Predicted impact of various clinical practice strategies on cardiovascular risk for the treatment of hypertension: a clinical trial simulation study

Yuyan Jin, Robert Bies, Marc R. Gastonguay, Yaning Wang, Norman Stockbridge, Jogarao Gobburu, Rajanikanth Madabushi

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Hypertension control rate in the US is low with the current clinical practice (JNC 7) and cardiovascular disease (CVD) remain is the leading cause of morbidity and mortality. A 6-month clinical trial simulation case study testing different virtual clinical practice strategies was performed in an attempt to increase the control rate. The CVD risk was calculated using the Framingham CVD risk model at baseline and 6 months post-treatment. The estimated CVD events for the baseline patient sample without any treatment was 998 (95 % CI: 967–1,026) over 6 months in 100,000 patients. Treating these patients for 6 months with current clinical practice, high dose strategy, high dose with low target BP strategy resulted in a reduction in CVD events of 191(95 % CI: 169–205), 284 (95 % CI: 261–305), and 353 (95 % CI: 331–375), respectively. Hence the two alternative strategies resulted in an increase in treatment effect by 49 % (95 %CI: 44–59 %) and 85 % (95 %CI: 79–99 %), respectively. The increased safety with the current low dose strategy may potentially be offset by increased CVD risk in the time necessary to control hypertension.

Original languageEnglish
Pages (from-to)693-704
Number of pages12
JournalJournal of Pharmacokinetics and Pharmacodynamics
Volume41
Issue number6
DOIs
StatePublished - Nov 9 2014

Fingerprint

Cardiovascular Diseases
Clinical Trials
Hypertension
Therapeutics
Morbidity
Safety
Mortality

Keywords

  • Cardiovascular risk
  • Clinical practice
  • Clinical trial simulation
  • Hypertension
  • Pharmacometrics
  • Public health

ASJC Scopus subject areas

  • Pharmacology
  • Medicine(all)

Cite this

Predicted impact of various clinical practice strategies on cardiovascular risk for the treatment of hypertension : a clinical trial simulation study. / Jin, Yuyan; Bies, Robert; Gastonguay, Marc R.; Wang, Yaning; Stockbridge, Norman; Gobburu, Jogarao; Madabushi, Rajanikanth.

In: Journal of Pharmacokinetics and Pharmacodynamics, Vol. 41, No. 6, 09.11.2014, p. 693-704.

Research output: Contribution to journalArticle

Jin, Yuyan ; Bies, Robert ; Gastonguay, Marc R. ; Wang, Yaning ; Stockbridge, Norman ; Gobburu, Jogarao ; Madabushi, Rajanikanth. / Predicted impact of various clinical practice strategies on cardiovascular risk for the treatment of hypertension : a clinical trial simulation study. In: Journal of Pharmacokinetics and Pharmacodynamics. 2014 ; Vol. 41, No. 6. pp. 693-704.
@article{6f492c0bbead40e880acd305c63c3cf2,
title = "Predicted impact of various clinical practice strategies on cardiovascular risk for the treatment of hypertension: a clinical trial simulation study",
abstract = "Hypertension control rate in the US is low with the current clinical practice (JNC 7) and cardiovascular disease (CVD) remain is the leading cause of morbidity and mortality. A 6-month clinical trial simulation case study testing different virtual clinical practice strategies was performed in an attempt to increase the control rate. The CVD risk was calculated using the Framingham CVD risk model at baseline and 6 months post-treatment. The estimated CVD events for the baseline patient sample without any treatment was 998 (95 {\%} CI: 967–1,026) over 6 months in 100,000 patients. Treating these patients for 6 months with current clinical practice, high dose strategy, high dose with low target BP strategy resulted in a reduction in CVD events of 191(95 {\%} CI: 169–205), 284 (95 {\%} CI: 261–305), and 353 (95 {\%} CI: 331–375), respectively. Hence the two alternative strategies resulted in an increase in treatment effect by 49 {\%} (95 {\%}CI: 44–59 {\%}) and 85 {\%} (95 {\%}CI: 79–99 {\%}), respectively. The increased safety with the current low dose strategy may potentially be offset by increased CVD risk in the time necessary to control hypertension.",
keywords = "Cardiovascular risk, Clinical practice, Clinical trial simulation, Hypertension, Pharmacometrics, Public health",
author = "Yuyan Jin and Robert Bies and Gastonguay, {Marc R.} and Yaning Wang and Norman Stockbridge and Jogarao Gobburu and Rajanikanth Madabushi",
year = "2014",
month = "11",
day = "9",
doi = "10.1007/s10928-014-9394-9",
language = "English",
volume = "41",
pages = "693--704",
journal = "Journal of Pharmacokinetics and Pharmacodynamics",
issn = "1567-567X",
publisher = "Springer New York",
number = "6",

}

TY - JOUR

T1 - Predicted impact of various clinical practice strategies on cardiovascular risk for the treatment of hypertension

T2 - a clinical trial simulation study

AU - Jin, Yuyan

AU - Bies, Robert

AU - Gastonguay, Marc R.

AU - Wang, Yaning

AU - Stockbridge, Norman

AU - Gobburu, Jogarao

AU - Madabushi, Rajanikanth

PY - 2014/11/9

Y1 - 2014/11/9

N2 - Hypertension control rate in the US is low with the current clinical practice (JNC 7) and cardiovascular disease (CVD) remain is the leading cause of morbidity and mortality. A 6-month clinical trial simulation case study testing different virtual clinical practice strategies was performed in an attempt to increase the control rate. The CVD risk was calculated using the Framingham CVD risk model at baseline and 6 months post-treatment. The estimated CVD events for the baseline patient sample without any treatment was 998 (95 % CI: 967–1,026) over 6 months in 100,000 patients. Treating these patients for 6 months with current clinical practice, high dose strategy, high dose with low target BP strategy resulted in a reduction in CVD events of 191(95 % CI: 169–205), 284 (95 % CI: 261–305), and 353 (95 % CI: 331–375), respectively. Hence the two alternative strategies resulted in an increase in treatment effect by 49 % (95 %CI: 44–59 %) and 85 % (95 %CI: 79–99 %), respectively. The increased safety with the current low dose strategy may potentially be offset by increased CVD risk in the time necessary to control hypertension.

AB - Hypertension control rate in the US is low with the current clinical practice (JNC 7) and cardiovascular disease (CVD) remain is the leading cause of morbidity and mortality. A 6-month clinical trial simulation case study testing different virtual clinical practice strategies was performed in an attempt to increase the control rate. The CVD risk was calculated using the Framingham CVD risk model at baseline and 6 months post-treatment. The estimated CVD events for the baseline patient sample without any treatment was 998 (95 % CI: 967–1,026) over 6 months in 100,000 patients. Treating these patients for 6 months with current clinical practice, high dose strategy, high dose with low target BP strategy resulted in a reduction in CVD events of 191(95 % CI: 169–205), 284 (95 % CI: 261–305), and 353 (95 % CI: 331–375), respectively. Hence the two alternative strategies resulted in an increase in treatment effect by 49 % (95 %CI: 44–59 %) and 85 % (95 %CI: 79–99 %), respectively. The increased safety with the current low dose strategy may potentially be offset by increased CVD risk in the time necessary to control hypertension.

KW - Cardiovascular risk

KW - Clinical practice

KW - Clinical trial simulation

KW - Hypertension

KW - Pharmacometrics

KW - Public health

UR - http://www.scopus.com/inward/record.url?scp=84912001855&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84912001855&partnerID=8YFLogxK

U2 - 10.1007/s10928-014-9394-9

DO - 10.1007/s10928-014-9394-9

M3 - Article

C2 - 25326066

AN - SCOPUS:84912001855

VL - 41

SP - 693

EP - 704

JO - Journal of Pharmacokinetics and Pharmacodynamics

JF - Journal of Pharmacokinetics and Pharmacodynamics

SN - 1567-567X

IS - 6

ER -