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W 39: Novel Use of a Medication Event Monitoring System to Track Rescue Medication Use in a Trial of a New Meloxicam Drug Product
Manager, Clinical Operations
Iroko Pharmaceuticals, LLC United States
To describe use of a Medication Event Monitoring System (MEMS), as an alternative to patient diary cards, to track the timing and patterns of rescue medication use for evaluating persistence of efficacy of a new low-dose meloxicam drug product in a trial of patients with osteoarthritis pain.
ORAL PRESENTATION SCHEDULED: Session 2B at 12:40- 12:50 PM
Acetaminophen rescue medication use was measured using a bottle equipped with an electronic MEMS cap. Continuous data collection enabled the following analyses by trial day and time of day: number of rescue events, time to first rescue event and proportion of subjects with rescue events.
Subjects treated with meloxicam required substantially less rescue medication compared with placebo, unrelated to the time of day or duration of treatment. Subjects treated with meloxicam required rescue medication on fewer days (P=0.0007) compared with placebo. Among subjects who received trial drug for more than 2 weeks, a gradual decrease in the amount of rescue medication use was observed with increasing trial duration. A lower proportion of patients treated with meloxicam required rescue medication for all time of day intervals compared with placebo, suggesting persistence of efficacy. Overall, standard rescue medication accountability (pill counts) overestimated the number of rescue medication doses recorded using MEMS bottle opening events (P<0.0001).
Use of MEMS was successful in assessing rescue medication use in a placebo-controlled trial that measured analgesic efficacy and addressed the common challenges associated with unreliable data recording in standard diary cards and the inadequacy of standard drug accountability to provide details on the timing of rescue medication. MEMS was found to provide reliable and rich electronic dosing data records over this 12-week, Phase 3, randomized controlled trial. Analyses of rescue medication usage by time of day suggested persistence of efficacy throughout the 24 hour dosing interval for this new low-dose meloxicam drug product. MEMS, generally considered the gold standard for measuring medication adherence in patients with HIV, asthma, and hypertension, represents a promising new approach for the collection of rescue medication data. Future outpatient analgesic trials may benefit from utilization of MEMS to enhance collection and analysis of data on rescue medication usage.
Full Author List:
1. Clarence Young (Iroko Pharmaceuticals, LLC, Philadelphia, PA, USA)
2. Daniel Solorio (Iroko Pharmaceuticals, LLC, Philadelphia, PA, USA)
3. Claire Sheridan (Iroko Pharmaceuticals, LLC, Philadelphia, PA, USA)
4. Olaolu Imasogie (Iroko Pharmaceuticals, LLC, Philadelphia, PA, USA)
5. Deborah O’Brien (Premier Research, Quincy, MA, USA)
6. Bernard Vrijens (WestRock Healthcare, Visé, Belgium and University of Liège, Liège, Belgium)