Article

Epidemiological data, efficacy and safety on a fixed combination of paracetamol (325mg) and tramadol (37.5mg) in the treatment of moderate to severe pain, in general practice (ELZA survey: Efficacite et to lerance de ZAldiar®)

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Abstract

The ELZA study (Efficacite et ToLerance de ZAldiar® [Efficacy and Safety of ZAldiar®]), a large prospective observational study, recruited 5495 patients to assess the efficacy and safety of a fixed combination of paracetamol (325mg) and tramadol (37.5mg) in the treatment of moderate to severe pain. This combination was prescribed as first-line therapy in 37.6% of patients and after treatment failure in the remaining 62.4% patients, mainly after paracetamol or a step 2 analgesic such as dextropropoxyphen. The study confirmed the efficacy of this combination, irrespective of the aetiology of pain or duration of the causal disorder, on pain intensity, pain relief, quality of sleep and patient satisfaction. It was well tolerated in patients aged over 60 years (31.7% of the population), including the subgroup of patients aged 75 years or over. Only 230 (4.2%) of patients in the study reported one or more adverse events; all these adverse events were already known and were anticipated with this combination. The complementary action of its two active ingredients make this combination an effective and well-tolerated therapy for the different types of pain found in general practice.

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... Indications reviewed separately below are osteoarthritis, low back pain, and rheumatoid arthritis. Three studies assessed tramadol/paracetamol for musculoskeletal pain of different origins and are discussed here [85][86][87]. The two latter studies are of particular interest to the family physician because they observed pain management in the clinical practice setting. ...
... The ELZA study assessed efficacy and safety of tramadol/paracetamol in 5495 patients aged over 12 years who presented with moderate-to-severe pain (for more than 3 months in 15.6% of the patients) to general practitioners in France [86]. The most common origin of pain was musculoskeletal (24.9% osteoarthritis, 20.1% low back pain, and 13.9% spinal nerve root compression). ...
... Both studies were described previously; both showed that tramadol/paracetamol was efficacious with a good safety profile for the elderly participants. Older patients (≥75 years old) in the observational ELZA study also showed significantly reduced pain intensity following treatment with the fixeddose combination; 65.1% reported important or complete pain relief [86]. For patients aged over 75 years, the minimum interval between doses should be not less than 6 hours, due to the presence of tramadol [118]. ...
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The family practitioner plays an important role in the prevention, diagnosis, and early management of chronic pain. He/she is generally the first to be consulted, the one most familiar with the patients and their medical history, and is likely the first to be alerted in case of inadequate pain control or safety and tolerability issues. The family practitioner should therefore be at the center of the multidisciplinary team involved in a patient’s pain management. The most frequent indications associated with chronic pain in family practice are of musculoskeletal origin, and the pain is often multimechanistic. Fixed-dose combination analgesics combine compounds with different mechanisms of action; their broader analgesic spectrum and potentially synergistic analgesic efficacy and improved benefit/risk ratio might thus be useful. A pain specialist meeting held in November 2010 agreed that the fixed-dose combination tramadol/paracetamol might be a useful pharmacological option for chronic pain management in family practice. The combination is effective in a variety of pain conditions with generally good tolerability. Particularly in elderly patients, it might be considered as an alternative to conventional analgesics such as NSAIDs, which should be used rarely with caution in this population.
... For French ELZA study to assessed efficacy and safety of tramadol/paracetamol in 5495 patients presented with moderate-to-severe pain. [17] A total of 4.2% of the patients reported adverse events, most commonly gastrointestinal disorders. Similarly, the SALZA French study assessed the clinical benefits of tramadol/paracetamol in 2663 patients aged ≥65 years with moderate-to-severe pain. ...
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Study to evaluate adverse effects mainly Central Nervous System (CNS) and Gastrointestinal (GI) in Pakistani subjects by using Tramadol 37.5mg/Paracetamol 325mg during the pain management in routine practice
... For French ELZA study to assessed efficacy and safety of tramadol/paracetamol in 5495 patients presented with moderate-to-severe pain. [17] A total of 4.2% of the patients reported adverse events, most commonly gastrointestinal disorders. Similarly, the SALZA French study assessed the clinical benefits of tramadol/paracetamol in 2663 patients aged ≥65 years with moderate-to-severe pain. ...
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evaluate adverse effects mainly Central Nervous System (CNS) and Gastrointestinal (GI) in Pakistani subjects by using Tramadol 37.5mg/Paracetamol 325mg combination during the pain management in routine practice.
... On the contrary, the combined mechanisms of action of paracetamol and tramadol are not merely analgesic; they may also provide a "ground-based" approach to FMS, as it is important that we remember that FMS is a "syndrome of symptoms" and not a single symptom or a disease sustained by a single pathogenetic mechanism. In addition, the tolerance of a fixed combination of paracetamol and tramadol is now documented by both published clinical trials and multiyear marketing experience [25,[27][28][29][30]. ...
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