Naslov
Skuteczność i bezpieczeństwo stosowania połączenia chlorowodorku tramadolu z paracetamolem u pacjentów z ostrym bólem dolnego odcinka kręgosłupa o nasileniu od umiarkowanego do dużego – badanie kliniczne TREASURE
(35. Efficacy and safety of tramadol hydrochloride /paracetamol in patients with moderate to severe acute low-back pain – TREASURE clinical study)

Autori
Malec-Milewska, M ; Grazio, Simeon ; Požlep, G ; Karen, I

Izvornik
Terapia (1230-3917) 3 (2020); 3-10

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
ból dolnego odcinka kr´gos∏upa ; tramadol ; paracetamol ; skutecznoÊç ; jakoÊç ˝ycia ; bezpieczeƒstwo
(low back pain ; tramadol ; paracetamol ; efficacy ; quality of life ; pain interference ; safety)

Sažetak
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 randomized, open-label, prospective, twoarm study in adults with moderate to severe aLBP [≥ 40 mm on Visual Analogue Scale (VAS)]. Patients were treated with 4-times daily IR T/P (Doreta®), 37.5 mg/325 mg or 2-times daily SR T/P (Doreta SR®) 75 mg/650 mg for up to 4 weeks. During treatment period, patients were allowed to take naproxen sodium 550 mg filmcoated tablets (Nalgesin® forte) max. twice daily as a rescue medication (in case sufficient pain relief was not achieved with 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: Results presented are limited to 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.

Izvorni jezik
Ostalo

Znanstvena područja
Kliničke medicinske znanosti, Biotehnologija u biomedicini (prirodno područje, biomedicina i zdravstvo, biotehničko područje)

POVEZANOST RADA