OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of ibuprofen arginate in the treatment of patients with primary dysmenorrhoea in normal clinical practice. STUDY DESIGN: In this open trial, patients received an initial oral dose of ibuprofen arginine 600mg at the onset of pain, followed by the same dose every 6 hours, if necessary, with a maximum daily dose of 2400mg. The study assessed the evolution of pain intensity, rapidity of action, need for supplementary analgesics, decrease in working or school hours lost, and safety and tolerability of ibuprofen arginine treatment. Each patient was evaluated prior to inclusion in the study and after one and three cycles. RESULTS: From the 1093 recruited patients, 854 women were evaluable for safety and tolerability, and 838 for efficacy. Significant improvement in pain relief was observed 15 minutes after treatment compared with baseline values (p < 0.001). At 15 and 30 minutes the percentage of patients reporting a marked decrease in pain intensity was 82.2% and 97.6%, respectively. Additionally, a significant reduction in absenteeism from work or school (from a mean of 4.6-0.8 hours per cycle) was observed (p < 0.001). Thirty-eight patients presented with adverse events in the trial period, but only 26 subjects (3% of 854) in the adverse events cohort reported having a possible adverse event, with gastrointestinal complaints being the most frequent. CONCLUSION: Ibuprofen arginine appears to be effective, fast, safe and well tolerated in the treatment of patients with primary dysmenorrhoea.
OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of ibuprofen arginate in the treatment of patients with primary dysmenorrhoea in normal clinical practice. STUDY DESIGN: In this open trial, patients received an initial oral dose of ibuprofen arginine 600mg at the onset of pain, followed by the same dose every 6 hours, if necessary, with a maximum daily dose of 2400mg. The study assessed the evolution of pain intensity, rapidity of action, need for supplementary analgesics, decrease in working or school hours lost, and safety and tolerability of ibuprofen arginine treatment. Each patient was evaluated prior to inclusion in the study and after one and three cycles. RESULTS: From the 1093 recruited patients, 854 women were evaluable for safety and tolerability, and 838 for efficacy. Significant improvement in pain relief was observed 15 minutes after treatment compared with baseline values (p < 0.001). At 15 and 30 minutes the percentage of patients reporting a marked decrease in pain intensity was 82.2% and 97.6%, respectively. Additionally, a significant reduction in absenteeism from work or school (from a mean of 4.6-0.8 hours per cycle) was observed (p < 0.001). Thirty-eight patients presented with adverse events in the trial period, but only 26 subjects (3% of 854) in the adverse events cohort reported having a possible adverse event, with gastrointestinal complaints being the most frequent. CONCLUSION:Ibuprofen arginine appears to be effective, fast, safe and well tolerated in the treatment of patients with primary dysmenorrhoea.
Authors: Paul Desjardins; Peter Black; Maria Papageorge; Tom Norwood; Danny D Shen; Lonnie Norris; Alfredo Ardia Journal: Eur J Clin Pharmacol Date: 2002-08-02 Impact factor: 2.953