Cefoperazone-sulbactam for treatment of intra-abdominal infections: results from a randomized, parallel group study in India.

BACKGROUND: Combinations of a third-generation cephalosporin and metronidazole, with or without an aminoglycoside, often are used for the treatment of intra-abdominal infections in surgical settings. Simpler regimens that preserve an adequate spectrum of coverage, but allow easier administration and have fewer side effects, may be a more desirable option. METHODS: This randomized, open-label, active comparator study evaluated the effectiveness (non-inferiority hypothesis) of the beta-lactam/beta-lactamase inhibitor combination cefoperazone-sulbactam (2-8 g/day), compared with ceftazidime (2-6 g/day)-amikacin (15 mg/kg/day)-metronidazole (500 mg three times daily) in 154 and 152 subjects, respectively, having intra-abdominal infections. The study was conducted at 17 centers in India. RESULTS: Non-inferiority of cefoperazone-sulbactam (91.9%) compared with ceftazidime-amikacin-metronidazole (81.8%) was demonstrated for continued resolution of clinical signs and symptoms at the 30-day follow-up (primary endpoint) with a treatment difference of 10.1% (95% confidence interval 2.1%, 18.1%; pre-defined non-inferiority limit > -12.5%). Superiority of cefoperazone-sulbactam also was demonstrated for this endpoint, with significantly more subjects achieving continued resolution at the 30-day follow-up than in the comparator group (p = 0.015). On microbiologic outcomes, cefoperazone-sulbactam had higher success rates than ceftazidime-amikacin-metronidazole (92.9% vs. 80.0%). The pathogens (202 isolated) isolated most commonly were Escherichia coli (38.6%) and Klebsiella spp. (12.9%). The incidence of treatment-related adverse events was 6.5% and 16.4% in the cefoperazone-sulbactam and ceftazidime-amikacin-metronidazole groups, respectively, with more discontinuations due to treatment-related adverse events in the comparator arm (3.2% vs. 9.9%). CONCLUSION: Empirical cefoperazone-sulbactam monotherapy could be a useful adjunct to surgical intervention for intra-abdominal infections.

A randomized, crossover, open label pilot study to evaluate the efficacy and safety of Xalatan in comparison with generic Latanoprost (Latoprost) in subjects with primary open angle glaucoma or ocular hypertension.

AIM: To compare the efficacy and tolerability of Xalatan with generic latanoprost (Latoprost) in subjects with primary open angle glaucoma (POAG) or ocular hypertension (OH). MATERIALS AND METHODS: This was a single-center, randomized, open label, crossover, two period comparative study. At the baseline visit, subjects were randomized to two groups. Group A received Xalatan for weeks 1-12 followed by Latoprost for weeks 13-24. Group B received Latoprost for weeks 1-12 followed by Xalatan for weeks 13-24. RESULTS: 30 subjects were recruited, 12 in Group A and 18 in Group B. In subjects administered Xalatan, intraocular pressure (IOP) showed a greater decrease (P < 0.001) from 23.64 +/- 3.13 mmHg at baseline to 14.29 +/- 1.61 mmHg at week 12 (fall of 9.35 +/- 3.55 mmHg, 38.66% +/- 10.29) than that seen in the Latoprost group (22.74 +/- 2.47 mmHg to 16.98 +/- 2.49 mmHg, fall of 5.76 +/- 1.41 mmHg; 25.42% +/- 5.98). In period 2 when subjects were crossed over to Xalatan from Latoprost, there was a further fall from 16.98 +/- 2.49 mmHg to 16.09 +/- 1.49 at week 24 (fall of 0.89 +/- 1.59 mmHg; 4.3% +/- 8.76). However, when subjects were crossed over to Latoprost from Xalatan, the IOP rose from 14.29 +/- 1.61 mmHg to 15.36 +/- 1.71 mmHg at week 24 (8.86% +/- 17.76). There was no significant difference in incidence of conjunctival hyperemia or any other adverse events in both the groups. CONCLUSION: The magnitude of IOP lowering in patients with POAG and OH with Xalatan and Latoprost is different. In our study, the IOP lowering with Xalatan was higher than that with Latoprost.