively on the same patients who provided the effectiveness data.
Study sample No power calculations were reported. All patients meeting the inclusion criteria were included. In total, 53 patients (34 men) with a mean age of 45.6 (+/- 14.5) years were enrolled in the study. There were 16 patients in group A, 18 in group B and 19 in group C. One patient from group A, one from group B and two from group C were excluded because of death during the treatment. Therefore, the analysis was performed with 15 patients from group A (mean age 47.2 +/- 15.2 years; 9 men), 17 patients from group B (mean age 42.1 +/- 16.9 years; 9 men) and 17 patients from group C (mean age 47.5 +/- 11.4 years; 13 men).
Study design This was a single-centred, randomised controlled trial (RCT) in which the patients were randomised to one of three treatment groups. The authors did not state clearly the period of follow-up, but it would appear that patients were followed up until hospital discharge.
Analysis of effectiveness The basis of the analysis was treatment completers only. The primary health outcomes used were infection resolution, incidence of complications, and mortality rates. Infection resolution was defined as a decrease in PMN cell count to a level of less than 250 in ascitis fluid, culture negativisation and the disappearance of all clinical signs of infection. Adverse events, defined as reactions to the medications, were also recorded. The authors presented data at baseline on the patients' demographic and clinical characteristics. There were no statistically significant differences between the three patient groups at baseline.
Effectiveness results The infection resolution was 80% in group A (ciprofloxacin), 76.4% in group B (cefotaxime) and 82.3% in group C (ceftriaxone), (p non significant).
The complication rate was 40% in group A, 29.4% in group B and 41.1% in group C, (p non significant).
Mortality was 13.3% in group A, 11.7% in group B and 17.6% in group C, (p non significant).
No adverse events were observed.
Clinical conclusions The authors concluded that cirrhotic patients with SBP treated with ciprofloxacin experienced similar health outcomes to patients treated with the other two antibiotics, cefotaxime and ceftriaxone.
Measure of benefits used in the economic analysis No summary measure of benefit was produced. As such, the authors carried out a cost-consequences analysis.
Direct costs No discounting was carried out as the costs were incurred during less than one year. The cost of the antibiotic treatment for 5 days and for each patient was calculated, and this cost was broken down into prices and quantities. No other costs were estimated. The costs were obtained from the pharmacy department of the authors' setting. No price year was given.
Statistical analysis of costs The average cost and statistical significance were presented.
Indirect Costs No indirect costs were calculated.
Sensitivity analysis No sensitivity analysis was carried out.
Estimated benefits used in the economic analysis See the 'Effectiveness Results' section.
Cost results The cost per patient was $6.61 in group A, $127 in group B and $118 in group C, (p<0.001 for the cost in group A versus the other two groups). The costs of treating complications were not included.
The costs were recorded for 5 days.
Synthesis of costs and benefits The costs and benefits were not combined as the study was, in effect, a cost-consequences analysis.
Authors' conclusions Ciprofloxacin was as effective as cefotaxime and ceftriaxone in the empirical treatment of spontaneous bacterial peritonitis (SBP) in cirrhotic patients. It is less expensive and can be applied orally to all patients admitted to hospital with SBP.
CRD COMMENTARY - Selection of comparators The choice of intravenous cefotaxime and ceftriaxone as the comparator treatments was justified by them being described as the first choice of treatment for cirrhotic patients with SBP in the authors' setting. You should consider how this relates to current practice in your setting prior to applying the results of this study.
Validity of estimate of measure of effectiveness The source of the effectiveness data was a single study. The study design, an RCT, was appropriate given the study question. As there was no sample selection, all patients who met the inclusion criteria being included, the reader should decide if the patients studied are representative of cirrhotic patients with SBP in their own setting. The patient groups were shown to be comparable at analysis. The analysis of effectiveness was handled credibly in some aspects, but the sample sizes were small and this may, perhaps, be the reason why no statistically significant differences in primary health outcomes (such as infection resolution and complications) were detected. In addition, the complication rates were analysed over a short period (5 days). The analysis should have been spread beyond the treatment period.
Validity of estimate of measure of benefit The authors did not derive a summary measure of health benefits. The study was, in effect, a cost-consequences analysis.
Validity of estimate of costs The paper did not clearly state the economic perspective adopted in the analysis. However, the study appears to have adopted a hospital perspective. Only one cost component (that of the drugs) was included; the costs of drug administration or complications were not included. In one way the omission is unlikely to have affected the authors' conclusions as the costs of administering drugs intravenously is likely to be higher than oral administration. On the other hand, the costs of dealing with complications should have been included so that the conclusions on the relative costs of the three treatments could be more firmly established. The costs were reported separately from the quantities. The resource use quantities were taken from a single study, while the prices were taken from the authors' setting, and no other sources were used. No statistical or sensitivity analyses of the quantities or prices were carried out. In addition, the price year was not given. These facts limit the generalisability of the study findings and will prevent any future reflation exercises.
Other issues The authors made appropriate comparisons of their results with the findings from other studies. The issue of generalisability was not addressed. The authors did not present their results selectively but, as already reported, the cost information was not sufficiently complete to be sure of the authors' conclusions. The authors did not report any limitations of their study.
Implications of the study The authors suggested that oral ciprofloxacin is just as effective as intravenous cefotaxime or ceftriaxone for cirrhotic patients with SBP. They argued that it is a cheaper treatment and could be administered in the patient's home, thus making it even cheaper. Their cost conclusions would have been more conclusive if detailed cost data had been given.
Bibliographic details Tuncer I, Topcu N, Durmus A, Turkdogan M K. Oral ciprofloxacin versus intravenous cefotaxime and ceftriaxone in the treatment of spontaneous bacterial peritonitis. Hepato-Gastroenterology 2003; 50(53): 1426-1430 Other publications of related interest Terg R, Cobas S, Fassio E, et al. Oral ciprofloxacin after a short course of intravenous ciprofloxacin in the treatment of spontaneous bacterial peritonitis: results of a multicenter, randomized study. Journal of Hepatology 2000;33:564-9.
Indexing Status Subject indexing assigned by NLM MeSH Adult; Anti-Infective Agents /administration & Ascitic Fluid; Cefotaxime /administration & Ceftriaxone /administration & Ciprofloxacin /administration & Drug Therapy, Combination; Female; Humans; Liver Cirrhosis /complications /drug therapy; Male; Middle Aged; Peritonitis /drug therapy /etiology; Prospective Studies; dosage /therapeutic use; dosage /therapeutic use; dosage /therapeutic use; dosage /therapeutic use AccessionNumber 22003001324 Date bibliographic record published 31/08/2005 Date abstract record published 31/08/2005 |
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