Pharmacy & Therapeutics - November 2008 - (Page 634)

DRUG FORECAST pending the results of culture, at the discretion of the clinician if suspected or documented anaerobic pathogens were present. The trial was of a non-inferiority design. The primary efficacy endpoint was the clinical cure rate at the TOC visit (7 to 14 days after the end of therapy). As with STRAUSS 1, the primary outcome was the rate of clinical cure, as measured in both the clinically evaluable and ITT populations. Based on an expected nonevaluable rate of 30%, 816 patients were needed to reject the null hypothesis of inferiority for ceftobiprole of 10%, using a power of 80% and a two-sided alpha of 0.05. Ceftobiprole was considered noninferior to the combination of vancomycin and ceftazidime if the lower limit of the 95% CI for the difference in clinical cure rate was –10% or above. A secondar y outcome in the group of micro biologically evaluable patients was analyzed to determine the microbiologic eradication rate at the TOC visit. A total of 828 patients were initially randomized and were included in the ITT analysis, with 33% of patients from the U.S.; 547 (66%) received ceftobiprole, and 281 (33%) were assigned to the comparator group. There were no significant differences between groups in terms of demographics, baseline characteristics, type of infection, or duration of treatment. Comparator 90.5 90.2 Ceftobiprole 100 90 80 70 Clinical cure (%) 60 50 40 30 20 10 0 77.8 77.5 Comparator 81.9 80.8 STRAUSS 1 STRAUSS 2 Figure 1 Clinical cure rates for the intent-to-treat population. (Data from Noel GJ, Straus RS, Amsler K, et al. Antimicrob Agents Chemother 2008; 52:37–44;24 and Noel GJ, Bush K, Bagchi P, et al. Clin Infect Dis 2008;46:647–655.26) baseline characteristics, type of infection, or duration of treatment between the two treatment groups. The proportion of men in the clinically evaluable group was significantly lower in the ceftobiprole group (55%) than in the vancomycin group (61%) (P = 0.025). Clinical cure rates in the ceftobiprole and vancomycin groups were similar in the ITT group (77.8% vs. 77.5%; CI, –5.5 to 6.1) and in the clinically evaluable group (93.3 vs. 93.5%; CI, –4.4 to 3.9). The STRAUSS 2 Study26 ceftobiprole 500 mg every eight hours as a 120-minute infusion and placebo every 12 hours as a 60-minute infusion, or vancomycin 1,000 mg every 12 hours as a 60-minute infusion and ceftazidime 1,000 mg every eight hours as a 120-minute infusion for 7 to 14 days. Metronidazole (e.g., Flagyl, Pfizer) could be added empirically in either group for 48 hours, Ceftobiprole 100 93.3 93.5 In STRAUSS 2, investigators compared ceftobiprole monotherapy with vancomycin and ceftazidime (Fortaz, GlaxoSmithKline) in combination for the treatment of cSSSIs. Patients were considered eligible if they were older than 18 years of age and had a cSSSI, including patients with diabetic foot infections. Patients with foreign-body infections, critical limb ischemia, septic ar thritis, or osteo myelitis were excluded. The patients were stratified by infection type, and the investigators limited the percentage of patients with cellulitis to less than 20%. Patients were randomly assigned, in a 2:1 ratio, to receive ceftobiprole plus placebo or vancomycin plus ceftazidime. Unlike STRAUSS 1, in which patients received ceftobiprole 500 mg ever y 12 hours, patients in STRAUSS 2 received 90 80 70 Clinical cure (%) 60 50 40 30 20 10 0 STRAUSS 1 STRAUSS 2 Figure 2 Clinical cure rates for the clinically evaluable population. (Data from Noel GJ, Straus RS, Amsler K, et al. Antimicrob Agents Chemother 2008; 52:37–44;24 and Noel GJ, Bush K, Bagchi P, et al. Clin Infect Dis 2008;46:647–655.26) continued on page 639 634 P&T® • November 2008 • Vol. 33 No. 11

Table of Contents Feed for the Digital Edition of Pharmacy & Therapeutics - November 2008

Pharmacy & Therapeutics - November 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/New Medical Devices Drug Forecast Heparin-Induced Thrombocytopenia Medication Utilization Patterns and Hypertension-Related Expenditures among Patients Who Were Switched From Fixed-Dose to Free-Combination Antihypertensive Therapy European Society for Medical Oncology and Association for the Study of Bone and Mineral Research Pharmaceutical Approval Update

Pharmacy & Therapeutics - November 2008

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