Vardenafil improves erectile function in men with erectile dysfunction irrespective of disease severity and disease classification

Craig Donatucci, Ian Eardley, Jacques Buvat, Marc Gittelman, Phillip Kell, Thom Segerson, Martin Homering, Francesco Montorsi, Roger De Bruyne, Georges Declercq, Dirk Vanderscheuren, Francis Duyck, Benny Verheyden, Eric Wespes, Thomas Gerstenberg, Overlæge Peter Lyngdorf, Francois Giuliano, Beatrice Cuzin, Albert Leriche, Pierre BondilPierre Costa, Thierry Lebret, Emmanuel Blanc, Olivier Lan, Robert Porto, Kanaiyalal Desai, Wilbert Dinsmore, Roger Kirby, M. Speakman, David Ralph, Geoffrey Hackett, Vincenzo Mirone, Francesco Paolo Selvaggi, Giorgio Carmignani, Francesco Francesca, Fabrizio Menchini Fabris, Enrico Pisani, Guglielmo Breda, Emanuele Belgrano, Gaetano Frajese, Arcangelo Pagliarulo, Vincenzo Gentile, Vincenzo Bonifacio, R. F. Kropman, E. J H Meuleman, H. Asscheman, Kazimierz Krajka, Andrzej Borkowski, Christer Dahlstrand, Peter Ekman, Björn Lundquist, Randall P. Abele, Gerald L. Andriole, Stephen M. Auerbach, Jack Barkin, Winston Barzell, Donald Bergner, Richard Casey, Stacy Childs, Selwyn Cohen, David O. Cook, Jeoffrey Deeths, Mostafa Elhilali, Pamela I. Ellsworth, Howard B. Epstein, Robert A. Feldman, Louis Fields, Roger Fincher, William III Fitch, Jenelle E. Foote, Jeffrey Frankel, Harold A. Fuselier, Larry I. Gilderman, Evan Goldfischer, James E. Gottesman, Fred Govier, Michael Greenspan, Wayne J. Hellstrom, Charles B. Herring, Gary S. Karlin, Joel M. Kaufman, Robert J. Krane, John N. Krieger, Alan Lau, William A. Leitner, Joel Lilly, Jack Lubensky, Nizamuddin Maruf, Keith Matthews, Kevin T. McVary, Andrew McCullough, Arnold Melman, William B. Monnig, Craig Niederberger, Harin Padma-Nathan, Allan B. Patrick, Jon Lee Peterson, Peter J. Pommerville, V. Gary Price

Research output: Contribution to journalArticle

32 Citations (Scopus)

Abstract

Background. Vardenafil (Levitra®) is a potent and selective phosphodiesterase 5 (PDE5) inhibitor used in the management of erectile dysfunction (ED). This retrospective subgroup analysis assessed the effectiveness of vardenafil treatment in men with ED of different baseline severity and disease classification. Methods. Data from two pi votal, randomized, double-blind, placebo-controlled clinical trials enrolling men from the general ED population who received placebo or vardenafil 5 mg, 10 mg, or 20 mg during a 12-week treatment period were retrospectively analysed, stratifying by psychogenic, organic, and mixed ED disease classification as determined by the investigator. Efficacy endpoints included the International Index of Erectile Function (IIEF)-Erectile Function (EF) domain score, per-patient diary response rates to questions on penile insertion [Sexual Encounter Profile (SEP-2)] and maintenance of erection (SEP-3) and rates of positive response to the Global Assessment Question (GAQ). Results. Data from 1,385 men who received at least one dose of study medication and had pre-and post-baseline measures of efficacy available (intent-to-treat population) are presented. At baseline 37-41% of patients had severe ED, 30-34% moderate, 22% mild-to-moderate and 6-8% mild ED. At baseline, 46-51% of patients were considered to have an organic cause for ED, 13-16% psychogenic ED, and 36-38% mixed classification of ED. For all classifications and for mild-to-moderate to severe ED, men treated with 10 or 20 mg of vardenafil showed statistically and clinically significant improvements (P < 0.001) in IIEF-EF scores, diary response rates to the SEP-2 and SEP-3 questions, and GAQ as compared with those given placebo. The greatest improvements relative to placebo were noted in patients with more severe ED. The most common treatment-emergent adverse events were headache, flushing, rhinitis, dyspepsia, and were dose-related, mostly mild to moderate in intensity and consistent with the class. Conclusions. Vardenafil improv es EF in men with ED irrespective of investigator-determined classification and baseline ED severity.

Original languageEnglish (US)
Pages (from-to)301-309
Number of pages9
JournalJournal of Sexual Medicine
Volume1
Issue number3
DOIs
StatePublished - 2004
Externally publishedYes

Fingerprint

Erectile Dysfunction
Placebos
Vardenafil Dihydrochloride
Research Personnel
Phosphodiesterase 5 Inhibitors
Dyspepsia
Controlled Clinical Trials
Rhinitis
Population
Headache
Maintenance

Keywords

  • Disease classification
  • Erectile dysfunction
  • Vardenafil

ASJC Scopus subject areas

  • Urology
  • Obstetrics and Gynecology

Cite this

Vardenafil improves erectile function in men with erectile dysfunction irrespective of disease severity and disease classification. / Donatucci, Craig; Eardley, Ian; Buvat, Jacques; Gittelman, Marc; Kell, Phillip; Segerson, Thom; Homering, Martin; Montorsi, Francesco; De Bruyne, Roger; Declercq, Georges; Vanderscheuren, Dirk; Duyck, Francis; Verheyden, Benny; Wespes, Eric; Gerstenberg, Thomas; Lyngdorf, Overlæge Peter; Giuliano, Francois; Cuzin, Beatrice; Leriche, Albert; Bondil, Pierre; Costa, Pierre; Lebret, Thierry; Blanc, Emmanuel; Lan, Olivier; Porto, Robert; Desai, Kanaiyalal; Dinsmore, Wilbert; Kirby, Roger; Speakman, M.; Ralph, David; Hackett, Geoffrey; Mirone, Vincenzo; Selvaggi, Francesco Paolo; Carmignani, Giorgio; Francesca, Francesco; Fabris, Fabrizio Menchini; Pisani, Enrico; Breda, Guglielmo; Belgrano, Emanuele; Frajese, Gaetano; Pagliarulo, Arcangelo; Gentile, Vincenzo; Bonifacio, Vincenzo; Kropman, R. F.; Meuleman, E. J H; Asscheman, H.; Krajka, Kazimierz; Borkowski, Andrzej; Dahlstrand, Christer; Ekman, Peter; Lundquist, Björn; Abele, Randall P.; Andriole, Gerald L.; Auerbach, Stephen M.; Barkin, Jack; Barzell, Winston; Bergner, Donald; Casey, Richard; Childs, Stacy; Cohen, Selwyn; Cook, David O.; Deeths, Jeoffrey; Elhilali, Mostafa; Ellsworth, Pamela I.; Epstein, Howard B.; Feldman, Robert A.; Fields, Louis; Fincher, Roger; Fitch, William III; Foote, Jenelle E.; Frankel, Jeffrey; Fuselier, Harold A.; Gilderman, Larry I.; Goldfischer, Evan; Gottesman, James E.; Govier, Fred; Greenspan, Michael; Hellstrom, Wayne J.; Herring, Charles B.; Karlin, Gary S.; Kaufman, Joel M.; Krane, Robert J.; Krieger, John N.; Lau, Alan; Leitner, William A.; Lilly, Joel; Lubensky, Jack; Maruf, Nizamuddin; Matthews, Keith; McVary, Kevin T.; McCullough, Andrew; Melman, Arnold; Monnig, William B.; Niederberger, Craig; Padma-Nathan, Harin; Patrick, Allan B.; Peterson, Jon Lee; Pommerville, Peter J.; Price, V. Gary.

In: Journal of Sexual Medicine, Vol. 1, No. 3, 2004, p. 301-309.

Research output: Contribution to journalArticle

Donatucci, C, Eardley, I, Buvat, J, Gittelman, M, Kell, P, Segerson, T, Homering, M, Montorsi, F, De Bruyne, R, Declercq, G, Vanderscheuren, D, Duyck, F, Verheyden, B, Wespes, E, Gerstenberg, T, Lyngdorf, OP, Giuliano, F, Cuzin, B, Leriche, A, Bondil, P, Costa, P, Lebret, T, Blanc, E, Lan, O, Porto, R, Desai, K, Dinsmore, W, Kirby, R, Speakman, M, Ralph, D, Hackett, G, Mirone, V, Selvaggi, FP, Carmignani, G, Francesca, F, Fabris, FM, Pisani, E, Breda, G, Belgrano, E, Frajese, G, Pagliarulo, A, Gentile, V, Bonifacio, V, Kropman, RF, Meuleman, EJH, Asscheman, H, Krajka, K, Borkowski, A, Dahlstrand, C, Ekman, P, Lundquist, B, Abele, RP, Andriole, GL, Auerbach, SM, Barkin, J, Barzell, W, Bergner, D, Casey, R, Childs, S, Cohen, S, Cook, DO, Deeths, J, Elhilali, M, Ellsworth, PI, Epstein, HB, Feldman, RA, Fields, L, Fincher, R, Fitch, WIII, Foote, JE, Frankel, J, Fuselier, HA, Gilderman, LI, Goldfischer, E, Gottesman, JE, Govier, F, Greenspan, M, Hellstrom, WJ, Herring, CB, Karlin, GS, Kaufman, JM, Krane, RJ, Krieger, JN, Lau, A, Leitner, WA, Lilly, J, Lubensky, J, Maruf, N, Matthews, K, McVary, KT, McCullough, A, Melman, A, Monnig, WB, Niederberger, C, Padma-Nathan, H, Patrick, AB, Peterson, JL, Pommerville, PJ & Price, VG 2004, 'Vardenafil improves erectile function in men with erectile dysfunction irrespective of disease severity and disease classification', Journal of Sexual Medicine, vol. 1, no. 3, pp. 301-309. https://doi.org/10.1111/j.1743-6109.04043.x
Donatucci, Craig ; Eardley, Ian ; Buvat, Jacques ; Gittelman, Marc ; Kell, Phillip ; Segerson, Thom ; Homering, Martin ; Montorsi, Francesco ; De Bruyne, Roger ; Declercq, Georges ; Vanderscheuren, Dirk ; Duyck, Francis ; Verheyden, Benny ; Wespes, Eric ; Gerstenberg, Thomas ; Lyngdorf, Overlæge Peter ; Giuliano, Francois ; Cuzin, Beatrice ; Leriche, Albert ; Bondil, Pierre ; Costa, Pierre ; Lebret, Thierry ; Blanc, Emmanuel ; Lan, Olivier ; Porto, Robert ; Desai, Kanaiyalal ; Dinsmore, Wilbert ; Kirby, Roger ; Speakman, M. ; Ralph, David ; Hackett, Geoffrey ; Mirone, Vincenzo ; Selvaggi, Francesco Paolo ; Carmignani, Giorgio ; Francesca, Francesco ; Fabris, Fabrizio Menchini ; Pisani, Enrico ; Breda, Guglielmo ; Belgrano, Emanuele ; Frajese, Gaetano ; Pagliarulo, Arcangelo ; Gentile, Vincenzo ; Bonifacio, Vincenzo ; Kropman, R. F. ; Meuleman, E. J H ; Asscheman, H. ; Krajka, Kazimierz ; Borkowski, Andrzej ; Dahlstrand, Christer ; Ekman, Peter ; Lundquist, Björn ; Abele, Randall P. ; Andriole, Gerald L. ; Auerbach, Stephen M. ; Barkin, Jack ; Barzell, Winston ; Bergner, Donald ; Casey, Richard ; Childs, Stacy ; Cohen, Selwyn ; Cook, David O. ; Deeths, Jeoffrey ; Elhilali, Mostafa ; Ellsworth, Pamela I. ; Epstein, Howard B. ; Feldman, Robert A. ; Fields, Louis ; Fincher, Roger ; Fitch, William III ; Foote, Jenelle E. ; Frankel, Jeffrey ; Fuselier, Harold A. ; Gilderman, Larry I. ; Goldfischer, Evan ; Gottesman, James E. ; Govier, Fred ; Greenspan, Michael ; Hellstrom, Wayne J. ; Herring, Charles B. ; Karlin, Gary S. ; Kaufman, Joel M. ; Krane, Robert J. ; Krieger, John N. ; Lau, Alan ; Leitner, William A. ; Lilly, Joel ; Lubensky, Jack ; Maruf, Nizamuddin ; Matthews, Keith ; McVary, Kevin T. ; McCullough, Andrew ; Melman, Arnold ; Monnig, William B. ; Niederberger, Craig ; Padma-Nathan, Harin ; Patrick, Allan B. ; Peterson, Jon Lee ; Pommerville, Peter J. ; Price, V. Gary. / Vardenafil improves erectile function in men with erectile dysfunction irrespective of disease severity and disease classification. In: Journal of Sexual Medicine. 2004 ; Vol. 1, No. 3. pp. 301-309.
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abstract = "Background. Vardenafil (Levitra{\circledR}) is a potent and selective phosphodiesterase 5 (PDE5) inhibitor used in the management of erectile dysfunction (ED). This retrospective subgroup analysis assessed the effectiveness of vardenafil treatment in men with ED of different baseline severity and disease classification. Methods. Data from two pi votal, randomized, double-blind, placebo-controlled clinical trials enrolling men from the general ED population who received placebo or vardenafil 5 mg, 10 mg, or 20 mg during a 12-week treatment period were retrospectively analysed, stratifying by psychogenic, organic, and mixed ED disease classification as determined by the investigator. Efficacy endpoints included the International Index of Erectile Function (IIEF)-Erectile Function (EF) domain score, per-patient diary response rates to questions on penile insertion [Sexual Encounter Profile (SEP-2)] and maintenance of erection (SEP-3) and rates of positive response to the Global Assessment Question (GAQ). Results. Data from 1,385 men who received at least one dose of study medication and had pre-and post-baseline measures of efficacy available (intent-to-treat population) are presented. At baseline 37-41{\%} of patients had severe ED, 30-34{\%} moderate, 22{\%} mild-to-moderate and 6-8{\%} mild ED. At baseline, 46-51{\%} of patients were considered to have an organic cause for ED, 13-16{\%} psychogenic ED, and 36-38{\%} mixed classification of ED. For all classifications and for mild-to-moderate to severe ED, men treated with 10 or 20 mg of vardenafil showed statistically and clinically significant improvements (P < 0.001) in IIEF-EF scores, diary response rates to the SEP-2 and SEP-3 questions, and GAQ as compared with those given placebo. The greatest improvements relative to placebo were noted in patients with more severe ED. The most common treatment-emergent adverse events were headache, flushing, rhinitis, dyspepsia, and were dose-related, mostly mild to moderate in intensity and consistent with the class. Conclusions. Vardenafil improv es EF in men with ED irrespective of investigator-determined classification and baseline ED severity.",
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doi = "10.1111/j.1743-6109.04043.x",
language = "English (US)",
volume = "1",
pages = "301--309",
journal = "Journal of Sexual Medicine",
issn = "1743-6095",
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TY - JOUR

T1 - Vardenafil improves erectile function in men with erectile dysfunction irrespective of disease severity and disease classification

AU - Donatucci, Craig

AU - Eardley, Ian

AU - Buvat, Jacques

AU - Gittelman, Marc

AU - Kell, Phillip

AU - Segerson, Thom

AU - Homering, Martin

AU - Montorsi, Francesco

AU - De Bruyne, Roger

AU - Declercq, Georges

AU - Vanderscheuren, Dirk

AU - Duyck, Francis

AU - Verheyden, Benny

AU - Wespes, Eric

AU - Gerstenberg, Thomas

AU - Lyngdorf, Overlæge Peter

AU - Giuliano, Francois

AU - Cuzin, Beatrice

AU - Leriche, Albert

AU - Bondil, Pierre

AU - Costa, Pierre

AU - Lebret, Thierry

AU - Blanc, Emmanuel

AU - Lan, Olivier

AU - Porto, Robert

AU - Desai, Kanaiyalal

AU - Dinsmore, Wilbert

AU - Kirby, Roger

AU - Speakman, M.

AU - Ralph, David

AU - Hackett, Geoffrey

AU - Mirone, Vincenzo

AU - Selvaggi, Francesco Paolo

AU - Carmignani, Giorgio

AU - Francesca, Francesco

AU - Fabris, Fabrizio Menchini

AU - Pisani, Enrico

AU - Breda, Guglielmo

AU - Belgrano, Emanuele

AU - Frajese, Gaetano

AU - Pagliarulo, Arcangelo

AU - Gentile, Vincenzo

AU - Bonifacio, Vincenzo

AU - Kropman, R. F.

AU - Meuleman, E. J H

AU - Asscheman, H.

AU - Krajka, Kazimierz

AU - Borkowski, Andrzej

AU - Dahlstrand, Christer

AU - Ekman, Peter

AU - Lundquist, Björn

AU - Abele, Randall P.

AU - Andriole, Gerald L.

AU - Auerbach, Stephen M.

AU - Barkin, Jack

AU - Barzell, Winston

AU - Bergner, Donald

AU - Casey, Richard

AU - Childs, Stacy

AU - Cohen, Selwyn

AU - Cook, David O.

AU - Deeths, Jeoffrey

AU - Elhilali, Mostafa

AU - Ellsworth, Pamela I.

AU - Epstein, Howard B.

AU - Feldman, Robert A.

AU - Fields, Louis

AU - Fincher, Roger

AU - Fitch, William III

AU - Foote, Jenelle E.

AU - Frankel, Jeffrey

AU - Fuselier, Harold A.

AU - Gilderman, Larry I.

AU - Goldfischer, Evan

AU - Gottesman, James E.

AU - Govier, Fred

AU - Greenspan, Michael

AU - Hellstrom, Wayne J.

AU - Herring, Charles B.

AU - Karlin, Gary S.

AU - Kaufman, Joel M.

AU - Krane, Robert J.

AU - Krieger, John N.

AU - Lau, Alan

AU - Leitner, William A.

AU - Lilly, Joel

AU - Lubensky, Jack

AU - Maruf, Nizamuddin

AU - Matthews, Keith

AU - McVary, Kevin T.

AU - McCullough, Andrew

AU - Melman, Arnold

AU - Monnig, William B.

AU - Niederberger, Craig

AU - Padma-Nathan, Harin

AU - Patrick, Allan B.

AU - Peterson, Jon Lee

AU - Pommerville, Peter J.

AU - Price, V. Gary

PY - 2004

Y1 - 2004

N2 - Background. Vardenafil (Levitra®) is a potent and selective phosphodiesterase 5 (PDE5) inhibitor used in the management of erectile dysfunction (ED). This retrospective subgroup analysis assessed the effectiveness of vardenafil treatment in men with ED of different baseline severity and disease classification. Methods. Data from two pi votal, randomized, double-blind, placebo-controlled clinical trials enrolling men from the general ED population who received placebo or vardenafil 5 mg, 10 mg, or 20 mg during a 12-week treatment period were retrospectively analysed, stratifying by psychogenic, organic, and mixed ED disease classification as determined by the investigator. Efficacy endpoints included the International Index of Erectile Function (IIEF)-Erectile Function (EF) domain score, per-patient diary response rates to questions on penile insertion [Sexual Encounter Profile (SEP-2)] and maintenance of erection (SEP-3) and rates of positive response to the Global Assessment Question (GAQ). Results. Data from 1,385 men who received at least one dose of study medication and had pre-and post-baseline measures of efficacy available (intent-to-treat population) are presented. At baseline 37-41% of patients had severe ED, 30-34% moderate, 22% mild-to-moderate and 6-8% mild ED. At baseline, 46-51% of patients were considered to have an organic cause for ED, 13-16% psychogenic ED, and 36-38% mixed classification of ED. For all classifications and for mild-to-moderate to severe ED, men treated with 10 or 20 mg of vardenafil showed statistically and clinically significant improvements (P < 0.001) in IIEF-EF scores, diary response rates to the SEP-2 and SEP-3 questions, and GAQ as compared with those given placebo. The greatest improvements relative to placebo were noted in patients with more severe ED. The most common treatment-emergent adverse events were headache, flushing, rhinitis, dyspepsia, and were dose-related, mostly mild to moderate in intensity and consistent with the class. Conclusions. Vardenafil improv es EF in men with ED irrespective of investigator-determined classification and baseline ED severity.

AB - Background. Vardenafil (Levitra®) is a potent and selective phosphodiesterase 5 (PDE5) inhibitor used in the management of erectile dysfunction (ED). This retrospective subgroup analysis assessed the effectiveness of vardenafil treatment in men with ED of different baseline severity and disease classification. Methods. Data from two pi votal, randomized, double-blind, placebo-controlled clinical trials enrolling men from the general ED population who received placebo or vardenafil 5 mg, 10 mg, or 20 mg during a 12-week treatment period were retrospectively analysed, stratifying by psychogenic, organic, and mixed ED disease classification as determined by the investigator. Efficacy endpoints included the International Index of Erectile Function (IIEF)-Erectile Function (EF) domain score, per-patient diary response rates to questions on penile insertion [Sexual Encounter Profile (SEP-2)] and maintenance of erection (SEP-3) and rates of positive response to the Global Assessment Question (GAQ). Results. Data from 1,385 men who received at least one dose of study medication and had pre-and post-baseline measures of efficacy available (intent-to-treat population) are presented. At baseline 37-41% of patients had severe ED, 30-34% moderate, 22% mild-to-moderate and 6-8% mild ED. At baseline, 46-51% of patients were considered to have an organic cause for ED, 13-16% psychogenic ED, and 36-38% mixed classification of ED. For all classifications and for mild-to-moderate to severe ED, men treated with 10 or 20 mg of vardenafil showed statistically and clinically significant improvements (P < 0.001) in IIEF-EF scores, diary response rates to the SEP-2 and SEP-3 questions, and GAQ as compared with those given placebo. The greatest improvements relative to placebo were noted in patients with more severe ED. The most common treatment-emergent adverse events were headache, flushing, rhinitis, dyspepsia, and were dose-related, mostly mild to moderate in intensity and consistent with the class. Conclusions. Vardenafil improv es EF in men with ED irrespective of investigator-determined classification and baseline ED severity.

KW - Disease classification

KW - Erectile dysfunction

KW - Vardenafil

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UR - http://www.scopus.com/inward/citedby.url?scp=20144365253&partnerID=8YFLogxK

U2 - 10.1111/j.1743-6109.04043.x

DO - 10.1111/j.1743-6109.04043.x

M3 - Article

C2 - 16422960

AN - SCOPUS:20144365253

VL - 1

SP - 301

EP - 309

JO - Journal of Sexual Medicine

JF - Journal of Sexual Medicine

SN - 1743-6095

IS - 3

ER -