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© Borgis - New Medicine 1/2005, s. 9-16
Joanna Kusowska
Cost-effectiveness analysis of therapy with standard antibiotics versus fluoroquinolone at Clinical Unit of diabetology, Medical University of ŁÓdŹ, Poland
Clinical Unit of Diabetology, Department of Clinical Pharmacology, Medical University of Łódź, Poland
Pharmacoeconomic studies of effectiveness, safety and costs of treatment have been scarce in Poland. Development of therapeutic standards for bacterial infections, based on pharmacoeconomic analysis and clinical studies evaluating treatment effectiveness and safety, allows for a more rational pharmacotherapy. The Alexander study of bacterial resistance to antibiotics conducted in Poland showed a high sensitivity of bacterial strains to simple and cheap antibiotics.
Clinical questions to be answered:
? Is the empirical therapy with cheap standard antibiotics [SAT] more effective than that with fluoroquinolone [FT] in patients with severe bacterial infections?
? What is the frequency of therapeutic failure in patients in severe clinical condition who were offered SAT or FT?
? What are the direct costs of the treatment of bacterial infections at the Clinical Unit in Łódź?
? What financial consequences may result from the introduction of treatment guidelines in bacterial infections, and a 5-day shorter hospital stay?
Material and methods
A prospective, randomized, single blind, pharmacoeconomic study was carried out in 420 patients with bacterial infections, admitted to our hospital from 1 July 2002 to 31 December 2002, who were given SAT versus FT.
Therapeutic effectiveness was evaluated daily from complaints reported by patients, complete physical examination, selected diagnostic and laboratory tests. The effectiveness of pharmacotherapy and the frequency of adverse drug reactions (ADR) were recorded.
The economic evaluation was done by assessing the direct cost of the treatment of patients with severe bacterial infections. Finally, the statistical significance was evaluated.
Effectiveness: Empirical sequential SAT vs FT therapy administered at the Clinical Unit of Diabetology, Łódź, Poland showed similar effectiveness, i.e. 87% and 90% respectively.
Cost estimation: The direct costs of the therapy were low - approximately 85 USD vs. 83 USD with therapeutic success, and 126 USD vs. 97 USD with therapeutic failure. The cost of specialist consultation per patient during the treatment accounted for 0.85% - 1.38% of the resources allocated by the Health Care Fund for patient hospital stay. Sequential pefloxacin therapy resulted in direct cost savings (excluding hotel cost) of about 2450 USD per 1000 patients, which was economically significant.
In order to reduce the costs and increase the effectiveness at the Clinical Unit of Diabetology, we followed the therapeutic guidelines for bacterial infections, which resulted in high effectiveness and reduced hospital stay from 13 to 8 days, with cost-effectiveness of approximately 101,850 USD per 1000 patients.
The Alexander resistance study of bacterial strains demonstrated a high susceptibility of the strains responsible for lower respiratory tract infections ( Haemophilus influenzae, Streptococcus pneumoniae, Moraxella cataralis), urinary tract infections (Escherichia coli, Proteus vulgaris) and other infections (Staphylococcus aureus) to cheap standard antibiotics (aminopenicillins) and pefloxacin which are rarely used in everyday clinical practice in Poland.
In patients with severe bacterial infections and at risk of developing side effects, administration of chemotherapy requires increased pharmacovigilance, monitoring of the treatment by performing clinical examination and laboratory tests, which increases treatment costs.
Clinical questions to be answered:
? Is administration of empirical cheap standard antibiotic therapy (SAT) vs fluoroquinolone (FT) effective in patients with severe bacterial infections?
? What is the frequency of therapeutic failure in patients in severe clinical condition who were given SAT or FT?
? What are the direct costs of the treatment of bacterial infections at the Clinical Unit of Diabetology?
? What may be the financial consequences of introducing treatment guidelines for bacterial infections?
A prospective, randomized, single-blind pharmacoeconomic study was performed in 416 patients (420 patients were enrolled in the study; 2 patients died of stroke and there were 2 sudden cardiac deaths in the course of the therapy).
Inclusion criteria: patients with severe infections, age> 45 years, the Caucasian race, severe clinical condition and/or> 75 years of age (diabetes with ketoacidosis, stroke) receiving prophylactic antibiotic treatment.
Exclusion criteria: symptoms and signs of renal failure (creatinine> 2.0 mg/dl), dehydration, stroke with tetraplegia, diabetes with ketoacidosis or hyperosmolar coma, hypotonia, neoplasia, mental disease, administration of antidepressants for 30 days prior to the inclusion in the study, hypersensitivity to antibiotics and fluoroquinolones, severe dermatitis and bacterial resistance to selected chemotherapeutic agents.
Characteristics of the study population: A group of 416 patients with infectious diseases treated from 1st July to 31st December, 2002 at the Clinical Unit of Diabetology, Department of Clinical Pharmacology, Medical University of Łódź, Poland.
Group I included 208 patients with severe bacterial infections who had not received antibiotics prior to hospitalization, and who were treated randomly with intravenous-to-oral ampicillin/amoxycillin. Group II included 130 patients with severe infections in whom aminopenicillin treatment prior to hospitalization had proved to be ineffective, and who received an intravenous-to-oral switch therapy with pefloxacin (FT).
In the therapeutic failure group of 37 patients with no response to the SAT or FT on day 4, an alternative antibiotic therapy was instituted (other antibiotic therapy - OAT) with cefuroxime, cefotaxime, occasionally given in combination with penicillin G.
OAT was given to these 37 patients, as follows:
Cefuroxime 20 patients
Cefotaxime 9 patients
Cefotaxime + Penicillin G 1 patient
Pefloxacin + cefuroxime + cloxacilline 7 patients
Sixteen severely ill patients (with congestive heart failure class IV according to NYHA and/or respiratory failure) were simultaneously given clindamycin against anaerobic bacteria.
Antibiotics were given using the empirical sequential therapy, pharmacodynamic/pharmacokinetic properties of the agents, as well as microbial culture and sensitivity of the strains. Once the clinical improvement had been achieved, the intravenous drug administration was converted to the oral route [1-3]. All the patients met the criteria for hospital admission, and were also treated for their concomitant diseases, i.e.; cardio-vascular disease (congestive heart failure class III/IV according to the NYHA criteria, chronic heart disease and arterial hypertension) and diabetes [1-3].
Study endpoints:
1. The effectiveness of pharmacotherapy and the frequency of ADR were recorded:
? a therapeutic success was noted with the regression of all the symptoms of bacterial infection;
? a progressive improvement was found with the remission of all the clinical symptoms and signs as well as some positive laboratory findings;
? the frequency of ADR was recorded.
2. Economic assessment:
? direct costs of treatment of bacterial infections with SAT versus FT;
? financial savings resulting from the introduction of guidelines in the treatment of infections increased the therapeutic effectiveness and reduced the hospital stay from 13 to 8 days.
Therapeutic effectiveness was assessed daily by monitoring fever, dyspnoea, chest pain, productive cough, wheezing, chills, dysuria and other reported complaints as well as daily evaluated physical findings. Laboratory results, i.e. complete blood count (CBC), urinalysis, comprehensive metabolic profile (CMP), including fasting blood glucose, acid-base balance, levels of urea and creatinine, electrolytes, liver function tests (levels of bilirubin, alanine and aspartic transaminase) were monitored on days: 1, 4, 7, 14 of hospital stay or on day 3 after the regression of infection. Prior to drug administration, chest X-ray, microbial culture and sensitivity had been assessed. Complete physical examination and laboratory tests were performed before and 30 days after discharge from hospital.
The economic assessment was performed of the direct treatment costs in patients with bacterial infections hospitalized at the Clinical Unit of Diabetology [4-8].
Baseline characteristics of the study population (mean values for both study groups).
Age (yrs)67 ? 869 ? 4
Lower respiratory tract infections [LRTIs]Community acquired pneumonia 49%51%
Bronchitis and chronic obstructive pulmonary diseases 11%10%
Urinary tract infections [UTIs]28%25%
Prophylactic chemotherapy [PCT]12%14%
The direct costs included:
1. medical and nursing care, and specialist consultation;
2. diagnostic and laboratory tests: CBC, CMP, antibiograms, imaging techniques (X-rays, ultrasound USG), computed tomography (CT), magnetic resonance imaging (MRI), electrocardiogram (ECG) including 24-hour Holter monitoring and 24-hour arterial blood pressure recording [9];
3. medication, i.e. antibiotics or fluoroquinolone [10].
Symptomatic treatment included pharmacotherapy with theophylline, mucolytics, b-adrenomimetics, cholinolytics, glycocorticosteroids, cromolyn sodium and antihistamine agents, NSAID (non-steroidal anti-inflammatory drugs), non-opioid analgesics, anxiolytics, hypnotics and antitussive drugs.
The costs of the medical, specialist, and nursing care were calculated from the following equation:
C = I / Np x Nph x T
C - cost of the medical and nursing care per patient during hospitalization,
I - income of physicians and/or nurses per annum (basic salary, on call duties, bonuses, additional rewards),
Np - number of patients hospitalized per year in the Clinical Unit of Diabetology,
Nph - number of physicians (and nurses) working at the Clinical Unit,
T - the length of hospital stay (days).
The costs of the following procedures were also estimated: intravenous infusion, single intravenous (IV), intra muscular (IM) drug administration, nursing procedures, measurement of blood pressure and temperature, and oxygen therapy. The cost of the procedures included the cost of pharmacological agents and materials, and nurses´ working hours. The costs of drug preparation, storage, distribution and administration were also included in the calculation.
The Health Care Fund established the total cost of the therapy per one hospital day at 385 USD in 2002 [9]. The hospitalization cost calculated by the HCF included the costs not related to the disease, number and type of procedures, diagnostic tests, specialist consultations and drug therapy, etc.
The discounting was not performed because the achieved benefits appeared to be parallel to the cost in the same calendar year.
Statistical analysis was done using the SPSS.PC v.8.0 computer programme. Demographic data and discrepancies in clinical effectiveness were analyzed by means of the chi-square test. The baseline characteristics for groups of continuous variables were evaluated using the Duncan test or the Kruskal - Wallis test. The cost differences were analyzed using the one-way Anova multigeneral linear model. The statistical significance was evaluated at p <0.05.
The study was approved by the Health Research Ethics Board of the Medical University of Łódź, Poland.
The effectiveness of treatment in patients with bacterial infections was assessed either as a therapeutic success or failure. The therapeutic success was consistent with regression of all the clinical and laboratory signs of infections, and the progressive improvement of the patients´ health was based on physical findings and results of accessory investigations.
Owing to the empirical intravenous-to-oral antibiotic therapy, the success was achieved in 87% patients treated with ampicillin/amoxycillin versus 90% of those receiving sequential pefloxacin.
The patients whose health did not improve, or deteriorated, were classified as therapeutic failure. The treatment failure was observed in 9%-13% of patients with a slight improvement after therapy and/or adverse drugs reactions (hypersensitivity, dyspepsia, headache, sleep disorders and insomnia). The average length of hospital stay of those patients was about 18 days.
Patients treated with SAT for approximately 11 days, were hospitalized for 14.3 days and the direct cost of standard antibiotic therapy per one patient successfully treated or with constant improvement totalled 85.51 USD. Pefloxacin was administered for 7.8 days, the direct cost was 83.06 USD, the number of hospital days did not decrease significantly.
The direct costs of treatment per patient without therapeutic success or with adverse reactions increased by 41.03 USD with SAT and by 14.86 USD with FT.
Table 1. Clinical effectiveness of standard antibiotic /SAT/ vs fluoroquinolone therapy /FT/ in the Clinical Unit of Diabetology, Łódź, Poland.
Direct costsSAT success (USd) SAT failure (USd) FT success (USd) FT failure (USd)
Physician*3.78 ? 0.195.31 ? 0.693.30 ? 0.283.34 ? 0.90
Nursing care*3.56 ? 0.185.08 ? 0.6613.16 ? 0.273.20 ? 0.86
Specialist consultation*23.89?2.236.55?8.7321.04?3.2121.76?11.70
Subtotal 30.00?2.3146.94?9.1727.50?3.4228.29?11.92
Laboratory tests29.92?1.5042.36 ? 5.4528.52?2.3148.09 ? 12.15
Microbial tests0.47 ? 0.101.09 ? 0.280.95 ? 0.190.41 ? 0.17
X-ray and other7.15 ? 0.937.26 ? 3.105.99 ? 1.291.14 ? 1.14
Antibacterial therapy8.08 ? 0.8319.49? 7.8816.01 ? 3.3511.77 ? 8.19
Symptomatic therapy6.10 ? 1.614.07 ? 1.814.09 ? 1.828.21 ? 6.7
Subtotal14.18 ? 2.0623.58 ? 8.1320.09 ? 3.8919.98 ? 14.48
FT* – Sequential Fluoroquinolone Therapy
SAT* – Sequential Standard Antibiotic Therapy
ADR* – Adverse Drug Reaction (14 patients with allergy, dyspepsia, headache, insomnia)

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