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. 2021 Jun 30;2021(6):CD003748. doi: 10.1002/14651858.CD003748.pub5

Comparison 1. Cilostazol versus placebo.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
1.1 Initial claudication distance (ICD) 6 1722 Mean Difference (IV, Fixed, 95% CI) 26.49 [18.93, 34.05]
1.1.1 Cilostazol 50 mg twice daily 2 400 Mean Difference (IV, Fixed, 95% CI) 19.50 [6.80, 32.21]
1.1.2 Cilostazol 100 mg twice daily 6 1236 Mean Difference (IV, Fixed, 95% CI) 32.19 [22.20, 42.18]
1.1.3 Cilostazol 150 mg twice daily 1 86 Mean Difference (IV, Fixed, 95% CI) 15.70 [‐12.20, 43.60]
1.2 Absolute claudication distance (ACD) 8 2360 Mean Difference (IV, Random, 95% CI) 39.57 [21.80, 57.33]
1.2.1 Cilostazol 50 mg twice daily 2 400 Mean Difference (IV, Random, 95% CI) 30.84 [8.81, 52.86]
1.2.2 Cilostazol 100 mg twice daily 8 1874 Mean Difference (IV, Random, 95% CI) 42.32 [18.12, 66.51]
1.2.3 Cilostazol 150 mg twice daily 1 86 Mean Difference (IV, Random, 95% CI) 51.80 [‐10.59, 114.19]
1.3 Arterial revascularisation 1 516 Odds Ratio (M‐H, Fixed, 95% CI) 0.16 [0.01, 4.07]
1.3.1 Cilostazol 50 mg twice daily 1 256 Odds Ratio (M‐H, Fixed, 95% CI) 0.16 [0.01, 4.07]
1.3.2 Cilostazol 100 mg twice daily 1 260 Odds Ratio (M‐H, Fixed, 95% CI) Not estimable
1.4 Amputation 1 516 Odds Ratio (M‐H, Fixed, 95% CI) 0.16 [0.01, 4.07]
1.4.1 Cilostazol 50 mg twice daily 1 256 Odds Ratio (M‐H, Fixed, 95% CI) 0.16 [0.01, 4.07]
1.4.2 Cilostazol 100 mg twice daily 1 260 Odds Ratio (M‐H, Fixed, 95% CI) Not estimable
1.5 Adverse event related to study medication ‐ headache 8 2584 Odds Ratio (M‐H, Fixed, 95% CI) 2.83 [2.26, 3.55]
1.5.1 Cilostazol 50 mg twice daily 2 453 Odds Ratio (M‐H, Fixed, 95% CI) 2.02 [1.19, 3.43]
1.5.2 Cilostazol 100 mg twice daily 8 2131 Odds Ratio (M‐H, Fixed, 95% CI) 3.05 [2.38, 3.92]
1.6 Adverse event related to study medication ‐ diarrhoea 7 2503 Odds Ratio (M‐H, Fixed, 95% CI) 2.73 [2.02, 3.70]
1.6.1 Cilostazol 50 mg twice daily 2 453 Odds Ratio (M‐H, Fixed, 95% CI) 2.02 [0.91, 4.52]
1.6.2 Cilostazol 100 mg twice daily 7 2050 Odds Ratio (M‐H, Fixed, 95% CI) 2.88 [2.07, 3.99]
1.7 Adverse event related to study medication ‐ abnormal stools 5 1804 Odds Ratio (M‐H, Fixed, 95% CI) 3.63 [2.45, 5.38]
1.7.1 Cilostazol 50 mg twice daily 2 453 Odds Ratio (M‐H, Fixed, 95% CI) 2.48 [1.08, 5.71]
1.7.2 Cilostazol 100 mg twice daily 5 1351 Odds Ratio (M‐H, Fixed, 95% CI) 4.04 [2.59, 6.31]
1.8 Adverse event related to study medication ‐ dizziness 4 1120 Odds Ratio (M‐H, Fixed, 95% CI) 2.42 [1.43, 4.08]
1.8.1 Cilostazol 50 mg twice daily 1 256 Odds Ratio (M‐H, Fixed, 95% CI) 1.95 [0.63, 6.06]
1.8.2 Cilostazol 100 mg twice daily 4 864 Odds Ratio (M‐H, Fixed, 95% CI) 2.57 [1.42, 4.63]
1.9 Adverse event related to study medication ‐ pain 4 1572 Odds Ratio (M‐H, Fixed, 95% CI) 0.96 [0.71, 1.30]
1.9.1 Cilostazol 50 mg twice daily 1 197 Odds Ratio (M‐H, Fixed, 95% CI) 1.53 [0.67, 3.48]
1.9.2 Cilostazol 100 mg twice daily 4 1375 Odds Ratio (M‐H, Fixed, 95% CI) 0.88 [0.64, 1.23]
1.10 Adverse event related to study medication ‐ palpitations 4 1681 Odds Ratio (M‐H, Fixed, 95% CI) 7.16 [3.95, 12.98]
1.10.1 Cilostazol 50 mg twice daily 1 256 Odds Ratio (M‐H, Fixed, 95% CI) 8.89 [0.51, 155.87]
1.10.2 Cilostazol 100 mg twice daily 4 1425 Odds Ratio (M‐H, Fixed, 95% CI) 7.06 [3.85, 12.96]
1.11 Cardiovascular event 2 692 Odds Ratio (M‐H, Fixed, 95% CI) 1.50 [0.51, 4.47]
1.11.1 Cilostazol 50 mg twice daily 1 256 Odds Ratio (M‐H, Fixed, 95% CI) 1.51 [0.30, 7.64]
1.11.2 Cilostazol 100 mg twice daily 2 436 Odds Ratio (M‐H, Fixed, 95% CI) 1.50 [0.35, 6.52]
1.12 All‐cause mortality 8 2642 Odds Ratio (M‐H, Fixed, 95% CI) 0.97 [0.41, 2.30]
1.12.1 Cilostazol 50 mg twice daily 2 453 Odds Ratio (M‐H, Fixed, 95% CI) 0.49 [0.03, 8.00]
1.12.2 Cilostazol 100 mg twice daily 8 2189 Odds Ratio (M‐H, Fixed, 95% CI) 1.04 [0.42, 2.59]
1.13 Ankle brachial index (ABI) 3 859 Mean Difference (IV, Random, 95% CI) 0.06 [0.04, 0.08]
1.13.1 Cilostazol 100 mg twice daily 3 859 Mean Difference (IV, Random, 95% CI) 0.06 [0.04, 0.08]
1.14 Initial claudication distance (ICD) sensitivity analysis 5 1543 Mean Difference (IV, Fixed, 95% CI) 29.52 [21.26, 37.78]
1.14.1 Cilostazol 50 mg twice daily 2 400 Mean Difference (IV, Fixed, 95% CI) 19.50 [6.80, 32.21]
1.14.2 Cilostazol 100 mg twice daily 5 1143 Mean Difference (IV, Fixed, 95% CI) 36.86 [25.98, 47.74]
1.15 Absolute claudication distance (ACD) sensitivity analysis 6 1732 Mean Difference (IV, Random, 95% CI) 48.44 [34.49, 62.39]
1.15.1 Cilostazol 50 mg twice daily 2 400 Mean Difference (IV, Random, 95% CI) 30.84 [8.81, 52.86]
1.15.2 Cilostazol 100 mg twice daily 6 1332 Mean Difference (IV, Random, 95% CI) 56.30 [40.37, 72.23]
1.16 Adverse event related to study medication ‐ headache, sensitivity analysis 7 2061 Odds Ratio (M‐H, Fixed, 95% CI) 2.83 [2.21, 3.61]
1.16.1 Cilostazol 50 mg twice daily 2 453 Odds Ratio (M‐H, Fixed, 95% CI) 2.02 [1.19, 3.43]
1.16.2 Cilostazol 100 mg twice daily 7 1608 Odds Ratio (M‐H, Fixed, 95% CI) 3.10 [2.35, 4.09]
1.17 Adverse event related to study medication ‐ diarrhoea, sensitivity analysis 6 1980 Odds Ratio (M‐H, Fixed, 95% CI) 2.91 [2.05, 4.12]
1.17.1 Cilostazol 50 mg twice daily 2 453 Odds Ratio (M‐H, Fixed, 95% CI) 2.02 [0.91, 4.52]
1.17.2 Cilostazol 100 mg twice daily 6 1527 Odds Ratio (M‐H, Fixed, 95% CI) 3.16 [2.15, 4.67]
1.18 Adverse event related to study medication ‐ pain, sensitivity analysis 3 1049 Odds Ratio (M‐H, Fixed, 95% CI) 1.07 [0.75, 1.54]
1.18.1 Cilostazol 50 mg twice daily 1 197 Odds Ratio (M‐H, Fixed, 95% CI) 1.53 [0.67, 3.48]
1.18.2 Cilostazol 100 mg twice daily 3 852 Odds Ratio (M‐H, Fixed, 95% CI) 0.98 [0.66, 1.47]
1.19 Adverse event related to study medication ‐ palpitations, sensitivity analysis 3 1158 Odds Ratio (M‐H, Fixed, 95% CI) 12.80 [5.06, 32.36]
1.19.1 Cilostazol 50 mg twice daily 1 256 Odds Ratio (M‐H, Fixed, 95% CI) 8.89 [0.51, 155.87]
1.19.2 Cilostazol 100 mg twice daily 3 902 Odds Ratio (M‐H, Fixed, 95% CI) 13.42 [5.05, 35.68]
1.20 All‐cause mortality sensitivity analysis 7 2119 Odds Ratio (M‐H, Fixed, 95% CI) 1.21 [0.47, 3.13]
1.20.1 Cilostazol 50 mg twice daily 2 453 Odds Ratio (M‐H, Fixed, 95% CI) 0.49 [0.03, 8.00]
1.20.2 Cilostazol 100 mg twice daily 7 1666 Odds Ratio (M‐H, Fixed, 95% CI) 1.36 [0.49, 3.75]