Academic Journal
Comparison of amitriptyline supplemented with pregabalin, pregabalin supplemented with amitriptyline, and duloxetine supplemented with pregabalin for the treatment of diabetic peripheral neuropathic pain (OPTION-DM): a multicentre, double-blind, randomised crossover trial
| العنوان: | Comparison of amitriptyline supplemented with pregabalin, pregabalin supplemented with amitriptyline, and duloxetine supplemented with pregabalin for the treatment of diabetic peripheral neuropathic pain (OPTION-DM): a multicentre, double-blind, randomised crossover trial |
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| المؤلفون: | Tesfaye, S., Sloan, G., Petrie, J., White, D., Bradburn, M., Julious, S., Rajbhandari, S., Sharma, S., Rayman, G., Gouni, R., Alam, U., Cooper, C., Loban, A., Sutherland, K., Glover, R., Waterhouse, S., Turton, E., Horspool, M., Gandhi, R., Maguire, D., Jude, E.B., Ahmed, S.H., Vas, P., Hariman, C., McDougall, C., Devers, M., Tsatlidis, V., Johnson, M., Rice, A.S.C., Bouhassira, D., Bennett, D.L., Selvarajah, D. |
| بيانات النشر: | Elsevier BV |
| سنة النشر: | 2022 |
| المجموعة: | White Rose Research Online (Universities of Leeds, Sheffield & York) |
| الوصف: | Background Diabetic peripheral neuropathic pain (DPNP) is common and often distressing. Most guidelines recommend amitriptyline, duloxetine, pregabalin, or gabapentin as initial analgesic treatment for DPNP, but there is little comparative evidence on which one is best or whether they should be combined. We aimed to assess the efficacy and tolerability of different combinations of first-line drugs for treatment of DPNP. Methods OPTION-DM was a multicentre, randomised, double-blind, crossover trial in patients with DPNP with mean daily pain numerical rating scale (NRS) of 4 or higher (scale is 0–10) from 13 UK centres. Participants were randomly assigned (1:1:1:1:1:1), with a predetermined randomisation schedule stratified by site using permuted blocks of size six or 12, to receive one of six ordered sequences of the three treatment pathways: amitriptyline supplemented with pregabalin (A-P), pregabalin supplemented with amitriptyline (P-A), and duloxetine supplemented with pregabalin (D-P), each pathway lasting 16 weeks. Monotherapy was given for 6 weeks and was supplemented with the combination medication if there was suboptimal pain relief (NRS >3), reflecting current clinical practice. Both treatments were titrated towards maximum tolerated dose (75 mg per day for amitriptyline, 120 mg per day for duloxetine, and 600 mg per day for pregabalin). The primary outcome was the difference in 7-day average daily pain during the final week of each pathway. This trial is registered with ISRCTN, ISRCTN17545443. Findings Between Nov 14, 2017, and July 29, 2019, 252 patients were screened, 140 patients were randomly assigned, and 130 started a treatment pathway (with 84 completing at least two pathways) and were analysed for the primary outcome. The 7-day average NRS scores at week 16 decreased from a mean 6·6 (SD 1·5) at baseline to 3·3 (1·8) at week 16 in all three pathways. The mean difference was –0·1 (98·3% CI –0·5 to 0·3) for D-P versus A-P, –0·1 (–0·5 to 0·3) for P-A versus A-P, and 0·0 (–0·4 to 0·4) for P-A ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | text |
| اللغة: | English |
| Relation: | https://eprints.whiterose.ac.uk/190400/1/first%20published%20online%20220822.pdf; https://eprints.whiterose.ac.uk/190400/6/supplementary%20appendix.pdf; Tesfaye, S., Sloan, G., Petrie, J. et al. (29 more authors) (2022) Comparison of amitriptyline supplemented with pregabalin, pregabalin supplemented with amitriptyline, and duloxetine supplemented with pregabalin for the treatment of diabetic peripheral neuropathic pain (OPTION-DM): a multicentre, double-blind, randomised crossover trial. The Lancet, 400 (10353). pp. 680-690. ISSN 0140-6736 |
| الاتاحة: | https://eprints.whiterose.ac.uk/190400/ https://eprints.whiterose.ac.uk/190400/1/first%20published%20online%20220822.pdf https://eprints.whiterose.ac.uk/190400/6/supplementary%20appendix.pdf |
| Rights: | cc_by_4 |
| رقم الانضمام: | edsbas.2E7B5841 |
| قاعدة البيانات: | BASE |
| الوصف غير متاح. |