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A challenge in anticipating generic entry is elucidating which patents and regulatory protections constrain generic entry.

Targeted antibiotics could delay emergence of resistant Neisseria gonorrhoeae. The DNA gyrase subunit A assay predicts susceptibility to ciprofloxacin. A model found that adding a $50 gyrase subunit A test for asymptomatic patients screened for N. gonorrhoeae resulted in cost neutrality. When ciprofloxacin susceptibility was high, a $114 test resulted in savings.

Background: Klebsiella pneumoniae liver abscess is the most common etiology of liver abscess in Singapore and much of Asia, and its incidence is increasing. Current management includes prolonged intravenous antibiotic therapy, but there is limited evidence to guide oral conversion. The implicated K1/K2 capsule strain of Klebsiella pneumoniae is almost universally susceptible to ciprofloxacin, an antibiotic with high oral bioavailability. Our primary aim is to compare the efficacy of early (< one week) step-down to oral antibiotics, to continuing four weeks of intravenous antibiotics, in patients with Klebsiella liver abscess., Methods/design: The study is designed as a multi-center randomized open-label active comparator-controlled non-inferiority trial, with a non-inferiority margin of 12%. Eligible participants will be inpatients over the age of 21 with a CT or ultrasound scan suggestive of a liver abscess, and Klebsiella pneumoniae isolated from abscess fluid or blood. Randomization into intervention or active control arms will be performed with a 1:1 allocation ratio. Participants randomized to active control will receive IV ceftriaxone 2 grams daily to complete a total of four weeks of IV antibiotics. Participants randomized to intervention will be immediately converted to oral ciprofloxacin 750 mg twice daily. At Week four, all participants will undergo abdominal imaging and be assessed for clinical response (CRP < 20 mg/l, absence of fever, plus scan showing that the maximal diameter of the abscess has reduced). If criteria are met, antibiotics are stopped; if not, oral antibiotics are continued, with reassessment for clinical response fortnightly. If criteria for clinical response are met by Week 12, the primary endpoint of clinical cure is met. A cost analysis will be performed to assess the cost saving of early conversion to oral antibiotics, and a quality of life analysis will be performed to assess whether treatment with oral antibiotics is less burdensome than prolonged IV antibiotics., Discussion: Our results would help inform local and international practice guidelines regarding the optimal antibiotic management of Klebsiella liver abscess. A finding of non-inferiority may translate to the wider adoption of a more cost-effective strategy that reduces hospital length of stay and improves patient-centered outcomes and satisfaction., Trial Registration: Clinical trials gov NCT01723150.

Policy makers around the world seek to encourage generic substitution. In this paper, the importance of prescribing physicians' imperfect agency is tested using the fact that some Swiss jurisdictions allow physicians to dispense drugs on their own account (physician dispensing, PD) while others disallow it. We estimate a model of physician drug choice with the help of drug claim data, finding a significant positive association between PD and the use of generics. While this points to imperfect agency, generics are prescribed more often to patients with high copayments or low incomes.

Background: Resistance of microorganisms to existing antimicrobial agents threatens the effective utilization of available resources in sub-Saharan Africa. Cost-effective utilization of antibacterial agents is essential in effective health care delivery in Nigeria., Objectives: To determine the most cost effective antibacterial agent in the treatment of S. aureus infections in Lagos metropolis., Setting: The study was carried out in a teaching hospital, a specialist hospital, a referral center and two private hospitals., Methods: Cost effectiveness analysis of ciprofloxacin, cefuroxime and gentamicin identified to be most effective agent against 463 clinical isolates of S. aureus obtained from the five hospitals was carried out on the basis of societal, health care and third party perspectives using 'decision table" as an analytical model. Criteria considered in the model included degree of efficacy of the agents, adherence tendencies and tolerability. Both direct (cost of drugs, diagnosis/monitoring, personnel and transportation) and indirect (loss of productivity) costs were evaluated., Main Outcome Measures: These include economic outcome as total therapy cost, clinical outcomes as extent of antibacterial effectiveness obtained from degree of antibacterial efficacy, a proxy measurement of cure rates, and adherence tendency. Humanistic outcome was also measured as tolerability prorated from literature reported degree of adverse drug reactions events, risk of infection and pains from drug administration., Results: Ciprofloxacin tablet is a dominant option and much more cost-effective than either cefuroxime or gentamicin in the treatment of S. aureus in Lagos. Regardless of the perspective of analysis, ciprofloxacin has the least cost effectiveness ratio of NGN4214.66 ($28.09), NGN2392.63 ($16.00) and NGN2048.66 ($13.65) from societal, health care and third party payer perspectives, respectively. Sensitivity analysis by increasing the effectiveness index of gentamicin injection-the least cost effective option to the value for the most cost effective option did not change the results., Conclusion: Ciprofloxacin should be used as first-line-treatment of S aureus in Lagos as it will lead to significant cost savings in the treatment of S. aureus infections.

The objectives of the present study were to determine the effects of multiple targeted interventions on the level of use of quinolones and the observed rates of resistance to quinolones in Escherichia coli isolates from hospitalized patients. A bundle consisting of four interventions to improve the use of quinolones was implemented. The outcome was measured from the monthly levels of use of intravenous (i.v.) and oral quinolones and the susceptibility patterns for E. coli isolates from hospitalized patients. Statistical analyses were performed using segmented regression analysis and segmented Poisson regression models. Before the bundle was implemented, the annual use of quinolones was 2.7 defined daily doses (DDDs)/100 patient days. After the interventions, in 2007, this was reduced to 1.7 DDDs/100 patient days. The first intervention, a switch from i.v. to oral medication, was associated with a stepwise reduction in i.v. quinolone use of 71 prescribed daily doses (PDDs) per month (95% confidence interval [CI] = 47 to 95 PDDs/month, P < 0.001). Intervention 2, introduction of a new antibiotic guideline and education program, was associated with a stepwise reduction in the overall use of quinolones (reduction, 107 PDDs/month [95% CI = 58 to 156 PDDs/month). Before the interventions the quinolone resistance rate was increasing, on average, by 4.6% (95% CI = 2.6 to 6.1%) per year. This increase leveled off, which was associated with intervention 2 and intervention 4, active monitoring of prescriptions and feedback. Trends in resistance to other antimicrobial agents did not change. This study showed that the hospital-wide use of quinolones can be significantly reduced by an active policy consisting of multiple interventions. There was also a stepwise reduction in the rate of quinolone resistance associated with the bundle of interventions.

Background: The introduction of generic versions of drugs has often resulted in an increase in the consumption of the agents involved. In December 2001, generic ciprofloxacin was marketed in Denmark. Our objective was to evaluate, in a community setting, the effect of price on consumption of ciprofloxacin and on ciprofloxacin resistance in Escherichia coli urine isolates., Methods: We conducted a retrospective ecological study collecting monthly national data on the number of marketed versions and primary healthcare (PHC) sales of ciprofloxacin during January 1995-December 2005. Data were compared with a median price per defined daily dose (DDD) of ciprofloxacin during September 1999-December 2005. Yearly PHC consumption data from seven Danish counties were compared with the antimicrobial resistance profiles of PHC E. coli urine isolates., Results: During 2002, the number of marketed versions increased from 3 to 10, and the median price per DDD decreased by 53%. From 2002 to 2005, the total consumption of oral ciprofloxacin in PHC increased significantly from 0.13 DDD/1000 inhabitant-days to 0.33 DDD/1000 inhabitant-days. During the same period, the frequency of ciprofloxacin resistance increased by 200%. A statistically significant correlation was found between the consumption of ciprofloxacin and the ciprofloxacin resistance rate in E. coli urine isolates, independent of the introduction of generic ciprofloxacin., Conclusions: After the introduction of generic ciprofloxacin, a significant increase in the total consumption of oral ciprofloxacin in PHC was observed in Denmark. The increase in consumption was significantly correlated with ciprofloxacin resistance in E. coli obtained from urine isolates.

The aim of cystic fibrosis (CF) care is to improve both the life expectancy and quality of life of patients. However, rising costs and limited resources of health services must be taken into account. There are many different antibiotic strategies for therapy of Pseudomonas aeruginosa infection in CF patients. In this 5-year retrospective study we found that the cost of treatment of initial infection is considerably lower than the cost of treating chronic P. aeruginosa infections. The percentage distribution of costs of antibiotic treatment in relationship to the administration route was considerably different between outpatients and inpatients. We observed an increase in antibiotic costs with the age of the patient and the decrease in FEV(1)values. The implementation of early eradication treatment, in addition to decreasing the prevalence of patients chronically infected by P. aeruginosa, might also bring about a notable decrease in costs.

Background: Empirical antibiotic treatment for febrile neutropenia is well established. The best regimen is still controversial. The purpose of this study was to evaluate the efficacy, safety, and cost of a once daily high dose of ceftriaxone plus ciprofloxacin versus thrice daily ceftazidime plus amikacin in neutropenic febrile patients., Methods: Ninety-five patients with febrile neutropenia were included in a prospective, controlled, randomized, non-blind, comparative study. Patients were randomly assigned to one of the treatment groups (63 to the ceftriaxone/ciprofloxacin group and 32 to the ceftazidime/amikacin group) and evaluated as successes or failures according to defined criteria. Daily assessments were made of all patients and all adverse events were recorded., Results: The overall incidence of documented infections was 45.9%: 24/47 (51.1%) in the ceftriaxone/ciprofloxacin group and 10/27 (37%) in the ceftazidime/amikacin group. There was a significant difference in clinical efficacy between the groups (p=0.011) at the end of therapy. The ceftriaxone/ciprofloxacin group had an overall incidence of resolution and improvement of 95.7% in comparison to 75% in the ceftazidime/amikacin group. Thirty-nine organisms were isolated, 26 (66.67%) gram-negative and 13 (33.33%) gram-positive. There was a low incidence of adverse events in both groups., Conclusion: The combination of a single, high dose of ceftriaxone plus ciprofloxacin daily was more effective than the standard combination of thrice daily ceftazidime plus amikacin with no significant adverse events in either group.

Background: A series of 459 hospitalized adults with complicated intra-abdominal infections participated in a randomized, double-blind, multicenter clinical trial. The present study was conducted to add a pharmacoeconomic analysis to the results., Methods: A cost-effectiveness analysis from the perspective of the hospital provider was carried out. Decision analysis was used to illustrate outcomes and to provide a basis on which to conduct a sensitivity analysis. Cost-effectiveness ratios, representing the cost per expected successfully treated patient, were calculated to determine the most cost-effective alternative., Results: Among 244 economically evaluable patients, enrolled from 34 centers in the U.S. and Canada, 131 patients received ciprofloxacin-metronidazole (75% clinical success rate), and 113 received piperacillin-tazobactam (65% clinical success rate; p = 0.06). Switch to oral antibiotics was possible for 81 patients who received ciprofloxacin-metronidazole (85% clinical success rate) and 67 piperacillin-tazobactam patients (70% clinical success rate; p = 0.027). The mean hospital cost was US$10,662 +/- 7,793 for patients in the ciprofloxacin-metronidazole group and $10,009 +/- 7,023 for patients in the piperacillin-tazobactam group (p = 0.492). Significantly lower costs were documented for patients who could be switched to oral antibiotics than for those continued on intravenous antibiotic orders ($8,684 +/- 4,120 vs. $12,945 +/- 10,204, respectively; p < 0.001). Patients with appendicitis had lower mean hospital costs than those with other infections ($7,169 +/- 3,705 vs. $12,097 +/- 8,342, respectively; p < 0.001). The cost-effectiveness ratios were $14,216:1 for patients in the ciprofloxacin-metronidazole group and $15,398:1 for patients in the piperacillin-tazobactam group., Conclusions: The mean hospital costs associated with ciprofloxacin-metronidazole were similar to those of piperacillin-tazobactam for the treatment of adults with complicated intra-abdominal infections. Lower costs were documented for patients able to be switched to oral antibiotics and for patients with appendicitis.

Objective: Intravenous-to-oral switch therapy is strongly recommended in the medical literature. The aim of this study was to assess how we can improve fluoroquinolone switch therapy., Methods: In this comparative prospective study, we analyzed 243 intravenous ciprofloxacin treatments and assessed the impact of promoting a switch to oral step-down therapy., Results: This study found that switches from intravenous to oral therapy increased, mainly in medical wards, and led to significant savings in direct costs., Discussion: Promoting switch therapy has improved clinical practices in antibiotic use and led to lower direct and probably indirect drug-related costs., Conclusion: Our findings will help define the role of switch therapy in improving clinical practices in inpatient antibiotic use.

The growing frequency of authorized generics has important implications for the welfare of prescription drug consumers. Authorized generic entry could affect the timing of generic entry, brand-name and generic prices, and generic penetration. We reviewed 1999-2003 data and found that generic entry in the absence of short-run exclusivity restrictions benefits consumers through lower short-run prices. We suggest that these benefits likely also result from authorized generics. We posit that long-run prices and shares are likely essentially unaffected by authorized generics and that potential costs to consumers from any delayed generic entry are likely small.

Introduction: Rhinosinusitis is one of the more common diseases encountered in outpatient visits to health care. The objective of this study was to determine the most cost-effective antibiotic treatment for patients with acute (RSA) and chronic rhinosinusitis (RSC) that is available at the Mexican Institute of Social Security (IMSS)., Methods: Cost-effectiveness analysis of RSA and RSC treatment from an institutional perspective. Effectiveness outcome was defined as the percentage of cure. A decision tree with a Bayesian approach included the following therapeutic alternatives: ciprofloxacin, gatifloxacin, trimetoprim/sulfametoxazol (TMP/SMX), amoxicilin/clavulanic acid (AAC) and clindamicin., Results: Treatment for RSA with AAC showed a mean cost per cured patient of $ 878 pesos. The remaining antibiotics had a higher cost per unit of success, and therefore the results showed that AAC was the best alternative considering this criterion. The therapy that showed a larger percentage of cured patients in RSC was clindamicin; however, the therapeutic alternative with the lowest cost per successful unit was the one based on ciprofloxacin, which dominates gatifloxacin and AAC., Conclusions: The most cost-effective alternative in the antibiotic treatment of patients with RSA was ACC while for RSC it was ciprofloxacin; sensitivity analysis showed the strength of the base study results.

Objective: The goal of this research was to determine the cost-effectiveness of ciprofloxacin 0.3%/dexamethasone 0.1% (CD) otic suspension versus ofloxacin 0.3% otic solution (OFX) for treatment of acute otitis media in tympanostomy tube patients., Methods: A decision-analytic model was used to emulate the ototopical treatment of acute otitis media in patients with tympanostomy tubes. The economic outcome was the cost per otorrhea-free day (OFD) achieved per episode of care. Three tiers of antimicrobial therapy were modeled, with each successive tier representing the retreatment of clinical failures from the preceding tier. First-tier therapy compared CD and OFX using outcome measures obtained from a randomized clinical trial (n = 599). Second-tier therapy modeled the use of amoxicillin/clavulanate (ACA) using outcome measures obtained from a physician survey and medical literature. Third-tier therapy was modeled as pathogen-specific and curative. It could follow one of three pathways: 1) intramuscular ceftriaxone; 2) oral fluconazole; or 3) hospitalization for intravenous antibiotics. Third-tier outcomes were based on a physician survey. Cost data were obtained from standard references and presented from a payer perspective., Results: The expected therapeutic costs were 249.40 dollars for the CD pathway and 265.44 dollars for the OFX pathway. The estimated number of OFDs per episode of care was 25.88 for the CD pathway and 23.86 for the OFX pathway. The cost-effectiveness ratios for CD and OFX therapies were 9.64 dollars and 11.13 dollars per OFD, respectively., Conclusion: CD is both more effective and less costly than OFX for the treatment of acute otitis media in patients with tympanostomy tubes.

Background: The optimal treatment regimen and duration of the therapy is still controversial in spinal brucellosis. The aim of this study is to compare the efficacy, adverse drug reactions, complications and cost of ciprofloxacin plus rifampicin versus doxycycline plus streptomycin in the treatment of spinal brucellosis., Methods: The patients diagnosed as spinal brucellosis between January 2002 to December 2004 were enrolled into the study. Patients were enrolled into the two antimicrobial therapy groups (doxycycline plus streptomycin vs. ciprofloxacin plus rifampicin) consecutively. For the cost analysis of the two regimens, only the cost of antibiotic therapy was analysed for each patient., Results: During the study period, 31 patients with spinal brucellosis were enrolled into the two antimicrobial therapy groups. Fifteen patients were included in doxycycline plus streptomycin group and 16 patients were included in ciprofloxacin plus rifampicin group. Forty-two levels of spinal column were involved in 31 patients. The most common affected site was lumbar spine (n = 32, 76%) and involvement level was not different in two groups. Despite the disadvantages (older age, more prevalent operation and abscess formation before the therapy) of the patients in the ciprofloxacin plus rifampicin group, the duration of the therapy (median 12 weeks in both groups) and clinical response were not different from the doxycycline plus streptomycin. The cost of ciprofloxacin plus rifampicin therapy was 1.2 fold higher than the cost of doxycycline plus streptomycin therapy., Conclusion: Classical regimen (doxycycline plus streptomycin), with the appropriate duration (at least 12 weeks), is still the first line antibiotics and alternative therapies should be considered when adverse drug reactions were observed.

The increasing prevalence of ciprofloxacin-resistant Neisseria gonorrhoeae has required replacing inexpensive oral ciprofloxacin treatment with more expensive injectable ceftriaxone. Further, monitoring antimicrobial resistance requires culture testing, but nonculture gonorrhea tests are rapidly replacing culture. Since the strategies were similar in effectiveness (> 99%), we evaluated, from the healthcare system perspective, cost-minimizing strategies for both diagnosis (culture followed by antimicrobial susceptibility tests versus nonculture-based tests) and treatment (ciprofloxacin versus ceftriaxone) of gonorrhea in women. Our results indicate that switching from ciprofloxacin to ceftriaxone is cost-minimizing (i.e., optimal) when the prevalence of gonorrhea is > 3% and prevalence of ciprofloxacin resistance is > 5%. Similarly, culture-based testing and susceptibility surveillance are optimal when the prevalence of gonorrhea is < 13%; nonculture-based testing is optimal (cost-minimizing) when gonorrhea prevalence is > or = 13%.

Background: Despite cost containment efforts, parenteral (IV) ciprofloxacin appears to be overutilized at Vancouver General Hospital. In November 2003, the Pharmacist-managed intravenous to oral (IV-PO) Dosage Form Conversion Service was implemented, enabling autonomous pharmacist-initiated dosage form conversion for ciprofloxacin. This study evaluates characteristics of ciprofloxacin use prior to and following implementation of this conversion service., Methods: This was a single-centre, two-phase (pre/post), unblinded study. Phase I occurred between November 12, 2002 and November 11, 2003 (365 days), and Phase II between November 12, 2003 and March 11, 2004 (120 days). All patients receiving ciprofloxacin IV during these periods were reviewed. The primary endpoint was IV:PO ciprofloxacin use ratio. Secondary endpoints were total number of ciprofloxacin doses, proportion of inappropriate IV ciprofloxacin doses, cost of therapy between phases, and estimated cost avoidance with the intervention., Results: Two hundred ciprofloxacin IV treatment courses were evaluated (100 per phase). The IV:PO ciprofloxacin use ratio was 3.03 (Phase I) vs. 3.48 (Phase II). Total number of doses and ratio of IV to total doses across phases were similar (p = 0.2830). IV-PO ciprofloxacin conversion occurred in 27/100 (27%) of IV courses in Phase I and 23/100 (23%) in Phase II. Proportion of inappropriate ciprofloxacin IV doses decreased between Phases I and II (244/521 (47%) vs. 201/554 (36%) (p = 0.0005), respectively). Furthermore, the proportion of pharmacist-preventable inappropriate ciprofloxacin IV doses was reduced between Phases I and II (114/244 (47%) vs. 65/201 (32%) (p = 0.0026). Proportional cost avoidance associated with total inappropriate IV use was 7,172 Can dollars/16,517 Can dollars (43%) (in Canadian dollars) in Phase I vs. 6,012 Can dollars/17,919 Can dollars (34%) in Phase II (p = 0.001). Similarly, proportional cost avoidance associated with pharmacist-preventable inappropriate IV doses was reduced from 3,367 Can dollars/16,517 Can dollars (20%) in Phase I to 1,975 Can dollars/17,919 Can dollars (11%) in Phase II (p = 0.001)., Conclusion: While overall utilization of ciprofloxacin remained unchanged and the proportion of IV to total doses was stable during the study period, the proportion of inappropriate IV doses and its associated costs appear to have declined subsequent to implementation of a Pharmacist-managed IV-PO Dosage Form Conversion Service. Such a program may be a beneficial adjunct in facilitating appropriate and cost-effective usage of ciprofloxacin.

Objectives: This study investigated the impact of a combined intervention strategy to improve antimicrobial prescribing at University Hospital Groningen. For the intervention, the antimicrobial treatment guidelines were updated and disseminated in paperback and electronic format. The credibility of the guidelines was improved by consultation with users. In a second phase, academic detailing (AD) was used to improve specific areas of low compliance with the guidelines., Materials and Methods: Prescribing data were prospectively collected for 2869 patients receiving 7471 prescriptions for an antimicrobial for an infection covered by the guidelines between July 2001 and September 2003. After collection of baseline data, the guidelines were actively disseminated in February 2002. Next, after a 5 month interval, a second intervention, i.e. an AD approach, addressed suboptimal prescribing of ciprofloxacin and co-amoxiclav. Segmented regression analysis was used to analyse the interrupted time-series data., Results: At baseline, compliance with the drug choice guidelines was 67%. The first intervention showed a significant change in the level of compliance of +15.5% (95% CI: 8%; 23%). AD did not lead to statistically significant additional changes in already high levels +12.5% (95% CI:-3%; 28%) of compliance. Post-intervention compliance was stable at 86%., Conclusions: Updating the guidelines in close collaboration with the specialists involved followed by active dissemination proved to be an efficient way to improve compliance with guideline recommendations. An 86% compliance level was achieved in this study without compulsory measures. A ceiling effect may have limited the added value of AD.

Background: Numerous combination and single-agent antimicrobial regimens are available for the treatment of intra-abdominal infections. Selection of empiric agents must be directed at providing reliable activity against endotoxin-generating Escherichia coli, other gram-negative facultative bacteria, and anaerobes such as Bacteroides fragilis. Safety profiles, pharmacokinetic profiles, and cost-effectiveness must also be considered. Use of fluoroquinolones for the treatment of intra-abdominal infections has recently been advocated., Methods: We review 2 prospective, comparative clinical trials conducted between 1992 and 2002 that evaluated the efficacy and safety of IV ciprofloxacin in patients with intra-abdominal infections. Separate pharmacoeconomic analyses conducted for each study are also reviewed., Results: A total of 4 ciprofloxacin studies (2 clinical, 2 pharmacoeconomic) comprise the database. The combination of ciprofloxacin plus metronidazole was at least as effective as imipenem/cilastatin and clinically more effective than piperacillin/tazobactam therapy, based on clinical success end points. In 1 trial, treatment success for the clinically valid population was reported for 84% (93/111) of patients treated with IV ciprofloxacin/metronidazole, 86% (91/106) of those treated with IV/oral ciprofloxacin/metronidazole, and 81% of those treated with IV imipenem/cilastatin (91/113). The IV/oral ciprofloxacin/metronidazole regimen had a statistically significant lower mean infection-related cost than the IV only ciprofloxacin/metronidazole plus imipenem groups (difference of approximately 1100 US dollars; P = 0.029). In the second clinical trial, clinical resolution rates were statistically different for patients receiving IV/oral ciprofloxacin/metronidazole (74%) versus IV piperacillin/tazobactam therapy (63%; P = 0.047). Ciprofloxacin/metronidazole was more cost-effective compared with piperacillin/tazobactam (2200 US dollars-3600 US dollars lower cost-effective ratios per patient) regardless of whether the patient had a diagnosis of appendicitis or whether a switch to an oral drug was permissible., Conclusions: In the studies reviewed herein, the combination of ciprofloxacin plus metronidazole was an effective and safe regimen for the treatment of intra-abdominal infections. This regimen has potential advantages over exclusively IV regimens, including the option of sequential IV/oral therapy, patient convenience, cost savings, and reduced hospital stay.

Objective: The aim of this study was to determine the cost-effectiveness hreshold of a ciprofloxacin 0.3% and dexamethasone 0.1% (CD) otic suspension relative to olfloxacin otic solution (OFX) for the treatment of acute otitis media in pediatric patients with tympanostomy tubes (AOMT)., Methods: This study used a decision-analytic model to simulate the costs and consequences of the ototopical treatment of AOMT. The AOMT model consisted of 3 tiers of antimicrobial therapy. Each successive tier represented the repeat treatment of clinical failures from the preceding tier. Patients were modeled for treatment until cured or until third-tier therapy was complete, at which time patients were considered cured. First-tier therapy modeled a comparison of CD and OFX using efficacy rates taken from a randomized clinical trial with a population of 599 patients. Second-tier therapy modeled the use of amoxicillin and clavulanic acid using an efficacy rate taken from the medical literature. Third-tier therapy was modeled as being pathogen specific and could follow 1 of 3 possible clinical pathways: (1) PO fluconazole, (2) IM ceftriaxone, or (3) IV antibiotics administered in a hospital setting. Third-tier therapeutic pathway probabilities were based on the microbiologic spectrum of the treatment failures from the clinical trial. Cost information (in year-2003 US dollars) was taken from accepted cost reference sources and presented from the perspective of a third-party payer. The economic outcome of interest was the cost-effectiveness threshold of CD relative to OFX., Results: Given the model parameters, CD had a cost-effectiveness threshold value of 4.5 times the wholesale acquisition cost of OFX. Based on actual cost, first-tier CD therapy was more cost-effective than OFX up to a threshold price of US 152.64 dollars., Conclusion: In this decision-analytic model, CD was more cost-effective than OFX for AOMT therapy in pediatric patients up to a threshold price of 4.5 times the price of OFX.

The University of Kentucky Hospital investigated the feasibility of choosing a sole fluoroquinolone for its formulary in an effort to reduce costs without affecting clinical outcomes. A three-step process was used to plan, implement, and monitor the selection program. Based on the range of clinical indications, safety profile, local susceptibility, cost, and dosing convenience, levofloxacin was chosen over ciprofloxacin and gatifloxacin as the sole fluoroquinolone. Since the implementation of the program in May 2001, susceptibility to levofloxacin has been maintained or increased for the most common pathogens. In addition, University Hospital has saved nearly 100,000 dollars in antibiotic acquisition costs during the first 12 months after the switch. This assessment did not take into account effects in clinical outcomes, such as clinical failures (such as readmission rates), mortality, and adverse events, or measure changes in overall medical expenditures beyond drug acquisition costs. In the future, monitoring of overall patient care and medical care costs, in addition to susceptibility patterns and drug costs, will allow for a better understanding of the long-term benefits of this switch.

Objective: Pouchitis is often diagnosed based on symptoms and empirically treated with antibiotics (treat-first strategy). However, symptom assessment alone is not reliable for diagnosis, and an initial evaluation with pouch endoscopy (test-first strategy) has been shown to be more accurate. Cost-effectiveness of these strategies has not been compared. The aim of this study was to compare cost-effectiveness of different clinical approaches for patients with symptoms suggestive of pouchitis., Methods: Pouchitis was defined as pouchitis disease activity index scores > or =7. The frequency of pouchitis in symptomatic patients with ileal pouch was estimated to be 51%; the efficacy for initial therapy with metronidazole (MTZ) and ciprofloxacin (CIP) was 75% and 85%, respectively. Cost estimates were obtained from Medicare reimbursement data., Results: Six competing strategies (MTZ trial, CIP trial, MTZ-then-CIP trial, CIP-then-MTZ trial, pouch endoscopy with biopsy, and pouch endoscopy without biopsy) were modeled in a decision tree. Costs per correct diagnosis with appropriate treatment were $194 for MTZ trial, $279 for CIP trial, $208 for MTZ-then-CIP trial, $261 for CIP-then-MTZ trial, $352 for pouch endoscopy with biopsy, and $243 for pouch endoscopy without biopsy. Of the two strategies with the lowest cost, the pouch endoscopy without biopsy strategy costs $50 more per patient than the MTZ trial strategy but results in an additional 15 days for early diagnosis and thus initiation of appropriate treatment (incremental cost-effectiveness ratio $3 per additional day gained). The results of base-case analysis were robust in sensitivity analyses., Conclusions: Although the MTZ-trial strategy had the lowest cost, the pouch endoscopy without biopsy strategy was most cost-effective. Therefore, based on its relatively low cost and the avoidance of both diagnostic delay and adverse effects associated with unnecessary antibiotics, pouch endoscopy without biopsy is the recommended strategy among those tested for the diagnosis of pouchitis.

The effect of fluoroquinolone use on the susceptibility of Pseudomonas aeruginosa to fluoroquinolones in U.S. hospitals was studied. Benchmarking surveys were sent annually to pharmacists practicing in U.S. hospitals from 1993 to 1999. Data collected included hospital characteristics, antimicrobial expenditures and use, antimicrobial stewardship activities, and bacterial susceptibilities. Antimicrobial expenditures were normalized for the number of occupied beds (OBs) per year. General linear modeling and repeated-measures mixed-effects modeling were used to determine factors predictive of P. aeruginosa susceptibility to fluoroquinolones. A total of 174 hospitals provided data for fluoroquinolone expenditures and susceptibility of P. aeruginosa; the median number of years of data was 3 (range, 1-6), representing 416 hospital years. Community hospitals contributed a majority of the data. Median fluoroquinolone expenditures increased gradually from $230 per OB in 1993 to $400 per OB in 1998. A 55% increase to $620 per OB occurred in 1999, largely because of increased spending on levofloxacin. Susceptibility to ciprofloxacin was commonly used to assess fluoroquinolone susceptibility. The median susceptibility of P. aeruginosa to ciprofloxacin decreased from 84% to 71%. Increasing expenditures for ofloxacin and levofloxacin, but not ciprofloxacin, were associated with decreasing P. aeruginosa susceptibility to ciprofloxacin. In the final multivariable model, each study year after 1993 and every increase in ofloxacin expenditure of $100 per OB were associated with decreases in P. aeruginosa susceptibility. Data from a benchmarking survey of U.S. hospitals for 1993-1999 revealed increases in levofloxacin expenditures, total fluoroquinolone expenditures, expenditures for nonfluoroquinolone antipseudomonal antimicrobials, and total antimicrobial expenditures in 1999. Increases in expenditures for levofloxacin and ofloxacin were associated with a significant decrease in P. aeruginosa susceptibility to ciprofloxacin.

Pharmacoeconomics is application of economical principles in health and pharmaceutical care sector. This is comparative analysis of treatment e.i. therapeutic alternatives (drugs), which takes into consideration both their costs and their health repercussions. Cost-benefit analysis (CBA) has been used where effectiveness of cost was calculated by calculating the sum of costs for urinary infections treatment which include the cost of examinations, the costs of therapy with ciprofloxacin and norfloksacin, other costs associated with treatment and total benefit for both of treatments. CBA of costs are pointing out that it is economically justified to prescribe both drugs, ciprofloxacin and norfloksacin, due the costs-benefit are the quite equal for both.

Objectives: Antibiotics are the mainstay for the treatment of men with bacterial prostatitis. Despite numerous treatment strategies involving various types, dosages and duration of antibiotics, no uniform standard has been widely adapted. Moreover, the economic burden of these therapies has been heretofore poorly described. The purpose of this study was to compare the cost effectiveness of various antibiotic treatment regimens for chronic bacterial prostatitis., Methods: After reviewing the literature, we constructed a model that compared 90 days of double strength trimethoprim-sulfamethoxazole and 14, 28 and 60 days of ciprofloxacin 500 mg. Parameters examined included initial cure rates, relapse rates, total cure rates, pharmaceutical costs, and total cost of treatment. Using a spreadsheet Markov model, we applied cure rates and relapse rates to a hypothetical cohort of 100 men with culture positive chronic bacterial prostatitis. We then calculated cost of medications and total healthcare costs for the various drug regimens., Results: Twice daily ciprofloxacin @ 500 mg for 28 days proved to be the most cost effective treatment for chronic bacterial prostatitis. Yet, after sensitivity analysis, only twice daily ciprofloxacin @ 500 mg for 60 days demonstrated consistent benefit over trimethoprim-sulfamethoxazole but at a substantially increased cost., Conclusions: Our model implies that ciprofloxacin 500 mg twice daily for 28 days appears to be the most cost effective treatment for chronic bacterial prostatitis. Given the limitations of this type of modeling, long term, prospective, comparative trials will provide the most definitive method of evaluating optimal therapy for chronic bacterial prostatitis.

A randomized controlled trial was carried out to assess the effectiveness of azithromycin versus a standard regimen with doxycycline/ciprofloxacin in the treatment of sexually transmitted infections in a resource-poor environment. Infection with Chlamydia trachomatis was cured in 23/24 (95.8%) of women in the azithromycin arm versus 19/21 (90.5%) in the doxycycline arm (P = 0.6), resulting in three treatment failures. Gonorrhoea was cured in 55/56 (98.2%) women, with one treatment failure in a patient with concomitant C. trachomatis infection. These results indicate that a single oral dose of azithromycin may prove to be a more effective and convenient treatment for sexually transmitted infections in women in a resource-poor environment

The effectiveness of a programme to reduce the use of i.v. ciprofloxacin was assessed. i.v. ciprofloxacin was removed from ward stock and discussion occurred regarding appropriate use of the drug. Six months later, a factsheet containing recommendations was distributed to all medical staff and a requirement for justification before prescription was introduced. The programme reduced expenditure on i.v. ciprofloxacin to 34% of original levels. Savings of > 36,000 pounds sterling were made for two consecutive years. A sustained reduction in the use of i.v. ciprofloxacin was obtained by a combination of education and restriction.

The abilities of therapeutic interchange (TI) and standard educational tools (SET) to change prescribing habits were compared. We evaluated the replacement of ciprofloxacin with levofloxacin in a four-hospital health system during a 14-month study period. Two hospitals used TI and two SET. The demographics, sites of infection, and severity of illness were analyzed for 554 patients treated at SET hospitals and 1323 patients treated at TI hospitals during a total of 2040 hospitalizations over a 14-month period. In TI hospitals, 97% of patients received levofloxacin, whereas 43% received levofloxacin in SET hospitals (p < 0.001). Clinical outcomes were not significantly different for the two groups, although more patients in the SET hospitals received combination antimicrobial therapy. Differences in savings per patient were significant between TI hospitals ($60) and SET hospitals ($37) (p < 0.001). The total annualized savings for all four hospitals was $156,444. TI was more effective than SET in facilitating changes in prescribing patterns in a health care system and resulted in significant cost savings to hospitals and payers.

Economic pressures on the delivery of health care have necessitated a focus on reducing costs and resource utilization while maintaining or improving the quality of care. A growing consensus holds that switching from intravenous to oral therapy is a cost-effective and clinically sound approach for a significantly large group of patients with community-acquired pneumonia (CAP). Drug utilization studies within the INOVA Health System revealed that levofloxacin is a cost-effective alternative to ciprofloxacin in infectious disease and that use of risk prediction criteria can reduce inappropriate hospitalizations for CAP, thereby reducing costs. In addition, the INOVA experience demonstrates that the strategy used to implement new antibiotic regimens such as switch-therapy regimens is an important factor in cost reduction: a therapeutic interchange mandate is more successful than standard educational techniques in changing treatment patterns.

Study Objective: To determine treatment outcomes and economic impact of a ciprofloxacin stepdown program for high-risk febrile neutropenic adults from the hospital's perspective., Design: Unblinded, two-phase, single-center study., Setting: Adult leukemia and stem cell transplant unit., Patients: High-risk adults with febrile neutropenia., Intervention: Two conditions were analyzed: a multidisciplinary ciprofloxacin stepdown program involving a reduction in parenteral ciprofloxacin dose from 400 to 200 mg (i.v.-i.v.) and conversion to oral ciprofloxacin (i.v.-p.o.) when criteria were met; and no i.v.-i.v. stepdown program., Measurements and Main Results: Forty-six sequential treatment courses were compared with 42 treatment course from 6-month periods in preintervention (P1) and postintervention (P2) phases. Assessed parameters were clinical and microbiologic outcomes, adverse drug reactions (ADRs), and direct medical resource use and costs (1998 $Canadian) for the episode of febrile neutropenia. A decision analytic model was used to map probabilities and costs and to conduct sensitivity analyses. To supplement standard statistical testing, 1,000 bootstrap samples were created, and the mean cost difference was calculated between phases for each sample. Patient demographics, percentage i.v.-p.o. stepdown, and duration of therapy were similar between phases. Clinical success (83% P1, 81% P2), microbiologic eradication (15% P1, 24% P2), and possible ADRs (6% P1, 9% P2) did not differ. Intravenous-to-intravenous dose stepdown occurred in 33% of P2 and no P1 treatment courses (p<0.001). Resource use and costs were similar between phases, although a reduction was seen in the drug's mean total cost/day ($58 P1, $52 P2, p=0.04). There was also a trend toward a decrease in mean total treatment costs ($4,843 P1, $3,493 P2, p=0.08). In 1,000 bootstrap samples, 99.8% showed a cost advantage for P2. The model was robust to sensitivity analyses., Conclusion: This intervention influenced administration of ciprofloxacin without apparent compromise of patient outcomes and resulted in a reduction in total costs of treating febrile neutropenia.

Context: The optimal antimicrobial regimen and treatment duration for acute uncomplicated pyelonephritis are unknown., Objective: To compare the efficacy and safety of a 7-day ciprofloxacin regimen and a 14-day trimethoprim-sulfamethoxazole regimen for the treatment of acute pyelonephritis in women., Design: Randomized, double-blind comparative trial conducted from October 1994 through January 1997., Setting: Twenty-five outpatient centers in the United States., Patients: Of 378 enrolled premenopausal women aged at least 18 years with clinical diagnosis of acute uncomplicated pyelonephritis, 255 were included in the analysis. Other individuals were excluded for no baseline causative organism, inadequate receipt of study drug, loss to follow-up, no appropriate cultures, and other reasons., Interventions: Patients were randomized to oral ciprofloxacin, 500 mg twice per day for 7 days (with or without an initial 400-mg intravenous dose) followed by placebo for 7 days (n = 128 included in analysis) vs trimethoprim-sulfamethoxazole, 160/800 mg twice per day for 14 days (with or without intravenous ceftriaxone, 1 g) (n = 127 included in the analysis)., Main Outcome Measure: Continued bacteriologic and clinical cure, such that alternative antimicrobial drugs were not required, among evaluable patients through the 4- to 11-day posttherapy visit, compared by treatment group., Results: At 4 to 11 days posttherapy, bacteriologic cure rates were 99% (112 of 113) for the ciprofloxacin regimen and 89% (90 of 101) for the trimethoprim-sulfamethoxazole regimen (95% confidence interval [CI] for difference, 0.04-0.16; P = .004). Clinical cure rates were 96% (109 of 113) for the ciprofloxacin regimen and 83% (92 of 111) for the trimethoprim-sulfamethoxazole regimen (95% CI, 0.06-0.22; P = .002). Escherichia coli, which caused more than 90% of infections, was more frequently resistant to trimethoprim-sulfamethoxazole (18%) than to ciprofloxacin (0%; P<.001). Among trimethoprim-sulfamethoxazole-treated patients, drug resistance was associated with greater bacteriologic and clinical failure rates (P<.001 for both). Drug-related adverse events occurred in 24% of 191 ciprofloxacin-treated patients and in 33% of 187 trimethoprim-sulfamethoxazole-treated patients, respectively (95% CI, -0.001 to 0.2)., Conclusions: In our study of outpatient treatment of acute uncomplicated pyelonephritis in women, a 7-day ciprofloxacin regimen was associated with greater bacteriologic and clinical cure rates than a 14-day trimethoprim-sulfamethoxazole regimen, especially in patients infected with trimethoprim-sulfamethoxazole-resistant strains.

Twice-daily dosing is recommended for ciprofloxacin for most indications. Trovafloxacin and grepafloxacin can be administered once-daily. Levofloxacin should probably be administered twice daily in serious, life-threatening infections. The acquisition cost of ciprofloxacin is currently higher than the newer agents, but a lower acquisition cost does not necessarily mean a lower overall cost of treatment. A cheaper agent which is less effective or safe just shifts costs to other areas by creating further clinical problems with their attendant costs. The total costs associated with treatment with newer agents are as yet undefined. Restricting the prescription of a particular antibiotic may result in the increased use of an alternative regimen which may cost the same or even more than the original ('cost shifting'). This interesting observation needs to be substantiated with future research. Ciprofloxacin is available in both intravenous and oral formulations and suitable for sequential intravenous-oral therapy with its attendant benefits. It is currently the gold-standard quinolone in the hospital setting for a broad range of infections, particularly Pseudomonas aeruginosa infections. Initially, the newer quinolones are most likely to be used to treat severe, community-acquired pneumonia.

The influence of using ofloxacin in place of ciprofloxacin on hospital fluoroquinolone expenditures, total antimicrobial expenditures, and susceptibility of Pseudomonas aeruginosa to fluoroquinolones was studied. Hospitals with fluoroquinolone expenditures of at least $1 per occupied bed per year were administered annual surveys covering the years 1993 through 1996. The two most recent consecutive years of data were compared among hospitals that used ciprofloxacin as their primary fluoroquinolone during both years (group 1), hospitals whose ofloxacin purchases increased from accounting for < or =25% of total fluoroquinolone expenditures during year 1 to accounting for >25% during year 2 (group 2), and hospitals whose ofloxacin purchases accounted for at least 25% of total fluoroquinolone expenditures for both years (group 3). A total of 109 hospitals were included in the study. Most hospitals spent more on fluoroquinolones and total antimicrobials in year 2 than year 1. Group 3 hospitals had a significant increase in expenditures for fluoroquinolones and non-fluoroquinolone antipseudomonal antimicrobials. Group 2 hospitals did not realize antimicrobial cost savings and had higher rates of Pseudomonas aeruginosa resistance than hospitals that used ciprofloxacin. Whether a hospital changed its pattern of ciprofloxacin and ofloxacin purchasing was not significantly associated with expenditures for fluoroquinolones, nonfluoroquinolone antimicrobial agents, or all antimicrobials. Susceptibility of P. aeruginosa to ciprofloxacin was lower in hospitals with greater proportions of ofloxacin use. Individual hospital, ciprofloxacin expenditures, and study year were found to be predictive of P. aeruginosa susceptibility to ciprofloxacin among all pooled hospitals.

Objective: To undertake a 1-year prospective economic evaluation of ciprofloxacin compared with usual antibacterial care (any antibacterial other than a quinolone) for the treatment of acute exacerbations of chronic bronchitis (AECB) in adults presenting with a type I or type II AECB., Design: Patients entered the study with an initial AECB and were randomised to the ciprofloxacin group or the usual care group. The following measurements were taken at the end of each AECB and every 3 months: resource utilisation, St. George's Respiratory Questionnaire, Nottingham Health Profile and Health Utilities Index (HUI). The following additional measurements were taken after each AECB: AECB-symptom days and willingness to pay to avoid the AECB. Economic evaluations were performed from the societal viewpoint and the viewpoint of a major third-party payer. Cost-effectiveness analysis was based on cost per AECB-symptom day averted; cost-utility analysis (CUA) was based on cost per quality-adjusted life-year (QALY) gained using the HUI as the basis for calculating QALYs. Cost-benefit analysis was based on the willingness-to-pay (WTP) data., Setting: This was a study of outpatients enrolled from 46 family physicians and 2 respirologists in Ontario (29 sites) and Québec (19 sites), Canada, between November 1993 and June 1994., Patients and Participants: 240 adult male and female patients aged > or = 18 years with chronic bronchitis., Main Outcome Measures and Results: WTP data did not pass scope tests for reasonableness. Ciprofloxacin was more costly and provided better outcomes compared with usual antibacterial care. The base-case results are as follows (1994/1995 values): the incremental annual cost was 578 Canadian dollars ($Can) from the societal viewpoint and $Can840 for the third-party payer; the cost-effectiveness ratio per AECB-symptom day averted was $Can209 from the societal viewpoint and $Can304 for the third-party payer; the cost-utility ratio per QALY gained was $Can18,600 from the societal viewpoint and $Can27,000 for the third-party payer. According to Laupacis criteria, these CUA results are strong evidence in favour of adoption from the societal viewpoint and moderate evidence in favour from the viewpoint of the third-party payer. A subgroup analysis suggests that ciprofloxacin may be particularly cost effective, even 'win-win', in patients with more severe disease., Conclusions: The sensitivity analyses indicate that the results are relatively robust. Nevertheless, the statistical uncertainty in the results is sufficient that the findings cannot be accepted unequivocally. A further study with a larger sample size would be useful to confirm (or deny) the findings of this study.

Objective: To compare the cost effectiveness of sequential intravenous (i.v.) to oral ciprofloxacin plus metronidazole (CIP/MTZ i.v./PO) with that of i.v. ciprofloxacin plus i.v. metronidazole (CIP/MTZ i.v.) and i.v. imipenem-cilastatin (IMI i.v.) in patients with intra-abdominal infections., Design and Participants: Patients enrolled in a double-blind randomised clinical trial were eligible for inclusion into this cost-effectiveness analysis. Decision analysis was used to characterise the economic outcomes between groups and provide a structure upon which to base the sensitivity analyses. 1996 cost values were used throughout., Setting: The economic perspective of the analysis was that of a hospital provider., Main Outcome Measures and Results: Among 446 economically evaluable patients, 176 could be switched from i.v. to oral administration. The 51 patients randomised to CIP/MTZ i.v./PO who received active oral therapy had a success rate of 98%, mean duration of therapy of 9.1 days and mean cost of $US7678. There were 125 patients randomized to either CIP/MTZ i.v. or IMI i.v. who received oral placebo while continuing on active i.v. antibacterials; their success rate was 94%, mean duration of therapy was 10.1 days and mean cost was $US8774 (p = 0.029 vs CIP/MTZ i.v./PO). Of the 270 patients who were unable to receive oral administration, 97 received IMI i.v. and had a success rate of 75%, mean duration of therapy of 13.8 days and a mean cost of $US12,418, and 173 received CIP/MTZ i.v. and had a success rate of 77%, mean duration of therapy of 13.4 days and mean cost of $US12,219 (p = 0.26 vs IMI i.v.)., Conclusions: In patients able to receive oral therapy, sequential i.v. to oral treatment with ciprofloxacin plus metronidazole was cost effective compared with full i.v. courses of ciprofloxacin plus metronidazole or imipenem-cilastatin. In patients unable to receive oral therapy, no difference in mean cost was found between i.v. imipenem-cilastatin or i.v. ciprofloxacin plus i.v. metronidazole.

This retrospective cohort study used North Carolina Medicaid paid-claims data to assess clinical and economic outcomes of treatments for urinary tract infection (UTI). The study population comprised female Medicaid recipients, between 15 and 64 years of age, with a paid claim filed for a primary diagnosis of UTI or acute UTI from January 1 to June 30, 1994, who were treated with ciprofloxacin, nitrofurantoin, or trimethoprim/sulfamethoxazole (TMP/SMZ). Patients had follow-up for 6 months after the primary diagnosis. Patients who did not receive further treatment for UTI with 1 of the 3 drugs within 30 days after initial treatment were assumed to be cured. Costs were measured as the sum of reimbursements for UTI-related medical services and drug treatments. Outcomes for 409 patients were assessed. Cure rates of initial treatment with ciprofloxacin, nitrofurantoin, and TMP/SMZ were 81%, 88%, and 93%, respectively. Cost-effectiveness ratios of initial treatment with the 3 drugs were $150.80, $81.20, and $69.00, respectively. When efficacy rates generated from published randomized clinical studies were applied, cost-effectiveness ratios for the 3 drugs were $130.96, $86.17, and $72.00, respectively. A decision model of treatment pattern and associated costs is presented. Several patient variables indicate that the ciprofloxacin group included more severe cases of UTI than did the other groups. Study limitations, confounders, and future research suggestions are discussed. Our results show that treatment for >7 days results in a better cure rate regardless of the drug used than does treatment for < or =7 days and that TMP/SMZ is the most cost-effective of the 3 drugs for UTI or acute UTI.

In a prospective randomized trial, 40 stage IV breast cancer patients undergoing intermediate high-dose chemotherapy (cyclophosphamide, 5-fluorouracil plus epirubicin or methotrexate), received either recombinant human G-CSF (rhG-CSF, group I) or ciprofloxacin and amphotericin B (CAB, group II) for prevention of febrile leucopenia (FL). In group I, seven of 18 patients developed FL (after 10/108 courses); in group II, seven of 22 patients (7/98 courses) (P = NS). Median hospitalization duration and costs were not different. RhG-CSF was 6.6 times more expensive per course than CAB. In conclusion, prophylactic CAB has similar efficacy to rhG-CSF in this setting, and is more cost-effective.

Limited data exist to guide physicians in the cost-effective treatment of acute exacerbation of chronic bronchitis (AECB). Therefore, the main objective of this study was to determine the antimicrobial efficacy and related costs for patients with AECB. A retrospective review of 60 outpatient medical records with a diagnosis of chronic obstructive pulmonary disease (COPD) and chronic bronchitis episodes from a pulmonary clinic of a teaching institution was undertaken. The participating patients had a total of 224 episodes of AECB requiring antibiotic treatment. Before review, empirical antibiotic choices were divided into first-line (amoxycillin, co-trimoxazole, tetracyclines, erythromycin), second-line (cephradine, cefuroxime, cefaclor, cefprozil) and third-line (co-amoxiclav, azithromycin, ciprofloxacin) agents. Patients receiving first-line agents failed significantly more frequently than third-line agents (19% vs 7%, P < 0.05). Additionally, patients prescribed first-line agents were hospitalized significantly more often for AECB within 2 weeks of outpatient treatment as compared with patients prescribed third-line agents (18.0% vs 5.3% third-line agents; P < 0.02). Time between subsequent AECB episodes requiring treatment was significantly longer for patients receiving third-line agents compared with first-line and second-line agents (P < 0.005). Pharmacy costs were lowest with first-line agents (first-line US$10.30 +/- 8.76; second-line US$24.45 +/- 25.65; third-line US$45.40 +/- 11.11; P < 0.0001), but third-line agents showed a trend towards lower mean total costs of AECB treatment (first-line US$942 +/- 2173; second-line, US$563 +/- 2296; third-line, US$542 +/- 1946). The use of third-line antimicrobials, co-amoxiclav, ciprofloxacin or azithromycin, significantly reduced the failure rate and need for hospitalization, prolonged the time between AECB episodes, and showed a lower total cost for the management of AECB. Prospective studies are needed to confirm these findings.

A recent multicentre clinical study evaluated the safety and efficacy of i.v. ciprofloxacin therapy compared with imipenem-cilastatin in hospitalized patients with severe pneumonia. Monotherapy with i.v. ciprofloxacin was at least equivalent to imipenem in terms of bacteriological eradication and clinical response. In a single-centre, retrospective, post-therapy evaluation of persistent and subsequent infection, the incidence of gram-negative infections and associated costs were compared. The main elements of the economic analysis included costs of additional antimicrobial therapy and hospitalization. Thirty-two patients were randomized into the study, of whom 27 were efficacy-valid. The 13 patients randomized into the ciprofloxacin group were not significantly different from the 14 patients in the imipenem group in terms of clinical parameters. Clinical cure occurred in ten of 13 patients (77%) in the ciprofloxacin group and in seven of 14 (50%) in the imipenem group. Bacteriological eradication was achieved in 11 of 13 (85%) ciprofloxacin-treated and eight of 14 (57%) imipenem-treated patients. Five of 13 (38%) patients in the ciprofloxacin group and nine of 14 (64%) in the imipenem group experienced persistent or subsequent infection requiring post-treatment antimicrobials. In these five ciprofloxacin patients, three had cultures with gram-positive organisms only and two had cultures with both gram-positive and gram-negative organisms. In the nine imipenem-treated patients requiring post-study antimicrobials, all had gram-negative bacteria and three also had gram-positive organisms. The incidence of subsequent gram-negative infection in the two groups (15% vs 64%) was significantly different (P < 0.05). Pseudomonas aeruginosa was isolated from seven patients in the imipenem group but only one in the ciprofloxacin group (P < 0.05). Subsequent costs for post-therapy antimicrobials and hospital stay while receiving study and post-study drug therapy were evaluated; the cost per patient cure was US$29,000 for ciprofloxacin and US$76,000 for imipenem. Initial treatment of severe pneumonia with ciprofloxacin resulted in significantly less subsequent gram-negative infection and was associated with substantially lower curative costs.

Objective: To evaluate the costs, consequences, effectiveness, and safety of ciprofloxacin vs standard antibiotic care in patients with an initial acute exacerbation of chronic bronchitis (AECB) as well as recurrent AECBs over a 1-year period., Design: Randomized, multicenter, parallel-group, open-label study., Setting: Outpatient general practice., Patients: A total of 240 patients, 18 years or older with chronic bronchitis, with a history of frequent exacerbations (three or more in the past year) presenting with a type 1 or 2 AECB (two or more of increased dyspnea, increased sputum volume, or sputum purulence)., Main Outcome Measures: The assessment included AECB symptoms, antibiotics prescribed, concomitant medications, adverse events, hospitalizations, emergency department visits, outpatient resources such as diagnostic tests, procedures, and patient and caregiver out-of-pocket expenses. Patients completed the Nottingham Health Profile, St. George's Respiratory Questionnaire, and the Health Utilities Index. The parameters were recorded with each AECB and at regular quarterly intervals for 1 year. These variables were compared between the ciprofloxacin-treated group and the usual-care-treated group., Results: Patients receiving ciprofloxacin experienced a median of two AECBs per patient compared to a median of three AECBs per patient receiving usual care. The mean annualized total number of AECB-symptom days was 42.9+/-2.8 in the ciprofloxacin arm compared to 45.6+/-3.0 days in the usual-care arm (p=0.50). The overall duration of the average AECB was 15.2+/-0.6 days for the ciprofloxacin arm compared to 16.3+/-0.6 days for the usual-care arm. Treatment with ciprofloxacin tended to accelerate the resolution of all AECBs compared to usual care (relative risk=1.20; 95% confidence interval [CI], 0.91 to 1.58; p=0.19). Treatment assignment did not affect the interexacerbation period but a history of severe bronchitis, prolonged chronic bronchitis, and an increased number of AECBs in the past year were associated with shorter exacerbations-free periods. There was a slight, but not statistically significant, improvement in all quality of life measures with ciprofloxacin over usual care. The only factors predictive of hospitalization were duration of chronic bronchitis (odds ratio=4.6; 95% CI, 1.6, 13.0) and severity of chronic bronchitis (odds ratio=4.3; 95% CI, 0.8, 24.6). The incremental cost difference of $578 Canadian in favor of usual care was not significant (95% CI, -$778, $1,932). The cost for the ciprofloxacin arm over the usual care arm was $18,588 Canadian per quality-adjusted life year gained. When the simple base case analysis was expanded to examine the effect of risk stratification, the presence of moderate or severe bronchitis and at least four AECBs in the previous year changed the economic and clinical analysis to one favorable to ciprofloxacin with the ciprofloxacin-treated group having a better clinical outcome at lower cost ("win-win" scenario)., Conclusions: Treatment with ciprofloxacin tended to accelerate the resolution of all AECBs compared to usual care; however, the difference was not statistically significant. Further, usual care was found to be more reflective of best available care rather than usual first-line agents such as amoxicillin, tetracycline, or trimethoprim-sulfamethoxazole as originally expected. Despite the similar antimicrobial activities and broad-spectrum coverage of both ciprofloxacin and usual care, the trends in clinical outcomes and all quality of life measurements favor ciprofloxacin. In patients suffering from an AECB with a history of moderate to severe chronic bronchitis and at least four AECBs in the previous year, ciprofloxacin treatment offered substantial clinical and economic benefits. In these patients, ciprofloxacin may be the preferred first antimicrobial choice.

A multicenter, prospective, randomized study was performed to compare the cost-effectiveness of parenteral antibiotic versus parenteral antibiotic + oral ciprofloxacin sequential therapy in the treatment of moderate and severe infections in hospitalized patients. After deciding on inclusion (n = 298), the patients were randomly allocated in group "A" (evaluable 120 cases) receiving only parenteral antibiotics, or in group "B" receiving parenteral antibiotic + oral ciprofloxacin from the 3.-5. day of therapy on. The local physician decided on the starting parenteral therapy and the necessity of other therapeutic interventions, and in case of group "B" patients on the possibility of switching parenteral to oral therapy. The overall cure rate was 68% in group "A" and 82% in group "B" (improved 33 and 21, failure 5 and 1 cases resp.). Of the direct costs in patients, care, the costs of antibiotic treatments based on purchase prices was compared: the cost of antibiotic treatment in group "B" was 32% less than in group "A", and the sequential therapy saved 9000 Ft/patient in average. In conclusion, ciprofloxacin proved to be an effective antimicrobial agent that can also be used in sequential therapy and the oral administration resulted in a significant save of money with the same therapeutic effectiveness.