Webb, Andrew J

ABSTRACT Infections due to nontuberculous mycobacteria (NTM) continue to increase in prevalence, leading to problematic clinical outcomes. Omadacycline (OMC) is an aminomethylcycline antibiotic with FDA orphan drug and fast-track designations for pulmonary NTM infections, including Mycobacteroides abscessus (MAB). This multicenter retrospective study across 16 U.S. medical institutions from January 2020 to March 2023 examined the long-term clinical success, safety, and tolerability of OMC for NTM infections. The cohort included patients aged ≥18 yr, who were clinically evaluable, and` had been treated with OMC for ≥3 mo without a previous diagnosis of cystic fibrosis. The primary outcome was 3 mo clinical success, with secondary outcomes including clinical improvement and mortality at 6- and 12 mo, persistence or reemergence of infection, adverse effects, and reasons for OMC utilization. Seventy-five patients were included in this analysis. Most patients were female (48/75, 64.0%) or Caucasian (58/75, 77.3%), with a median (IQR) age of 59 yr (49–67). Most had NTM pulmonary disease (33/75, 44.0%), skin and soft tissue disease (19/75, 25.3%), or osteomyelitis (10/75, 13.3%), and Mycobacterium abscessus (60/75, 80%) was the most commonly isolated NTM pathogen. The median (IQR) treatment duration was 6 mo ( 4 – 14 ), and the most commonly co-administered antibiotic was azithromycin (33/70, 47.1%). Three-month clinical success was observed in 80.0% (60/75) of patients, and AEs attributable to OMC occurred in 32.0% (24/75) of patients, leading to drug discontinuation in 9.3% (7/75).

Abstract Twelve patients were treated with omadacycline (OMC) as part of a multidrug regimen for Mycobacterium abscessus. The majority of infections were of pulmonary origin (7/12; 58.3%). The median (interquartile range) duration of OMC was 6.2 (4.2–11.0) months. Clinical success occurred in 9/12 (75.0%) patients. Three patients experienced a possible adverse effect while on therapy.

Abstract Purpose Transgender patients face considerable healthcare disparities. Improved means of recognizing transgender patients and understanding their medical needs is important to provide optimal care. The electronic medical record (EMR) of our health system allows for differentiation of gender identity, legal sex, and sex at birth. With EMR recognition of transgender patients, a recommendation for estimating creatinine clearance (CLcr) and ideal body weight (IBW) was needed to standardize medication dosing. Summary The literature was reviewed for evidence on the effect of gender-affirming hormone therapy on serum creatinine concentration and lean body mass. Findings informed a recommendation for drug dosing based on CLcr and IBW in transgender patients. Four studies that reported the effect of hormone therapy on biometric laboratory values were found. Three studies reported that values of transgender patients more closely resembled the standard values of their gender identity vs sex at birth after hormone therapy; 1 study reported a range of values that more closely resembled those associated with sex at birth while still overlapping with values associated with gender identity. Consequently, it was recommended that pharmacists dose medications based on CLcr and IBW calculations consistent with gender identity after a patient has been on hormone therapy for 6 months or longer. Conclusion Providing optimal care to transgender patients includes considering the effect of gender-affirming hormone therapy on overall physiology. Consistently using the appropriate CLcr and IBW calculations for each patient ensures safe and effective care. Additional studies are needed to confirm the effect of hormone therapy on renal clearance and lean body mass.