OBJECTIVE: The aim of this study was to compare the incidence of post-operative infections in patients undergoing coronary artery bypass grafting (CABG) surgery who received generic cefuroxime (gCFX) instead of original cefuroxime (oCFX) as antimicrobial prophylaxis. METHODS: The study had two parts, a prospective and a retrospective one (4 weeks with oCFX followed by 4 weeks with gCFX in each part; total study duration of 16 weeks). The studied patient population was 618 consecutive adult patients who underwent on pump CABG surgery. Patients were divided into two groups according to type of formulation they received: 313 patients received oCFX and 305 gCFX. RESULTS: Eight (2.5%) and 39 (12.8%) patients in the oCFX and gCFX group, respectively, developed postoperative infections (p<0.001). There were 6 (1.9%) surgical site infections in the oCFX group and 31 (10.1%) in the gCFX group (p<0.001). Bacteremia occurred in 2 (0.6%) patients in the oCFX group and in 8 (2.6%) patients in the gCFX group (p=0.1). In addition, septic shock occurred in 6 cases (2.0%, p=0.04) and multiple organ failure in another 4 patients (1.3%, p=0.1) in the gCFX group. The most common pathogens isolated were Gram-positive cocci in both groups. CONCLUSIONS: This study revealed a higher incidence of postoperative infections in adult patients undergoing CABG surgery receiving gCFX compared to oCFX as antimicrobial prophylaxis. The findings of our study provide additional evidence regarding the problem of substandard drugs, in our case a formulation of a generic antibiotic, even in developed countries. ULTRAMINI- SUMMARY: The incidence of post-operative infections following CABG surgery was higher in adult patients receiving generic instead of original cefuroxime as antimicrobial prophylaxis. The findings of our study provide additional evidence regarding the problem of substandard drugs, in our case a formulation of a generic antibiotic, even in developed countries.
OBJECTIVE: The aim of this study was to compare the incidence of post-operative infections in patients undergoing coronary artery bypass grafting (CABG) surgery who received generic cefuroxime (gCFX) instead of original cefuroxime (oCFX) as antimicrobial prophylaxis. METHODS: The study had two parts, a prospective and a retrospective one (4 weeks with oCFX followed by 4 weeks with gCFX in each part; total study duration of 16 weeks). The studied patient population was 618 consecutive adult patients who underwent on pump CABG surgery. Patients were divided into two groups according to type of formulation they received: 313 patients received oCFX and 305 gCFX. RESULTS: Eight (2.5%) and 39 (12.8%) patients in the oCFX and gCFX group, respectively, developed postoperative infections (p<0.001). There were 6 (1.9%) surgical site infections in the oCFX group and 31 (10.1%) in the gCFX group (p<0.001). Bacteremia occurred in 2 (0.6%) patients in the oCFX group and in 8 (2.6%) patients in the gCFX group (p=0.1). In addition, septic shock occurred in 6 cases (2.0%, p=0.04) and multiple organ failure in another 4 patients (1.3%, p=0.1) in the gCFX group. The most common pathogens isolated were Gram-positive cocci in both groups. CONCLUSIONS: This study revealed a higher incidence of postoperative infections in adult patients undergoing CABG surgery receiving gCFX compared to oCFX as antimicrobial prophylaxis. The findings of our study provide additional evidence regarding the problem of substandard drugs, in our case a formulation of a generic antibiotic, even in developed countries. ULTRAMINI- SUMMARY: The incidence of post-operative infections following CABG surgery was higher in adult patients receiving generic instead of original cefuroxime as antimicrobial prophylaxis. The findings of our study provide additional evidence regarding the problem of substandard drugs, in our case a formulation of a generic antibiotic, even in developed countries.
Authors: Mario Del Tacca; Giuseppe Pasqualetti; Giovanni Gori; Pasquale Pepe; Antonello Di Paolo; Marianna Lastella; Ferdinando De Negri; Corrado Blandizzi Journal: Ther Clin Risk Manag Date: 2013-07-24 Impact factor: 2.423