Tapentadol Prolonged Release for Severe Chronic Osteoarthritis Pain in the Elderly-A Subgroup Analysis of Routine Clinical Practice Data.

Background: Tapentadol prolonged release (PR) has been shown effective and generally well tolerated in a broad range of chronic pain conditions. This subgroup analysis investigated its benefits for elderly patients with severe chronic osteoarthritis (OA) pain in routine clinical practice. Patients and Methods. Data of all patients with chronic OA pain were extracted from the database of a prospective, 3-month noninterventional tapentadol PR trial. The data of elderly OA patients (>65 years of age; n = 752) were compared with the data of younger OA patients (≤65 years; n = 282). Results: Almost all patients (elderly 98.7% and younger patients 99.3%) had received long-term analgesic medication prior to the start of tapentadol PR treatment but presented with severe pain accompanied by considerable impairments in sleep quality and quality of life measures. Tapentadol PR provided effective pain relief in both patient groups, with slightly better outcomes in younger patients. However, the mean baseline pain intensity of 7.1 (SD 1.5) was reduced by 3.8 points (p ≤ 0.001), and sleep and quality of life measures had also markedly improved in the elderly: quality of sleep by 3 points, quality of life by 3.4 points, social activities by 3 points, and independence by 2.7 points (p ≤ 0.001 for all measures; 11-point scale). At the end of observation, 68% of the elderly had clinically relevant pain reductions of at least 50% (vs baseline), and 87.9% attained either their intended pain reduction target and/or an additional individual treatment target (both predefined during baseline examination). Only 8.4% of the elderly experienced adverse drug reactions, most frequently nausea (2.7% of patients) and dizziness (1.5%). Conclusion: Tapentadol PR provided effective and well-tolerated treatment of severe chronic OA pain for elderly patients in routine clinical practice. The favorable tolerability profile in particular suggests tapentadol PR as a treatment option before classical strong opioids are considered.

[Fentanyl buccal tablets in the treatment of breakthrough cancer pain. German cohort of a pan-European multicentre study]. / Fentanyl-Buccaltabletten in der Behandlung von Durchbruchschmerzen : Deutsche Kohorte einer paneuropäischen multizentrischen Studie.

BACKGROUND: Patients with breakthrough cancer pain (BtCP) experience significant limitations in their physical, mental and social functions. Fentanyl buccal tablets (FBT), a rapid onset opioid, are specifically indicated for the treatment of BtCP. METHOD: The results of the German cohort of a pan-European study are presented. This included cancer pain patients from 32 German centers. Patients were on continuous opioid medication and had at least 4 BtCP episodes per day. After randomization to 2 groups, 66 patients started the titration of FBT with 100 µg (group A) and 200 µg (group B), respectively. All patients were titrated to their individual EAD, which could be a maximum of 800 µg FBT per episode, regardless of the initial dose. Subsequently, up to 8 BtCP episodes were treated with this EAD. At baseline and after treatment, patients assessed the effects of BtCP on their functional status using the modified BPI-7S and answered questions about the efficacy, simplicity, and ease-of-use of the treatment. RESULTS AND CONCLUSIONS: Successful titration was achieved by 49 patients (74.2%). There was no statistically significant difference between group A and group B. The global score of the modified BPI-7S increased by 8.5 (± 12.8) points (from 34.7 ± 13.6 at the beginning to 26.2 ± 15.8 at the end of treatment), from which a statistically significant improvement in the quality of life of patients can be derived. Global patient contentment improved, most notably the rapid onset of 2.4 points to 3.4 points at the end of the study. 76.9% of patients found taking FBT simple or very simple.

Efficacy of a new once daily hydromorphone formulation in comparison with twice daily administration in chronic pain: a randomized, double-blind, cross-over study.

Objective Efficacy and safety of a novel multiple-unit hydromorphone once daily (HOD) was compared to an established hydromorphone twice daily (HTD) regimen in patients with moderate-to-severe chronic pain. Design and methods The results from a randomized, double-blind, multicenter, cross-over trial in patients (n = 37) with chronic malignant or non-malignant pain are reported. The primary efficacy parameter was current pain on 0-100 mm VAS assessed four times daily and prior to intake of rescue medication (immediate-release hydromorphone) throughout the last 5 days with each treatment (after an 8 day build-up period to avoid carry-over effects). Total daily dose of hydromorphone (TDD: 8-32 mg/day) was kept stable during the double-blind treatment phase. Results The difference observed in mean current pain (-0.92 mm VAS) over the 5 day assessment period between HOD and HTD (28.44 mm vs. 29.36 mm VAS) was found to lack clinical relevance, as the 95% CI (-4.10 to 2.28 mm VAS) did not exceed the prespecified limit for non-inferiority of 9 mm VAS. Results from the full analysis set were consistent with per protocol data confirming robustness, as did the data for 12 h recalled pain assessed at 08:00 h and 20:00 h, showing no significant differences between once and twice daily medication. Both treatments produced effective and stable pain control with only minor day-to-day and intra-day fluctuations. Switching between treatments was suitable, considering both efficacy and safety, as no relevant or significant differences in adverse events were seen (25.0% HOD, 24.3% HTD). Most frequently typical side-effects of opioid therapy were observed, such as nausea, vomiting and headache. Conclusion Although this study was of short duration and included a limited number of patients, the results confirm that the new HOD is as effective and safe as the established HTD.