ABSTRACT
Pain is a health issue affecting all populations, regardless of age, gender, economic status, race, or geography. Acute pain is the most common type of pain, with a complex aetiology. Inadequately managed acute pain adversely affects quality of life and imposes significant economic burden. The majority of the available pain-relieving drugs have monomodal mechanisms of analgesia, which necessitates combining drugs with non-redundant mechanisms of action in order to provide adequate pain relief and reduce the side effects from higher doses of individual drugs. In this regard, combining an oral opioid (such as codeine or tramadol) and a non-opioid (such as paracetamol or non-steroidal anti-inflammatory drug) offers a plausible option. Tramadol/diclofenac fixed-dose combination (FDC) is one such analgesic combination which has demonstrated promising clinical activity via its multimodal mechanisms of action. This review seeks to provide an up-to-date narrative on the current scientific literature regarding the pharmacological properties, clinical efficacy, and tolerability of tramadol/diclofenac FDC in the treatment of acute severe pain. A comprehensive, qualitative review of the literature was conducted using a structured search strategy in Medline/PubMed and additional Internet-based sources to identify relevant studies. Based on the available scientific literature, evidence of the efficacy and safety of tramadol/diclofenac FDC for treatment of patients with acute severe pain, including musculoskeletal pain, postoperative pain, and acute flare-up of osteoarthritis or rheumatoid arthritis, appears to be substantial. Although additional comparative studies would be required to definitively position tramadol/diclofenac FDC with respect to other analgesic combinations, the available data suggest that tramadol/diclofenac FDC is a valuable treatment option for patients with acute severe pain.
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.
