Articles: analgesics.
-
Randomized Controlled Trial Multicenter Study
Development and Preliminary Validation of an Integrated Efficacy-Tolerability Composite Measure for the Evaluation of Analgesics.
The goal of this analysis was to develop and evaluate integrated measures of benefit and tolerability of analgesic drugs in clinical trials. We evaluated an efficacy-tolerability composite (ETC) measure combining different cutoff values for daily pain reduction (≥20%, ≥30%, or ≥50% pain reduction) and adverse events (AEs) (no AE, no or mild AEs, no or mild drug-related AEs). Nine ETC cutoff values (3 × 3) were tested using data from a randomized double-blind trial comparing tapentadol extended release (ER) (n = 310), oxycodone controlled release (CR) (n = 322), and placebo (n = 314) in subjects with chronic low back pain. ⋯ For all 9 ETC measures, validity was demonstrated by significant correlation of ETC scores with patients' Global Impression of change and with change from baseline in pain scores. Tapentadol ER ETC scores were statistically significantly higher than oxycodone CR ETC scores for 4 of the ETC measures. "No/mild drug-related AE and ≥20% pain reduction" demonstrated the best overall validity (correlation with patients' global impression of change) and responsiveness (discrimination between treatment groups), yielding a higher standardized effect size for tapentadol ER compared with placebo (0.19 [95% confidence interval: 0.031-0.346]) and with oxycodone CR (0.23 [95% confidence interval: 0.070-0.383]) than other cutoff values. Thus, we have identified herein a composite measure that seems to be a valid and responsive measure of the overall efficacy and tolerability of analgesics in clinical trials.
-
Randomized Controlled Trial Multicenter Study Comparative Study
Effectiveness and Safety of Transdermal Buprenorphine Versus Sustained-Release Tramadol in Patients with Moderate to Severe Musculoskeletal Pain: An 8-Week, Randomized, Double Blind, Double Dummy, Multi-Center, Active-controlled, Non-inferiority Study.
The aim of this noninferiority study was to investigate clinical effectiveness and safety of buprenorphine transdermal system (BTDS) in patients with moderate to severe musculoskeletal pain inadequately controlled with nonsteroidal anti-inflammatory drugs, compared with sustained-release tramadol tablets. ⋯ Our results suggest that BTDS is a good therapeutic option for patients experiencing chronic musculoskeletal pain of moderate to severe intensity that is insufficiently controlled by nonsteroidal anti-inflammatory drugs.
-
Randomized Controlled Trial Multicenter Study
The Contribution of Differential Opioid Responsiveness to Identification of Opioid Risk in Chronic Pain Patients.
The Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) predicts increased risk of opioid misuse in chronic pain patients. We evaluated whether higher SOAPP-R scores are associated with greater opioid reinforcing properties, potentially contributing to their predictive utility. Across 2 counterbalanced laboratory sessions, 55 chronic low back pain sufferers completed the SOAPP-R at baseline and measures of back pain intensity, evoked pain responsiveness (thermal, ischemic), and subjective opioid effects after receiving intravenous morphine (.08 mg/kg) or saline placebo. Morphine effect measures were derived for all outcomes, reflecting the difference between morphine and placebo condition values. Higher SOAPP-R scores were significantly associated with greater desire to take morphine again, less feeling down and feeling bad, and greater reductions in sensory low back pain intensity following morphine administration. This latter effect was due primarily to SOAPP-R content assessing medication-specific attitudes and behavior. Individuals exceeding the clinical cutoff (18 or higher) on the SOAPP-R exhibited significantly greater morphine liking, desire to take morphine again, and feeling sedated; less feeling bad; and greater reductions in sensory low back pain following morphine. The SOAPP-R may predict elevated opioid risk in part by tapping into individual differences in opioid reinforcing effects. ⋯ Based on placebo-controlled morphine responses, associations were observed between higher scores on a common opioid risk screener (SOAPP-R) and greater desire to take morphine again, fewer negative subjective morphine effects, and greater analgesia. Opioids may provide the best analgesia in those patients at greatest risk of opioid misuse.
-
Multicenter Study
Physical Functioning and Opioid use in Patients with Neuropathic Pain.
To evaluate the association between opioid dosage and ongoing therapy with physical function and disability in patients with neuropathic pain (NeP). ⋯ Physical functioning and disability did not improve in patients with NeP who were prescribed opioids compared with those who are not prescribed, even after adjusting for disease severity.
-
Support Care Cancer · Jul 2015
Randomized Controlled Trial Multicenter StudyImproved patient functioning after treatment of breakthrough cancer pain: an open-label study of fentanyl buccal tablet in patients with cancer pain.
This open-label study evaluated the effects of fentanyl buccal tablet (FBT) on functioning and mood in cancer patients with breakthrough cancer pain (BTcP). ⋯ FBT may improve patient functioning, mood, and overall satisfaction in the management of BTcP. Long-term data did not indicate new safety concerns with FBT doses up to 800 μg.