Epidemiological data, efficacy and safety of a paracetamol–tramadol fixed combination in the treatment of moderate-to-severe pain. SALZA: a post-marketing study in general practice

Abstract

Objective:

To evaluate the efficacy and safety of the paracetamol–tramadol combination (PTC) in treating moderate-to-severe pain, in patients aged 65 years and over within general practitioner (GP) practice centers.

Research design and methods:

This was an observational, non-interventional, longitudinal, multicenter, open, non-comparative, prospective study. This intermediary analysis was of patients recruited before the French Health Authority confirmation (25th June, 2009) of the EMEA decision to withdraw all analgesics containing dextropropoxyphen.

Trial registration information: This study has been submitted for approval to the CNIL and French Medical Council (CNOM) only.

Results:

A total of 2663 patients aged 65 years or over were assessed 1 month after inclusion in the study. PTC was prescribed as first-line treatment in 30% of patients and, in the other cases, after failed or inadequate efficacy (69.8%), and/or as a result of safety problems (7.8%) with at least one other analgesic. During the month of the study period 14.7% of patients received an additional rescue analgesic. The study confirmed the efficacy of PTC with regard to pain intensity (−3.1 points reduction of pain scored 6.1 points on inclusion), pain relief (64.8% of patients experienced significant pain relief), patient satisfaction (90.5% of patients satisfied or completely satisfied) and clinical global impression evaluated by the patient (78.7% much or very much improved), regardless of the pain etiologies or duration of the underlying pathology.

PTC was well-tolerated in this patient group, who had a mean age of 73.6 ± 6.6 years. A total of 119 patients (4.5%) reported at least one adverse event (AE). All were known and predictable AEs. This percentage is comparable to that found under similar conditions in patients of all ages (4.2%).

Conclusions:

PTC, due to the complementary action of its two analgesics, is effective in treating the different types of pain in a GP’s practice setting and is well-tolerated, even in an elderly population. Study limitations include all those inherent to non-interventional and open-label observations.

Key words::

• Efficacy
• Elderly patients
• Epidemiology
• General practice
• Pain
• Paracetamol
• tramadol combination
• Safety

Transparency

Declaration of funding

This research for this study was funded by Grünenthal.

Declaration of financial/other relationships

O.M. and A.S. received fees from Grünenthal for study coordination and oral communication respectively. H.G. is an employee of Grünenthal, France. CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

The authors acknowledge the medical writing support and editorial assistance of G.P. Gorniak of Euromed Communications, which was financially supported by Grünenthal.

Oral communication

A. Serrie. Etude descriptive en médecine générale du traitement de la douleur aiguë ou chronique, chez les patients âgés de 65 ans et plus, par l’association fixe de paracétamol (325 mg) – tramadol (37.5 mg). French National Congress of Geriatrics, Grünenthal Symposium, 29th March, 2010, Paris.

Poster

Mejjad O, Serrie A, Ganry H, Draï S. Efficacy and safety of paracetamol (325 mg) – tramadol (37.5 mg) combination (PTC) in patients ≥65 years: a PMS in general practice (SALZA study). IASP, poster session, PW 118, 1st September 2010, Montreal.