Clinical efficacy of IV prostaglandin E<sub>1</sub>and IV pentoxifylline in patients with arterial occlusive disease of fontaine stage IIb: A multicenter, randomized comparative study

Hepp, W.; Bary, S. v.; Corovic, D.; Diehm, Curt; Mühe, E; Rudofsky, Gottfried; Scheffler, P; M, Vogelpohl

doi:10.1007/bf02043461

Cited by 13 publications

(1 citation statement)

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“…Studies in patients with intermittent claudication demonstrated promising increases in walking distance and quality of life with alprostadil, a synthetic form of prostanoid prostaglandin E 1 (PGE 1 ), vs. control treatment [1][2][3][4]. The aim of the present prospective, randomised, active-controlled, multicentre, double-blind study (NCT01263925) was to determine, if alprostadil is superior to pentoxifylline, a common treatment for intermittent claudication at the time of the inception of the study.…”

Section: Letter To the Editormentioning

confidence: 98%

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

Schellong

Bilderling²,

Gruss

et al. 2017

Vasa

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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

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Section: Letter To the Editormentioning

confidence: 98%