Intravenous alprostadil treatment compared to oral pentoxifylline treatment in outpatients with intermittent claudication – results of a randomised clinical trial

Abstract

8UCB Pharma, Brussels, Belgium old of 1.05 for the change from baseline to the end of period 2 (ratio 0.97) and the null-hypothesis could not be rejected ( Figure 1). Maximum walking distance (MWD) also increased progressively from baseline to the end of the follow-up period (ESM 2). Quality of life improved in both groups, in particular in terms of pain and functional status; changes were comparable between treatments. Both drugs were well-tolerated, with very few drug-related adverse events reported. Treatment emergent adverse events occurred in 35.5 % of patients receiving alprostadil and 33.7 % of those receiving pentoxifylline.While alprostadil is known to be eff ective for the treatment of critical limb ischaemia, its effi cacy as a therapy for patients with intermittent claudication has not been previously clarifi ed. We found that the drug increased PFWD and MWD; the ratio between the end of period 1 and baseline was slightly higher for alprostadil than for pentoxifylline, with the ratio of the two treatments being above the predefi ned threshold of 1.05. However, the value did not pass the pre-defi ned threshold when comparing the ratios between baseline and the end of period 2 meaning overall, alprostadil was not statistically superior to pentoxifylline. Study limitations include: the use of an active control (as mandated by the regulatory authorities), meant we were unable to assess the contribution of the patients receiving regular feedback regarding their walking distances. It is possible that this monitoring, as well as the knowledge

Sildenafil corrects the increased contractility of rat detrusor muscle induced by alprostadil in vitro

“…However, it has not been approved by the Food and Drug Administration until 1995 when it has been marketed under the brand name Caverject® as intracavernous injection. A year later, it was approved for usage by intraurethral route under the brand name Muse® [16] Alprostadil is also used with success in the management of patent Ductus Arteriosus, intermittent claudication, Buerger's disease and Raynaud's phenomenon [19][20][21][22]. PGE 1 is reported to provoke strong micturition reflexes in dogs and in rabbits [23,24], and induces contraction of human detrusor muscles [25].…”