Summary: Objective: To evaluate the efficacy, safety and effects on quality of life (QoL) of immediate release 37.5 mg/325 mg (IR T/P) and sustained release tramadol/paracetamol 75 mg/650 mg (SR T/P) tablets in patients with moderate to severe acute low back pain (aLBP).
Methods: This was a randomized, open-label, prospective, two-arm study in adults with moderate to severe aLBP [≥ 40 mm on the Visual Analogue Scale (VAS)]. Patients were treated with four-times daily IR T/P (Doreta®),37.5 mg/325 mg or twice daily SR T/P (Doreta SR®) 75 mg/650 mg for up to four weeks. During the treatment period, patients were allowed to take naproxen sodium 550 mg film-coated tablets (Nalgesin® forte) max. twice daily as a rescue medication (in case sufficient pain relief was not achieved with the study medication). In patients taking naproxen, pantoprazole 20 mg (Nolpaza®) once daily was permitted for gastric protection.
The primary endpoint was the percentage of patients with pain intensity reduced to < 30 mm on VAS at therapy conclusion. Secondary endpoints included pain intensity differences, cumulative pain intensity, QoL, pain interference and proportions of patients with excellent response. Safety was assessed by adverse events monitoring.
Results: The results presented are limited to the IR T/P arm, as products containing modified-release paracetamol were suspended from markets in Europe. Out of 157 patients treated with IR T/P, target reduction of pain intensity was observed in 79.6%. Pain intensity reduced from 70.3 mm on VAS at baseline to 16.3 mm at endpoint. Improvements in all domains of QoL and pain interference with activities of daily life were noted. Treatment was safe and well tolerated.
Conclusion: IR T/P 37.5 mg/325 mg is effective and safe in relieving moderate to severe aLBP. Good pain control with this combination was accompanied by markedly reduced pain-related interference with activities of daily living and improved QoL.