A Non-inferiority Pilot Study Comparing the Clinical Efficacy and Safety of Generic Wide-spectrum Antibiotic Use in Septic Oncology Patients

Abstract

The present study is a non-inferiority study based on a descriptive and comparative case series for comparison of generic vs. original intravenous antimicrobials in septic oncology patients at an oncology private ICU. 1906 cancer patients admitted to Arturo Lopez Perez Foundation, Chile, were included in this study. After recruitment, a first retrospective group of 206 septic cancer patients recorded from 1st January, 2008 until July 14th, 2010, treated with original antibiotics (cefoperazone-sulbactam, imipenem-cilastatin, piperacillin-tazobactam) were included for analyses and a second prospective group of 143 septic cancer patients recorded from July 15th, 2010 until January 02, 2013, treated with the same but generic antibiotics were also included for comparisons. The trial protocol was developed in accordance with Helsinki and Good Clinical Practices recommendations. The results of this study showed no significant differences between the 2 groups in days of treatment, rate of success and lab test determinations (white cell count, PCR and procalcitonin), with lower, but not significant, total bed days and CPU bed days for generic antibiotics. Therefore, we conclude that the safety and efficacy of the generic antibiotics cefactam®, imipen® and Piperazam® are not inferior to original antibiotics for the treatment of severe sepsis in hospitalised patients at the Arturo Lopez Perez Foundation.

Comparative analysis of the cost and effectiveness of generic and brand‐name antibiotics: the case of uncomplicated urinary tract infection

“…performed a non‐inferiority study of generic wide‐spectrum antibiotic agents at a septic oncology intensive care unit in Chile. No significant differences between the two groups in days of treatment, rates of treatment success, and laboratory indicators (e.g., white cell counts) were found . Our results, derived from a nationally representative sample and a PS‐matched subject set, were consistent with the previous findings and indicated similar treatment effects of generic antibiotics to their brand‐name counterparts.…”

Clinical Equivalence between Generic Versus Branded Antibiotics: Systematic Review and Meta-Analysis

“…Seven studies showed no statistically significant difference in primary outcomes comparing generic antibiotics and their respective branded counterparts [6,[21][22][23][24]27,28].…”

“…The studies had a heterogeneous population. Araya et al, (2015) [22] analyzed cancer patients, and Punpanich et al, (2012) [23] was the only that included patients under 18 years. Snyman et al, (2009) [6] and Lin et al, (2016) [24] included outpatients, while the others only included inpatients.…”

Results of the effectiveness of two piperacillin–tazobactam molecules in the real world

“…Some of these patterns exhibited statistically significant differences, and this approach could have altered the conclusions to some extent, despite the fact that the outcomes in the multivariate analyses were adjusted. The differences can be explained by possible physician fear regarding use of the generic antibiotic in complicated infections, although in clinical and in vitro studies, it has not been demonstrated that the results are different in terms of the resolution of morbidity or mortality (Agudelo et al, 2015;Charoenpong et al, 2013;Araya et al, 2015).…”

“…Through in vitro studies, murine models, and observational investigations, it has been shown that the generic form of piperacillin-tazobactam is bioequivalent to the innovator molecules, with no significant difference in pharmacokinetic, effectiveness, or safety parameters (Agudelo et al, 2015;Tschudin-Sutter et al, 2011;Charoenpong et al, 2013;Araya et al, 2015). However, the quality of the generic presentations has been questioned, with some studies reporting that they present lower in vitro activity (Jones et al, 2008;Jones et al, 2013).…”