Durapain in symptomatic treatment of severe acute pain: a post-marketing, prospective, multicenter, observational study – PRIME study

Abstract

Objective

To assess the effectiveness, overall tolerability, and gastrointestinal (GI) tolerability of Durapain (fixed dose combination of tramadol hydrochloride immediate release [50 mg] and diclofenac sodium sustained release [75 mg]) in symptomatic treatment of severe acute pain in physician’s routine clinical practice.

Materials and methods

In this prospective, multicenter, observational, post-marketing study, adult patients (aged 18–60 years) with severe acute pain were treated with tramadol hydrochloride/diclofenac sodium as per approved prescribing information. Evaluation was done at base-line, day 2, and day 5. Primary end point was pain intensity difference from baseline to day 5.

Results

A total of 351 patients (mean age 44.2 years; male 43%; female 57%) were included. The mean pain score was reduced from 9.2±1.09 at baseline to 2.8±1.73 at day 5 (p<0.0001). The number of patients with severe intensity of pain reduced from 100% at baseline to 18.3% at day 2 and 6.96% at day 5. According to the patient assessment, 68.36% of patients reported tolerability as “very good to good”, whereas according to physician’s assessment, “very good to good” tolerability was reported in 68.27% of patients. Five (1.43 %) patients discontinued the study because of adverse drug reaction. Five patients developed nine GI-related events of moderate intensity. Two patients developed three adverse reactions (burning sensation in urine, giddiness, and urine retention) other than GI events. No serious adverse drug reactions were reported during the study period.

Conclusion

Tramadol hydrochloride/diclofenac sodium is an effective and well-tolerated treatment in Indian patients with severe acute pain. Treatment with tramadol hydrochloride/diclofenac sodium provides significant pain relief on day 2 and maintained until day 5 without any serious adverse reactions.

Keywords:

• Durapain
• severe acute pain
• tramadol and diclofenac combination

Acknowledgments

The authors would like to thank Dr. Pankaj Gupta and Dr. Rajnish Gupta from Delhi, and Dr. Suhas Shah, Dr. Rutuj Kamdar, Dr. Milind Patil, Dr. Shailesh Kamble, Dr. Pushkar Likhite, Dr. Faisal Bape, and Dr. Vikram Rajwadkar from Mumbai for their participation in this study. This study was funded by Abbott Healthcare Pvt Ltd.

Dr Gauri Billa, Medical Advisor, Medical Services has authored this publication in the capacity of employee of Abbott Healthcare Pvt Ltd. Dr. Kshitij Shah, Dr. Omvijay B Chaudhari, Dr. Palash Gupta, Dr. R. Hom Chaudhuri, Dr. Ranjan Kamilya, Dr. S.S. Kulkarni, Dr. S. Subbaiah, Dr. Zubair H Sorathia have co-authorized this publication. Financial support for the project was provided by Abbott Healthcare Pvt Ltd, India. Dr Gauri Billa is an employee of Abbott Healthcare Pvt Ltd, India.

Disclosure

The authors report no conflicts of interest in this work.