Rasagiline improves quality of life in patients with early Parkinson's disease

Kevin M. Biglan, Steven Schwid, Shirley Eberly, Karen Blindauer, Stanley Fahn, Tamar Goren, Karl Kieburtz, David Oakes, Sandra Plumb, Andrew Siderowf, Matthew Stern, Ira Shoulson, Denni Day, Aileen Shinaman, Mark Lew, Connie Kawai, Howard Hurtig, Mary Lloyd, Robert Hauser, Lisa GaugerRobert Wood, Lawrence Golbe, Joanne Wojcieszek, Joann Belden, Andrew Feigin, Mary Lou Klimek, Barbara Shannon, William Ondo, Christine Hunter, Vincent Calabrese, Paul Atchinson, Frederick Marshall, Debra Berry, Irenita Gardiner, Janis Miyasaki, Luisa Del Rizzo, Tilak Mendis, Neila Mendis, Peggy Gray, Jean Hubble, Karen Betcher, Rajesh Pahwa, Eric Molho, Diane Brown, Sharon Evans, Lisa Shulman, Ali Rajput, Marianne Ewanishin, Mark Stacy, Kelli Williamson, John Bertoni, Carolyn Peterson, Paul Tuite, Brenda Ebbitt, Kathleen Shannon, Jean Jaglin, Caroline Taner, Kenneth Marek, Karen Stavris, Michael Aminoff, Mariaane DiMinno, Glenna Dowling, Un Jung Kang, Judy Richman, Kapil Sethi, Wayne Martin, Pamela King, Germaine McInnes, Charles Adler, Marlene Lind, Peter LeWitt, Maryan DeAngelis, Mark Forrest Gordon, Roberta Winnick, Robert Feldman, Cathi Ann Thomas, Kelly Conn, Alicia Brocht, Chris Chadwick, Jeannette Connolly, Susan Daigneault, Janice Bausch, Lee Josephson, Rosemary Oliva, Antonio Lang, Christopher Cox, Carrie Irvine, John Nutt, William White

Research output: Contribution to journalArticle

57 Citations (Scopus)

Abstract

The objective of this study was to determine the effects of rasagiline as monotherapy on quality of life (QOL) in patients with early Parkinson's disease (PD). Rasagiline, a potent, second-generation, irreversible, selective monoamine oxidase B inhibitor improves PD symptoms in patients with early PD. Patients with early untreated PD were randomly assigned to once-daily rasagiline 1 mg/day, rasagiline 2 mg/day, or placebo in a 6-month, double-blind trial (n = 404). At the end of 6 months, patients entered the preplanned, active-treatment phase in which those receiving 1 mg/day and 2 mg/day of rasagiline continued on their previously assigned dosages and those receiving placebo switched to rasagiline 2 mg/day, while maintaining blinding to treatment assignments. QOL was measured with the Parkinson's Disease Quality of Life questionnaire (PDQUALIF) at 0, 14, 26, and 52 weeks after randomization. Analysis of the change in PDQUALIF scores from baseline to 6 months showed adjusted treatment effects (with 95% confidence interval) favoring rasagiline over placebo of -2.91 units (-5.19, -0.64, P = 0.01) for the 1 mg/day group and -2.74 units (-5.02, -0.45, P = 0.02) for the 2 mg/day. Subscore analysis attributed most of this benefit to the self-image/sexuality domain. At 12 months (n = 266), with all groups receiving rasagiline for at least 6 months, no significant differences in PDQUALIF scores were seen between groups. Rasagiline improved QOL compared with placebo. This QOL improvement appears to be accounted for primarily by the symptomatic benefit of rasagiline.

Original languageEnglish (US)
Pages (from-to)616-623
Number of pages8
JournalMovement Disorders
Volume21
Issue number5
DOIs
StatePublished - May 2006

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Parkinson Disease
Quality of Life
Placebos
rasagiline
Monoamine Oxidase Inhibitors
Monoamine Oxidase
Sexuality
Random Allocation
Quality Improvement
Therapeutics
Confidence Intervals

Keywords

  • Parkinson's disease
  • Quality of life
  • Rasagiline

ASJC Scopus subject areas

  • Clinical Neurology
  • Neuroscience(all)

Cite this

Biglan, K. M., Schwid, S., Eberly, S., Blindauer, K., Fahn, S., Goren, T., ... White, W. (2006). Rasagiline improves quality of life in patients with early Parkinson's disease. Movement Disorders, 21(5), 616-623. https://doi.org/10.1002/mds.20764

Rasagiline improves quality of life in patients with early Parkinson's disease. / Biglan, Kevin M.; Schwid, Steven; Eberly, Shirley; Blindauer, Karen; Fahn, Stanley; Goren, Tamar; Kieburtz, Karl; Oakes, David; Plumb, Sandra; Siderowf, Andrew; Stern, Matthew; Shoulson, Ira; Day, Denni; Shinaman, Aileen; Lew, Mark; Kawai, Connie; Hurtig, Howard; Lloyd, Mary; Hauser, Robert; Gauger, Lisa; Wood, Robert; Golbe, Lawrence; Wojcieszek, Joanne; Belden, Joann; Feigin, Andrew; Klimek, Mary Lou; Shannon, Barbara; Ondo, William; Hunter, Christine; Calabrese, Vincent; Atchinson, Paul; Marshall, Frederick; Berry, Debra; Gardiner, Irenita; Miyasaki, Janis; Del Rizzo, Luisa; Mendis, Tilak; Mendis, Neila; Gray, Peggy; Hubble, Jean; Betcher, Karen; Pahwa, Rajesh; Molho, Eric; Brown, Diane; Evans, Sharon; Shulman, Lisa; Rajput, Ali; Ewanishin, Marianne; Stacy, Mark; Williamson, Kelli; Bertoni, John; Peterson, Carolyn; Tuite, Paul; Ebbitt, Brenda; Shannon, Kathleen; Jaglin, Jean; Taner, Caroline; Marek, Kenneth; Stavris, Karen; Aminoff, Michael; DiMinno, Mariaane; Dowling, Glenna; Kang, Un Jung; Richman, Judy; Sethi, Kapil; Martin, Wayne; King, Pamela; McInnes, Germaine; Adler, Charles; Lind, Marlene; LeWitt, Peter; DeAngelis, Maryan; Gordon, Mark Forrest; Winnick, Roberta; Feldman, Robert; Thomas, Cathi Ann; Conn, Kelly; Brocht, Alicia; Chadwick, Chris; Connolly, Jeannette; Daigneault, Susan; Bausch, Janice; Josephson, Lee; Oliva, Rosemary; Lang, Antonio; Cox, Christopher; Irvine, Carrie; Nutt, John; White, William.

In: Movement Disorders, Vol. 21, No. 5, 05.2006, p. 616-623.

Research output: Contribution to journalArticle

Biglan, KM, Schwid, S, Eberly, S, Blindauer, K, Fahn, S, Goren, T, Kieburtz, K, Oakes, D, Plumb, S, Siderowf, A, Stern, M, Shoulson, I, Day, D, Shinaman, A, Lew, M, Kawai, C, Hurtig, H, Lloyd, M, Hauser, R, Gauger, L, Wood, R, Golbe, L, Wojcieszek, J, Belden, J, Feigin, A, Klimek, ML, Shannon, B, Ondo, W, Hunter, C, Calabrese, V, Atchinson, P, Marshall, F, Berry, D, Gardiner, I, Miyasaki, J, Del Rizzo, L, Mendis, T, Mendis, N, Gray, P, Hubble, J, Betcher, K, Pahwa, R, Molho, E, Brown, D, Evans, S, Shulman, L, Rajput, A, Ewanishin, M, Stacy, M, Williamson, K, Bertoni, J, Peterson, C, Tuite, P, Ebbitt, B, Shannon, K, Jaglin, J, Taner, C, Marek, K, Stavris, K, Aminoff, M, DiMinno, M, Dowling, G, Kang, UJ, Richman, J, Sethi, K, Martin, W, King, P, McInnes, G, Adler, C, Lind, M, LeWitt, P, DeAngelis, M, Gordon, MF, Winnick, R, Feldman, R, Thomas, CA, Conn, K, Brocht, A, Chadwick, C, Connolly, J, Daigneault, S, Bausch, J, Josephson, L, Oliva, R, Lang, A, Cox, C, Irvine, C, Nutt, J & White, W 2006, 'Rasagiline improves quality of life in patients with early Parkinson's disease', Movement Disorders, vol. 21, no. 5, pp. 616-623. https://doi.org/10.1002/mds.20764
Biglan KM, Schwid S, Eberly S, Blindauer K, Fahn S, Goren T et al. Rasagiline improves quality of life in patients with early Parkinson's disease. Movement Disorders. 2006 May;21(5):616-623. https://doi.org/10.1002/mds.20764
Biglan, Kevin M. ; Schwid, Steven ; Eberly, Shirley ; Blindauer, Karen ; Fahn, Stanley ; Goren, Tamar ; Kieburtz, Karl ; Oakes, David ; Plumb, Sandra ; Siderowf, Andrew ; Stern, Matthew ; Shoulson, Ira ; Day, Denni ; Shinaman, Aileen ; Lew, Mark ; Kawai, Connie ; Hurtig, Howard ; Lloyd, Mary ; Hauser, Robert ; Gauger, Lisa ; Wood, Robert ; Golbe, Lawrence ; Wojcieszek, Joanne ; Belden, Joann ; Feigin, Andrew ; Klimek, Mary Lou ; Shannon, Barbara ; Ondo, William ; Hunter, Christine ; Calabrese, Vincent ; Atchinson, Paul ; Marshall, Frederick ; Berry, Debra ; Gardiner, Irenita ; Miyasaki, Janis ; Del Rizzo, Luisa ; Mendis, Tilak ; Mendis, Neila ; Gray, Peggy ; Hubble, Jean ; Betcher, Karen ; Pahwa, Rajesh ; Molho, Eric ; Brown, Diane ; Evans, Sharon ; Shulman, Lisa ; Rajput, Ali ; Ewanishin, Marianne ; Stacy, Mark ; Williamson, Kelli ; Bertoni, John ; Peterson, Carolyn ; Tuite, Paul ; Ebbitt, Brenda ; Shannon, Kathleen ; Jaglin, Jean ; Taner, Caroline ; Marek, Kenneth ; Stavris, Karen ; Aminoff, Michael ; DiMinno, Mariaane ; Dowling, Glenna ; Kang, Un Jung ; Richman, Judy ; Sethi, Kapil ; Martin, Wayne ; King, Pamela ; McInnes, Germaine ; Adler, Charles ; Lind, Marlene ; LeWitt, Peter ; DeAngelis, Maryan ; Gordon, Mark Forrest ; Winnick, Roberta ; Feldman, Robert ; Thomas, Cathi Ann ; Conn, Kelly ; Brocht, Alicia ; Chadwick, Chris ; Connolly, Jeannette ; Daigneault, Susan ; Bausch, Janice ; Josephson, Lee ; Oliva, Rosemary ; Lang, Antonio ; Cox, Christopher ; Irvine, Carrie ; Nutt, John ; White, William. / Rasagiline improves quality of life in patients with early Parkinson's disease. In: Movement Disorders. 2006 ; Vol. 21, No. 5. pp. 616-623.
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AU - Biglan, Kevin M.

AU - Schwid, Steven

AU - Eberly, Shirley

AU - Blindauer, Karen

AU - Fahn, Stanley

AU - Goren, Tamar

AU - Kieburtz, Karl

AU - Oakes, David

AU - Plumb, Sandra

AU - Siderowf, Andrew

AU - Stern, Matthew

AU - Shoulson, Ira

AU - Day, Denni

AU - Shinaman, Aileen

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AU - Golbe, Lawrence

AU - Wojcieszek, Joanne

AU - Belden, Joann

AU - Feigin, Andrew

AU - Klimek, Mary Lou

AU - Shannon, Barbara

AU - Ondo, William

AU - Hunter, Christine

AU - Calabrese, Vincent

AU - Atchinson, Paul

AU - Marshall, Frederick

AU - Berry, Debra

AU - Gardiner, Irenita

AU - Miyasaki, Janis

AU - Del Rizzo, Luisa

AU - Mendis, Tilak

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AU - Betcher, Karen

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AU - Brown, Diane

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AU - Bertoni, John

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AU - Taner, Caroline

AU - Marek, Kenneth

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AU - Aminoff, Michael

AU - DiMinno, Mariaane

AU - Dowling, Glenna

AU - Kang, Un Jung

AU - Richman, Judy

AU - Sethi, Kapil

AU - Martin, Wayne

AU - King, Pamela

AU - McInnes, Germaine

AU - Adler, Charles

AU - Lind, Marlene

AU - LeWitt, Peter

AU - DeAngelis, Maryan

AU - Gordon, Mark Forrest

AU - Winnick, Roberta

AU - Feldman, Robert

AU - Thomas, Cathi Ann

AU - Conn, Kelly

AU - Brocht, Alicia

AU - Chadwick, Chris

AU - Connolly, Jeannette

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AU - Bausch, Janice

AU - Josephson, Lee

AU - Oliva, Rosemary

AU - Lang, Antonio

AU - Cox, Christopher

AU - Irvine, Carrie

AU - Nutt, John

AU - White, William

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N2 - The objective of this study was to determine the effects of rasagiline as monotherapy on quality of life (QOL) in patients with early Parkinson's disease (PD). Rasagiline, a potent, second-generation, irreversible, selective monoamine oxidase B inhibitor improves PD symptoms in patients with early PD. Patients with early untreated PD were randomly assigned to once-daily rasagiline 1 mg/day, rasagiline 2 mg/day, or placebo in a 6-month, double-blind trial (n = 404). At the end of 6 months, patients entered the preplanned, active-treatment phase in which those receiving 1 mg/day and 2 mg/day of rasagiline continued on their previously assigned dosages and those receiving placebo switched to rasagiline 2 mg/day, while maintaining blinding to treatment assignments. QOL was measured with the Parkinson's Disease Quality of Life questionnaire (PDQUALIF) at 0, 14, 26, and 52 weeks after randomization. Analysis of the change in PDQUALIF scores from baseline to 6 months showed adjusted treatment effects (with 95% confidence interval) favoring rasagiline over placebo of -2.91 units (-5.19, -0.64, P = 0.01) for the 1 mg/day group and -2.74 units (-5.02, -0.45, P = 0.02) for the 2 mg/day. Subscore analysis attributed most of this benefit to the self-image/sexuality domain. At 12 months (n = 266), with all groups receiving rasagiline for at least 6 months, no significant differences in PDQUALIF scores were seen between groups. Rasagiline improved QOL compared with placebo. This QOL improvement appears to be accounted for primarily by the symptomatic benefit of rasagiline.

AB - The objective of this study was to determine the effects of rasagiline as monotherapy on quality of life (QOL) in patients with early Parkinson's disease (PD). Rasagiline, a potent, second-generation, irreversible, selective monoamine oxidase B inhibitor improves PD symptoms in patients with early PD. Patients with early untreated PD were randomly assigned to once-daily rasagiline 1 mg/day, rasagiline 2 mg/day, or placebo in a 6-month, double-blind trial (n = 404). At the end of 6 months, patients entered the preplanned, active-treatment phase in which those receiving 1 mg/day and 2 mg/day of rasagiline continued on their previously assigned dosages and those receiving placebo switched to rasagiline 2 mg/day, while maintaining blinding to treatment assignments. QOL was measured with the Parkinson's Disease Quality of Life questionnaire (PDQUALIF) at 0, 14, 26, and 52 weeks after randomization. Analysis of the change in PDQUALIF scores from baseline to 6 months showed adjusted treatment effects (with 95% confidence interval) favoring rasagiline over placebo of -2.91 units (-5.19, -0.64, P = 0.01) for the 1 mg/day group and -2.74 units (-5.02, -0.45, P = 0.02) for the 2 mg/day. Subscore analysis attributed most of this benefit to the self-image/sexuality domain. At 12 months (n = 266), with all groups receiving rasagiline for at least 6 months, no significant differences in PDQUALIF scores were seen between groups. Rasagiline improved QOL compared with placebo. This QOL improvement appears to be accounted for primarily by the symptomatic benefit of rasagiline.

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