Analgesic efficacy of flupirtine in primary care of patients with osteoporosis related pain. A multivariate analysis.

OBJECTIVE

Although chronic pain in elderly patients with osteoporosis is extremely common it has rarely been addressed in pharmacotherapy studies. The efficacy and tolerability of flupirtine (CAS 56995-20-1, Trancopal Dolo) up to 600 mg/day was investigated under daily practice conditions.

DESIGN

This was an open-label, multicentre, prospective, observational phase IV study on 869 patients performed in 290 practices (mainly orthopedists) throughout Germany.

MAIN OUTCOME MEASURE: Decrease in pain scores on a visual analogue scale (VAS, from 0 = none to 10 = maximum) after an average 3-week therapy, and evaluation of adverse events. Multivariate analyses were performed to identify factors associated with the efficacy of pain reduction.

RESULTS

81% of patients were female; the mean age of all patients was 67 years, and the mean body mass index was 25.7 kg/m2. 81% of patients had reduced bone density, 30% had a family history of osteoporosis, and 32% had previous bone fractures. The mean daily flupirtine dose was 270 +/- 12 mg. The mean baseline pain VAS scores were 7.1 (low back pain), 5.8 (neck pain), 5.6 (shoulder-arm pain), and 6.6 (other pain). Mean pain reduction at the end of flupirtine treatment was 43% for low back pain, 44% for neck pain, 40% for shoulder-arm pain, and 40% for other pain (all reductions p < 0.05 vs. baseline). Rates of pain reduction at the various sites were closely correlated, and the efficacy of pain reduction was independent of age. The pain reduction was more pronounced in patients with recent onset of pain and with higher pain intensity at entry. Tolerability of treatment was excellent with only 2.4% of patients reporting adverse events and only 12 patients (1.4%) withdrawing from the trial.

CONCLUSION

This trial performed under daily practice conditions in a large unselected sample of patients confirms the efficacy and safety of flupirtine in the treatment of chronic pain in patients with osteoporosis, independent of the age of the patient.