Manjunath P. Pai
WASHINGTON — The efficacy and safety of the antibiotic omadacycline are comparable in patients with and without diabetes, according to researchers.
Omadacycline — the first drug in a new class of tetracyclines known as aminomethylcyclines — was approved by the FDA in 2018 for the treatment of adults with community-acquired bacterial pneumonia and acute skin and skin structure infections (ABSSSIs).
Previous findings have shown that the risks for serious infections and poor treatment outcomes are higher in patients with diabetes compared with the general population.
Manjunath P. Pai, PharmD , an associate professor of clinical pharmacy and deputy director of the pharmacokinetics core at the University of Michigan, and colleagues analyzed findings from the phase 3 OASIS and OPTIC studies, which the FDA based its approvals on, to assess the safety and efficacy of omadacycline in patients with diabetes. Their analysis included 2,150 study participants.
According to Pai, 7.6% of patients in the OASIS studies and 17.3% of those in the OPTIC study had diabetes. Averaged out, the rate of diabetes is representative of the general population, he said.
The researchers found that the clinical success rates were similar between patients with and without diabetes, and between omadacycline and comparator groups. One exception was found in the pooled results from the OASIS studies, which showed that the clinical success rate was 100% among patients who received omadacycline for ABSSSIs vs. 87% of those who received linezolid for the same condition. However, the researchers noted that the 95% confidence intervals overlapped, and given that it was a noninferiority trial, the finding is only suggestive of better outcomes in patients with diabetes.
One interesting finding, according to Pai, is that nausea rates were almost a third lower among patients with diabetes who took omadacycline compared with patients without diabetes.
“I’m not sure we have an explanation for that,” he told Infectious Disease News.
Pai said there is no obvious signal based on the clinical trial data to suggest that the efficacy and safety of omadacycline are any different for patients with diabetes, which should be reassuring for both physicians and researchers. – by John Schoen
Pai MP, et al. Poster 1561. Presented at: IDWeek; Oct. 2-6, 2019; Washington, D.C.
Abu-Ashour W, et al. BMC Infect Dis. 2018;doi:10.1186/s12879-018-2975-2.
Disclosure: Pai reports receiving consulting fees from Paratek.