American journal of therapeutics
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Pacemaker (PM) and implantable cardioverter-defibrillator (ICD) therapy are two examples of remarkable technological advances that have revolutionized cardiovascular device therapy. Understanding the history of early PM and ICD device development, recognizing the importance of the clinical data that was required to launch the current "era" of exponential device use, and appreciating the challenge of maintaining device innovation without sacrificing device reliability, are important lessons that may offer insights into future cardiovascular device development.
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Multicenter Study Clinical Trial
Safety, tolerability, and effectiveness of oxymorphone extended release for moderate to severe osteoarthritis pain: a one-year study.
A 52-week, multicenter, open-label extension study was performed to evaluate the safety, tolerability, and effectiveness of oxymorphone extended release (ER), a novel tablet formulation of oxymorphone hydrochloride, in 153 patients with moderate to severe chronic osteoarthritis-related pain. Sixty-one patients (39.9%) completed the study. Common opioid-related nonserious adverse events (AEs) caused most withdrawals. ⋯ Mean pain scores initially decreased as previously opioid-naive patients achieved adequate pain relief, reached stable levels after the first 6 weeks, and remained stable at mild levels throughout the remainder of the study (average pain, 20-25 mm on 100-mm Visual Analog Scale). Average daily dosing remained stable throughout the study (median, 40 mg/d). At each assessment, at least 80% of patients rated their global satisfaction with oxymorphone ER as "excellent," "very good," or "good." Oxymorphone ER provides a new 12-hour analgesic for the treatment of moderate to severe chronic osteoarthritis-related pain in patients who may require long-term opioid therapy.