Objective : To evaluate the effect of beraprost sodium (beraprost) on the vascular events occurring in patients with peripheral arterial disease (PAD) in a meta-analysis of placebo-controlled, randomized trials.
Design : Meta-analysis
Methods : Among the clinical trials of beraprost in patients with intermittent claudication associated with PAD, placebo-controlled, randomized trials with vascular events as outcome measures were selected. Two trials met the criteria, each of which was a comparative trial of beraprost (40 μg t.i.d.) and placebo (t.i.d.), with a six-month follow-up period.
Results : With both trials combined, the analysis included 594 patients in the beraprost group and 590 in the placebo group. The risk ratio was 0.608 (95%CI : 0.41 to 0.90, p =0.012), demonstrating the efficacy of beraprost on all vascular events. The risk ratio for lower limb deterioration was 0.598 (95% CI : 0.34 to 1.06, p =0.079), which was similar to that for all vascular events. A statistically insignificant but similar result was also obtained for cardio/cerebrovascular events with a risk ratio of 0.619 (95%CI : 0.36 to 1.07, p = 0.085). Heterogeneity between the two studies was not found for any of the events.
Conclusion : The results demonstrated the efficacy of beraprost on the vascular events in patients with PAD. The potential benefit of beraprost on vascular events will require evaluation in a larger prospective investigation.

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The Anatomical Therapeutic Chemical (ATC) classification system and the Defined Daily Dose (DDD) as a measuring unit was developed along with an increased concern about drug utilization studies in Europe in the 1960s. Its use was recommended by the WHO Regional Office of Europe on 1981, then by the WHO Headquarters in Geneva in 1996. It is maintained by the WHO Collaborating Centre on Drug Statistics Methodology in Olso (http://www.whocc.no/) and widely used in Europe. However, it is rarely used in other parts of the world. This paper aims to inform the Japanese public about the ATC/ DDD system towards a more rational use of drugs in Japan. It attempts to answer the five Ws on ATC/ DDD, i.e., “What is ATC/DDD?”; “Why is ATC/DDD used?”; “When was ATC/DDD established?”; “Who decide ATC/DDD and how?”; and “Where is ATC/DDD used?”

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