Plazomicin has received FDA approval to treat complicated urinary tract infections (cUTI), including pyelonephritis, due to certain Enterobacteriaceae bacteria in adults with limited or no alternative treatment options.
The drug, which is being marketed as Zemdri by Achaogen, Inc., of South San Francisco, California), is administered once daily by intravenous infusion. According to an Achaogen press release, it is indicated for patients aged 18 years or older for cUTI caused the following susceptible bacteria: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae.
The approval was supported in part by data from the phase 3 EPIC (Evaluating Plazomicin in cUTI) clinical trial, the first randomized controlled study of once-daily aminoglycoside therapy for treating cUTI, including pyelonephritis, the company said in the press release. In the trial, plazomicin demonstrated non-inferiority to meropenem for the co-primary efficacy endpoints of composite cure (clinical cure and microbiologic eradication) in the microbiological modified intent-to-treat population at day 5 and test-of-cure (TOC) visit. Composite cure rates at TOC were 81.7% for plazomicin vs 70.1% for meropenem, the company said.
In addition, composite cure at the TOC visit in patients with concomitant bacteremia at baseline was achieved in 72% of plazomicin-treated patients compared with 56.5% of meropenem recipients.
Early rather than delayed lithotripsy is better for patients with symptomatic, obstructing ureteral stones, according to a new study.
“Emergent lithotripsy, either ureteroscopic or extracorporeal, can be offered as an effective and safe treatment for patients with symptomatic ureteral stone,” Riccardo Autorino, MD, of Case Western Reserve University in Richmond Heights, Ohio, and colleagues concluded in Urolithiasis, published online ahead of print.
Dr Autorino' s group evaluated emergent vs delayed lithotripsy in separate systematic reviews and meta-analyses of ureteroscopy (URS) and extracorporeal shock wave lithotripsy (ESWL). An “emergency” procedure occurred variably within 6 to 72 hours of presentation.
Emergent URS performed as well as delayed URS, according to a meta-analysis based on 4 studies (including 1 randomized controlled trial) of 1513 patients. The investigators reported no significant differences in stone-free rate, complication rate, and the need for auxiliary procedures. Stone-free meant the absence of a stone or fragments of 3 mm or less. Emergent ureteroscopy typically is reserved for distal stones, they noted.
Emergent ESWL was associated with more than twice the odds of achieving stone-free status and half the odds of auxiliary procedures compared with delayed ESWL. Again, no differences in rates of complications, such as hematuria or mucosal injury, were observed. “If amenable to ESWL, based on stone and patient characteristics, an emergent approach should be strongly considered,” Dr Autorino and colleagues stated. This meta-analysis involved 6 studies (including 4 randomized trials) of 711 patients. The investigators could not perform sensitivity analyses by stone size and location.
Early treatment of stones with colic is preferable because ureteral edema can develop within 48 hours and interfere with stone clearance, the team suggested. A previous study published in the Journal of Endourology (2010;24:2059-2066) found that treatment after 48 hours is associated with longer clearance of proximal ureteral stones less than 1 cm and higher rates of retreatment and auxiliary procedures.
Implementing emergent lithotripsy would depend on the availability of URS and ESWL. It is possible that specific machines and technologies affect results. More research is warranted.
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