Long-term outcome of early versus delayed rasagiline treatment in early Parkinson's disease

Robert A. Hauser, Mark F. Lew, Howard I. Hurtig, William G. Ondo, Joanne Wojcieszek, Cheryl J. Fitzer-Attas, Frederick Marshall, Irenita Flynn Gardiner, Nancy Pearson, Debra Berry, Kathleen Shannon, Jean A. Jaglin, William Ondo, Christine Hunter, Cathy R. Anderson, Peter A. LeWitt, Patricia Kaminski, Dawn Miller, Maryan DeAngelis, Janis MiyasakiJulie So, Lisa Johnston, Caroline Tanner, Tracy Stewart, Lisa Tagg, Sheila Everett, Georgia Germain, Mickie Welsh, Micki McCollister, Linda L. Mann, Carlos Singer, William C. Koller, William J. Weiner, Dinorah Bateman, Tilak Mendis, Melodie Moterson, Cynthia Alcorn-Costa, Keely Haas, Peggy Gray, Davoud Mohtat, Neila Mendis, Laura Sutherland, Howard Hurtig, Mary Lloyd, Mary Mathews, Robert Hauser, Lisa Gauger, Patricia Dyches, Cheryl Newcomb, Kapil Dev Sethi, Karen Betcher, Carolyn C. Weeks, Sandra Kostyk, Ali H. Rajput, Marlene Gerow, Linda Klassen, Marianne Ewasnishin, Lawrence I. Golb, Vanessa Patterson, Deborah Caputo, Patricia Seuffert, Rajesh Pahwa, Tamara Gales, Lorette J. Jenkins, Amy Parsons, Scott Cradr, Jovianna N. Wellinghoff, Shantelle Coe, Mark F. Lew, Cheryl Armstrong, Connie Kawai, Katherine B. Hawthorne, Kellie Gelles, Xiaoming Lu, Suzanne W. Schuman, Cheryl Cooper, Kenneth Marek, Barbara Fussell, Karen Caplan, Erica Barnabei, Karen Stavris, Kapil D. Sethi, Joan G. Carpenter, James Osborne, Shoba Narayan, Kathy M. Ligon, Eric Molho, Sharon Evans, Jacqueline Nash, Diane Brown, Mark Stacy, Kelli Williamson, Peter Novak, Robert G. Feldman, Cathi Thomas, Wayne Martin, Pam King, Germanine McInnes, Shaunna Caouette, Joanne Wojcieszek, Jo Ann Belden, Andew Feigin, Jean Ayan, Barbara Shannon, Charles H. Adler, Stephanie Newman, Teri Radam, Myrna Schear, Naomi Santoni, Sharon Wortzel, Nancy Saton, Paul Tuite, Susan Rolandelli, Jody Lowery, Brenda J. Ebbitt, Adrienne Baranauskas, Michael J. Aminoff, Mirann DiMinno, Jessie Roth, Tracey Borst, Julie Hevezi, Carolyn Deloa, Tracey Tam, Anita Lopez, John M. Bertoni, Larisa I. Skrypnik, C. Carolyn Peterson, Mark Forrest Gordon, Roberta Winnick, Sharyn Parness, Joanne Hamann, Vincent Calabrese, Peggy Roberge, Paul R. Atchison, Cathy W. Allen, Susan Rolli, Arif Dalvi, Un Jung Kang, Judy Richman, Shirley Uy

Research output: Contribution to journalArticle

101 Citations (Scopus)

Abstract

The purpose of this study was to compare the long-term clinical outcome of early versus delayed rasagiline treatment in early Parkinson's disease (PD). Subjects (N = 404) were randomly assigned to initial treatment with rasagiline (early-start group) or placebo for 6 months followed by rasagiline (delayed-start group) in the TEMPO study. Subjects who chose to participate in an open-label extension (N = 306) continued to receive rasagiline as well as other PD medications as needed. Average (±SD) duration in the study was 3.6 ± 2.1 years; 177 subjects received rasagiline for ≥5.0 years. Over the entire 6.5-year follow-up period, the adjusted mean difference in change from baseline in total UPDRS scores was 2.5 units (SE 1.1; P 5 0.021) or 16% (SE 5.7; P 5 0.006) in favor of the early-start versus delayed-start rasagiline group. Although the interaction between treatment and time was signi.cant, values for the early-start group were better than the delayed-start group across all time points. Significantly less worsening (percent change) in total UPDRS scores was observed in the early-start group at the time points 0.5, 1.5, 2.0, 3.0, 4.5, 5.0, and 5.5 years (P < 0.05). Compared to delayed start, early initiation of rasagiline provided long-term clinical benefit, even in the face of treatment with other dopaminergic agents. This might re.ect enduring benefits due to neuroprotection or effects on compensatory mechanisms in early PD.

Original languageEnglish (US)
Pages (from-to)564-573
Number of pages10
JournalMovement Disorders
Volume24
Issue number4
DOIs
StatePublished - Mar 15 2009

Fingerprint

Parkinson Disease
Therapeutics
Dopamine Agents
rasagiline
Placebos

Keywords

  • Disease modification
  • MAO-B inhibitor
  • Parkinson's disease
  • Rasagiline
  • Treatment neuroprotection

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

Cite this

Hauser, R. A., Lew, M. F., Hurtig, H. I., Ondo, W. G., Wojcieszek, J., Fitzer-Attas, C. J., ... Uy, S. (2009). Long-term outcome of early versus delayed rasagiline treatment in early Parkinson's disease. Movement Disorders, 24(4), 564-573. https://doi.org/10.1002/mds.22402

Long-term outcome of early versus delayed rasagiline treatment in early Parkinson's disease. / Hauser, Robert A.; Lew, Mark F.; Hurtig, Howard I.; Ondo, William G.; Wojcieszek, Joanne; Fitzer-Attas, Cheryl J.; Marshall, Frederick; Gardiner, Irenita Flynn; Pearson, Nancy; Berry, Debra; Shannon, Kathleen; Jaglin, Jean A.; Ondo, William; Hunter, Christine; Anderson, Cathy R.; LeWitt, Peter A.; Kaminski, Patricia; Miller, Dawn; DeAngelis, Maryan; Miyasaki, Janis; So, Julie; Johnston, Lisa; Tanner, Caroline; Stewart, Tracy; Tagg, Lisa; Everett, Sheila; Germain, Georgia; Welsh, Mickie; McCollister, Micki; Mann, Linda L.; Singer, Carlos; Koller, William C.; Weiner, William J.; Bateman, Dinorah; Mendis, Tilak; Moterson, Melodie; Alcorn-Costa, Cynthia; Haas, Keely; Gray, Peggy; Mohtat, Davoud; Mendis, Neila; Sutherland, Laura; Hurtig, Howard; Lloyd, Mary; Mathews, Mary; Hauser, Robert; Gauger, Lisa; Dyches, Patricia; Newcomb, Cheryl; Sethi, Kapil Dev; Betcher, Karen; Weeks, Carolyn C.; Kostyk, Sandra; Rajput, Ali H.; Gerow, Marlene; Klassen, Linda; Ewasnishin, Marianne; Golb, Lawrence I.; Patterson, Vanessa; Caputo, Deborah; Seuffert, Patricia; Pahwa, Rajesh; Gales, Tamara; Jenkins, Lorette J.; Parsons, Amy; Cradr, Scott; Wellinghoff, Jovianna N.; Coe, Shantelle; Lew, Mark F.; Armstrong, Cheryl; Kawai, Connie; Hawthorne, Katherine B.; Gelles, Kellie; Lu, Xiaoming; Schuman, Suzanne W.; Cooper, Cheryl; Marek, Kenneth; Fussell, Barbara; Caplan, Karen; Barnabei, Erica; Stavris, Karen; Sethi, Kapil D.; Carpenter, Joan G.; Osborne, James; Narayan, Shoba; Ligon, Kathy M.; Molho, Eric; Evans, Sharon; Nash, Jacqueline; Brown, Diane; Stacy, Mark; Williamson, Kelli; Novak, Peter; Feldman, Robert G.; Thomas, Cathi; Martin, Wayne; King, Pam; McInnes, Germanine; Caouette, Shaunna; Wojcieszek, Joanne; Belden, Jo Ann; Feigin, Andew; Ayan, Jean; Shannon, Barbara; Adler, Charles H.; Newman, Stephanie; Radam, Teri; Schear, Myrna; Santoni, Naomi; Wortzel, Sharon; Saton, Nancy; Tuite, Paul; Rolandelli, Susan; Lowery, Jody; Ebbitt, Brenda J.; Baranauskas, Adrienne; Aminoff, Michael J.; DiMinno, Mirann; Roth, Jessie; Borst, Tracey; Hevezi, Julie; Deloa, Carolyn; Tam, Tracey; Lopez, Anita; Bertoni, John M.; Skrypnik, Larisa I.; Peterson, C. Carolyn; Gordon, Mark Forrest; Winnick, Roberta; Parness, Sharyn; Hamann, Joanne; Calabrese, Vincent; Roberge, Peggy; Atchison, Paul R.; Allen, Cathy W.; Rolli, Susan; Dalvi, Arif; Kang, Un Jung; Richman, Judy; Uy, Shirley.

In: Movement Disorders, Vol. 24, No. 4, 15.03.2009, p. 564-573.

Research output: Contribution to journalArticle

Hauser, RA, Lew, MF, Hurtig, HI, Ondo, WG, Wojcieszek, J, Fitzer-Attas, CJ, Marshall, F, Gardiner, IF, Pearson, N, Berry, D, Shannon, K, Jaglin, JA, Ondo, W, Hunter, C, Anderson, CR, LeWitt, PA, Kaminski, P, Miller, D, DeAngelis, M, Miyasaki, J, So, J, Johnston, L, Tanner, C, Stewart, T, Tagg, L, Everett, S, Germain, G, Welsh, M, McCollister, M, Mann, LL, Singer, C, Koller, WC, Weiner, WJ, Bateman, D, Mendis, T, Moterson, M, Alcorn-Costa, C, Haas, K, Gray, P, Mohtat, D, Mendis, N, Sutherland, L, Hurtig, H, Lloyd, M, Mathews, M, Hauser, R, Gauger, L, Dyches, P, Newcomb, C, Sethi, KD, Betcher, K, Weeks, CC, Kostyk, S, Rajput, AH, Gerow, M, Klassen, L, Ewasnishin, M, Golb, LI, Patterson, V, Caputo, D, Seuffert, P, Pahwa, R, Gales, T, Jenkins, LJ, Parsons, A, Cradr, S, Wellinghoff, JN, Coe, S, Lew, MF, Armstrong, C, Kawai, C, Hawthorne, KB, Gelles, K, Lu, X, Schuman, SW, Cooper, C, Marek, K, Fussell, B, Caplan, K, Barnabei, E, Stavris, K, Sethi, KD, Carpenter, JG, Osborne, J, Narayan, S, Ligon, KM, Molho, E, Evans, S, Nash, J, Brown, D, Stacy, M, Williamson, K, Novak, P, Feldman, RG, Thomas, C, Martin, W, King, P, McInnes, G, Caouette, S, Wojcieszek, J, Belden, JA, Feigin, A, Ayan, J, Shannon, B, Adler, CH, Newman, S, Radam, T, Schear, M, Santoni, N, Wortzel, S, Saton, N, Tuite, P, Rolandelli, S, Lowery, J, Ebbitt, BJ, Baranauskas, A, Aminoff, MJ, DiMinno, M, Roth, J, Borst, T, Hevezi, J, Deloa, C, Tam, T, Lopez, A, Bertoni, JM, Skrypnik, LI, Peterson, CC, Gordon, MF, Winnick, R, Parness, S, Hamann, J, Calabrese, V, Roberge, P, Atchison, PR, Allen, CW, Rolli, S, Dalvi, A, Kang, UJ, Richman, J & Uy, S 2009, 'Long-term outcome of early versus delayed rasagiline treatment in early Parkinson's disease', Movement Disorders, vol. 24, no. 4, pp. 564-573. https://doi.org/10.1002/mds.22402
Hauser RA, Lew MF, Hurtig HI, Ondo WG, Wojcieszek J, Fitzer-Attas CJ et al. Long-term outcome of early versus delayed rasagiline treatment in early Parkinson's disease. Movement Disorders. 2009 Mar 15;24(4):564-573. https://doi.org/10.1002/mds.22402
Hauser, Robert A. ; Lew, Mark F. ; Hurtig, Howard I. ; Ondo, William G. ; Wojcieszek, Joanne ; Fitzer-Attas, Cheryl J. ; Marshall, Frederick ; Gardiner, Irenita Flynn ; Pearson, Nancy ; Berry, Debra ; Shannon, Kathleen ; Jaglin, Jean A. ; Ondo, William ; Hunter, Christine ; Anderson, Cathy R. ; LeWitt, Peter A. ; Kaminski, Patricia ; Miller, Dawn ; DeAngelis, Maryan ; Miyasaki, Janis ; So, Julie ; Johnston, Lisa ; Tanner, Caroline ; Stewart, Tracy ; Tagg, Lisa ; Everett, Sheila ; Germain, Georgia ; Welsh, Mickie ; McCollister, Micki ; Mann, Linda L. ; Singer, Carlos ; Koller, William C. ; Weiner, William J. ; Bateman, Dinorah ; Mendis, Tilak ; Moterson, Melodie ; Alcorn-Costa, Cynthia ; Haas, Keely ; Gray, Peggy ; Mohtat, Davoud ; Mendis, Neila ; Sutherland, Laura ; Hurtig, Howard ; Lloyd, Mary ; Mathews, Mary ; Hauser, Robert ; Gauger, Lisa ; Dyches, Patricia ; Newcomb, Cheryl ; Sethi, Kapil Dev ; Betcher, Karen ; Weeks, Carolyn C. ; Kostyk, Sandra ; Rajput, Ali H. ; Gerow, Marlene ; Klassen, Linda ; Ewasnishin, Marianne ; Golb, Lawrence I. ; Patterson, Vanessa ; Caputo, Deborah ; Seuffert, Patricia ; Pahwa, Rajesh ; Gales, Tamara ; Jenkins, Lorette J. ; Parsons, Amy ; Cradr, Scott ; Wellinghoff, Jovianna N. ; Coe, Shantelle ; Lew, Mark F. ; Armstrong, Cheryl ; Kawai, Connie ; Hawthorne, Katherine B. ; Gelles, Kellie ; Lu, Xiaoming ; Schuman, Suzanne W. ; Cooper, Cheryl ; Marek, Kenneth ; Fussell, Barbara ; Caplan, Karen ; Barnabei, Erica ; Stavris, Karen ; Sethi, Kapil D. ; Carpenter, Joan G. ; Osborne, James ; Narayan, Shoba ; Ligon, Kathy M. ; Molho, Eric ; Evans, Sharon ; Nash, Jacqueline ; Brown, Diane ; Stacy, Mark ; Williamson, Kelli ; Novak, Peter ; Feldman, Robert G. ; Thomas, Cathi ; Martin, Wayne ; King, Pam ; McInnes, Germanine ; Caouette, Shaunna ; Wojcieszek, Joanne ; Belden, Jo Ann ; Feigin, Andew ; Ayan, Jean ; Shannon, Barbara ; Adler, Charles H. ; Newman, Stephanie ; Radam, Teri ; Schear, Myrna ; Santoni, Naomi ; Wortzel, Sharon ; Saton, Nancy ; Tuite, Paul ; Rolandelli, Susan ; Lowery, Jody ; Ebbitt, Brenda J. ; Baranauskas, Adrienne ; Aminoff, Michael J. ; DiMinno, Mirann ; Roth, Jessie ; Borst, Tracey ; Hevezi, Julie ; Deloa, Carolyn ; Tam, Tracey ; Lopez, Anita ; Bertoni, John M. ; Skrypnik, Larisa I. ; Peterson, C. Carolyn ; Gordon, Mark Forrest ; Winnick, Roberta ; Parness, Sharyn ; Hamann, Joanne ; Calabrese, Vincent ; Roberge, Peggy ; Atchison, Paul R. ; Allen, Cathy W. ; Rolli, Susan ; Dalvi, Arif ; Kang, Un Jung ; Richman, Judy ; Uy, Shirley. / Long-term outcome of early versus delayed rasagiline treatment in early Parkinson's disease. In: Movement Disorders. 2009 ; Vol. 24, No. 4. pp. 564-573.
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title = "Long-term outcome of early versus delayed rasagiline treatment in early Parkinson's disease",
abstract = "The purpose of this study was to compare the long-term clinical outcome of early versus delayed rasagiline treatment in early Parkinson's disease (PD). Subjects (N = 404) were randomly assigned to initial treatment with rasagiline (early-start group) or placebo for 6 months followed by rasagiline (delayed-start group) in the TEMPO study. Subjects who chose to participate in an open-label extension (N = 306) continued to receive rasagiline as well as other PD medications as needed. Average (±SD) duration in the study was 3.6 ± 2.1 years; 177 subjects received rasagiline for ≥5.0 years. Over the entire 6.5-year follow-up period, the adjusted mean difference in change from baseline in total UPDRS scores was 2.5 units (SE 1.1; P 5 0.021) or 16{\%} (SE 5.7; P 5 0.006) in favor of the early-start versus delayed-start rasagiline group. Although the interaction between treatment and time was signi.cant, values for the early-start group were better than the delayed-start group across all time points. Significantly less worsening (percent change) in total UPDRS scores was observed in the early-start group at the time points 0.5, 1.5, 2.0, 3.0, 4.5, 5.0, and 5.5 years (P < 0.05). Compared to delayed start, early initiation of rasagiline provided long-term clinical benefit, even in the face of treatment with other dopaminergic agents. This might re.ect enduring benefits due to neuroprotection or effects on compensatory mechanisms in early PD.",
keywords = "Disease modification, MAO-B inhibitor, Parkinson's disease, Rasagiline, Treatment neuroprotection",
author = "Hauser, {Robert A.} and Lew, {Mark F.} and Hurtig, {Howard I.} and Ondo, {William G.} and Joanne Wojcieszek and Fitzer-Attas, {Cheryl J.} and Frederick Marshall and Gardiner, {Irenita Flynn} and Nancy Pearson and Debra Berry and Kathleen Shannon and Jaglin, {Jean A.} and William Ondo and Christine Hunter and Anderson, {Cathy R.} and LeWitt, {Peter A.} and Patricia Kaminski and Dawn Miller and Maryan DeAngelis and Janis Miyasaki and Julie So and Lisa Johnston and Caroline Tanner and Tracy Stewart and Lisa Tagg and Sheila Everett and Georgia Germain and Mickie Welsh and Micki McCollister and Mann, {Linda L.} and Carlos Singer and Koller, {William C.} and Weiner, {William J.} and Dinorah Bateman and Tilak Mendis and Melodie Moterson and Cynthia Alcorn-Costa and Keely Haas and Peggy Gray and Davoud Mohtat and Neila Mendis and Laura Sutherland and Howard Hurtig and Mary Lloyd and Mary Mathews and Robert Hauser and Lisa Gauger and Patricia Dyches and Cheryl Newcomb and Sethi, {Kapil Dev} and Karen Betcher and Weeks, {Carolyn C.} and Sandra Kostyk and Rajput, {Ali H.} and Marlene Gerow and Linda Klassen and Marianne Ewasnishin and Golb, {Lawrence I.} and Vanessa Patterson and Deborah Caputo and Patricia Seuffert and Rajesh Pahwa and Tamara Gales and Jenkins, {Lorette J.} and Amy Parsons and Scott Cradr and Wellinghoff, {Jovianna N.} and Shantelle Coe and Lew, {Mark F.} and Cheryl Armstrong and Connie Kawai and Hawthorne, {Katherine B.} and Kellie Gelles and Xiaoming Lu and Schuman, {Suzanne W.} and Cheryl Cooper and Kenneth Marek and Barbara Fussell and Karen Caplan and Erica Barnabei and Karen Stavris and Sethi, {Kapil D.} and Carpenter, {Joan G.} and James Osborne and Shoba Narayan and Ligon, {Kathy M.} and Eric Molho and Sharon Evans and Jacqueline Nash and Diane Brown and Mark Stacy and Kelli Williamson and Peter Novak and Feldman, {Robert G.} and Cathi Thomas and Wayne Martin and Pam King and Germanine McInnes and Shaunna Caouette and Joanne Wojcieszek and Belden, {Jo Ann} and Andew Feigin and Jean Ayan and Barbara Shannon and Adler, {Charles H.} and Stephanie Newman and Teri Radam and Myrna Schear and Naomi Santoni and Sharon Wortzel and Nancy Saton and Paul Tuite and Susan Rolandelli and Jody Lowery and Ebbitt, {Brenda J.} and Adrienne Baranauskas and Aminoff, {Michael J.} and Mirann DiMinno and Jessie Roth and Tracey Borst and Julie Hevezi and Carolyn Deloa and Tracey Tam and Anita Lopez and Bertoni, {John M.} and Skrypnik, {Larisa I.} and Peterson, {C. Carolyn} and Gordon, {Mark Forrest} and Roberta Winnick and Sharyn Parness and Joanne Hamann and Vincent Calabrese and Peggy Roberge and Atchison, {Paul R.} and Allen, {Cathy W.} and Susan Rolli and Arif Dalvi and Kang, {Un Jung} and Judy Richman and Shirley Uy",
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month = "3",
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TY - JOUR

T1 - Long-term outcome of early versus delayed rasagiline treatment in early Parkinson's disease

AU - Hauser, Robert A.

AU - Lew, Mark F.

AU - Hurtig, Howard I.

AU - Ondo, William G.

AU - Wojcieszek, Joanne

AU - Fitzer-Attas, Cheryl J.

AU - Marshall, Frederick

AU - Gardiner, Irenita Flynn

AU - Pearson, Nancy

AU - Berry, Debra

AU - Shannon, Kathleen

AU - Jaglin, Jean A.

AU - Ondo, William

AU - Hunter, Christine

AU - Anderson, Cathy R.

AU - LeWitt, Peter A.

AU - Kaminski, Patricia

AU - Miller, Dawn

AU - DeAngelis, Maryan

AU - Miyasaki, Janis

AU - So, Julie

AU - Johnston, Lisa

AU - Tanner, Caroline

AU - Stewart, Tracy

AU - Tagg, Lisa

AU - Everett, Sheila

AU - Germain, Georgia

AU - Welsh, Mickie

AU - McCollister, Micki

AU - Mann, Linda L.

AU - Singer, Carlos

AU - Koller, William C.

AU - Weiner, William J.

AU - Bateman, Dinorah

AU - Mendis, Tilak

AU - Moterson, Melodie

AU - Alcorn-Costa, Cynthia

AU - Haas, Keely

AU - Gray, Peggy

AU - Mohtat, Davoud

AU - Mendis, Neila

AU - Sutherland, Laura

AU - Hurtig, Howard

AU - Lloyd, Mary

AU - Mathews, Mary

AU - Hauser, Robert

AU - Gauger, Lisa

AU - Dyches, Patricia

AU - Newcomb, Cheryl

AU - Sethi, Kapil Dev

AU - Betcher, Karen

AU - Weeks, Carolyn C.

AU - Kostyk, Sandra

AU - Rajput, Ali H.

AU - Gerow, Marlene

AU - Klassen, Linda

AU - Ewasnishin, Marianne

AU - Golb, Lawrence I.

AU - Patterson, Vanessa

AU - Caputo, Deborah

AU - Seuffert, Patricia

AU - Pahwa, Rajesh

AU - Gales, Tamara

AU - Jenkins, Lorette J.

AU - Parsons, Amy

AU - Cradr, Scott

AU - Wellinghoff, Jovianna N.

AU - Coe, Shantelle

AU - Lew, Mark F.

AU - Armstrong, Cheryl

AU - Kawai, Connie

AU - Hawthorne, Katherine B.

AU - Gelles, Kellie

AU - Lu, Xiaoming

AU - Schuman, Suzanne W.

AU - Cooper, Cheryl

AU - Marek, Kenneth

AU - Fussell, Barbara

AU - Caplan, Karen

AU - Barnabei, Erica

AU - Stavris, Karen

AU - Sethi, Kapil D.

AU - Carpenter, Joan G.

AU - Osborne, James

AU - Narayan, Shoba

AU - Ligon, Kathy M.

AU - Molho, Eric

AU - Evans, Sharon

AU - Nash, Jacqueline

AU - Brown, Diane

AU - Stacy, Mark

AU - Williamson, Kelli

AU - Novak, Peter

AU - Feldman, Robert G.

AU - Thomas, Cathi

AU - Martin, Wayne

AU - King, Pam

AU - McInnes, Germanine

AU - Caouette, Shaunna

AU - Wojcieszek, Joanne

AU - Belden, Jo Ann

AU - Feigin, Andew

AU - Ayan, Jean

AU - Shannon, Barbara

AU - Adler, Charles H.

AU - Newman, Stephanie

AU - Radam, Teri

AU - Schear, Myrna

AU - Santoni, Naomi

AU - Wortzel, Sharon

AU - Saton, Nancy

AU - Tuite, Paul

AU - Rolandelli, Susan

AU - Lowery, Jody

AU - Ebbitt, Brenda J.

AU - Baranauskas, Adrienne

AU - Aminoff, Michael J.

AU - DiMinno, Mirann

AU - Roth, Jessie

AU - Borst, Tracey

AU - Hevezi, Julie

AU - Deloa, Carolyn

AU - Tam, Tracey

AU - Lopez, Anita

AU - Bertoni, John M.

AU - Skrypnik, Larisa I.

AU - Peterson, C. Carolyn

AU - Gordon, Mark Forrest

AU - Winnick, Roberta

AU - Parness, Sharyn

AU - Hamann, Joanne

AU - Calabrese, Vincent

AU - Roberge, Peggy

AU - Atchison, Paul R.

AU - Allen, Cathy W.

AU - Rolli, Susan

AU - Dalvi, Arif

AU - Kang, Un Jung

AU - Richman, Judy

AU - Uy, Shirley

PY - 2009/3/15

Y1 - 2009/3/15

N2 - The purpose of this study was to compare the long-term clinical outcome of early versus delayed rasagiline treatment in early Parkinson's disease (PD). Subjects (N = 404) were randomly assigned to initial treatment with rasagiline (early-start group) or placebo for 6 months followed by rasagiline (delayed-start group) in the TEMPO study. Subjects who chose to participate in an open-label extension (N = 306) continued to receive rasagiline as well as other PD medications as needed. Average (±SD) duration in the study was 3.6 ± 2.1 years; 177 subjects received rasagiline for ≥5.0 years. Over the entire 6.5-year follow-up period, the adjusted mean difference in change from baseline in total UPDRS scores was 2.5 units (SE 1.1; P 5 0.021) or 16% (SE 5.7; P 5 0.006) in favor of the early-start versus delayed-start rasagiline group. Although the interaction between treatment and time was signi.cant, values for the early-start group were better than the delayed-start group across all time points. Significantly less worsening (percent change) in total UPDRS scores was observed in the early-start group at the time points 0.5, 1.5, 2.0, 3.0, 4.5, 5.0, and 5.5 years (P < 0.05). Compared to delayed start, early initiation of rasagiline provided long-term clinical benefit, even in the face of treatment with other dopaminergic agents. This might re.ect enduring benefits due to neuroprotection or effects on compensatory mechanisms in early PD.

AB - The purpose of this study was to compare the long-term clinical outcome of early versus delayed rasagiline treatment in early Parkinson's disease (PD). Subjects (N = 404) were randomly assigned to initial treatment with rasagiline (early-start group) or placebo for 6 months followed by rasagiline (delayed-start group) in the TEMPO study. Subjects who chose to participate in an open-label extension (N = 306) continued to receive rasagiline as well as other PD medications as needed. Average (±SD) duration in the study was 3.6 ± 2.1 years; 177 subjects received rasagiline for ≥5.0 years. Over the entire 6.5-year follow-up period, the adjusted mean difference in change from baseline in total UPDRS scores was 2.5 units (SE 1.1; P 5 0.021) or 16% (SE 5.7; P 5 0.006) in favor of the early-start versus delayed-start rasagiline group. Although the interaction between treatment and time was signi.cant, values for the early-start group were better than the delayed-start group across all time points. Significantly less worsening (percent change) in total UPDRS scores was observed in the early-start group at the time points 0.5, 1.5, 2.0, 3.0, 4.5, 5.0, and 5.5 years (P < 0.05). Compared to delayed start, early initiation of rasagiline provided long-term clinical benefit, even in the face of treatment with other dopaminergic agents. This might re.ect enduring benefits due to neuroprotection or effects on compensatory mechanisms in early PD.

KW - Disease modification

KW - MAO-B inhibitor

KW - Parkinson's disease

KW - Rasagiline

KW - Treatment neuroprotection

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