Table 3.
Studies on the efficacy of trandsermal buprenorphine (BUP TDS) in cancerous or non-cancerous nociceptive pain conditions
| Study | Design/methods | Condition(s) | Intervention/control/length of treatment | Outcome measures | Results | Quality grade |
|---|---|---|---|---|---|---|
| Poulain et al55 | Enriched design study (n = 289) | Opioid-tolerant cancer patients | Efficacy and safety of BUP TDS 70 μg/h vs placebo Maintenance phase of 2 weeks, after 2 weeks run-in |
Mean pain intensity (0–10) Mean daily sublingual buprenorphine tablet intake |
131 patients discontinued due to adverse events or lack of efficacy Lower daily pain intensity with BUP TDS, lower intake of buprenorphine tables and lower drop-outs with BUP TDS |
4 |
| Muriel56 | Open post-marketing surveillance study (n = 1223) | Chronic moderate to severe cancer pain (unresponsive to non-opioids) | BUP TDS 35 μg/h for majority of patients Treatment period of 3 months |
Continuation of therapy Pain relief |
52% of patients continued the same treatment 89% of patients were satisfied with treatment |
1 |
| Muriel et al57 | Open, multi-center, retrospective study (n = 164) | Moderate to severe cancer pain | BUP TDS 35 or 52.5 μg/h for majority of patients Treatment period of 8 weeks |
Pain score | Significant reductions in pain score after 2 and 8 weeks of treatment | 1 |
| Aurilio et al64 | Randomized, placebo-controlled study (n = 86) | Patients suffering from ischemic pain | BUP TDS 35 μg/h + epidural infusion to epidural infusion alone Treatment period of 4 weeks |
VAS score Short form MPQ Pain interference with sleep |
Reduction of pain Increased sleep and Lower side effects with BUP TDS |
5 |
| Schutter et al65 | Multicenter observational study (n = 4263) | Chronic osteoarthritis pain | Low dose 7 days buprenorphine patch | 11-point NRS scale Aspects of QoL Need for additional analgesics |
BUP TDS leads to significant decrease in pain Decrease in additional analgesics and better QoL 4.5% showed side effects |
1 |
| Karlsson and Berggren66 | Randomized, open-label, parallel group non-inferiority study (n = 134) | Chronic (moderate to severe) osteoarthritis pain of knee and hip | Low dose 7-day BUP TDS (max 20 μg/h) vs twice daily prolonged-release tramadol tablets (max 400 mg/d) 12 weeks treatment period |
BS-11 scale Rescue medication use Quality of sleep and sleep disturbance Global assessment of pain relief (patient + investigator) |
Both treatments induced a clinically meaningful decrease in pain Efficacy of BUP TDS non-inferior to tramadol Comparable incidence of adverse events in both groups |
3 |
| Landau et al67 | Multicenter, doubleblind, parallel group study (n = 588) | Non-cancer related pain for which opioid treatment was needed | Efficacy and safety profile of BUP TDS vs placebo Acetaminophen 500-mg tablets as rescue medication 14 days treatment period (after 7- to 21-day run-in phase) |
Proportion of subjects with ineffective treatment Time to ineffective R/ Need for rescue medication Drop-outs |
Significantly higher risk for ineffective R/ with placebo versus BUP TDS Lower drop-outs with BUP TDS and significantly less rescue medication needed |
5 |
| Likar et al68 | Comparative study (n = 82) | Moderate to severe chronic pain in elderly and younger patients | Compare efficacy and tolerability of BUP TDS 28-day treatment period |
Pain intensity Sleep duration Need for rescue medication |
Significant reduction in pain from BUP TDS, without difference between age groups Increase in sleep duration Need for rescue medication lowest in elderly Comparable safety profile for all age groups |
2 |
Abbreviations: AE, adverse event; MPQ, McGill Pain Questionnaire; NRS, numeric rating scale; QoL, quality of life; R, treatment; SL, slow release; V AS, visual analogue scale; SF-36, 36-item Short-Form Health Survey.