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Sequential parenteral and oral ciprofloxacin regimen versus parenteral therapy for bacteremia: a pharmacoeconomic analysis |
Amodio-Groton M, Madu A, Madu C N, Briceland L L, Seligman M, McMaster P, Miller M H |
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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 Initial intravenous antibiotic regimen followed by oral ciprofloxacin (a broad-spectrum fluoroquinolone antimicrobial) in the treatment of patients with gram negative bacteremia.
Economic study type Cost-effectiveness analysis.
Study population Hospitalised adult patients with gram negative bacteremia. Patients were excluded if they had a history of allergy to quinolones, were pregnant, had severe renal impairment, bacterium from anaerobic isolates, sepsis or sepsis syndrome, neutropenia, AIDS, were in an oncology or intensive care ward, or hadinfections from Ciprofloxacin resistant sources or not in the biliary system.
The mean age of patients in the study was 62.1 years (range: 23 -91). Bacteremia was secondary to urinary tract infection in 35 cases, to respiratory tract infection in 5 cases, to skinft tissue infections in 2 cases, to biliary tract infections in 3 cases, and to otherknown infections in 7 cases. The underlying health status was poor in 10 cases, fair in 29 cases and good in 10 cases. 50% (25) of the study population had cardiovascular disease, 33% (16) had diabetes mellitus. Other underlying disease states included intravenous drug use (2), cancer (2), AIDS (2), sickle cell disease (1), and asthma. (1)
Setting Hospital. The economic analysis was conducted in New York, USA.
Dates to which data relate Effectiveness and resource data were collected between October 1987 and August 1989. The price year used was not stated.
Source of effectiveness data Link between effectiveness and cost data Costing was undertaken prospectively on the same patient sample as used in the effectiveness analysis.
Study sample No power calculations were reported.50 patients were randomly assigned between Group 1, which received the intervention, and Group 2, which continued to receive parenteral therapy only. There were 24 patients in Group 1 and 26 patients in Group 2.
Study design Single centre prospective randomised control trial. The duration of patient follow up was, on average, 12.4 months following therapy (range: 1-18 months). A stratified allocation method, based on the underlying health status, was used to assign patients randomly to the two groups. There was no loss to follow up.
Analysis of effectiveness The analysis of the clinical study was based on the intention to treat. The primary health outcomes were the resolution rates for bacteremia and adverse effects (toxicity levels) of the therapy. There were no statistically significant differences between the groups in terms of age, sex, concomitant diseases, underlying health status or the primary focus of the bacteremia.
Effectiveness results The level of clinical response in the two study groups and the non intervention group were not significantly different from each other. In Group 1 there was a clinical resolution of symptoms in 20 patients (83.3%) and an improvement in a further 3 (12.5%). For Group 2 these rates were 20 patients (76.9%) and 4 patients (15.4%). Three patients suffered adverse reactions in the two groups due to antimicrobial regimens.
Clinical conclusions Parenteral therapy for 72 hours followed by a combination of parenteral therapy and oral ciprofloxacin or a continuation of parenteral therapy alone are equally effective and safe.
Measure of benefits used in the economic analysis Since the effectiveness analysis showed no difference in the effectiveness/clinical benefit between the intervention and the comparator, the economic analysis was based on the difference in costs only.
Direct costs Quantities of resource use were reported separately from the prices. Costs and savings were determined from the perspective of the hospital. The marginal cost of care per bed per day was estimated. Hospital length of stay and length of time on antibiotics between groups were estimated. The mean length of stay for patients was estimated as was the reimbursement rate from new admissions to hospital. Administration and supply costs (other than the drugs) were not considered in the analysis. The estimation of costs was based on actual data from the institution, Medicare reimbursement rates and the authors' assumptions (bed occupancy rate). The price year was not reported.
Statistical analysis of costs Mean values, confidence intervals and p values were reported for quantities.
Estimated benefits used in the economic analysis Cost results Savings for the hospital with ciprofloxacin were $77,946 compared with the group of patients remaining on parenteral therapy alone. If outliers were excluded the savings would still be $68,202. In addition, further savings of $3,193 were estimated from differences in the costs of antimicrobial agents between the two groups. The authors also stated that, even if they are unable to fill the beds made available by the use of oral ciprofloxacin, it would still be cost effective as the marginal cost of caring for the average patient is estimated to be $300 per day. Extending this analysis the authors estimated that the yearly savings over the period from July 1988 to June 1989 would have been $209,166. The estimated incremental costs of the intervention relative to the comparator were $3,338.40 per patient (CRD Reviewer's calculation).
Synthesis of costs and benefits Authors' conclusions The authors concluded that the use of oral ciprofloxacin was cost effective.
CRD COMMENTARY - Selection of comparators The comparator used was continued parenteral therapy, which was reported as the standard treatment for gram-negative bacteremia. Validity of estimate of measure of effectiveness The results are likely to be valid, given the randomization procedure used, although there may be some problems of lack of power for detecting small differences in effectiveness (response). Validity of estimate of costs The most relevant quantities of resource use were reported separately from costs. Adequate details of the cost estimation were given. However, administration and supply costs other than drug acquisition costs were omitted from the analysis. Other issues The conclusions were not justified given the uncertainties in the effectiveness data. The issue of generalisability was not addressed. The authors presented the result of a previously completed study showing the equivalence in cost-effectiveness between the strategies in question. The results were not presented selectively. The authors used an extra group of patients for the purposes of analysing differences in length of stay. In fact, as the authors themselves recognised, this group does not represent a valid comparator group for the cost-effectiveness analysis. Implications of the study A study including higher numbers would be desirable after determining an adequate sample size by carrying out power calculations. In addition, all the relevant costs should be included in the analysis.
Source of funding Support provided by a grant from Pharmaceutical Division, Miles Inc, West Haven, CT. Bibliographic details Amodio-Groton M, Madu A, Madu C N, Briceland L L, Seligman M, McMaster P, Miller M H. Sequential parenteral and oral ciprofloxacin regimen versus parenteral therapy for bacteremia: a pharmacoeconomic analysis. Annals of Pharmacotherapy 1996; 30(6): 596-602 Other publications of related interest Discussion in: Journal of Clinical Psychiatry 1996;57(Suppl 3):47-9.
Indexing Status Subject indexing assigned by NLM MeSH Administration, Oral; Adult; Aged; Aged, 80 and over; Anti-Infective Agents /administration & Bacteremia /drug therapy /microbiology; Ciprofloxacin /administration & Female; Humans; Infusions, Parenteral; Injections, Intravenous; Length of Stay; Male; Middle Aged; Prospective Studies; dosage /economics /therapeutic use; dosage /economics /therapeutic use AccessionNumber 21996000715 Date bibliographic record published 31/05/1998 Date abstract record published 31/05/1998 |
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