RESUMO
Inhaled treprostinil (Tyvaso) has been shown to be a safe and effective addition to pulmonary arterial hypertension (PAH) oral therapies; however, the respiratory-related safety profile of inhaled treprostinil required further elucidation in the setting of routine clinical care. The objectives of this study were to characterize respiratory-related adverse events (AEs) associated with current or recent treatment with inhaled treprostinil and to compare the incidence of respiratory-related AEs in PAH patients treated with inhaled treprostinil with that in patients treated with other Food and Drug Administration (FDA)-approved PAH therapies. This was a long-term, prospective, observational study. All respiratory-related AEs were recorded during the study. The number of PAH patients enrolled was 1,333, 666 treated with inhaled treprostinil and 667 controls (treated with an FDA-approved PAH therapy other than inhaled treprostinil), for a total of 958 and 1,094 patient-years of exposure, respectively. In the inhaled-treprostinil group, 1,281 respiratory-related AEs were reported in 403 patients (61%), and in the control group, 1,295 respiratory-related AEs were reported in 388 patients (58%). Cough, throat irritation, nasal discomfort, and hemoptysis were the most common respiratory-related AEs (occurring in ≥2% of patients in either treatment group) that demonstrated a higher number of events per patient-year of exposure in the inhaled-treprostinil group than in the control group (risk ratio [95% confidence interval]: 1.487 [1.172-1.887], 3.777 [2.050-6.956], 2.039 [1.072-3.879], and 1.957 [1.024-3.741], respectively). Overall, inhaled treprostinil was well tolerated by PAH patients in routine clinical care, with respiratory-related AEs consistent with the known safety profile (trial registration: clinicaltrials.gov identifier: NCT01266265).
RESUMO
OBJECTIVE: To determine the effect of adding a trained intensivist on patient care and educational outcomes in a community teaching hospital. MATERIAL AND METHODS: We retrospectively reviewed outcomes for patients admitted to the medical intensive-care unit (MICU) of a 270-bed community teaching hospital between July 1992 and June 1994. Mortality rates and durations of stay were determined for the year before (BD, 1992 through 1993) and the first year after (AD, 1993 through 1994) introduction of a full-time director of critical care. Performance of resident trainees on a standardized critical-care examination was measured for the same periods. RESULTS: Overall, 459 patients in the BD period were compared with 471 patients in the AD period. The mix of cases and severity of illness (acute physiology and chronic health evaluation or APACHE II scores) on admission were similar for the BD and AD periods. MICU mortality decreased from 20.9% during the BD to 14.9% during the AD period (P = 0.02), and in-hospital mortality decreased from 34.0% to 24.6% (P = 0.002). Disease-specific mortalities were lower during the AD period for most categories of illness. Detailed analysis of a subgroup of patients (those with pneumonia) demonstrated no differences in distribution of patients by gender, race, or acuity of illness (APACHE II scores). The mortality rate due to pneumonia decreased from 46% during the BD period to 31% during the AD period. This decrease was consistent across categories of APACHE II scores. From BD to AD periods, mean durations of total hospital stay decreased from 22.6 +/- 1.4 days to 17.7 +/- 1.0 days, and mean MICU stay decreased from 5.0 +/- 0.3 days to 3.9 +/- 0.3 days (P < 0.05). Critical-care in-service examination scores for 22 residents increased from 53.8 +/- 1.7% to 67.5 +/- 2.2% (P < 0.01), and AD scores were significantly higher than BD scores for residents at similar levels of training. CONCLUSION: Addition of a medical intensivist was temporally associated with improved clinical and educational outcomes in our community teaching hospital.
