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DN Naftidrofurylq7 PD 3-Col Drug notes Naftidrofuryl 1 Vasodilatation Inhibit atherothrombosis Ruwan Parakramawansha MD, MRCP(UK), Specialty Trainee in Clinical Pharmacology and Therapeutics ICAM-1 Miles Fisher1 5-HTR ↑ NO MD, FRCP, Consultant Physician Gerry McKay1 NFT 5-HTR x BSc (Hons), FRCP, Consultant Physician Platelet x NFT 1 Endothelin-1 aggregation Glasgow Royal Infirmary, Glasgow, UK ↑ NO TNF-α x Correspondence to: 5-HT Professor Gerry McKay, Wards 3, 4 & 5, NFT 5-HT Glasgow Royal Infirmary, Glasgow G4 0SF, UK; email: [email protected] NOTES. Naftidrofuryl (NFT) is a selective inhibitor of serotonin 5-HT2 receptors (5-HTR) blocking the vasoconstrictive effect of 5-HT released from endothelial cells and platelets in response to hypoxia and atherogenesis, and inhibits serotonin mediated platelet aggregation. It promotes vasodilatation by antagonising endogenous vasoconstrictor cytokine endothelin-1, increasing nitric oxide (NO) levels, a potent vasodilator and an inhibitor of platelet aggregation and platelet induced vasospasm. Nitric oxide inhibits intercellular adhesion molecule-1 (ICAM-1) up regulation in endothelial cells upon stimulation by TNF-α, the latter being important for leucocyte recruitment in the atherosclerotic process. Figure 1. The pharmacological action of naftidrofuryl Introduction pharmacologically active as an Peripheral arterial disease (PAD), oxalate salt. The precise mechanism whether symptomatic or not, is preva- is complex and not fully understood. lent in about 12% of adults in the It appears to exert its effect in a Western world.1 Medical treatment is number of different ways. It inhibits aimed at reducing cardiovascular mediators promoting atherothrom- morbidity and mortality, symptomatic bosis and improves oxygen supply to relief and improving quality of life. leg muscles. PAD develops as a consequence of Naftidrofuryl is a selective inhibitor atherosclerosis with superimposed of serotonin 5-HT2 receptors blocking thrombosis. The pain in intermittent the vasoconstrictive effect of 5-HT claudication results from inadequate released from endothelial cells and oxygenation of lower limb muscles platelets in response to hypoxia and due to impaired blood supply. atherogenesis, and inhibits serotonin Naftidrofuryl is a vasodilator that has mediated platelet aggregation. It been used in the symptomatic treat- appears to promote vasodilatation by ment of intermittent claudication in antagonising endogenous vasocon- Europe for more than 30 years. strictor cytokine endothelin-1. It has During recent years it has regained been shown to increase nitric oxide prominence with the emergence of levels, a potent vasodilator and an more evidence of its clinical effective- inhibitor of platelet aggregation and ness, resulting in it being recom- platelet induced vasospasm, in the mended for use in PAD in the UK by endothelial milieu. Additionally, nitric NICE and the Scottish Intercollegiate oxide inhibits intercellular adhesion Guidelines Network. molecule-1 (ICAM-1) up regulation in endothelial cells upon stimulation by Pharmacology TNF-α, the latter being important for Figure 1 outlines the pharmacologi- leucocyte recruitment in the athero- cal action of naftidrofuryl which is sclerotic process. PRACTICAL DIABETES VOL. 31 NO. 3 COPYRIGHT © 2014 JOHN WILEY & SONS 129 Drug notes Naftidrofuryl Finally, naftidrofuryl also appears where WDf and WD0 are designated to improve aerobic metabolism in the as final and baseline PFWD values, Key points blood vessel wall and has been shown respectively). The treatment effect ● Naftidrofuryl oxalate is a vasodilator to increase flexibility and reduce was measured by the ratio RInaftidrofuryl that exerts its effects mainly via aggregability of erythrocytes enhanc- /RIplacebo. A further clinical primary ing blood flow to the tissues. endpoint assessed in the systematic selective inhibition of 5-HT2 receptors review was the responder analysis. A on vascular endothelium and platelets Trials of safety and efficacy patient was considered as a respon- ● It is found to be efficacious in improving Efficacy der to therapy when the PFWD PFWD, MWD and HR-QOL when used Several small (n<50) to medium-scale improved by at least 50% from for six months or more in the treatment of intermittent claudication due to (n=100–200) randomised placebo- baseline. The ratio of RInaftidrofuryl/ peripheral vascular disease controlled trials of naftidrofuryl have RIplacebo MWD is measured as a been carried out from 1978–2001 secondary outcome. The ratio of ● There was no difference in therapeutic in patients with PAD. Among the the relative improvement in PFWD efficacy of naftidrofuryl between trials that were conforming with the (naftidrofuryl compared with patients with type 2 diabetes and those current European guidelines on clin- placebo) was 1.37 (95% CI 1.27–1.49; without ical trial methodology in PAD is the p<0.001). The corresponding figure Naftidrofuryl Clinical Ischemia Study for the ratio of relative improvement patient data meta-analysis included (NCIS).2 This was a randomised, in MWD was 1.40 (95% CI 13.4% patients with type 2 diabetes. double-blinded, parallel-group and 1.19–1.63). The responder analysis placebo-controlled clinical trial car- for PFWD identified 30.2% and Discussion ried out in 196 patients recruited 54.7% responders for placebo Peripheral vascular disease is a com- from five hospitals in Paris but who and naftidrofuryl, respectively. The mon condition with evidence that were assessed in a single centre. The absolute difference in responder rate treatment may help symptoms, and patients were men and women aged was 22.3%(95% CI 17.1–27.6). The this is reflected in studies comparing 35–85 years who were at Fontaine number needed to treat was 4.48 it with placebo in improving health Stage II PAD for at least six months. (95% CI 3.62–5.85). related quality of life (HR-QOL). The primary endpoints were the There are no head-to-head com- change from baseline in pain-free Safety parisons between naftidrofuryl and walking distance (PFWD) and maxi- In the NCIS trial there were no dif- other vasodilator medicines. However, mum walking distance (MWD) meas- ferences between the naftidrofuryl or a meta-analysis conducted by NICE ured on a treadmill. Ankle brachial placebo groups in terms of number revealed that naftidrofuryl and cilosta- index (ABI) was measured as a of serious or non-serious adverse zol are the only vasoactive medicines secondary outcome. Patients were events. In the Cochrane systematic having clinically significant efficacy in randomised to receive naftidrofuryl review there was no significant differ- the treatment of PAD, and the former 200mg three times a day or matching ence between both groups in relation is more effective than the latter.4 placebo for six months. Results were to moderately severe adverse events. A cost-effectiveness analysis con- reported as geometric means to However, the proportion of cardio- ducted by NICE revealed naftidro- reduce the impact of normal varia- vascular adverse events was slightly furyl oxalate is cost effective to be tion in walking distance and the higher in the placebo group. In the used in the UK NHS, as opposed effect of extreme values. In the inten- naftidrofuryl group the proportion to cilostazol and pentoxifylline that tion-to-treat analysis, PFWD was of gastric disorders was higher with failed to reach the cost-effectiveness increased by 91.8% (158.2m) in a risk difference of 2.85% (95% CI threshold.4 the naftidrofuryl group compared 0.78–4.91%) compared with placebo. In conclusion, naftidrofuryl may to an increase of 16.8% (29.9m) The reported gastric adverse events have a use in providing symptomatic in the placebo group (p<0.001). were minor side effects such as benefit in patients with peripheral The increase in MWD was 82.7% nausea, epigastric pain, oesophagitis vascular disease including those with (158.7m) and 13.9% (28.1m) for the and diarrhoea. diabetes, but as borne out by the clin- naftidrofuryl and placebo groups, ical evidence there may be those who respectively (p<0.001). There was no Specific evidence for use respond and those who do not, so significant difference in change in in diabetes assessment of clinical response after a ABI between the groups. Patients with type 1 diabetes mellitus period of treatment (six months) is A recent Cochrane systematic were excluded from the NCIS trial recommended. review using individual patient data and other studies included in the from six trials (1083 patients) looked Cochrane review. Twenty percent of Declaration of interests at the effect of oral naftidrofuryl the patients in the NCIS trial had There are no conflicts of interest (200mg three times a day) compared type 2 diabetes and they were strati- declared. with placebo in patients with inter- fied between treatment groups. mittent claudication (Fontaine Stage There was no significant difference References II).3 The main endpoint was the rela- in results in this study between those References are available in Practical tive improvement (RI) in geometric with or without diabetes. The whole Diabetes online at www.practical mean of PFWD (RI=WDf/WD0, database of the Cochrane individual diabetes.com. 130 PRACTICAL DIABETES VOL. 31 NO. 3 COPYRIGHT © 2014 JOHN WILEY & SONS Drug notes Naftidrofuryl References 1. Hiatt WR, et al. Effect of diagnostic criteria on the prevalence of peripheral arterial disease. The San Luis Valley Diabetes Study. Circulation 1995; 91(5):1472–9. 2. Kieffer E, et al. A new study demonstrates the efficacy of naftidrofuryl in the treatment of inter- mittent claudication. Findings of the Naftidrofuryl Clinical Ischemia Study (NCIS). Int Angiol 2001; 20(1):58–65. 3. De Backer TLM, et al. Naftidrofuryl for intermittent claudication. Cochrane Database Syst Rev 2012; 12:CD001368. 4. National Institute for Health and Care Excellence. Cilostazol, naftidrofuryl oxalate, pentoxifylline and inositol nicotinate for the treatment of intermittent claudication in people with peripheral arterial dis- ease. TA223. London: National Institute for Health and Care Excellence, 2011. PRACTICAL DIABETES VOL. 31 NO.
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