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Rivista di Angiologia

Official Journal of the International Union of Angiology, the International Union of Phlebology and the Central European Vascular Forum
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International Angiology 2002 March;21(1):20-27

lingua: Inglese

Findings of the Naftidrofuryl in Quality of Life (NIQOL) European study program

Spengel F. *, Clément D. **, Boccalon H. ***, Liard F. °, Brown T. °°, Lehert P. °°°

From ­the
* Klinik Feldafing, Feldafing, Germany,
** University Hospital, Gent, Belgium,
*** CHU Rangueil, Toulouse, France,
° MG Recherche, Paris, France,
°° Lipha SA, Lyon, France,
°°° University of Mons, Mons, Belgium


Background. We ­report in ­this ­paper ­the find­ings of a ­pooled anal­y­sis of ­3 pre­vi­ous­ly pub­lished stud­ies under­tak­en in Germany, France ­and Belgium to ­assess ­the ­effects of naf­ti­drof­u­ryl on ­the qual­ity of ­life of ­patients ­with inter­mit­tent claud­i­ca­tion.
Methods. A ­total of 754 ­patients ­were ran­dom­ised in ­the ­3 stud­ies, 709 of ­whom (358 naf­ti­drof­u­ryl, 351 pla­ce­bo) ­were avail­able ­for ­the pri­mary inten­tion-to-­treat anal­y­sis. The pri­mary out­come var­i­able ­was ­the ­change in ­the dis­ease-relat­ed lim­i­ta­tion of ­the qual­ity of ­life as meas­ured by ­the ­CLAU-S ques­tion­naire. This instru­ment ­which ­has ­been val­i­dat­ed in an inter­na­tion­al ­study, com­pris­es 47 ques­tions cov­er­ing 5 dimen­sions: “dai­ly liv­ing”, “­pain”, “­social ­life”, “dis­ease spe­cif­ic anx­ie­ty” ­and “­mood”.
Results. A mul­ti­var­i­ate anal­y­sis of covar­i­ance adjust­ed ­for base­line val­ues, ­study ­effect ­and ­first ­order ­study treat­ment inter­ac­tion, dem­on­strat­ed ­the glo­bal super­ior­ity of naf­ti­drof­u­ryl ­over pla­ce­bo (p<0.001). A sep­ar­ate covar­i­ance anal­y­sis ­for ­the ­5 dimen­sions ­showed high­ly sig­nif­i­cant dif­fer­enc­es ­for “dai­ly liv­ing”, “­pain”, “­social ­life” ­and “­mood” (­all p<0.01).
Conclusions. In con­clu­sion, ­this ­pooled anal­y­sis ­has ­shown ­that naf­ti­drof­u­ryl ­can sig­nif­i­cant­ly ­improve ­the qual­ity of ­life of ­patients ­with inter­mit­tent claud­i­ca­tion. These find­ings, tak­en togeth­er ­with evi­dence ­from pre­vi­ous stud­ies ­that it ­improves tread­mill walk­ing dis­tanc­es, sug­gest ­that naf­ti­drof­u­ryl ­can ­play a use­ful ­role in ­the treat­ment of ­this con­di­tion.

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