Effect of Intensive vs Standard Blood Pressure Control on Probable Dementia

A Randomized Clinical Trial

Jeff D. Williamson, Nicholas M. Pajewski, Alexander P. Auchus, R. Nick Bryan, Gordon Chelune, Alfred K. Cheung, Maryjo L. Cleveland, Laura H. Coker, Michael G. Crowe, William Cushman, Jeffrey A. Cutler, Christos Davatzikos, Lisa Desiderio, Guray Erus, Larry J. Fine, Sarah A. Gaussoin, Darrin Harris, Meng Kang Hsieh, Karen Johnson, Paul L. Kimmel & 27 others Manjula Kurella Tamura, Lenore J. Launer, Alan J. Lerner, Cora E. Lewis, Jennifer Martindale-Adams, Claudia S. Moy, Ilya M. Nasrallah, Linda Nichols, Suzanne Oparil, Paula K. Ogrocki, Mahboob Rahman, Stephen R. Rapp, David M. Reboussin, Michael V. Rocco, Bonnie C. Sachs, Kaycee M. Sink, Carolyn H. Still, Mark A. Supiano, Joni K. Snyder, Virginia G. Wadley, Jennifer Walker, Daniel E. Weiner, Paul K. Whelton, Valerie M. Wilson, Nancy Woolard, Jackson T. Wright, Clinton B. Wright

Research output: Contribution to journalArticle

39 Citations (Scopus)

Abstract

Importance: There are currently no proven treatments to reduce the risk of mild cognitive impairment and dementia. Objective: To evaluate the effect of intensive blood pressure control on risk of dementia. Design, Setting, and Participants: Randomized clinical trial conducted at 102 sites in the United States and Puerto Rico among adults aged 50 years or older with hypertension but without diabetes or history of stroke. Randomization began on November 8, 2010. The trial was stopped early for benefit on its primary outcome (a composite of cardiovascular events) and all-cause mortality on August 20, 2015. The final date for follow-up of cognitive outcomes was July 22, 2018. Interventions: Participants were randomized to a systolic blood pressure goal of either less than 120 mm Hg (intensive treatment group; n = 4678) or less than 140 mm Hg (standard treatment group; n = 4683). Main Outcomes and Measures: The primary cognitive outcome was occurrence of adjudicated probable dementia. Secondary cognitive outcomes included adjudicated mild cognitive impairment and a composite outcome of mild cognitive impairment or probable dementia. Results: Among 9361 randomized participants (mean age, 67.9 years; 3332 women [35.6%]), 8563 (91.5%) completed at least 1 follow-up cognitive assessment. The median intervention period was 3.34 years. During a total median follow-up of 5.11 years, adjudicated probable dementia occurred in 149 participants in the intensive treatment group vs 176 in the standard treatment group (7.2 vs 8.6 cases per 1000 person-years; hazard ratio [HR], 0.83; 95% CI, 0.67-1.04). Intensive BP control significantly reduced the risk of mild cognitive impairment (14.6 vs 18.3 cases per 1000 person-years; HR, 0.81; 95% CI, 0.69-0.95) and the combined rate of mild cognitive impairment or probable dementia (20.2 vs 24.1 cases per 1000 person-years; HR, 0.85; 95% CI, 0.74-0.97). Conclusions and Relevance: Among ambulatory adults with hypertension, treating to a systolic blood pressure goal of less than 120 mm Hg compared with a goal of less than 140 mm Hg did not result in a significant reduction in the risk of probable dementia. Because of early study termination and fewer than expected cases of dementia, the study may have been underpowered for this end point. Trial Registration: ClinicalTrials.gov Identifier: NCT01206062.

Original languageEnglish (US)
Pages (from-to)553-561
Number of pages9
JournalJAMA - Journal of the American Medical Association
Volume321
Issue number6
DOIs
StatePublished - Feb 12 2019

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Dementia
Randomized Controlled Trials
Blood Pressure
Hypertension
Therapeutics
Puerto Rico
Risk Reduction Behavior
Random Allocation
Stroke
Outcome Assessment (Health Care)
Cognitive Dysfunction
Mortality

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Williamson, J. D., Pajewski, N. M., Auchus, A. P., Bryan, R. N., Chelune, G., Cheung, A. K., ... Wright, C. B. (2019). Effect of Intensive vs Standard Blood Pressure Control on Probable Dementia: A Randomized Clinical Trial. JAMA - Journal of the American Medical Association, 321(6), 553-561. https://doi.org/10.1001/jama.2018.21442

Effect of Intensive vs Standard Blood Pressure Control on Probable Dementia : A Randomized Clinical Trial. / Williamson, Jeff D.; Pajewski, Nicholas M.; Auchus, Alexander P.; Bryan, R. Nick; Chelune, Gordon; Cheung, Alfred K.; Cleveland, Maryjo L.; Coker, Laura H.; Crowe, Michael G.; Cushman, William; Cutler, Jeffrey A.; Davatzikos, Christos; Desiderio, Lisa; Erus, Guray; Fine, Larry J.; Gaussoin, Sarah A.; Harris, Darrin; Hsieh, Meng Kang; Johnson, Karen; Kimmel, Paul L.; Tamura, Manjula Kurella; Launer, Lenore J.; Lerner, Alan J.; Lewis, Cora E.; Martindale-Adams, Jennifer; Moy, Claudia S.; Nasrallah, Ilya M.; Nichols, Linda; Oparil, Suzanne; Ogrocki, Paula K.; Rahman, Mahboob; Rapp, Stephen R.; Reboussin, David M.; Rocco, Michael V.; Sachs, Bonnie C.; Sink, Kaycee M.; Still, Carolyn H.; Supiano, Mark A.; Snyder, Joni K.; Wadley, Virginia G.; Walker, Jennifer; Weiner, Daniel E.; Whelton, Paul K.; Wilson, Valerie M.; Woolard, Nancy; Wright, Jackson T.; Wright, Clinton B.

In: JAMA - Journal of the American Medical Association, Vol. 321, No. 6, 12.02.2019, p. 553-561.

Research output: Contribution to journalArticle

Williamson, JD, Pajewski, NM, Auchus, AP, Bryan, RN, Chelune, G, Cheung, AK, Cleveland, ML, Coker, LH, Crowe, MG, Cushman, W, Cutler, JA, Davatzikos, C, Desiderio, L, Erus, G, Fine, LJ, Gaussoin, SA, Harris, D, Hsieh, MK, Johnson, K, Kimmel, PL, Tamura, MK, Launer, LJ, Lerner, AJ, Lewis, CE, Martindale-Adams, J, Moy, CS, Nasrallah, IM, Nichols, L, Oparil, S, Ogrocki, PK, Rahman, M, Rapp, SR, Reboussin, DM, Rocco, MV, Sachs, BC, Sink, KM, Still, CH, Supiano, MA, Snyder, JK, Wadley, VG, Walker, J, Weiner, DE, Whelton, PK, Wilson, VM, Woolard, N, Wright, JT & Wright, CB 2019, 'Effect of Intensive vs Standard Blood Pressure Control on Probable Dementia: A Randomized Clinical Trial', JAMA - Journal of the American Medical Association, vol. 321, no. 6, pp. 553-561. https://doi.org/10.1001/jama.2018.21442
Williamson, Jeff D. ; Pajewski, Nicholas M. ; Auchus, Alexander P. ; Bryan, R. Nick ; Chelune, Gordon ; Cheung, Alfred K. ; Cleveland, Maryjo L. ; Coker, Laura H. ; Crowe, Michael G. ; Cushman, William ; Cutler, Jeffrey A. ; Davatzikos, Christos ; Desiderio, Lisa ; Erus, Guray ; Fine, Larry J. ; Gaussoin, Sarah A. ; Harris, Darrin ; Hsieh, Meng Kang ; Johnson, Karen ; Kimmel, Paul L. ; Tamura, Manjula Kurella ; Launer, Lenore J. ; Lerner, Alan J. ; Lewis, Cora E. ; Martindale-Adams, Jennifer ; Moy, Claudia S. ; Nasrallah, Ilya M. ; Nichols, Linda ; Oparil, Suzanne ; Ogrocki, Paula K. ; Rahman, Mahboob ; Rapp, Stephen R. ; Reboussin, David M. ; Rocco, Michael V. ; Sachs, Bonnie C. ; Sink, Kaycee M. ; Still, Carolyn H. ; Supiano, Mark A. ; Snyder, Joni K. ; Wadley, Virginia G. ; Walker, Jennifer ; Weiner, Daniel E. ; Whelton, Paul K. ; Wilson, Valerie M. ; Woolard, Nancy ; Wright, Jackson T. ; Wright, Clinton B. / Effect of Intensive vs Standard Blood Pressure Control on Probable Dementia : A Randomized Clinical Trial. In: JAMA - Journal of the American Medical Association. 2019 ; Vol. 321, No. 6. pp. 553-561.
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abstract = "Importance: There are currently no proven treatments to reduce the risk of mild cognitive impairment and dementia. Objective: To evaluate the effect of intensive blood pressure control on risk of dementia. Design, Setting, and Participants: Randomized clinical trial conducted at 102 sites in the United States and Puerto Rico among adults aged 50 years or older with hypertension but without diabetes or history of stroke. Randomization began on November 8, 2010. The trial was stopped early for benefit on its primary outcome (a composite of cardiovascular events) and all-cause mortality on August 20, 2015. The final date for follow-up of cognitive outcomes was July 22, 2018. Interventions: Participants were randomized to a systolic blood pressure goal of either less than 120 mm Hg (intensive treatment group; n = 4678) or less than 140 mm Hg (standard treatment group; n = 4683). Main Outcomes and Measures: The primary cognitive outcome was occurrence of adjudicated probable dementia. Secondary cognitive outcomes included adjudicated mild cognitive impairment and a composite outcome of mild cognitive impairment or probable dementia. Results: Among 9361 randomized participants (mean age, 67.9 years; 3332 women [35.6{\%}]), 8563 (91.5{\%}) completed at least 1 follow-up cognitive assessment. The median intervention period was 3.34 years. During a total median follow-up of 5.11 years, adjudicated probable dementia occurred in 149 participants in the intensive treatment group vs 176 in the standard treatment group (7.2 vs 8.6 cases per 1000 person-years; hazard ratio [HR], 0.83; 95{\%} CI, 0.67-1.04). Intensive BP control significantly reduced the risk of mild cognitive impairment (14.6 vs 18.3 cases per 1000 person-years; HR, 0.81; 95{\%} CI, 0.69-0.95) and the combined rate of mild cognitive impairment or probable dementia (20.2 vs 24.1 cases per 1000 person-years; HR, 0.85; 95{\%} CI, 0.74-0.97). Conclusions and Relevance: Among ambulatory adults with hypertension, treating to a systolic blood pressure goal of less than 120 mm Hg compared with a goal of less than 140 mm Hg did not result in a significant reduction in the risk of probable dementia. Because of early study termination and fewer than expected cases of dementia, the study may have been underpowered for this end point. Trial Registration: ClinicalTrials.gov Identifier: NCT01206062.",
author = "Williamson, {Jeff D.} and Pajewski, {Nicholas M.} and Auchus, {Alexander P.} and Bryan, {R. Nick} and Gordon Chelune and Cheung, {Alfred K.} and Cleveland, {Maryjo L.} and Coker, {Laura H.} and Crowe, {Michael G.} and William Cushman and Cutler, {Jeffrey A.} and Christos Davatzikos and Lisa Desiderio and Guray Erus and Fine, {Larry J.} and Gaussoin, {Sarah A.} and Darrin Harris and Hsieh, {Meng Kang} and Karen Johnson and Kimmel, {Paul L.} and Tamura, {Manjula Kurella} and Launer, {Lenore J.} and Lerner, {Alan J.} and Lewis, {Cora E.} and Jennifer Martindale-Adams and Moy, {Claudia S.} and Nasrallah, {Ilya M.} and Linda Nichols and Suzanne Oparil and Ogrocki, {Paula K.} and Mahboob Rahman and Rapp, {Stephen R.} and Reboussin, {David M.} and Rocco, {Michael V.} and Sachs, {Bonnie C.} and Sink, {Kaycee M.} and Still, {Carolyn H.} and Supiano, {Mark A.} and Snyder, {Joni K.} and Wadley, {Virginia G.} and Jennifer Walker and Weiner, {Daniel E.} and Whelton, {Paul K.} and Wilson, {Valerie M.} and Nancy Woolard and Wright, {Jackson T.} and Wright, {Clinton B.}",
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TY - JOUR

T1 - Effect of Intensive vs Standard Blood Pressure Control on Probable Dementia

T2 - A Randomized Clinical Trial

AU - Williamson, Jeff D.

AU - Pajewski, Nicholas M.

AU - Auchus, Alexander P.

AU - Bryan, R. Nick

AU - Chelune, Gordon

AU - Cheung, Alfred K.

AU - Cleveland, Maryjo L.

AU - Coker, Laura H.

AU - Crowe, Michael G.

AU - Cushman, William

AU - Cutler, Jeffrey A.

AU - Davatzikos, Christos

AU - Desiderio, Lisa

AU - Erus, Guray

AU - Fine, Larry J.

AU - Gaussoin, Sarah A.

AU - Harris, Darrin

AU - Hsieh, Meng Kang

AU - Johnson, Karen

AU - Kimmel, Paul L.

AU - Tamura, Manjula Kurella

AU - Launer, Lenore J.

AU - Lerner, Alan J.

AU - Lewis, Cora E.

AU - Martindale-Adams, Jennifer

AU - Moy, Claudia S.

AU - Nasrallah, Ilya M.

AU - Nichols, Linda

AU - Oparil, Suzanne

AU - Ogrocki, Paula K.

AU - Rahman, Mahboob

AU - Rapp, Stephen R.

AU - Reboussin, David M.

AU - Rocco, Michael V.

AU - Sachs, Bonnie C.

AU - Sink, Kaycee M.

AU - Still, Carolyn H.

AU - Supiano, Mark A.

AU - Snyder, Joni K.

AU - Wadley, Virginia G.

AU - Walker, Jennifer

AU - Weiner, Daniel E.

AU - Whelton, Paul K.

AU - Wilson, Valerie M.

AU - Woolard, Nancy

AU - Wright, Jackson T.

AU - Wright, Clinton B.

PY - 2019/2/12

Y1 - 2019/2/12

N2 - Importance: There are currently no proven treatments to reduce the risk of mild cognitive impairment and dementia. Objective: To evaluate the effect of intensive blood pressure control on risk of dementia. Design, Setting, and Participants: Randomized clinical trial conducted at 102 sites in the United States and Puerto Rico among adults aged 50 years or older with hypertension but without diabetes or history of stroke. Randomization began on November 8, 2010. The trial was stopped early for benefit on its primary outcome (a composite of cardiovascular events) and all-cause mortality on August 20, 2015. The final date for follow-up of cognitive outcomes was July 22, 2018. Interventions: Participants were randomized to a systolic blood pressure goal of either less than 120 mm Hg (intensive treatment group; n = 4678) or less than 140 mm Hg (standard treatment group; n = 4683). Main Outcomes and Measures: The primary cognitive outcome was occurrence of adjudicated probable dementia. Secondary cognitive outcomes included adjudicated mild cognitive impairment and a composite outcome of mild cognitive impairment or probable dementia. Results: Among 9361 randomized participants (mean age, 67.9 years; 3332 women [35.6%]), 8563 (91.5%) completed at least 1 follow-up cognitive assessment. The median intervention period was 3.34 years. During a total median follow-up of 5.11 years, adjudicated probable dementia occurred in 149 participants in the intensive treatment group vs 176 in the standard treatment group (7.2 vs 8.6 cases per 1000 person-years; hazard ratio [HR], 0.83; 95% CI, 0.67-1.04). Intensive BP control significantly reduced the risk of mild cognitive impairment (14.6 vs 18.3 cases per 1000 person-years; HR, 0.81; 95% CI, 0.69-0.95) and the combined rate of mild cognitive impairment or probable dementia (20.2 vs 24.1 cases per 1000 person-years; HR, 0.85; 95% CI, 0.74-0.97). Conclusions and Relevance: Among ambulatory adults with hypertension, treating to a systolic blood pressure goal of less than 120 mm Hg compared with a goal of less than 140 mm Hg did not result in a significant reduction in the risk of probable dementia. Because of early study termination and fewer than expected cases of dementia, the study may have been underpowered for this end point. Trial Registration: ClinicalTrials.gov Identifier: NCT01206062.

AB - Importance: There are currently no proven treatments to reduce the risk of mild cognitive impairment and dementia. Objective: To evaluate the effect of intensive blood pressure control on risk of dementia. Design, Setting, and Participants: Randomized clinical trial conducted at 102 sites in the United States and Puerto Rico among adults aged 50 years or older with hypertension but without diabetes or history of stroke. Randomization began on November 8, 2010. The trial was stopped early for benefit on its primary outcome (a composite of cardiovascular events) and all-cause mortality on August 20, 2015. The final date for follow-up of cognitive outcomes was July 22, 2018. Interventions: Participants were randomized to a systolic blood pressure goal of either less than 120 mm Hg (intensive treatment group; n = 4678) or less than 140 mm Hg (standard treatment group; n = 4683). Main Outcomes and Measures: The primary cognitive outcome was occurrence of adjudicated probable dementia. Secondary cognitive outcomes included adjudicated mild cognitive impairment and a composite outcome of mild cognitive impairment or probable dementia. Results: Among 9361 randomized participants (mean age, 67.9 years; 3332 women [35.6%]), 8563 (91.5%) completed at least 1 follow-up cognitive assessment. The median intervention period was 3.34 years. During a total median follow-up of 5.11 years, adjudicated probable dementia occurred in 149 participants in the intensive treatment group vs 176 in the standard treatment group (7.2 vs 8.6 cases per 1000 person-years; hazard ratio [HR], 0.83; 95% CI, 0.67-1.04). Intensive BP control significantly reduced the risk of mild cognitive impairment (14.6 vs 18.3 cases per 1000 person-years; HR, 0.81; 95% CI, 0.69-0.95) and the combined rate of mild cognitive impairment or probable dementia (20.2 vs 24.1 cases per 1000 person-years; HR, 0.85; 95% CI, 0.74-0.97). Conclusions and Relevance: Among ambulatory adults with hypertension, treating to a systolic blood pressure goal of less than 120 mm Hg compared with a goal of less than 140 mm Hg did not result in a significant reduction in the risk of probable dementia. Because of early study termination and fewer than expected cases of dementia, the study may have been underpowered for this end point. Trial Registration: ClinicalTrials.gov Identifier: NCT01206062.

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