PMID- 37653223
OWN - NLM
STAT- MEDLINE
DCOM- 20230925
LR  - 20230925
IS  - 1179-1918 (Electronic)
IS  - 1173-2563 (Linking)
VI  - 43
IP  - 9
DP  - 2023 Sep
TI  - Real-World Safety and Effectiveness of Controlled-Release Cilostazol in Patients 
      with Symptomatic Peripheral Artery Disease.
PG  - 729-738
LID - 10.1007/s40261-023-01302-6 [doi]
AB  - BACKGROUND: Cilostazol 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). OBJECTIVE: The 
      objective of the study was to assess the safety and effectiveness of cilostazol 
      CR in patients with symptomatic peripheral artery disease (PAD). METHODS: In 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. RESULTS: Among 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). CONCLUSIONS: This study 
      demonstrated the tolerability and effectiveness of cilostazol CR treatment in 
      patients with symptomatic PAD.
CI  - (c) 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
FAU - Shin, Woo-Young
AU  - Shin WY
AUID- ORCID: 0000-0002-9495-7182
AD  - Department of Family Medicine, Chung-Ang University College of Medicine, 
      Heukseok-ro 102, Dongjak-gu, Seoul, 06973, Republic of Korea.
FAU - Lee, Hye Jun
AU  - Lee HJ
AUID- ORCID: 0000-0001-5810-9787
AD  - Department of Family Medicine, Chung-Ang University College of Medicine, 
      Heukseok-ro 102, Dongjak-gu, Seoul, 06973, Republic of Korea.
FAU - Kim, Jung-Ha
AU  - Kim JH
AUID- ORCID: 0000-0002-7630-9501
AD  - Department of Family Medicine, Chung-Ang University College of Medicine, 
      Heukseok-ro 102, Dongjak-gu, Seoul, 06973, Republic of Korea. 
      girlpower219@cau.ac.kr.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20230831
PL  - New Zealand
TA  - Clin Drug Investig
JT  - Clinical drug investigation
JID - 9504817
RN  - N7Z035406B (Cilostazol)
RN  - 0 (Delayed-Action Preparations)
SB  - IM
MH  - Humans
MH  - Cilostazol/adverse effects
MH  - Intermittent Claudication/drug therapy
MH  - Delayed-Action Preparations/adverse effects
MH  - *Peripheral Arterial Disease/drug therapy/epidemiology
MH  - *Coronary Artery Disease
MH  - *Drug-Related Side Effects and Adverse Reactions
EDAT- 2023/09/01 00:41
MHDA- 2023/09/25 06:42
CRDT- 2023/08/31 23:37
PHST- 2023/08/16 00:00 [accepted]
PHST- 2023/09/25 06:42 [medline]
PHST- 2023/09/01 00:41 [pubmed]
PHST- 2023/08/31 23:37 [entrez]
AID - 10.1007/s40261-023-01302-6 [pii]
AID - 10.1007/s40261-023-01302-6 [doi]
PST - ppublish
SO  - Clin Drug Investig. 2023 Sep;43(9):729-738. doi: 10.1007/s40261-023-01302-6. Epub 
      2023 Aug 31.