Amit B Yeole1, G Sree Ranga Lakshmi2, C J Selvakumar3, Vijay G Goni4, C L Nawal5, Bhanoth J Valya6, Brijesh J Patel7, Rohit D Patel8, Eknath D Pawar9, Ranajit Panigrahi10, Ashish Y Kumar11, Shrinivas S Shintre12, Prashant H Devkare13, Shruti K Dharmadhikari14, Sanjay Y Choudhari15, Maulik S Doshi16, Suyog C Mehta14, Sadhna J Joglekar13. 1. Supe Heart and Diabetes Hospital and Research Centre, Nashik, India. 2. Osmania General Hospital, Hyderabad, India. 3. Kovai Diabetes Speciality Centre and Hospital, Coimbatore, India. 4. Postgraduate Institute of Medical Education and Research, Chandigarh, India. 5. SMS Hospital, Jaipur, India. 6. Gandhi Hospital, Secunderabad, India. 7. Hi-Tech Multispeciality Hospital, Gandhinagar, India. 8. Kanoria Hospital and Research Centre, Gandhinagar, India. 9. Grant Government Medical College and Sir JJ Group of Hospitals, Mumbai, India. 10. Sparsh Hospital and Critical Care Pvt. Ltd, Bhubaneshwar, India. 11. King George's Medical College, Lucknow, India. 12. BJ Government Medical College and Sassoon General Hospitals, Pune, India. 13. Medical Affairs, Sun Pharmaceutical Industries Limited, Mumbai, India. 14. Medical Affairs, Sun Pharma Laboratories Limited, Sun House, Plot No. 201 B/1, Western Express Highway, Goregaon (East), Mumbai, 400063, Maharashtra, India. 15. Medical Affairs, Sun Pharma Laboratories Limited, Sun House, Plot No. 201 B/1, Western Express Highway, Goregaon (East), Mumbai, 400063, Maharashtra, India. Sanjay.Choudhari@sunpharma.com. 16. India Clinical Research, Sun Pharma Laboratories Limited, Mumbai, India.
Abstract
INTRODUCTION: Currently available treatments for chronic lower back pain (CLBP) do not adequately address both nociceptive and neuropathic components of pain. We evaluated efficacy and safety of fixed-dose combination (FDC) of low-dose pregabalin prolonged release 75 mg-etoricoxib 60 mg to address both pain components. METHODS: This randomized phase 3 trial conducted at 12 centres across India evaluated efficacy (based on mean change in numeric rating scale [NRS], Roland-Morris disability questionnaire [RDQ], visual analogue scale [VAS], patient global impression of improvement [PGI-I], clinical global impression of improvement [CGI-I] and rescue medication consumption) and safety of FDC in comparison to etoricoxib alone in adult patients with CLBP. Treatment duration was 8 weeks. RESULTS: Of the 371 patients screened, 319 were randomized and considered for efficacy and safety analysis. Both treatment groups had no significant difference in terms of demography and baseline disease characteristics. Significantly better outcomes with FDC compared to etoricoxib were observed at week 4 onwards. At week 8, both groups showed significant reduction in mean NRS score from baseline (- 4.00 ± 1.65 in FDC; - 2.92 ± 1.59 in etoricoxib) with mean NRS score being significantly less in the FDC group compared to etoricoxib group (3.26 ± 1.56 vs 4.31 ± 1.56; p < 0.0001). The FDC was more effective than etoricoxib in terms of significantly greater reduction in RDQ score (- 9.28 ± 4.48 vs - 6.78 ± 4.34; p < 0.0001) and VAS score (- 37.66 ± 18.7 vs - 28.50 ± 16.31; p < 0.0001) at week 8. The FDC was also better in terms of significantly more patients reporting their condition as 'very much better' (36.9% vs 5.0%; p < 0.0001) and clinicians reporting patient's condition as 'very much improved' (36.3% vs 5.7%; p < 0.0001). Overall, study medications were well tolerated. CONCLUSION: FDC of pregabalin and etoricoxib provided significant benefits in reducing pain and improving functional status compared with etoricoxib alone in patients with CLBP. Pregabalin prolonged release-etoricoxib FDC could be one of the treatment options for early and sustained pain relief and improvement in quality-of-life in treating CLBP as it addresses both neuropathic and nociceptive components of pain. TRIAL REGISTRATION: CTRI/2018/10/015886.
INTRODUCTION: Currently available treatments for chronic lower back pain (CLBP) do not adequately address both nociceptive and neuropathic components of pain. We evaluated efficacy and safety of fixed-dose combination (FDC) of low-dose pregabalin prolonged release 75 mg-etoricoxib 60 mg to address both pain components. METHODS: This randomized phase 3 trial conducted at 12 centres across India evaluated efficacy (based on mean change in numeric rating scale [NRS], Roland-Morris disability questionnaire [RDQ], visual analogue scale [VAS], patient global impression of improvement [PGI-I], clinical global impression of improvement [CGI-I] and rescue medication consumption) and safety of FDC in comparison to etoricoxib alone in adult patients with CLBP. Treatment duration was 8 weeks. RESULTS: Of the 371 patients screened, 319 were randomized and considered for efficacy and safety analysis. Both treatment groups had no significant difference in terms of demography and baseline disease characteristics. Significantly better outcomes with FDC compared to etoricoxib were observed at week 4 onwards. At week 8, both groups showed significant reduction in mean NRS score from baseline (- 4.00 ± 1.65 in FDC; - 2.92 ± 1.59 in etoricoxib) with mean NRS score being significantly less in the FDC group compared to etoricoxib group (3.26 ± 1.56 vs 4.31 ± 1.56; p < 0.0001). The FDC was more effective than etoricoxib in terms of significantly greater reduction in RDQ score (- 9.28 ± 4.48 vs - 6.78 ± 4.34; p < 0.0001) and VAS score (- 37.66 ± 18.7 vs - 28.50 ± 16.31; p < 0.0001) at week 8. The FDC was also better in terms of significantly more patients reporting their condition as 'very much better' (36.9% vs 5.0%; p < 0.0001) and clinicians reporting patient's condition as 'very much improved' (36.3% vs 5.7%; p < 0.0001). Overall, study medications were well tolerated. CONCLUSION: FDC of pregabalin and etoricoxib provided significant benefits in reducing pain and improving functional status compared with etoricoxib alone in patients with CLBP. Pregabalin prolonged release-etoricoxib FDC could be one of the treatment options for early and sustained pain relief and improvement in quality-of-life in treating CLBP as it addresses both neuropathic and nociceptive components of pain. TRIAL REGISTRATION: CTRI/2018/10/015886.
Authors: Sheena Derry; Rae Frances Bell; Sebastian Straube; Philip J Wiffen; Dominic Aldington; R Andrew Moore Journal: Cochrane Database Syst Rev Date: 2019-01-23