In this 6-week trial, CR oxycodone was effective for the treatment of moderate to severe pain due to diabetic neuropathy. Adverse events were typical of opioid-related side effects.

Tanezumab is a humanized monoclonal antibody that specifically inhibits nerve growth factor as a treatment for chronic pain. This phase IIB study investigated the efficacy and safety of tanezumab for chronic low back pain vs placebo and naproxen. Patients (N=1347) received intravenous tanezumab (5, 10, or 20mg every 8weeks), naproxen (500mg twice daily), or placebo. The primary efficacy end point was mean change in daily average low back pain intensity (LBPI) from baseline to week 16. Secondary end points included mean change from baseline to week 16 in the Roland Morris Disability Questionnaire and Patient's Global Assessment (PGA) of low back pain. Tanezumab 10 and 20mg had similar efficacy profiles and significantly improved LBPI, Roland Morris Disability Questionnaire, and PGA scores vs both placebo and naproxen (P⩽.05). Tanezumab 5mg provided improvement of PGA scores vs placebo (P⩽.05), and naproxen resulted in significant improvement of LBPI vs placebo (P⩽.05). Adverse event incidence was comparable across tanezumab doses but higher than with placebo or naproxen. Arthralgia, pain in extremity, headache, and paresthesia were the most commonly reported adverse events by tanezumab-treated patients. The most frequently reported adverse events resulting in discontinuation of tanezumab treatment were arthralgia and paresthesia; the highest frequency was observed with tanezumab 20mg (both 1.4%). Serious adverse event incidence was similar across treatments. In conclusion, tanezumab provided significantly greater improvement in pain, function, and global scores vs placebo and naproxen in patients with chronic low back pain.

Tanezumab provides efficacious treatment of knee or hip OA and may have therapeutic utility in patients with OA who experience inadequate analgesia with nonsteroidal antiinflammatory drugs.

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Supplemental Digital Content is Available in the Text.In opioid-experienced patients (30-160 mg MSE/d), buccal buprenorphine was superior to placebo in 30%-50% pain reductions and PGIC, with similar constipation incidence.

This prospective, 6-week, multicenter, open-label, nonrandomized pilot study was designed to assess the effectiveness and safety of a lidocaine patch 5% in patients with low back pain (LBP). Patients with moderate to severe LBP, defined as acute/subacute (< 3 months, n = 21), short-term chronic (3-12 months, n = 33), or long-term chronic (> 12 months, n = 77), were recruited from 5 clinics; participants applied < or = 4 patches (560 cm total) once daily to area of maximal LBP as add-on treatment through week 2, with the option to taper concomitant analgesics during weeks 3-6. Scores on Brief Pain Inventory (BPI) were obtained at weeks 2 and 6. Safety analyses included reports of adverse events (AEs) and skin sensitivity to pinprick/light touch. Significant improvements in average daily pain intensity on the BPI were noted at weeks 2 and 6 (P < or = 0.001). Significant improvements in pain interference with quality of life (QOL) were noted for all BPI measures of QOL at weeks 2 and 6 for the acute/subacute (P < or = 0.007) and long-term chronic LBP groups (P < 0.0001) and for 5 of 7 BPI measures for the short-term chronic LBP group (P < or = 0.042). Fifty-eight percent of patients reported being "satisfied" or "very satisfied" with treatment. The lidocaine patch was well tolerated. Most common AEs were dizziness and rash (n = 5, 3.8%), and most AEs (80%) were mild to moderate in intensity. Significant improvement in pain intensity and QOL in this cohort of LBP patients was noted during treatment with the lidocaine patch 5%. Controlled clinical trials are warranted.

PurposeTo evaluate the efficacy and safety of pregabalin (150 or 300 mg/d) as an adjunctive therapy for the treatment of postoperative pain.Patients and methodsThis study reports findings from three separate, multicenter, randomized, double-blind, placebo-controlled trials of adjunctive pregabalin for the treatment of postoperative pain. Patients underwent one of three categories of surgical procedures (one procedure per study): elective inguinal hernia repair (post-IHR); elective total knee arthroplasty (post-TKA); or total abdominal hysterectomy (posthysterectomy). The primary endpoint in each trial, mean worst pain over the past 24 hours, was assessed 24 hours post-IHR and posthysterectomy, and 48 hours post-TKA. Patients rated their pain on a scale from 0 to 10, with higher scores indicating greater pain severity.ResultsIn total, 425 (post-IHR), 307 (post-TKA), and 501 (posthysterectomy) patients were randomized to treatment. There were no statistically significant differences between the pregabalin and placebo groups with respect to the primary endpoint in any of the three trials. The least squares mean difference in worst pain, between 300 mg/d pregabalin and placebo, was −0.7 (95% confidence interval [CI] =−1.4, −0.1; Hochberg adjusted P=0.067) post-IHR; −0.34 (95% CI =−1.07, 0.39; P=0.362) post-TKA; and −0.2 (95% CI =−0.66, 0.31; P=0.471) posthysterectomy.ConclusionThere were no significant differences between pregabalin and placebo with respect to the primary pain intensity measure in each of the three clinical trials. These studies encompass a large dataset (1,233 patients in total), and their results should be considered when assessing pregabalin’s effectiveness in postoperative pain. Further studies are required to determine the potential pain-reducing benefit of pregabalin in the postoperative setting.