Observational studyClinical drug investigation2023
Real-World Safety and Effectiveness of Controlled-Release Cilostazol in Patients with Symptomatic Peripheral Artery Disease.
Observational study in Clinical drug investigation, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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0 citing papers in PubMed, 1 citations in OpenAlex.
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Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCilostazol is the only first-line medication for treating intermittent claudication, and the controlled-release (CR) formulation is associated with a lower prevalence of adverse events (AEs).
objectiveThe objective of the study was to assess the safety and effectiveness of cilostazol CR in patients with symptomatic peripheral artery disease (PAD).
methodsIn this multicentre (113 sites), open-label, prospective observational study, we evaluated the real-world safety and effectiveness of cilostazol CR 200 mg once daily in patients with symptomatic PAD treated in routine clinical settings. The primary endpoint was the incidence and severity of AEs, and their causal relationship with cilostazol CR. The secondary endpoint was the effectiveness of the drug, as assessed by each patient's physician, for improving intermittent claudication.
resultsAmong 2063 participants who received cilostazol CR for a mean duration of 88.6 days, 99 (4.80 %) experienced adverse drug reactions (ADRs), although no unexpected adverse reactions were observed. There was no significant difference in the incidence of ADRs according to patient demographics and comorbidities (all p > 0.05). The treatment was 'effective' in 1600 patients (78.93 %), although effectiveness significantly differed according to the patients' sex and the presence of comorbidities, including diabetes mellitus, hypertension, and coronary artery disease (all p < 0.01).
conclusionsThis study demonstrated the tolerability and effectiveness of cilostazol CR treatment in patients with symptomatic PAD.
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