| Study characteristics |
| Methods |
Study design: single‐centre, randomised, double‐blind, placebo‐controlled
Intention‐to‐treat: yes
Country: USA |
| Participants |
Number randomised: 19 (cilostazol n = 10; placebo n = 9)
Age (mean years): cilostazol = 62; placebo = 65
Sex (% M): cilostazol = 60%; placebo = 67%
Inclusion criteria: aged 45 to 70 years (both sexes); IC which was stable (3 months); ICD ≤ 100 m on a constant load treadmill test with no greater than 20% variation between observations in washout period
Exclusion criteria: lower extremity ischaemic rest pain, severe ulceration or gangrene; female of childbearing potential; decompensated congestive heart failure or MI within six months; cardiac valve disorder or replacement; respiratory insufficiency; vascular surgery, splenectomy, or gastrointestinal surgery within past 12 months; clinically significant abnormal lab value pretreatment; decreased mobility due to joint disorders, or chronic lumbar vertebral column syndrome; malignancy; renal insufficiency; neuropathy; history of analgesic abuse or use of an investigational drug within the past 30 days; diabetes mellitus: either requiring insulin or duration > 5 years; a requirement for the uninterrupted use of pentoxifylline, dipyridamole, certain vasodilators, acetylsalicylic acid, PDE inhibitors or prostacyclin |
| Interventions |
Treatment: cilostazol 100 mg, twice daily, oral route
Control: placebo, twice daily, oral route
Duration: 12 weeks |
| Outcomes |
ACD, ICD, adverse events; measured at baseline and then weeks 4, 8 and 12 |
| Funding |
Otsuka America Pharmaceutical Inc. |
| Declaration of interests |
Not reported ‐ source of the study data was a medical review by the FDA. |
| Notes |
Immediate incline treadmill test where the incline load started immediately at 10% and remained constant with a constant 3.2 km/h.
Three‐week placebo lead‐in period |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Insufficient description of sequence generation methods |
| Allocation concealment (selection bias) |
Unclear risk |
Insufficient description of allocation concealment methods |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Although study used a placebo, there was insufficient description to determine if blinding was adequate. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Blinding of assessors was not adequately discussed. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Accounted for all dropouts |
| Selective reporting (reporting bias) |
Low risk |
Although no study protocol was available, all outcomes appeared to be reported on. |
| Other bias |
Low risk |
No evidence of other bias |
