PHARMACOECONOMIC ANALYSIS OF EFFICACY OF DIFFERENT MODES OF ANTIBIOTIC PROPHYLAXIS IN CHOLECYSTECTOMY.

Pharmacoeconomic assessment of efficacy of different modes of antibiotic prophylaxis was made in 27 patients with diagnosis of acute calculous cholecystitis using method of «cost-efficacy¼. Patients have taken ampicillin/sulbactam intravenously in the dose of 1,5 g or cephazolin intravenously in the dose 2,0 g. Medicine should be taken in 30 min. before the operation. The most expensive was antibiotic prophylaxis by cephazolin. The coefficient of «cost-efficacy¼ was 774,2 rubles on 1 unit of efficacy in case of cephazolin and it was 506,1 rubles on 1 unit of efficacy in other group with antibiotic prophylaxis by ampicillin/sulbactam. The authors noted the economical and clinical advantage of antibiotic prophylaxis by ampicillin /sulbactam.

Efficacy of prophylactic antibiotic administration for breast cancer surgery in overweight or obese patients: a randomized controlled trial.

OBJECTIVE: To assess the impact of prophylactic antibiotics on the prevention of surgical site infection (SSI) and the cost-effectiveness of this prophylaxis for breast cancer surgery in overweight or obese women. BACKGROUND DATA: SSI is higher than expected after breast surgery. Obesity was found to be one of the risk factors. METHODS: The trial was designed as a phase IV randomized, controlled, parallel-group efficacy trial. It was conducted at a tertiary university hospital. Overweight or obese women with clinically early-stage breast cancer who had been assigned to undergo surgery were eligible. Patients were randomly allocated to either a prophylaxis or a control group by using a computer-generated list. The prophylaxis group received 1 g ampicillin-sulbactam intravenously at anesthesia. The control group received no intervention. Patients and observers were blinded to the assignments. The primary outcome was the comparison of SSI incidences of the 2 groups. Patients were monitored for 30 days. RESULTS: A total of 369 patients were included in final analysis, out of which 187 were allocated for prophylaxis and 182 were randomly assigned to the control group. Analysis was done according to the intention-to-treat principle. Prophylaxis significantly reduced the SSI rate (4.8%) in the prophylaxis group when compared with that in the control group [13.7%; relative risk (RR) 0.35; 95% CI: 0.17-0.73]. No adverse reaction was observed. The mean SSI-related cost (20.26 USD) was found to be significantly higher in the control group when compared with that (8.48 USD) in the prophylaxis group. CONCLUSION: Antibiotic prophylaxis significantly decreased SSI incidence after elective surgery and was shown to be cost-effective in obese breast cancer patients. ClinicalTrials.gov Identifier: NCT00356148.

Management and prevention of diabetic foot ulcers and infections: a health economic review.

Diabetic foot ulcers and infections are common and incur substantial economic burden for society, patients and families. We performed a comprehensive review, on a number of databases, of health economic evaluations of a variety of different prevention, diagnostic and treatment strategies in the area of diabetic foot ulcers and infections. We included English-language, peer-reviewed, cost-effectiveness, cost-minimization, cost-utility and cost-benefit studies that evaluated a treatment modality against placebo or comparator (i.e. drug, standard of care), regardless of year. Differences were settled through consensus. The search resulted in 1885 potential citations, of which 20 studies were retained for analysis (3 cost minimization, 13 cost effectiveness and 4 cost utility). Quality scores of studies ranged from 70.8% (fair) to 87.5% (good); mean = 78.4% +/- 5.33%.In diagnosing osteomyelitis in patients with diabetic foot infection, magnetic resonance imaging (MRI) showed 82% sensitivity and 80% specificity. MRI cost less than 3-phase bone scanning + Indium (In)-111/Gallium (Ga)-67; however, when compared with prolonged antibacterials, MRI cost $US120 (year 1993 value) more without additional quality-adjusted life-expectancy. Prevention strategies improved life expectancy and QALYs and reduced foot ulcer rates and amputations.Ampicillin/sulbactam and imipenem/cilastatin were both 80% successful in treating diabetic foot infections but the latter cost $US2924 more (year 1994 value). Linezolid cure rates were higher (97.7%) than vancomycin (86.0%) and cost $US873 less (year 2004 value). Ertapenem costs were significantly lower than piperacillin/tazobactam ($US356 vs $US503, respectively; year 2005 values). Becaplermin plus good wound care may be cost effective in specific populations. Bioengineered living-skin equivalents increased ulcer-free months and ulcers healed, but costs varied between countries. Promogran produced more ulcer-free months than wound care alone (3.75 vs 3.41 months, respectively). Treatment with cadexomer iodine resulted in higher rates of healed ulcer (29% vs 11%) and lower weekly treatment costs (Swedish krona [SEK]903 vs SEK1421; year 1993 values) than standard care. Filgrastim decreased hospital stays, time to resolution and costs (36% lower) compared with usual care. Adjunctive hyperbaric oxygen produced an incremental cost per QALY at year 1 of $US27 310 and $US2255 at year 12 (year 2001 values).Overall, preventive strategies were shown to be cost effective and potentially cost saving. Various antibacterial regimens are cost effective but empiric choices should be based on local resistance patterns. MRI was cost effective compared with three-phase bone scanning + In-111/Ga-67 but not against prolonged antibacterial therapy. Other innovations (becaplermin, bioengineered living-skin equivalents, filgrastim, cadexomer iodine ointment, hyperbaric oxygen, Promogran may be cost effective in this population but more studies are needed to confirm these findings.

Cost-effectiveness study comparing cefoperazone-sulbactam to a three-drug combination for treating intraabdominal infections in an Indian health-care setting.

OBJECTIVE: This article presents the methodology and results of the pharmacoeconomic analysis of the Magnex Against Standard COmbination Therapy study comparing cefoperazone-sulbactam (Magnex) versus ceftazidime+ amikacin+metronidazole, in the treatment of intra-abdominal infections. METHODS: This prospective, open label, phase IV study was conducted at 17 study sites in India and randomized subjects to receive either cefoperazone-sulbactam or the combination. Pharmacoeconomic analysis was included as a secondary objective and conducted in the clinical efficacy-evaluable (CEE) and the successfully treated patients. All comparisons between treatment groups were conducted using analysis of variance (ANOVA) or Wilcoxon Two-Sample tests. All costs were reported as Indian Rupee (INR) and actual unit costs collected in 2006 were used for the analyses [1 USD approximately 40 INR; 1 Euro approximately 56 INR]. RESULTS: In the CEE and the successfully treated subset of patients, the average cost of treatment was numerically lower in the cefoperazone-sulbactam arm (not statistically significant). The analyses found that the cost-effectiveness ratio (CER) for cefoperazone-sulbactam was INR 17,640.53 and that for the comparator group was INR 22,075.16. Additionally, the incremental CER results showed that the cost of treatment was INR 21,505.59 lower per additional successfully treated patient in the cefoperazone-sulbactam group. CONCLUSIONS: The present study was the first of its kind to be conducted in the "price sensitive" Indian health-care setting. Though study was not powered for the difference in average cost of treatments, there was a trend favoring cefoperazone sulbactam. The findings from this study should encourage further conduct of similar analyses and increase the knowledge regarding pharmacoeconomics in India.

Pharmaceutical cost comparison analysis of antimicrobial use for surgical prophylaxis on gastrectomy patients in a tertiary care hospital.

The present study investigated the clinical effects and therapeutic cost of cefazolin (CEZ) and ampicillin/sulbactam (SBT/ABPC) compared to analyze cost-effectiveness for surgical prophylaxis in gastric cancer patients. 157 inpatients who underwent surgery for gastric cancer were investigated. There was no difference between the two groups with regard to sex, age, incidence of complication, stage of cancer, operative time and blood loss, length of hospitalization, the appearance of systematic inflammatory responses syndrome and the prophylactic effect of infection. Meanwhile, decision analysis indicated that the anticipated therapeutic cost per patient in CEZ group was less than that of SBT/ABPC group (USD 142.72 and USD 187.17, respectively). In this case, CEZ use was more cost-effective, insofar as only drug cost was considered.

[Comparison of the effects of prophylactic antibiotic therapy and cost-effectiveness between cefazolin (CEZ) and Sulbactam/Ampicillin (SBT/ABPC) in gastric cancer surgery employing clinical pathway].

The present study was designed to investigate the effects of prophylactic antibiotic therapy and the cost-effectiveness of Cefazolin (CEZ) and Sulbactam/Ampicillin (SBT/ABPC) in gastric cancer surgery employing clinical pathway. 157 patients (62 in the CEZ group and 95 in the SBT/ABPC group), who underwent surgery for gastric cancer at the First Department of Surgery of our hospital, were investigated. There was no significant difference between the groups with regard to sex, age, incidence of complication, stage of cancer, surgical method, operative time and blood loss, length of hospitalization, the appearance of systemic inflammatory response syndrome (SIRS), changes body temperature, white blood cell count (WBC), C-reactive protein (CRP), or clinical outcome of postoperative care by a nurse during post-operation for 7 days. The prophylactic effect of infection was also no different between the CEZ (69.4%) and SBT/ABPC (69.5%) groups. In contrast, decision analysis strongly indicated that the anticipate cost of antibiotics was higher in the latter group (yen 20402) than in the CEZ group (yen 15556), suggesting that the prophylactic effect of CEZ may be more cost-effective. Thus, evaluations of pharmacotherapy from the aspect of cost may be one of the important responsibility of hospital pharmacists in the future.

[Comparison of efficacy between ceftriaxone and cefoperazone plus sulbactam in peri-operative treatment of acute suppurative cholangitis].

OBJECTIVE: To compare the efficacy of ceftriaxone and that of cefoperazone plus sulbactam (sulperazon) in controlling infection, in scavenging bacteria from bile, and in their costs when treating acute suppurative cholangitis with choledochostomy. METHODS: Patients were randomly assigned to two groups: the ceftriaxone group (R-group, n=95) and sulperazon group (S-group, n=95). Before choledochostomy, both groups received one intravenous dose of the corresponding antibiotics: and 2 g ceftriaxnoe for the R-group, 2 g sulperazon, containing 1 g cefoperazone and 1 g sulbactam, for the S-group. After the operation, the patients in the R-group received ceftriaxone 2 g i.v. q.d.; the patients in the S-group received sulperazon 2 g i.v. b.i.d.. In addition, all patients in both groups received metronidazole 0.5 g daily before and after the operation. The efficacy was evaluated by efficiency in controlling infection and the persisting days of symptoms due to infection, fever and leukocytosis; the persisting days was compared using the life table method to calculate the "cumulative probability of persistence of symptoms (CPPS)". The two groups were also compared in regards to their biliary bacterial clearance rates and the costs directly attributable to the antibiotics. RESULTS: The efficiency in controlling infection was 98.9% (94/95) in both groups. However, the CPPS of the R-group decreased more rapidly than that of the S-group, Log-Rankchi2=6.7901, P=0.0092. Biliary bacterial clearance rate on post-operative day 3 was 72.0% (36/50) for the R-group, 41.3% (19/46) for the S-group, P=0.0037. Cost directly attributable to the antibiotics were (1788.29 +/- 518.46) yuan (RMB) for the R-group, and (3768.74 +/- 820.55) yuan for the S-group, F=395.51, P=0.0000. CONCLUSION: Both ceftriaxone and sulperazon are effective in treating acute suppurative cholangitis when used before and after choledochostomy. Ceftriaxone is superior in expediting symptom relief and bacterial clearance from bile, and is more cost-effective.

[Comparative clinical and epidemiological evaluation of beta-lactam antibiotics in the treatment of intraabdominal infections]. / Sravnitel'naia kliniko-ékonomicheskaia otsenka betalaktamnykh antibiotikov pri lechenii intraabdominal'nykh infektsii.

We performed a retrospective, comparative study to evaluate efficacy, safety and economic outcomes of empiric cefoperazone/sulbactam monotherapy compared with the meropenem, imipenem/cilastatine and combination of cefepime plus metroindazol in patients with intra-abdominal infection. A total of 468 patients diagnosed with intra-abdominal abscess, peritonitis, pancreatitis were included in the study (the severity of infection according to scale APACHE II was less than 15). Patients were randomized to be treated with either 500 mg meropemen i.v. every 8 hours or 500 mg imipenem/cilastatine i.v. every 8 hours or 2 g cefepime i.v. every 12 hours plus 500 mg metronidazol twice daily or cefoperazone/sulbactam 2 g daily administered every 12 hours. Overall positive clinical responses (cure or improvement) were achieved at the end of treatment for 87.5 patients in meropenem group, 86.6% in the imipenem/cilastatin group, 85.3% in the cefepime group and 86.8% in cefoperazone/sulbactam group. Total cost of the treatment per 100 patients with intra-abdominal infections for cefoperazone/sulbactam was 1957031 roubles, for combinations of cefepime with metronidazol--2497815 roubles. For carbapenem group cost achieved for meropenem--3085291 rub., for imipenem/cilastatin--2653388 roubles. Rate "cost-effectiveness" in total: 784.47$ for cefepime, and 834.39$ for imipenem/cilastatine, 970.21$ for meropenem and 615.4$ for cefoperazone/sulbactam. The most expensive treatment was considered to be with meropenem and imipenem/cilastatine, main share is determined by initial cost of preparations. Less expensive was treatment by cefoperazone/sulbactam with cefepime and by metronidazol.

Pharmacokinetics of antibiotic prophylaxis in major orthopedic surgery and blood-saving techniques.

The pharmacokinetics of cefuroxime, cefotiam, cefamandole, and ampicillin/sulbactam were randomly measured in 40 patients undergoing major orthopedic surgery associated with high blood and volume turnover and intraoperative blood salvage. Serum and bone concentrations and the pharmacokinetics occurring in the context of these procedures were measured. No changes in elimination half-life relative to a normal population occurred with cefuroxime, cefotiam, and ampicillin. Serum and tissue concentrations were slightly lower with cefamandole and sulbactam, but reapplication of the initial dose was required with all antibiotics 4 hours after the first application.

Epidemiology, resistance, and outcomes of Acinetobacter baumannii bacteremia treated with imipenem-cilastatin or ampicillin-sulbactam.

STUDY OBJECTIVE: To evaluate epidemiology, resistance, and treatment outcomes of Acinetobacter baumannii bacteremia treated with imipenem-cilastatin or ampicillin-sulbactam for 72 hours or longer. DESIGN: Retrospective analysis. SETTING: University teaching hospital. PATIENTS: Forty-eight patients with A. baumannii bacteremia. INTERVENTION: Evaluation of susceptibility and clinical data from 48 patients treated with either ampicillin-sulbactam or imipenem-cilastatin from 1987-1999. MEASUREMENTS AND MAIN RESULTS: Comparing ampicillin-sulbactam and imipenem-cilastatin, there were no differences between days of bacteremia (4 vs 2 days, p=0.05), days to resolution of temperature or white blood cell count, success or failure during or at end of treatment, or intensive care unit total or antibiotic-related length of stay (13 vs 10 days, p=0.05). Patients treated with ampicillin-sulbactam had significantly decreased antibiotic treatment costs (1500 dollars vs 500 dollars, p=0.004). CONCLUSION: Ampicillin-sulbactam is at least as effective as imipenem-cilastatin based on clinical response at days 2, 7, and end of treatment and is a cost-effective alternative for treatment of A. baumannii infections.

Efficacy and cost of ampicillin-sulbactam and ticarcillin-clavulanate in the treatment of hospitalized patients with bacterial infections.

STUDY OBJECTIVE: To evaluate the efficacy and cost of treatment with two beta-lactam/beta-lactamase-inhibitor combinations. DESIGN: Retrospective, open-label multicenter study. SETTING: Fifty-four hospitals across the United States. PATIENTS: Eight hundred ninety patients with skin and soft tissue, intraabdominal, gynecologic, respiratory, urinary tract, or other infections that required parenteral antibiotic therapy. INTERVENTION: Patients were administered either ampicillin-sulbactam 1.5 or 3.0 g every 6 hours or ticarcillin-clavulanate 3.1 g every 6 hours. MEASUREMENTS AND MAIN RESULTS: The agents did not differ significantly in efficacy for most infections; although, ampicillin-sulbactam was bacteriologically superior to ticarcillin-clavulanate in the treatment of intraabdominal infections (p=0.0011). Costs of ampicillin-sulbactam, particularly the 1.5-g dose, were lower than those of ticarcillin-clavulanate for skin and soft tissue (p<0.001), intraabdominal (p=0.005), and respiratory tract (p<0.001) infections. CONCLUSION: Ampicillin-sulbactam provides effective coverage for patients with the above infections and is as effective as the broader-spectrum agent.

Pharmacoeconomic analysis of ampicillin-sulbactam versus cefoxitin in the treatment of intraabdominal infections.

We conducted a retrospective pharmacoeconomic analysis of a prospective, multicenter, double-blind, randomized, controlled trial comparing the beta-lactamase inhibitor combination ampicillin-sulbactam (96 patients) and the cephalosporin cefoxitin (101) in the treatment of intraabdominal infections. An institutional perspective was adopted for the analysis. The primary outcomes of interest were cure and failure rates, development of new infection, and antibiotic-related adverse events. Epidemiologic data pertaining to outcomes was retrieved primarily from the trial, although results of other published studies were taken into consideration through extensive sensitivity analyses. Data pertaining to potential resource use and economic impact were retrieved mainly from the University Health Consortium and hospital-specific sources. When considering only costs associated with drug acquisition through cost-minimization analysis, a potential savings of $37.24/patient may be realized with ampicillin-sulbactam relative to cefoxitin based on an average 7-day regimen. Outcome data collected for the entire hospitalization during the trial revealed an approximately 9% greater frequency of failure with cefoxitin relative to ampicillin-sulbactam. When considering all outcomes of interest in the initial base-case analysis, a potential cost savings of approximately $890/patient may be realized with ampicillin-sulbactam relative to cefoxitin. In assessing the impact of the significant variability in probability and cost estimates, Monte Carlo analysis revealed a savings of $425/patient for ampicillin-sulbactam over cefoxitin (95% CI -$618 to $1516 [corrected]). Given the model assumptions, our analysis suggests a 78% certainty level that savings will be experienced when ampicillin-sulbactam is chosen over cefoxitin.

Cost-effectiveness of ampicillin/sulbactam versus imipenem/cilastatin in the treatment of limb-threatening foot infections in diabetic patients.

A cost-effectiveness analysis was performed following a double-blind, randomized study of ampicillin/sulbactam (A/S) versus imipenem/cilastatin (I/C) for the treatment of limb-threatening foot infections in 90 diabetic patients. There were no significant differences between the treatments in terms of clinical success rate, adverse-event frequency, duration of study antibiotic treatment, or length of hospitalization. Costs of the study antibiotics, treatment of failures and adverse events, and hospitalization were calculated. Mean per-patient treatment cost in the A/S group was $14,084, compared with $17,008 in the I/C group (P = .05), primarily because of lower drug and hospitalization costs and less-severe adverse events in the A/S group. Sensitivity analyses varying drug prices or hospital costs demonstrated that A/S was consistently more cost-effective than I/C. Varying the clinical success rate for each drug revealed that I/C would have to be 30% more effective than A/S to change the economic decisions.

Ampicillin-sulbactam versus cefoxitin for prophylaxis in high-risk patients undergoing abdominal surgery.

This double-blind study compared ampicillin-sulbactam 3 g versus cefoxitin 2 g in 136 adult patients at risk for developing an infection after abdominal surgery. Separate randomization schedules were used for colorectal, upper gastrointestinal/biliary, and other abdominal procedures. Study antibiotics were administered within 30 minutes before incision and repeated 6 hours later. Patients having colorectal surgery received a third dose of antibiotic 6 hours after the second. Efficacy evaluations were made on 123 patients, 62 in the ampicillin-sulbactam group and 61 in the cefoxitin group. The overall postoperative infection rates were 12.9% for ampicillin-sulbactam and 9.8% for cefoxitin (p > 0.05); one wound infection occurred in each group. Adverse events were experienced by 13.2% of the ampicillin-sulbactam and 19.1% of the cefoxitin recipients (p > 0.05). Cost-minimization analysis revealed that ampicillin-sulbactam was a cost-effective alternative to cefoxitin for the prevention of infection after abdominal surgery.