Recently, new concerns on the safety profile of nonsteroidal anti-inflammatory drugs (
NSAIDs) have been raised by the European Medicines Agency (EMEA) and other regulatory authorities. The safety profile of oral
dexketoprofen trometamol for the treatment of acute mild to moderate
pain of different causes in actual conditions of use in the primary care setting was assessed. A prospective cohort study was designed to evaluate the tolerability of
dexketoprofen compared with other commonly prescribed
analgesics. Medications were given according to specifications in the summary of product characteristics. The intensity of
pain was assessed at baseline and at days 1 and 7 of
drug treatment using a 100-mm visual analog scale (VAS). Adverse events (AEs) were recorded. A total of 7,337 patients (median age [IQR] = 46 [33-61] years) were included in the study comparing
dexketoprofen (n = 5,429),
diclofenac (n = 485),
ibuprofen (n = 479),
paracetamol (n = 459),
metamizole (n = 207),
aceclofenac (n = 103),
naproxen (n = 74),
piroxicam (n = 69) and
dexibuprofen (n = 32). The reasons for use were: musculoskeletal disorders,
headache,
dysmenorrhea and
odontalgia. Treatment compliance was very high.
Metamizole-
paracetamol and
dexketoprofen showed the lowest prevalence of AEs (2.7% and 3.6%, respectively), while
aceclofenac-
diclofenac showed the highest prevalence (8.2%) (P < 0.0001). AEs most frequently observed during
NSAID treatment were those related to the gastrointestinal tract (3.5% of subjects, 84% of all AEs), followed by AEs related to the nervous system (0.4%) and skin (0.1%). Most of the reported AEs (91.3%) were of mild to moderate intensity (303 of 332) and only 3.3% of them were considered severe (11 of 332). Risks for gastrointestinal AEs were adjusted for age, gender, history of previous
NSAID intake, gastroprotective drugs and reason for prescription. Taking
metamizole-
paracetamol as the reference group, the odds ratios (OR, 95%) were: 1.30 (0.77-2.19) for
dexketoprofen, 1.57 (0.79-3.13) for
ibuprofen and
dexibuprofen, 2.31 (0.64-8.27) for
naproxen, 2.63 (0.85-8.15) for
piroxicam and 3.37 (1.87-6.06) for
aceclofenac-
diclofenac. These results confirm the safety of oral treatment with
dexketoprofen in patients with
acute pain of various etiologies observed in previous studies and support the use of
dexketoprofen as a first-line
drug for the approved therapeutic indications.