Once-Daily Opioids for Chronic Dyspnea: A Dose Increment and Pharmacovigilance Study
Journal of Pain and Symptom Management, 04/19/2011Currow DC et al.
Ten milligrams of sustained–release oral morphine once daily is safe and effective for most people who respond.
In a Phase II dose increment study
10mg daily of sustained–release morphine was administered, and increased in nonresponders by 10mg daily each week to a maximum of 30mg daily.
The participant was withdrawn if there were unacceptable side effects or no response to maximum dose.
If participants had a 10% improvement in dyspnea over their own baseline, they joined a long–term Phase IV effectiveness/safety study at that dose.
Complying with Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines, response and side effects are described, with demographic and clinical characteristics of responders
83 participants (53 males, mean age 75 years, 54% with chronic obstructive pulmonary disease) provided more than 30 patient–years of data
52 participants derived ≥ 10% benefit (on average 35% improvement over baseline) giving a response rate of 62% (number needed to treat of 1.6: number needed to harm 4.6); for 70%, this dose was 10mg/24h
Benefit was maintained at three months for 28 (33%) people
Ranking of breathlessness was reduced significantly (P<0.001), but constipation increased (P<0.001) despite laxatives
There were no episodes of respiratory depression or hospitalizations as a result of the sustained–release morphine
Overall, one in three people continued to derive benefit at three months
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