The effect of withdrawal of drugs treating intermittent claudication.
BACKGROUND
Pharmacologic treatment for intermittent claudication is a management option. This study evaluated the effect of withdrawal of drug therapies, cilostazol and pentoxifylline, on the walking ability of peripheral artery disease patients.


METHODS
Single-blind placebo crossover from a randomized, double-blind trial; 45 claudication patients received either cilostazol 100 mg orally twice daily (n = 16), pentoxifylline 400 mg orally three times daily (n = 13), or placebo (n = 16) for 24 weeks. After 24 weeks of double-blind therapy, treatment for all groups was placebo only, and follow-up continued through week 30. Treatment efficacy was established with treadmill testing.


RESULTS
Profile analysis demonstrated a highly significant loss of treatment benefit after crossover (P = 0.001) for cilostazol-treated patients, but no significant change after crossover was observed with pentoxifylline.


CONCLUSIONS
Drug withdrawal worsened the walking of claudicants who had benefited from cilostazol therapy. This decline with crossover to placebo suggests that the initial improvement with cilostazol treatment was due to the drug's action. Withdrawal of pentoxifylline did not adversely affect walking.
Dawson
D L
DL
Department of General Surgery, Wilford Hall Medical Center, Lackland AFB, Texas, USA.
DeMaioribus
C A
CA
Hagino
R T
RT
Light
J T
JT
Bradley
D V
DV
Britt
K E
KE
Charles
B E
BE
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000077407:Cilostazol; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005080:Exercise Test; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007383:Intermittent Claudication / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D010431:Pentoxifylline / Q000008:administration & dosage / Q000627:therapeutic use*; D010919:Placebos; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D016037:Single-Blind Method; D013777:Tetrazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D016138:Walking / Q000502:physiology
D010919:Placebos; D010975:Platelet Aggregation Inhibitors; D013777:Tetrazoles; D014665:Vasodilator Agents; D000077407:Cilostazol; D010431:Pentoxifylline