Economic impact of standard antibiotic therapy combined with amikacin, in clinical unit, Lodz, Poland--part II.

The study "Alexander" on bacterial resistance to antibiotics conducted in Poland revealed high sensitivity of bacterial strains to simple and cheap antibiotics. In Poland pharmacoeconomic studies on the safety, effectiveness and costs of treatment are rare. Development of therapeutic standards in bacterial infections on the basis of pharmacoeconomic analyses and clinical studies determining effectiveness and safety of therapy allows for more rational pharmacotherapy. The following problems were investigated: is the treatment of serious bacterial infections with cheap standard antibiotics [SAT] or other antibiotics therapy [OAT] combined with amikacin safe and effective? What are the direct costs? How can reduction in costs be achieved? Prospective, randomized, single-blind study was performed in the group of 152 patients, admitted from 1 January to 31 July 2000, treated with amikacin combined with aminopenicillin/amoxicillin [SAT] versus other antibiotic therapy [OAT]. The economic evaluation was done by estimation of direct cost of treatment in patients with risk factors of nephrotoxicity [NT] and therapeutic drug monitoring [TDM] versus without TDM. The statistical significance was evaluated. This study revealed that effectiveness of the SAT versus OAT combined with amikacin in serious infections is high, 80% vs. 87%, respectively. Amikacin used in high once daily dose [HODD] in combined therapy with SAT or OAT was more safe in patients with risk of nephrotoxicity and TDM (21%) vs without TDM (10%) than used in conventional therapy [CT] 40% vs 19% [p < 05]. Evaluation of the absolute risk of nephrotoxicity increase in patients with TDM was 0.16 vs 0.34 Absolute Risk Increase (ARI) 0.18, Relative Risk Reduction (RRR): 0.53; 95% Confidence Interval (CI): 0.87-2.82. The number needed to tread (NNT): 5.43; reduction of the risk of nephrotoxicity in patients without TDM treated with HODD was 0.19 vs 0.09, Absolute Risk Reduction (ARR): 0.09; RRR: 0.47; 95% CI: 0.74-1.34; NNT: 11.1; reduction of the risk of nephrotoxicity in patients with TDM treated with amikacin HODD was 0.21 vs 0.40, ARR: 0.19; RRR: 0.48; 95% CI: 0.68-1.74; NNT: 5.3; Direct costs of the treatment with SAT vs OAT combined with amikacin are low [EU 78.30 vs EU 145.16] in the Clinical Unit of Lodz, compared with other countries. Out of EU 530 for the hospitalization of one patient, 86% constituted "hotel costs". Omitting TDM in patients without risk factors can significantly decrease costs by EU 66 860 per 1000 patients. Introduction of safe and cheap standard in the treatment of bacterial infections in clinical unit, shortening hospitalization by 5 days and limiting the number of patients requiring TDM service allows for a decrease in direct cost of about EU 235410 per 1000 patients/year.