Once-Daily Opioids for Chronic Dyspnea: A Dose Increment and Pharmacovigilance Study
Journal of Pain and Symptom Management, 04/19/2011
Currow DC et al. – Ten milligrams of sustained–release oral morphine once daily is safe and effective for most people who respond.
Methods- 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- The participant was withdrawn if there were unacceptable side effects or no response to maximum dose.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
