Effect of cilostazol on treadmill walking, community-based walking ability, and health-related quality of life in patients with intermittent claudication due to peripheral arterial disease: meta-analysis of six randomized controlled trials.
OBJECTIVE
To assess whether cilostazol, a phosphodiesterase III inhibitor, improves treadmill and community-based walking ability and health-related quality of life (HQL) in patients with intermittent claudication resulting from peripheral arterial disease (PAD).


METHODS
Retrospective meta-analysis of data pooled from six Phase 3, multicenter, double-blind, placebo-controlled, parallel-group, randomized studies.


METHODS
Patients were recruited from outpatient ambulatory medical care facilities.


METHODS
Patients' (n = 1,751) mean age +/- standard deviation was 65 +/- 9, and they had a history of PAD for 6 months or longer and an ankle brachial index (ABI) of 0.90 or less.


METHODS
Cilostazol 50 mg bid or 100 mg bid for 12, 16, or 24 weeks.


METHODS
ABI; maximal walking distance (MWD); pain-free walking distance on a graded and constant-load treadmill; and HQL, measured using the Walking Impairment Questionnaire (WIQ) and the Medical Outcomes Study Short Form-36 (SF-36).


RESULTS
Maximal treadmill walking distance improved more in both cilostazol groups than in the placebo group (both P <.0001). WIQ and SF-36 physical summary scores improved significantly more with cilostazol than with placebo (for instance, WIQ distance score, P <.0001 and SF-36 physical summary score, P <.0001, comparing persons taking cilostazol with controls). Improved MWD correlated with improvements in WIQ (correlation with distance score, r = 0.34, P <.0001) and SF-36 physical summary scores (r = 0.29, P <.0001).


CONCLUSIONS
Treatment with cilostazol was associated with greater improvements in community-based walking ability and HQL in patients with intermittent claudication than treatment with placebo. These improvements correlated with increased MWD. This analysis of effects of cilostazol on improving walking ability in persons with claudication is the first cilostazol study focused on community-based measures of functional status and HQL. Questionnaires assessing walking ability and HQL provide important patient-based information about clinical outcomes of claudication therapy.
Regensteiner
Judith G
JG
Department of Medicine, Division of Internal Medicine and Cardiology, The University of Colorado Health Sciences Center, Denver 80262, USA. judy.regensteiner@uchsc.edu
Ware
John E
JE
McCarthy
Walter J
WJ
Zhang
Peter
P
Forbes
William P
WP
Heckman
Jeffrey
J
Hiatt
William R
WR
D000368:Aged; D000077407:Cilostazol; D005080:Exercise Test; D006801:Humans; D007383:Intermittent Claudication / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology*; D020765:Intracranial Arterial Diseases; D008297:Male; D015337:Multicenter Studies as Topic; D016491:Peripheral Vascular Diseases / Q000150:complications*; D010726:Phosphodiesterase Inhibitors / Q000627:therapeutic use*; D011102:Polyhydroxyethyl Methacrylate / Q000031:analogs & derivatives*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D013777:Tetrazoles / Q000627:therapeutic use*; D016138:Walking / Q000502:physiology*
D010726:Phosphodiesterase Inhibitors; D013777:Tetrazoles; C020689:methoxypolyethylene glycol 400 methacrylate; D011102:Polyhydroxyethyl Methacrylate; D000077407:Cilostazol