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Online ISSN 1827-1707
Istituto Clinico San Siro, Milan, Italy
Aim. The aim of the study was to determine the tolerability and therapeutic safety of a new formulation of 1% diclofenac foam in patients with mild/moderate musculoskeletal disorders.
Methods. Fifty-six patients of both sexes (29 females, 27 males, mean age 47.8 years) with a diagnosis of musculoskeletal disease basically involving inflammation/pain were included in the study. The patients were treated for 1 week with 1% diclofenac foam twice daily, morning and evening. Endpoint criteria for efficacy, evaluated at baseline and after 1 week, were as follows: passive pain, oedema, impaired joint function, pain on contraction and muscle pain. The following were determined at the end of the treatment: the doctor’s opinion on the efficacy of the treatment; the patient’s opinion on the acceptability/cosmetic validity; and the patient’s preference compared to other topical treatments.
Results. There was an improvement in disappearance of passive pain in 94.4% of cases, oedema in 79.3%, impaired joint function in 75.5%, pain on contraction in 80.8% and muscle pain in 76.9%. Tolerability according to the patients was excellent. The product was described as better than previous topical treatments known to the patient in 55.4% of cases.
The doctor’s opinion on the overall efficacy of the treatment was positive in 94.6% of cases and acceptability according to the patients was positive in 98.2% of cases.
Conclusion. It can be confirmed that 1% diclofenac foam by topical route shows excellent acceptability in mild/moderate clinical conditions, with an excellent risk/benefit ratio.
language: English, Italian