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Raloxifene and risk for stroke based on the framingham stroke risk score.
Am J Med. 2009 Aug; 122(8):754-61.AJ

Abstract

PURPOSE

Raloxifene reduces vertebral fracture and invasive breast cancer risks, but increases fatal strokes in postmenopausal women at increased coronary risk. We assessed whether this risk is concentrated in postmenopausal women already at high stroke risk.

METHODS

Raloxifene Use for The Heart (RUTH) enrolled 10,101 postmenopausal women (mean age 67 years) with or at increased coronary heart disease risk; Multiple Outcomes of Raloxifene Evaluation (MORE) enrolled 7705 osteoporotic postmenopausal women (mean age 66 years). A Framingham Stroke Risk Score (FSRS) was calculated for all women with no prior cerebrovascular events (n = 16,858). The validity of the FSRS was assessed in the placebo groups, and then raloxifene-associated stroke risk was analyzed by FSRS subgroups.

RESULTS

FSRS predicted an increased stroke risk in the placebo group of both clinical trials. There was no difference in the incidence of nonfatal strokes between the raloxifene and placebo groups in MORE or RUTH, regardless of baseline Framingham stroke risk. In RUTH, women with FSRS <13 showed no increase in raloxifene-associated fatal stroke risk (hazard ratio [HR] 1.08; 95% confidence interval [CI], 0.49-2.37). Those with FSRS >or=13 had a 75% increased risk of raloxifene-associated fatal stroke (HR 1.75; 95% CI, 1.01-3.02; interaction P = .33). In MORE, where 80% of women had a FSRS <13, no increase in fatal (HR 0.57; 95% CI, 0.19-1.68) stroke risk was observed.

DISCUSSION

Risk of fatal stroke associated with raloxifene was greater in women at high stroke risk. These results might be useful for identifying postmenopausal women at high risk of first stroke who should avoid raloxifene therapy.

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Authors+Show Affiliations

Barrett-Connor E
Division of Epidemiology, Department of Family and Preventive Medicine, University of California, San Diego, La Jolla, Calif 92093-0607, USA. ebarrettconnor@ucsd.edu
Cox DA
No affiliation info available
Song J
No affiliation info available
Mitlak B
No affiliation info available
Mosca L
No affiliation info available
Grady D
No affiliation info available

MeSH

AgedBone Density Conservation AgentsBreast NeoplasmsFemaleHumansMiddle AgedOsteoporosis, PostmenopausalRaloxifene HydrochlorideRandomized Controlled Trials as TopicRisk AssessmentRisk FactorsSpinal FracturesStroke

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19540454

Citation

Barrett-Connor, Elizabeth, et al. "Raloxifene and Risk for Stroke Based On the Framingham Stroke Risk Score." The American Journal of Medicine, vol. 122, no. 8, 2009, pp. 754-61.
Barrett-Connor E, Cox DA, Song J, et al. Raloxifene and risk for stroke based on the framingham stroke risk score. Am J Med. 2009;122(8):754-61.
Barrett-Connor, E., Cox, D. A., Song, J., Mitlak, B., Mosca, L., & Grady, D. (2009). Raloxifene and risk for stroke based on the framingham stroke risk score. The American Journal of Medicine, 122(8), 754-61. https://doi.org/10.1016/j.amjmed.2009.01.033
Barrett-Connor E, et al. Raloxifene and Risk for Stroke Based On the Framingham Stroke Risk Score. Am J Med. 2009;122(8):754-61. PubMed PMID: 19540454.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Raloxifene and risk for stroke based on the framingham stroke risk score. AU - Barrett-Connor,Elizabeth, AU - Cox,David A, AU - Song,Jingli, AU - Mitlak,Bruce, AU - Mosca,Lori, AU - Grady,Deborah, Y1 - 2009/06/18/ PY - 2008/10/28/received PY - 2009/01/23/revised PY - 2009/01/31/accepted PY - 2009/6/23/entrez PY - 2009/6/23/pubmed PY - 2009/8/19/medline SP - 754 EP - 61 JF - The American journal of medicine JO - Am J Med VL - 122 IS - 8 N2 - PURPOSE: Raloxifene reduces vertebral fracture and invasive breast cancer risks, but increases fatal strokes in postmenopausal women at increased coronary risk. We assessed whether this risk is concentrated in postmenopausal women already at high stroke risk. METHODS: Raloxifene Use for The Heart (RUTH) enrolled 10,101 postmenopausal women (mean age 67 years) with or at increased coronary heart disease risk; Multiple Outcomes of Raloxifene Evaluation (MORE) enrolled 7705 osteoporotic postmenopausal women (mean age 66 years). A Framingham Stroke Risk Score (FSRS) was calculated for all women with no prior cerebrovascular events (n = 16,858). The validity of the FSRS was assessed in the placebo groups, and then raloxifene-associated stroke risk was analyzed by FSRS subgroups. RESULTS: FSRS predicted an increased stroke risk in the placebo group of both clinical trials. There was no difference in the incidence of nonfatal strokes between the raloxifene and placebo groups in MORE or RUTH, regardless of baseline Framingham stroke risk. In RUTH, women with FSRS <13 showed no increase in raloxifene-associated fatal stroke risk (hazard ratio [HR] 1.08; 95% confidence interval [CI], 0.49-2.37). Those with FSRS >or=13 had a 75% increased risk of raloxifene-associated fatal stroke (HR 1.75; 95% CI, 1.01-3.02; interaction P = .33). In MORE, where 80% of women had a FSRS <13, no increase in fatal (HR 0.57; 95% CI, 0.19-1.68) stroke risk was observed. DISCUSSION: Risk of fatal stroke associated with raloxifene was greater in women at high stroke risk. These results might be useful for identifying postmenopausal women at high risk of first stroke who should avoid raloxifene therapy. SN - 1555-7162 UR - https://www.unboundmedicine.com/medline/citation/19540454/Raloxifene_and_risk_for_stroke_based_on_the_framingham_stroke_risk_score_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-9343(09)00333-7 DB - PRIME DP - Unbound Medicine ER -