Impact of a Dynamic Microbiological Environment on the Clinical Efficacy of Ertapenem and Piperacillin/Tazobactam in the Treatment of Complicated Community-Acquired Intra-Abdominal Infection in Spain: A Cost-Consequence Analysis
- 223 Downloads
Background and Objective
The microbial susceptibility of many antibiotics has been affected by prescribing patterns and their extensive use. The purpose of this evaluation was to assess how these changes could affect the initial efficacy of ertapenem and piperacillin/tazobactam in the treatment of complicated intra-abdominal infections (IAIs) acquired in the community and the potential consequences this may have in healthcare costs in Spain.
The Initial efficacy of ertapenem and piperacillin/tazobactam for patients with APACHE (Acute Physiology and Chronic Health Evaluation) II scores <10 was extracted from a multicenter randomized study and were combined with the current microbial susceptibilities obtained from the SMART study, a multinational surveillance program. Country-specific pathogens distribution was extracted from a national study in patients with community-acquired IAI. The estimated effectiveness was used in a decision-analytic model to compare total costs between ertapenem and piperacillin/tazobactam in the treatment of complicated IAI. The model performs extensive one-way and probabilistic sensitivity analyses.
The model suggested a savings of €209 (year 2012 values) per patient when complicated IAIs acquired in the community (APACHE II <10) were treated with ertapenem instead of piperacillin/tazobactam. One-way sensitivity analyses showed length of stay as the key driver parameter. Further analysis of this parameter and probabilistic sensitivity analysis confirmed the robustness of our evaluation, with a 58 % likelihood of ertapenem being dominant.
Ertapenem appears to be a cost-saving strategy over piperacillin/tazobactam for the treatment of patients with complicated IAIs acquired in the community in Spain.
KeywordsTigecycline Probabilistic Sensitivity Analysis Ertapenem Spanish National Health System Smart Study
The study described in this article was sponsored by Merck & Co., Inc. The study sponsor played a significant role in the analysis and interpretation of data. Pharmacoeconomics and Outcomes Research Iberia (PORIB), a consultant company specialized in economic evaluation of health interventions, was hired by Merck & Co., Inc. to collect the data, conduct the analysis, and write the manuscript. S. Grau, V. Lozano, A. Valladares, and R. Cavanillas have participated in acquisition, analysis, and interpretation of data and have been involved in drafting and reviewing the manuscript. G. Nocea has participated in the study design and interpretation of data and has been involved in reviewing the manuscript. Y. Xie has participated in the study design and has reviewed the manuscript. The final version submitted for publication was approved by all authors. A. Valladares acts as guarantor for the overall content. The authors thank Miguel Ángel Casado (PhD; medical writer) and Itziar Oyagüez (BA; medical writer), employees of PORIB, for their assistance with the preparation of this manuscript.
Conflict of interest
S. Grau has received honoraria for speaking at symposia organized on behalf of Pfizer, Astellas, Merck Sharp & Dohme, and Novartis. V. Lozano has served as an external consultant for Merck Sharp & Dohme. A. Valladares, R. Cavanillas, Y. Xie, and G. Nocea are current employees of Merck Sharp & Dohme.
- 6.Solomkin JS, Yellin AE, Rotstein OD, Protocol 017 Study Group, et al. Ertapenem versus piperacillin/tazobactam in the treatment of complicated intra-abdominal infections: results of a double-blind, randomized comparative phase III trial. Ann Surg. 2003;237(2):235–45.PubMedCentralPubMedGoogle Scholar
- 7.Hawser SP, Bouchillon SK, Hoban DJ, et al. Epidemiologic trends, occurrence of extended-spectrum beta-lactamase production, and performance of ertapenem and comparators in patients with intra-abdominal infections: analysis of global trend data from 2002–2007 from the SMART study. Surg Infect (Larchmt). 2010;11(4):371–8.PubMedCrossRefGoogle Scholar
- 8.Cantón R, Loza E, Aznar J, SMART-Spain Working Group, et al. Antimicrobial susceptibility of Gram-negative organisms from intra-abdominal infections and evolution of isolates with extended spectrum β-lactamases in the SMART study in Spain (2002–2010). Rev Esp Quimioter. 2011;24(4):223–32.PubMedGoogle Scholar
- 11.EMA. Questions and answers on the review of Tygacil (tigecycline). Outcome of a renewal procedure. 2011. http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/human/000644/WC500102228.pdf. Accessed 25 June 2013.
- 12.FDA. Drug Safety Communication. Increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections. 2010. http://www.fda.gov/Drugs/DrugSafety/ucm224370.htm. Accessed 25 June 2013.
- 24.Sauerland S, Lefering R, Neugebauer EAM. Laparoscopic versus open surgery for suspected appendicitis. Cochrane Database Syst Rev. 2004;(4):CD001546. doi: 10.1002/14651858.CD001546.pub2.
- 25.Spanish Ministry of Health, Social Policy and Equality, Institute for Health Information. CMBD Minimum Basis Data Set. 2011. http://pestadistico.msc.es. Accessed 25 June 2013.
- 26.Spanish Ministry of Health, Social Policy and Equality. Institute for Health Information. Diagnosis Related Group costs in Spain. http://www.msssi.gob.es/estadEstudios/estadisticas/docs/SNS2011_PESOS_COSTES_AP27_DEF.pdf. Accessed 25 June 2013.
- 27.Spanish General Council of Official Colleges of Pharmacists. Bot PLUS 2.0. https://botplusweb.portalfarma.com/. Accessed 25 June 2013.
- 28.Royal decree-law 8/2010, of May 20, on extraordinary measures to reduce Government deficit (RDL 8/2010). http://www.boe.es/boe/dias/2010/05/24/pdfs/BOE-A-2010-8228.pdf. Accessed 25 June 2013.
- 32.Dinubile MJ, Friedland I, Chan CY, et al. Bowel colonization with resistant gram-negative bacilli after antimicrobial therapy of intra-abdominal infections: observations from two randomized comparative clinical trials of ertapenem therapy. Eur J Clin Microbiol Infect Dis. 2005;24(7):443–9.PubMedCrossRefGoogle Scholar
- 36.Namias N, Solomkin JS, Jensen EH, et al. Randomized, multicenter, double-blind study of efficacy, safety, and tolerability of intravenous ertapenem versus piperacillin/tazobactam in treatment of complicated intra-abdominal infections in hospitalized adults. Surg Infect (Larchmt). 2007;8(1):15–28.PubMedCrossRefGoogle Scholar