Treatment of intermittent claudication with pentoxifylline: a 12-month, randomized trial--walking distance and microcirculation.
The efficacy, safety and cost of pentoxifylline (PXF) in severe intermittent claudication was studied comparing PXF and placebo in a 12-month study. A treadmill test and microcirculatory evaluation with laser Doppler flowmetry were performed at inclusion and at the end of 6 and 12 months. A physical training plan (based on walking) and reduction in risk factor levels plan was used in both groups. Of the 120 included patients, 101 completed the study: 56 in the PXF group and 45 in the placebo group. There were 19 dropouts (due to low compliance). The two groups were comparable for age, sex distribution, walking distance, and the presence of risk factors and smoking. Intention-to-treat analysis indicated a 268% increase in walking distance in the PXF group (vs 198% in the placebo group; p<0.05) at 6 months and an increase of 404% (vs 280% in the placebo group; p<0.02) at 12 months. The absolute and percent increase in pain-free walking distance (PFWD) was greater in the PXF group (p<0.05). Treatment was well tolerated. No serious drug-related side effects were observed. Microcirculatory evaluation indicated an increase in flux (p < 0.05) in the PXF group (not significant in the placebo group); the after-exercise flux (AEF) was increased (p<0.05) in both groups at 6 months but the increase in AEF was greater in the PXF group at 12 month. In conclusion, between-group analysis favors PXF considering walking distance and microcirculatory parameters. Results indicate good efficacy and tolerability.
De Sanctis
M T
MT
Department of Biomedical Sciences, Chieti University and San Valentino Vascular Screening Project, Pe, Italy.
Cesarone
M R
MR
Belcaro
G
G
Nicolaides
A N
AN
Griffin
M
M
Incandela
L
L
Bucci
M
M
Geroulakos
G
G
Ramaswami
G
G
Vasdekis
S
S
Agus
G
G
Bavera
P
P
Ippolito
E
E
D000368:Aged; D001794:Blood Pressure / Q000187:drug effects / Q000502:physiology; D004311:Double-Blind Method; D005080:Exercise Test; D005260:Female; D006801:Humans; D007383:Intermittent Claudication / Q000188:drug therapy* / Q000503:physiopathology; D017078:Laser-Doppler Flowmetry; D008297:Male; D008833:Microcirculation / Q000187:drug effects* / Q000503:physiopathology*; D008875:Middle Aged; D010349:Patient Compliance; D010431:Pentoxifylline / Q000191:economics* / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013997:Time Factors; D014665:Vasodilator Agents / Q000191:economics* / Q000627:therapeutic use*; D016138:Walking / Q000502:physiology*
D014665:Vasodilator Agents; D010431:Pentoxifylline