Effect of Generic vs. Brand-Name Meropenem on Mortality in a Colombian Hospital’s Intensive Care Unit

Abstract

BackgroundThe quality of antibiotics is a crucial element in successful treatment of infections. Recently, the use of generic antibiotics has caused controversy because of studies reporting clinical failure and the emergence of antibacterial resistance associated with the sustained use of generic antibiotics. The present study was designed to determine the mortality associated with the use of generic meropenem (GM) and brand-name meropenem (BNM) used to treat Gram-negative infections.MethodsWe conducted an ambispective cohort study comparing adult patients who received GM and BNM while in the intensive care unit of a tertiary care hospital in Colombia. Patients treated between January 2011 and May 2014 received GM while patients treated between June 2014 and March 2017 received BNM. Patients were included in the study only if the infecting organism was susceptible to meropenem. The GM and BNM cohorts were paired by age, infection type, and infection severity as measured by Sequential Organ Failure Assessment score. Mortality was compared between groups. Data were analyzed using descriptive and inferential statistics.ResultsA total of 168 patients were included; 68 patients (40%) were treated with GM and 100 (60%) were treated with BNM. The mean age was 57 years old; 72 (43%) women and 96 (57%) men. The most common infecting organism was E. coli (35%) followed by K. pneumoniae (19%). Bacteremia (49%) was the most common infection type, followed by intraabdominal infection (24%). Multivariate analysis demonstrated that patients treated with GM had a risk of death 18 times higher (OR: 18.45 95% CI 1.47-232, P = 0.024) than patients treated with BNM. Patients with a history of cardiovascular disease had an independent risk of death compared with those without cardiovascular disease. Other comorbidities and time between bacterial culture and initiation of treatment with meropenem did not have a statistically significant effect on mortality.ConclusionThe present study suggests that patients treated with GM have worse clinical outcomes compared with those treated with BNM. More studies are needed to confirm the clinical superiority of brand-name vs. generic antibiotics, not only for meropenem but also for other commonly-used molecules.Disclosures C. Pallares, Merck Sharp & Dohme, Pfizer: Consultant, Consulting fee. C. Hernández-Gómez, Merck Sharp & Dohme: Consultant, Consulting fee. Pfizer: Consultant, Consulting fee. M. V. Villegas, Merck Sharp & Dohme: Consultant, Consulting fee and Research support. Pfizer: Consultant, Consulting fee and Research support.