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SAT0124 Comparative safety and efficacy of transdermal fentanyl (durogesic®) and sustained-release oral morphine (ms contin®) in patients with chronic non-cancer pain: results of a large, multicenter, randomised, crossover trial
  1. L Allan1,
  2. E Kalso2
  1. 1The Pain Clinic, Northwick Park and St Mark’s NHS Trust, Harrow, UK
  2. 2Helsinki University, Central Hospital Pain Clinic, Helsinki, Finland

Abstract

Background Opioids are the most powerful analgesics, but politics, prejudice and continuing ignorance still impede optimum prescribing.1 Furthermore, opioids are the mainstay of cancer pain management. Retrospective and survey data have confirmed the efficacy of opioids in chronic non-cancer pain (CNCP) and found that fears of addiction were not justified in patients with no prior history of drug abuse.2 While morphine, usually prescribed orally in a sustained-release formulation for the treatment of CNCP, is the standard opioid against which others are judged, severe constipation (a persistent complication of some opioids) may adversely affect some patients? quality-of-life more than their chronic pain.3 Fentanyl, delivered in a transdermal controlled-release formulation, has demonstrated analgesic efficacy in cancer pain and is associated with less constipation than morphine.4 Recognising the increasing importance of patient preference and choice, the authors investigated whether CNCP patients accustomed to opioids would prefer transdermal fentanyl (TDF) to sustained-release oral morphine (SRM).

Methods A randomised, multicenter, international, open-label crossover trial assessed 8 weeks of TDF and SRM therapy. Patients previously treated with opioids with CNCP, were randomised to receive TDF and then SRM, each for 4 weeks, or the same treatments in reverse order.

Results Of the 256 patients entering the study 196 completed the trial, with 38 and 22 patients withdrawing during the TDF (n = 126) and SRM (n = 130) treatment periods, respectively. Most patients (65.1%) preferred TDF (p < 0.001), 27.8% preferred SRM and 7.1% expressed no preference. More patients considered that pain control was ?good? or ?very good? with TDF than with SRM (35% vs 23%, p = 0.002). Patients using TDF had, on average, higher quality-of-life scores than those receiving SRM. The incidence of adverse events was similar in both treatment groups; however, more subjects experienced constipation when treated with SRM than with TDF (48% vs 29%, respectively; p < 0.001). More patients withdrew because of adverse events during the TDF than in the SRM treatment periods (10% vs 5%, respectively). However, within a subgroup of 66 patients that had used neither fentanyl nor morphine prior to the study (they had used other opioids), similar numbers withdrew due to adverse effects during TDF and SRM treatments (11% vs 10%, respectively).

Conclusion Both TDF and SRM treatments were well tolerated, with good safety profiles in patients with CNCP who had previously been treated with opioids. Superior pain relief and less constipation were associated with TDF compared with SRM therapy.

References

  1. McQuay H. Lancet 1999;353:2229–32

  2. Portenoy RK. J Pain Symptom Manage. 1996;11:203–17

  3. Cummings-Ajemian I. In: Patt RB, ed. Cancer pain. Philadelphia: JB Lippencott Company, 1993

  4. Ahmedzai S, Brooks D. J Pain Symptom Manage. 1997;13:254–61

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