OROS® hydromorphone may be particularly

well suited to the long-term management of cancer pain because it provides consistent plasma concentrations, sustained analgesia, and convenient once-daily dosing. In this open-label, single treatment extension study, OROS® hydromorphone was administered to patients with moderate-to-severe chronic cancer pain who had successfully completed a previous short-term equivalence study and whose pain was controlled with a stable dose of medication. Prior opioid therapy in the previous equivalence study (OROS® hydromorphone versus CR morphine) did not affect clinical outcomes such as efficacy or safety in this study. The results demonstrate that pain control achieved Inhibitors,research,lifescience,medical with OROS® hydromorphone is maintained for up to Inhibitors,research,lifescience,medical 1 year with repeated once-daily dosing in patients with chronic cancer pain. This was shown using a variety of measures, including the BPI items pain at its worst, pain at its

least, pain on average, current pain, and pain relief, and patient and investigator global evaluations of overall treatment effectiveness. Throughout the study, pain scores were maintained at mild to moderate levels. These results support short-term studies of OROS® hydromorphone for chronic Inhibitors,research,lifescience,medical cancer pain [20-22,34]. In addition, the degree to which patients’ cancer pain interfered with their general activity, mood, ability to walk, work, relationships, sleep, and enjoyment of life was also maintained, suggesting that there was no Selleck PD0332991 worsening of QoL during the year. This has been demonstrated before; previous studies have shown a positive impact on QoL with CR opioid formulations [11,48]. There were no clear differences in the Inhibitors,research,lifescience,medical results when comparing patients who had received OROS® hydromorphone or CR morphine in the previous equivalence study. Although most efficacy measures were maintained at similar levels Inhibitors,research,lifescience,medical throughout the study, for most

measures, the mean scores were slightly worsened at end point compared with baseline. However, owing to the progressive nature of the disease, some deterioration is to be expected. The most commonly Idoxuridine reported AEs, with an incidence of at least 10%, were nausea, constipation, vomiting, anaemia, peripheral oedema, dyspnoea, asthenia, disease progression, somnolence, and urinary tract infection. These are events typically seen with the use of strong opioids or in a chronic cancer pain population. Slightly more AEs overall and AEs considered related to study treatment were reported in patients who had previously received OROS® hydromorphone compared with CR morphine in the equivalence study; however, the clinical significance of this difference is questionable because of the degree and nature of AEs expected in an advanced cancer population. In addition, the majority of AEs were mild or moderate in severity.