Comparison of two methodologies to analyze exposure to statins in an observational study on effectiveness

Anke Hilse Maitland-van der Zee; Olaf H Klungel; Bruno H Ch Stricker; W M Monique Verschuren; Jacqueline C M Witteman; Theo Stijnen; Albert Hofman; Monique M B Breteler; Hubertus G M Leufkens; Anthonius de Boer

doi:10.1016/j.jclinepi.2003.07.011

Comparison of two methodologies to analyze exposure to statins in an observational study on effectiveness

Anke Hilse Maitland-van der Zee, Olaf H Klungel, Bruno H Ch Stricker, W M Monique Verschuren, Jacqueline C M Witteman, Theo Stijnen, Albert Hofman, Monique M B Breteler, Hubertus G M Leufkens, Anthonius de Boer

Dept of Pharmaceutical Sciences

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

OBJECTIVE: Estimates of efficacy of drugs from clinical trials may differ from estimates in observational studies. To obtain valid results, the definition of exposure in an observational study is critical. The objective of our study was to compare different exposure definitions for assessing the effectiveness of statins.

STUDY DESIGN AND SETTING: The study was performed in the Rotterdam Study, a population-based cohort study that included 7983 subjects of > or =55 years of age. We selected 3806 subjects who received antihyperlipidemic drug treatment (n=179) or had a total cholesterol > or =6.5 mmol/L at baseline. We conducted analyses with two different exposure definitions.

RESULTS: Treatment with statins was assessed at baseline. The adjusted relative risk (RR) of myocardial infarction (MI) and stroke was 0.75 (95% confidence interval [CI] 0.41-1.37) and of total mortality was 1.34 (95% CI 0.66-2.74) in subjects treated with statins. We used pharmacy data, which give insight into drug use on a continuous basis. The adjusted RR of MI and stroke after 2 years of cumulative treatment was 0.63 (95% CI 0.34-1.15) and of total mortality was 0.91 (95% CI 0.59-1.39).

CONCLUSION: Our results suggest that use of a time-dependent exposure definition is more accurate because estimates of effectiveness were more in agreement with results from randomized controlled trials of statin treatment.

Original language	English
Pages (from-to)	237-242
Number of pages	6
Journal	Journal of Clinical Epidemiology
Volume	57
Issue number	3
DOIs	https://doi.org/10.1016/j.jclinepi.2003.07.011
Publication status	Published - 2004

Keywords

Aged
Drug Administration Schedule
Epidemiologic Methods
Female
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Male
Middle Aged
Mortality
Myocardial Infarction
Netherlands
Stroke
Treatment Outcome

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Maitland-van der Zee, A. H., Klungel, O. H., Stricker, B. H. C., Verschuren, W. M. M., Witteman, J. C. M., Stijnen, T., Hofman, A., Breteler, M. M. B., Leufkens, H. G. M., & de Boer, A. (2004). Comparison of two methodologies to analyze exposure to statins in an observational study on effectiveness. Journal of Clinical Epidemiology, 57(3), 237-242. https://doi.org/10.1016/j.jclinepi.2003.07.011

@article{157f7996bfad4153ab5499195eb2e593,

title = "Comparison of two methodologies to analyze exposure to statins in an observational study on effectiveness",

abstract = "OBJECTIVE: Estimates of efficacy of drugs from clinical trials may differ from estimates in observational studies. To obtain valid results, the definition of exposure in an observational study is critical. The objective of our study was to compare different exposure definitions for assessing the effectiveness of statins.STUDY DESIGN AND SETTING: The study was performed in the Rotterdam Study, a population-based cohort study that included 7983 subjects of > or =55 years of age. We selected 3806 subjects who received antihyperlipidemic drug treatment (n=179) or had a total cholesterol > or =6.5 mmol/L at baseline. We conducted analyses with two different exposure definitions.RESULTS: Treatment with statins was assessed at baseline. The adjusted relative risk (RR) of myocardial infarction (MI) and stroke was 0.75 (95% confidence interval [CI] 0.41-1.37) and of total mortality was 1.34 (95% CI 0.66-2.74) in subjects treated with statins. We used pharmacy data, which give insight into drug use on a continuous basis. The adjusted RR of MI and stroke after 2 years of cumulative treatment was 0.63 (95% CI 0.34-1.15) and of total mortality was 0.91 (95% CI 0.59-1.39).CONCLUSION: Our results suggest that use of a time-dependent exposure definition is more accurate because estimates of effectiveness were more in agreement with results from randomized controlled trials of statin treatment.",

keywords = "Aged, Drug Administration Schedule, Epidemiologic Methods, Female, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Male, Middle Aged, Mortality, Myocardial Infarction, Netherlands, Stroke, Treatment Outcome",

author = "{Maitland-van der Zee}, {Anke Hilse} and Klungel, {Olaf H} and Stricker, {Bruno H Ch} and Verschuren, {W M Monique} and Witteman, {Jacqueline C M} and Theo Stijnen and Albert Hofman and Breteler, {Monique M B} and Leufkens, {Hubertus G M} and {de Boer}, Anthonius",

year = "2004",

doi = "10.1016/j.jclinepi.2003.07.011",

language = "English",

volume = "57",

pages = "237--242",

journal = "Journal of Clinical Epidemiology",

issn = "0895-4356",

publisher = "Elsevier USA",

number = "3",

}

Maitland-van der Zee, AH, Klungel, OH, Stricker, BHC, Verschuren, WMM, Witteman, JCM, Stijnen, T, Hofman, A, Breteler, MMB, Leufkens, HGM & de Boer, A 2004, 'Comparison of two methodologies to analyze exposure to statins in an observational study on effectiveness', Journal of Clinical Epidemiology, vol. 57, no. 3, pp. 237-242. https://doi.org/10.1016/j.jclinepi.2003.07.011

TY - JOUR

T1 - Comparison of two methodologies to analyze exposure to statins in an observational study on effectiveness

AU - Maitland-van der Zee, Anke Hilse

AU - Klungel, Olaf H

AU - Stricker, Bruno H Ch

AU - Verschuren, W M Monique

AU - Witteman, Jacqueline C M

AU - Stijnen, Theo

AU - Hofman, Albert

AU - Breteler, Monique M B

AU - Leufkens, Hubertus G M

AU - de Boer, Anthonius

PY - 2004

Y1 - 2004

N2 - OBJECTIVE: Estimates of efficacy of drugs from clinical trials may differ from estimates in observational studies. To obtain valid results, the definition of exposure in an observational study is critical. The objective of our study was to compare different exposure definitions for assessing the effectiveness of statins.STUDY DESIGN AND SETTING: The study was performed in the Rotterdam Study, a population-based cohort study that included 7983 subjects of > or =55 years of age. We selected 3806 subjects who received antihyperlipidemic drug treatment (n=179) or had a total cholesterol > or =6.5 mmol/L at baseline. We conducted analyses with two different exposure definitions.RESULTS: Treatment with statins was assessed at baseline. The adjusted relative risk (RR) of myocardial infarction (MI) and stroke was 0.75 (95% confidence interval [CI] 0.41-1.37) and of total mortality was 1.34 (95% CI 0.66-2.74) in subjects treated with statins. We used pharmacy data, which give insight into drug use on a continuous basis. The adjusted RR of MI and stroke after 2 years of cumulative treatment was 0.63 (95% CI 0.34-1.15) and of total mortality was 0.91 (95% CI 0.59-1.39).CONCLUSION: Our results suggest that use of a time-dependent exposure definition is more accurate because estimates of effectiveness were more in agreement with results from randomized controlled trials of statin treatment.

AB - OBJECTIVE: Estimates of efficacy of drugs from clinical trials may differ from estimates in observational studies. To obtain valid results, the definition of exposure in an observational study is critical. The objective of our study was to compare different exposure definitions for assessing the effectiveness of statins.STUDY DESIGN AND SETTING: The study was performed in the Rotterdam Study, a population-based cohort study that included 7983 subjects of > or =55 years of age. We selected 3806 subjects who received antihyperlipidemic drug treatment (n=179) or had a total cholesterol > or =6.5 mmol/L at baseline. We conducted analyses with two different exposure definitions.RESULTS: Treatment with statins was assessed at baseline. The adjusted relative risk (RR) of myocardial infarction (MI) and stroke was 0.75 (95% confidence interval [CI] 0.41-1.37) and of total mortality was 1.34 (95% CI 0.66-2.74) in subjects treated with statins. We used pharmacy data, which give insight into drug use on a continuous basis. The adjusted RR of MI and stroke after 2 years of cumulative treatment was 0.63 (95% CI 0.34-1.15) and of total mortality was 0.91 (95% CI 0.59-1.39).CONCLUSION: Our results suggest that use of a time-dependent exposure definition is more accurate because estimates of effectiveness were more in agreement with results from randomized controlled trials of statin treatment.

KW - Aged

KW - Drug Administration Schedule

KW - Epidemiologic Methods

KW - Female

KW - Humans

KW - Hydroxymethylglutaryl-CoA Reductase Inhibitors

KW - Male

KW - Middle Aged

KW - Mortality

KW - Myocardial Infarction

KW - Netherlands

KW - Stroke

KW - Treatment Outcome

U2 - 10.1016/j.jclinepi.2003.07.011

DO - 10.1016/j.jclinepi.2003.07.011

M3 - Article

C2 - 15066683

SN - 0895-4356

VL - 57

SP - 237

EP - 242

JO - Journal of Clinical Epidemiology

JF - Journal of Clinical Epidemiology

IS - 3

ER -

Comparison of two methodologies to analyze exposure to statins in an observational study on effectiveness

Abstract

Keywords

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