Dose Conversion and Titration with a Novel, Once-Daily, OROS® Osmotic Technology, Extended-Release Hydromorphone Formulation in the Treatment of Chronic.

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Presentation transcript:

Dose Conversion and Titration with a Novel, Once-Daily, OROS® Osmotic Technology, Extended-Release Hydromorphone Formulation in the Treatment of Chronic Malignant or Nonmalignant Pain Mark Palangio, MS, Donald W Northfelt, MD, MS, FACP, Russell K Portenoy, MD, Daniel Brookoff, MD, PhD, Ralph T Doyle, BA, Bruce E Dornseif, PhD, Michael C Damask, MD Journal of Pain and Symptom Management Volume 23, Issue 5, Pages 355-368 (May 2002) DOI: 10.1016/S0885-3924(02)00390-1

Fig. 1 The OROS® osmotic technology, extended-release hydromorphone formulation tablet. This formulation consists of a drug layer and a push layer enclosed in a semipermeable tablet shell membrane that is pervious to water but not the drug. As water is absorbed from the gastrointestinal tract, the push layer expands and presses on the drug layer, slowly releasing hydrated hydromorphone through a laser-drilled orifice in the tablet shell. Journal of Pain and Symptom Management 2002 23, 355-368DOI: (10.1016/S0885-3924(02)00390-1)

Fig. 2 Patient disposition. Journal of Pain and Symptom Management 2002 23, 355-368DOI: (10.1016/S0885-3924(02)00390-1)

Fig. 3 Percent of patients by the number of titration steps required in reaching a stable dose of ER hydromorphone. Dose stabilization was attained by 73.8% of patients (298/404). Among these, 70.1% (209/298) were stabilized with ≤2 titration steps. Journal of Pain and Symptom Management 2002 23, 355-368DOI: (10.1016/S0885-3924(02)00390-1)

Fig. 4 Comparisons of mean ± standard deviation (SD) pain intensity ratings from the Brief Pain Inventory between pretreatment (Visit 2 at the end of the prior opioid stabilization phase) and endpoint (Visit 5 or the last observation carried forward during treatment, whether at Visits 3 or 4) in the intent-to-treat analysis. Pain at its worst, at its least, and on average in the last 24 hours and pain right now were rated on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). *P < 0.001 when comparing pretreatment to endpoint (Wilcoxon signed rank test). †P < 0.01 when comparing pretreatment to endpoint (Wilcoxon signed rank test). Journal of Pain and Symptom Management 2002 23, 355-368DOI: (10.1016/S0885-3924(02)00390-1)

Fig. 5 Comparisons of mean ± standard deviation (SD) pain interference ratings from the Brief Pain Inventory between pretreatment (Visit 2 at the end of the prior opioid stabilization phase) and endpoint (Visit 5 or the last observation carried forward during treatment, whether at Visits 3 or 4) in the intent-to-treat analysis. Pain interference of function (general activity, mood, walking ability, normal work, relationships with others, sleep, and enjoyment of life) was rated on a scale from 0 (no interference) to 10 (complete interference). *P < 0.0001 when comparing pretreatment to endpoint (Wilcoxon signed rank test). Journal of Pain and Symptom Management 2002 23, 355-368DOI: (10.1016/S0885-3924(02)00390-1)