M T De Sanctis’s research while affiliated with University of Chieti-Pescara and other places

The efficacy, safety, and cost of pentoxifylline (PXF) in the treatment of severe intermittent claudication were studied comparing PXF and placebo in a randomized 40-week study. A treadmill test was performed at inclusion and at the end of weeks 20 and 40. A progressive training plan and the control of risk factors (with antiplatelet treatment) were used in both groups. Of the 200 included patients, 178 completed the study: 88 in the PXF group and 90 in the placebo group. There were 22 dropouts. The two groups were comparable for age, sex distribution, and for the presence of risk factors and smoking. There was a significant increase in pain-free walking distance (PFWD) in both groups. The absolute and percent increase in PFWD was significantly greater in the PXF group (p<0.05). At 20 weeks, the increase was 360.5% in the PXF vs 252% in the placebo group. At 40 weeks, the increase was 386% in the PXF and 369% in the placebo group (p<0.02). Total walking distance (TWD) increased at 20 weeks (up to 254%) and up to 329% at 40 weeks. In the placebo groups the increase was 158% at 20 weeks and 183% at 40 weeks. The excess increase produced by PXF treatment was 30% at 20 weeks and 38% at 40 weeks (p<0.02). Unwanted effects treatment was well tolerated. No serious drug-related side effects were observed. In summary, between-group analysis favors PXF considering walking distance and costs. Results indicate good efficacy and tolerability.

The aim of this study was to evaluate PXF (pentoxifylline; 1600 mg daily vs placebo) in patients with retinal vein thrombosis (RVT) in a 4-week trial, evaluating clinical outcome and retinal flow. Inclusion criteria were sudden loss of vision (SLV); retinal vein thrombosis (RVT); decrease in retinal vein flow; asymmetry between retinal veins (>40%) documented by duplex scanning (retinal vein thrombosis flow = RVTF). All 18 included patients completed the study. The groups were comparable. No side effect was observed. An improvement in arterial flow (p<0.05) and a decrease in analogue score (p<0.05) were observed in both groups (due to the spontaneous evolution with partial thrombus lysis in 4 weeks). The increase in arterial flow (PSF and EDF) were greater (p<0.05) in the PXF group. The RVFV increase was better in the PXF group (350% increase vs 200% increase in the placebo group; p<0.05). There was a significant difference in the analogue score decrease (4 vs 7) in the PXF group (p<0.05). In conclusion, PXF improved retinal flow after RVT better than placebo. It should be considered as an important treatment option.

The aims of this study were to evaluate the effect of PXF (1600 mg daily) in diabetic patients with intermittent claudication. Of the 60 included patients, 53 completed the study (27 in the PXF group). There were seven dropouts. The groups were comparable for age, sex distribution, and total walking distance (TWD), and risk factors. There was an increase in TWD at 3 and 6 months in both groups (p<0.05) possibly due to exercise. However the increase (both absolute and percentage) in TWD was significantly larger in the PXF group. At 6 months, PXF produced a 292% increase in TWD (vs 180% produced by placebo) (p<0.02). The excess increase produced by PXF treatment was 112% at 6 months in comparison with placebo (p<0.02). Treatment was well tolerated. Between-group analysis favors PXF considering TWD, and results indicate good efficacy and tolerability.

The efficacy of Pentoxifylline in vascular inner ear disease (VIED) was studied comparing PXF and placebo in a 4-week study; 40 patients with vascular disease and monolateral loss of hearing, vertigo, dizziness, tinnitus (analyzed with an analogue scale line), and cochlear flow reduction were included. The aims of the study were to study the effects of PXF (1600 mg daily) in VIED considering clinical outcome and cochlear flow. Of the 20 included patients, 19 completed the study. One dropout in the placebo group was due to low compliance. Intention-to-treat analysis indicated an improvement in cochlear flow (p<0.05) and a decrease in score in both groups. The cochlear flow increase was 287.5% in the PXF group vs 168% in the placebo group (119.5% difference; p<0.02). There was a difference in score decrease (44.1% larger) in the PXF group (p<0.05).Between-group analysis favors PXF considering blood flow and symptoms. Results indicate good efficacy and tolerability of PXF in VIED.

The aim of this study was to evaluate the effect of PXF (1800 mg daily) in patients with sudden loss of vision (SLV) in a 4-week trial, evaluating clinical outcome and retinal flow parameters. Inclusion criteria were SLV associated with thrombosis of the retinal artery; decrease in retinal blood flow (PSF: peak-systolic flow; EDF: end-diastolic flow velocity) and asymmetry between the two retinal arteries (>40%) documented by duplex scanning. All 10 included patients completed the study. The groups were comparable. No side effects were reported. A significant improvement in flow velocity (p<0.05) and a decrease in analogue score in both groups were observed. PSF increase was 550% in the PXF group vs 288% in the placebo group (262% difference). EDF increase was 400% in the PXF group vs 200% in the placebo group (200% difference). There was a significant difference in the analogue score decrease (33.3% difference larger in the PXF group; p<0.05). In conclusion, PXF treatment improved retinal flow after retinal artery occlusion better than placebo and should be considered as an important option in this condition.

The efficacy, safety, and cost of pentoxifylline (PXF) in long-range (>400 m interval) intermittent claudication was studied comparing PXF and placebo in a 12-month study. A standardized treadmill test was performed at inclusion and at 6 and 12 months. A training plan based on walking was associated with the control of risk factor levels. Of the 194 included patients, 135 completed the study: 75 in the PXF group and 60 in the placebo group. There were 59 dropouts (due to low compliance). The authors observed a 148% increase in total walking distance (TWD) at 6 months with PXF (vs 110% with placebo; p<0.05); at 12 months, the increase was 170% with PXF (vs 131% with placebo; p<0.02). There was a 38% difference at 6 months and 39% at 12 months in favor of PXF. Treatment was well tolerated. In conclusion, PXF improved walking distance significantly better than placebo.

The aim of this study was to compare, in a prospective, randomised study, flush ligation/section of the sapheno-femoral junction (SFJ) including collaterals dissection/ligation to simple, distal (3-5 from the SFJ) long saphenous vein (LSV) ligation/section considering, after 10 years, recurrence of reflux, occurrence of new varices, lenght of obstruction after ligation of the LSV and comparing time/costs. Methods: Surgery. Flush ligation/section or distal ligation/section were performed under general (34%) or spinal anesthesia (76%). All patients went home the same day. Endpoints were variations in AVP (ambulatory venous pressure), RT (refilling time), color duplex reflux, number of recurrent or new incompetent venous sites, time, costs, and lenght of the LSV. Results: 400 patients were included in each group; 369 (age 43.3; SD11) completed the study in the flush ligation group and 377 (43.5;12) in the distal ligation group. AVP was 55 mmHg in both groups at inclusion; at 10 years it was comparable (41 in flush vs 40 in distal ligation). RT was 14 sec vs 13 at inclusion (ns); at 10 years 19 vs 18 (normalised in comparison with initial value; ns between groups). At 10 years major incompetent sites were 5 in both, groups; also minor sites were comparable. The occluded venous segment was 6.5 cm in flush vs 1.4 cm in distal ligation (p<0.025). The average number of sclerotherapy sessions per each patient, needed to control varices, was in favour of distal ligation (12; range 3-20, vs 22; 6-32). Operating time in flush ligation was 29 minutes, average cost was 455(SD55)$US. Operating time in distal ligation was 21% shorter; cost was 28% lower. Conclusions: In this study we used a combination of duplex and AVP. Results indicate that distal LSV ligation achieves, on the control and recurrency of varicose veins results comparable to flush ligation. This is obtained in a shorter operating time, with lower cost. As varicose veins surgery is very common, saving operating time, costs and making procedures simpler is an important option.

The efficacy of pentoxifylline (PXF) in severe intermittent claudication was studied comparing PXF and placebo. Patients were randomized into two treatment plans: PXF (2400 mg, four 600-mg tablets daily) or equivalent placebo was administered for 10 days. The exercise protocol associated with treatment was conducted under supervision. Skin flux (RF) was measured at rest and after 1 minute of exercise (AEF = after exercise flux; 3 km/hr, 12% inclination) with laser Doppler. PO2 and PCO2 were measured at the dorsum of the foot. All 20 included patients completed the study. The two groups were comparable. In the PXF group there was a significant increase in RF, AEF, and in PO2 (p<0.05); PCO2 was decreased (p<0.05). There were also changes in the placebo group, significantly lower than those observed in the PXF group (p<0.05). In conclusion high-dose PXF treatments improved all microcirculatory parameters in subjects with short-range claudication even with a short period of treatment.