Long-Term Safety of a Coordinated Delivery Tablet of Enteric-Coated Aspirin 325 mg and Immediate-Release Omeprazole 40 mg for Secondary Cardiovascular Disease Prevention in Patients at GI Risk

Introduction: In two, 6-month, randomized, double-blind Phase 3 trials, PA32540 (enteric-coated aspirin 325 mg and immediate-release omeprazole 40 mg) compared to aspirin alone was associated with fewer endoscopic gastric and duodenal ulcers in patients requiring aspirin therapy for secondary cardiovascular disease (CVD) prevention who were at risk for upper gastrointestinal (UGI) events. Aims: In this 12-month, open-label, multicenter Phase 3 study, we evaluated the long-term cardiovascular and gastrointestinal safety of PA32540 in subjects who were taking aspirin 325 mg daily for =3 months for secondary CVD prevention and were at risk for aspirin-associated UGI events. Enrolled subjects received PA32540 once daily for up to 12 months and were assessed at baseline, month 1, month 6, and month 12. Results: The overall safety population consisted of 379 subjects, and 290 subjects (76%) were on PA32540 for =348 days (12-month completers). Adverse events (AEs) caused study withdrawal in 13.5% of subjects, most commonly gastroesophageal reflux disease (1.1%). Treatment-emergent AEs occurred in 76% of the safety population (11% treatment-related) and 73% of 12-month completers (8% treatment-related). The most common treatment-related AE was dyspepsia (2%). One subject had a gastric ulcer observed on for-cause endoscopy. There were five cases of adjudicated nonfatal myocardial infarction, one nonfatal stroke, and one cardiovascular death, but none considered treatment-related. Conclusions: Long-term treatment with PA32540 once daily for up to 12 months in subjects at risk for aspirin-associated UGI events is not associated with any new or unexpected safety events

The Balloon Array for RBSP Relativistic Electron Losses (BARREL)

BARREL is a multiple-balloon investigation designed to study electron losses from Earth’s Radiation Belts. Selected as a NASA Living with a Star Mission of Opportunity, BARREL augments the Radiation Belt Storm Probes mission by providing measurements of relativistic electron precipitation with a pair of Antarctic balloon campaigns that will be conducted during the Austral summers (January-February) of 2013 and 2014. During each campaign, a total of 20 small (∼20 kg) stratospheric balloons will be successively launched to maintain an array of ∼5 payloads spread across ∼6 hours of magnetic local time in the region that magnetically maps to the radiation belts. Each balloon carries an X-ray spectrometer to measure the bremsstrahlung X-rays produced by precipitating relativistic electrons as they collide with neutrals in the atmosphere, and a DC magnetometer to measure ULF-timescale variations of the magnetic field. BARREL will provide the first balloon measurements of relativistic electron precipitation while comprehensive in situ measurements of both plasma waves and energetic particles are available, and will characterize the spatial scale of precipitation at relativistic energies. All data and analysis software will be made freely available to the scientific community