Reply

Abstract

We conducted a multicenter retrospective study to evaluate the economic effectiveness of cilostazol (the purchase price of 200 mg cilostazol in the United States is $4.0-$5.2 US dollars) in patients with critical limb ischemia (CLI), with the understanding that this study had many limitations. The efficacy of cilostazol was retrospectively evaluated in 618 patients who had developed CLI for the first time.1Soga Y. Iida O. Hirano K. Suzuki K. Kawasaki D. Miyashita Y. et al.Impact of cilostazol after endovascular treatment for infrainguinal disease in patients with critical limb ischemia.J Vasc Surg. 2011; 54: 1659-1667Abstract Full Text Full Text PDF PubMed Scopus (37) Google Scholar No significant difference in overall survival was found, but major amputation was significantly decreased in the cilostazol-treated group. To evaluate the economic effectiveness of cilostazol, it was assumed that administration of cilostazol did not change the mortality and provided a 50% risk reduction in the rate of major amputation of 20% in 5 years. If 500 of 1000 patients with CLI treated with endovascular therapy are treated with aspirin and cilostazol and the other 500 with aspirin alone, major amputation will be required in 100 patients in the aspirin group and 50 in the aspirin+cilostazol group over 5 years; therefore, the number needed to treat value is 10 (50 of 500). The drug price of cilostazol at 200 mg per person is 379 yen/day ($4.7 US dollars/day; $1 = ¥80), 138,335 yen/year ($1729 US dollars/year), and 691,675 yen/5 years ($8646 US dollars/5 years). Assuming no deaths, it takes 350 million yen ($4.3 million US dollars) to treat 500 patients with cilostazol for 5 years. Therefore, it is estimated that it takes approximately 7 million yen ($90,000 US dollars) to prevent major amputation in a patient with CLI. However, the mortality is actually around 11% per year, which gives an estimate of 4 to 5 million yen (%50,000-$62,500 US dollars) to prevent major amputation in a patient with CLI. The mean total hospitalization cost was 3.41 million yen ($43,000 US dollars) and the additional hospitalization cost due to major amputation was 730,000 yen ($9100 US dollars) in 40 patients who were randomly extracted from this study. In patients who did not undergo major amputation, a hospitalization cost of 390,000 yen ($4900 US dollars) was added due to minor amputation and wound treatment. The hospitalization cost in patients with major amputation was 340,000 yen ($4250 US dollars) higher (Δ cost) than that in patients without major amputation. Although the costs were not the same in all patients, these results suggest that cilostazol decreased the hospitalization cost when administered to patients with CLI. The health care costs at other hospitals and the expense of hospital visits were not included and these costs should also be considered. The costs estimated in this study are only an approximation. The economic validity of administration of cilostazol to patients with CLI requires evaluation by specialists. This evaluation should also consider the major decrease in quality of life after major amputation, the decreased productivity associated with major amputation, newly required nursing care costs, and economic and time burdens on the patient's family. However, we believe that cilostazol has been sufficiently evaluated and should be used in patients in whom the drug is expected to be particularly effective for major event reduction (age ≤75 years old, ambulatory, not receiving dialysis, Rutherford class V), as suggested in Fig 6 of our original article.1Soga Y. Iida O. Hirano K. Suzuki K. Kawasaki D. Miyashita Y. et al.Impact of cilostazol after endovascular treatment for infrainguinal disease in patients with critical limb ischemia.J Vasc Surg. 2011; 54: 1659-1667Abstract Full Text Full Text PDF PubMed Scopus (37) Google Scholar Regarding “Impact of cilostazol after endovascular treatment for infrainguinal disease in patients with critical limb ischemia”Journal of Vascular SurgeryVol. 55Issue 3PreviewWe were delighted to read the recent publication of the work by Soga et al1 regarding the use of cilostazol in patients with critical limb ischemia (CLI). To our knowledge, this is the first and extremely valuable multicenter, retrospective analysis study that investigates the effects of cilostazol in this cohort of patients. Full-Text PDF Open Archive