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Cilostazol Added to Rosuvastatin Significantly Improves Quality of Life in Symptomatic PAD
In a 24-week multicenter randomized controlled trial, patients with symptomatic peripheral artery disease who received cilostazol plus rosuvastatin showed a statistically significant 5.1-point greater improvement in patient-reported health status compared with rosuvastatin alone (95% CI 1.5–8.7; P = 0.005). The combination also produced additional favorable shifts in atherogenic lipid markers, suggesting a meaningful pharmacological benefit beyond statin monotherapy.
What Was Studied
The trial investigated whether adding cilostazol 200 mg to background rosuvastatin therapy would produce clinically meaningful improvements in health-related quality of life, walking performance, and lipid profiles compared with rosuvastatin alone. The primary endpoint was the change in the Korean Peripheral Artery Questionnaire (KPAQ) summary score from baseline to week 24, a validated patient-reported instrument capturing symptom burden and functional status in lower extremity PAD.
How It Was Studied
This was a multicenter, double-blind, randomized placebo-controlled trial conducted across 52 sites in Korea. A total of 260 patients with chronic symptomatic lower extremity PAD classified as Rutherford category 2 or 3 were enrolled and randomly assigned in a 1:1 ratio, with 257 ultimately included in the full analysis set. One group received cilostazol 200 mg combined with rosuvastatin, while the comparator group received a matching placebo combined with rosuvastatin, with both arms followed for 24 weeks. Assessments were conducted at week 12 and week 24 to track the trajectory of treatment response over time.
What Was Observed
- Patient-reported quality of life improved significantly with combination therapy. The KPAQ summary score increased by 15.4 points in the combination group versus 10.3 points in the rosuvastatin monotherapy group — a between-group difference of 5.1 points (95% CI 1.5–8.7; P = 0.005). This effect became statistically significant as early as week 12 and continued to grow through week 24, indicating a sustained and progressive benefit.
- Walking distance improved in both groups but did not differ significantly between arms. Treadmill walking distances increased numerically more in the combination therapy group at both week 12 and week 24; however, these differences did not reach statistical significance, meaning the trial was unable to confirm a definitive advantage in objective walking capacity from the addition of cilostazol.
- Combination therapy conferred additional favorable effects on atherogenic lipid markers. Compared with rosuvastatin alone, the combination produced greater reductions in triglycerides, smaller increases in apolipoprotein B (ApoB), and greater increases in HDL cholesterol — a pattern consistent with a more comprehensive modification of the lipid profile beyond LDL lowering.
- Diarrhea was the only adverse event occurring significantly more often with combination therapy. Although adverse events, adverse drug reactions, and treatment discontinuations due to adverse events were numerically more common in the combination group, no unexpected safety signals emerged, and no other individual adverse event reached statistical significance.
Why This Matters
Symptomatic PAD substantially impairs patient quality of life and functional capacity, yet treatment options targeting these dimensions remain limited. This trial demonstrates that a fixed-dose combination of cilostazol and rosuvastatin can provide statistically and potentially clinically meaningful improvements in patient-reported health status that go beyond what statin monotherapy achieves alone. The additional lipid-modifying effects — particularly on triglycerides, HDL, and ApoB — suggest this combination may offer a broader pharmacological impact on cardiovascular risk factors relevant to this patient population.
How to Read This Result
This well-designed, double-blind, multicenter RCT provides moderately strong evidence for a quality-of-life benefit with the cilostazol–rosuvastatin combination, though the 24-week duration limits conclusions about long-term efficacy and safety, and the absence of a significant between-group difference in objective walking distance tempers the overall interpretation of functional benefit.
Limitations
The abstract does not explicitly report study limitations.