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Article ; Online: Science fiction inspires innovation.

Macfadyen, Jean S

2014 Volume 28, Issue 3, Page(s) 161–163

MeSH term(s)	Holistic Nursing/trends ; Humans ; Inventions ; Literature ; Science
Language	English
Publishing date	2014-05
Publishing country	United States
Document type	Journal Article
ZDB-ID	639032-8
ISSN	1550-5138 ; 0887-9311
ISSN (online)	1550-5138
ISSN	0887-9311
DOI	10.1097/HNP.0000000000000029
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Article ; Online: Rosuvastatin for primary prevention among individuals with elevated high-sensitivity c-reactive protein and 5% to 10% and 10% to 20% 10-year risk. Implications of the Justification for Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) trial for "intermediate risk".

Ridker, Paul M / Macfadyen, Jean G / Nordestgaard, Børge G / Koenig, Wolfgang / Kastelein, John J P / Genest, Jacques / Glynn, Robert J

Circulation. Cardiovascular quality and outcomes

2010 Volume 3, Issue 5, Page(s) 447–452

Abstract: Background: Recent primary prevention guidelines issued in Canada endorse the use of statin therapy among individuals at "intermediate risk" who have elevated levels of high-sensitivity C-reactive protein (hsCRP). However, trial data directly addressing ...

Abstract	Background: Recent primary prevention guidelines issued in Canada endorse the use of statin therapy among individuals at "intermediate risk" who have elevated levels of high-sensitivity C-reactive protein (hsCRP). However, trial data directly addressing whether this recommendation defines a patient population in which statin therapy is effective have not previously been published. Methods and results: In the Justification for Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) trial, which demonstrated a 44% reduction in first vascular events when rosuvastatin 20 mg was compared with placebo among 17 802 primary prevention patients with LDL cholesterol <130 mg/dL and hsCRP ≥2 mg/L, 6091 participants (2525 women, 3566 men) had baseline estimated 10-year Framingham risks of 5% to 10% and 7340 participants (1404 women, 5936 men) had baseline estimated Framingham risk of 11% to 20%. In these 2 "intermediate risk" subgroups, relative risk reductions consistent with the overall trial treatment effect were observed (hazard ratio, 0.55; 95% confidence interval, 0.36 to 0.84; 5-year number needed to treat=40, P=0.005 for those with 5% to 10% risk; hazard ratio, 0.51; 95% confidence interval, 0.39 to 0.68, 5-year number needed to treat=18, P<0.0001 for those with 11% to 20% risk). Use of the Reynolds Risk Score to stratify the study population gave similar results but reclassified large numbers of individuals into lower- or higher-risk groups. The majority of women with elevated hsCRP who benefited from rosuvastatin were at 5% to 10% 10-year risk at study entry using either global risk scoring system. Conclusions: Consistent with recent evidence-based Canadian Cardiovascular Society guidelines for primary prevention, the JUPITER trial demonstrates that rosuvastatin 20 mg significantly reduces major cardiovascular events among men and women with elevated hsCRP and "intermediate risk" defined either as 5% to 10% or 10% to 20% 10-year risk.
MeSH term(s)	Aged ; C-Reactive Protein/metabolism ; Canada ; Cardiovascular Diseases/epidemiology ; Cardiovascular Diseases/physiopathology ; Cardiovascular Diseases/prevention & control ; Cholesterol, LDL/metabolism ; Evidence-Based Medicine ; Female ; Fluorobenzenes/administration & dosage ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage ; Male ; Middle Aged ; Practice Guidelines as Topic ; Primary Prevention ; Pyrimidines/administration & dosage ; Risk ; Rosuvastatin Calcium ; Sulfonamides/administration & dosage ; Treatment Outcome
Chemical Substances	Cholesterol, LDL ; Fluorobenzenes ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; Pyrimidines ; Sulfonamides ; Rosuvastatin Calcium (83MVU38M7Q) ; C-Reactive Protein (9007-41-4)
Language	English
Publishing date	2010-09
Publishing country	United States
Document type	Clinical Trial ; Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2483197-9
ISSN	1941-7705 ; 1941-7713
ISSN (online)	1941-7705
ISSN	1941-7713
DOI	10.1161/CIRCOUTCOMES.110.938118
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Zs.A 6744: Show issues

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Article ; Online: Rationale and design of the Cardiovascular Inflammation Reduction Trial: a test of the inflammatory hypothesis of atherothrombosis.

Everett, Brendan M / Pradhan, Aruna D / Solomon, Daniel H / Paynter, Nina / Macfadyen, Jean / Zaharris, Elaine / Gupta, Milan / Clearfield, Michael / Libby, Peter / Hasan, Ahmed A K / Glynn, Robert J / Ridker, Paul M

American heart journal

2013 Volume 166, Issue 2, Page(s) 199–207.e15

Abstract: Background: Inflammation plays a fundamental role in atherothrombosis. Yet, whether direct inhibition of inflammation will reduce the occurrence of adverse cardiovascular outcomes is not known.: Design: The Cardiovascular Inflammation Reduction Trial ...

Abstract	Background: Inflammation plays a fundamental role in atherothrombosis. Yet, whether direct inhibition of inflammation will reduce the occurrence of adverse cardiovascular outcomes is not known. Design: The Cardiovascular Inflammation Reduction Trial (CIRT) (ClinicalTrials.govNCT01594333) will randomly allocate 7,000 patients with prior myocardial infarction (MI) and either type 2 diabetes or the metabolic syndrome to low-dose methotrexate (target dose 15-20 mg/wk) or placebo over an average follow-up period of 3 to 5 years. Low-dose methotrexate is a commonly used anti-inflammatory regimen for the treatment of rheumatoid arthritis and lacks significant effects on lipid levels, blood pressure, or platelet function. Both observational and mechanistic studies suggest that low-dose methotrexate has clinically relevant antiatherothrombotic effects. The CIRT primary end point is a composite of nonfatal MI, nonfatal stroke, and cardiovascular death. Secondary end points are all-cause mortality, coronary revascularization plus the primary end point, hospitalization for congestive heart failure plus the primary end point, all-cause mortality plus coronary revascularization plus congestive heart failure plus the primary end point, incident type 2 diabetes, and net clinical benefit or harm. CIRT will use standardized central methodology designed to ensure consistent performance of all dose adjustments and safety interventions at each clinical site in a manner that protects the blinding to treatment but maintains safety for enrolled participants. Summary: CIRT aims to test the inflammatory hypothesis of atherothrombosis in patients with prior MI and either type 2 diabetes or metabolic syndrome, conditions associated with persistent inflammation. If low-dose methotrexate reduces cardiovascular events, CIRT would provide a novel therapeutic approach for the secondary prevention of heart attack, stroke, and cardiovascular death.
MeSH term(s)	Algorithms ; Anti-Inflammatory Agents/administration & dosage ; Anti-Inflammatory Agents/therapeutic use ; Atherosclerosis ; Cardiovascular Diseases/mortality ; Cardiovascular Diseases/prevention & control ; Diabetes Mellitus, Type 2/complications ; Humans ; Inflammation/complications ; Inflammation/drug therapy ; Metabolic Syndrome/complications ; Methotrexate/administration & dosage ; Methotrexate/therapeutic use ; Myocardial Infarction/complications ; Myocardial Infarction/drug therapy ; Research Design
Chemical Substances	Anti-Inflammatory Agents ; Methotrexate (YL5FZ2Y5U1)
Language	English
Publishing date	2013-05-03
Publishing country	United States
Document type	Journal Article ; Multicenter Study ; Randomized Controlled Trial
ZDB-ID	80026-0
ISSN	1097-6744 ; 0002-8703
ISSN (online)	1097-6744
ISSN	0002-8703
DOI	10.1016/j.ahj.2013.03.018
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Article ; Online: Vitamins E and C and medical record-confirmed age-related macular degeneration in a randomized trial of male physicians.

Christen, William G / Glynn, Robert J / Sesso, Howard D / Kurth, Tobias / Macfadyen, Jean / Bubes, Vadim / Buring, Julie E / Manson, Joann E / Gaziano, J Michael

Ophthalmology

2012 Volume 119, Issue 8, Page(s) 1642–1649

Abstract: Purpose: To test whether supplementation with alternate-day vitamin E or daily vitamin C affects the incidence of the diagnosis of age-related macular degeneration (AMD) in a large-scale randomized trial of male physicians.: Design: Randomized, ... ...

Abstract	Purpose: To test whether supplementation with alternate-day vitamin E or daily vitamin C affects the incidence of the diagnosis of age-related macular degeneration (AMD) in a large-scale randomized trial of male physicians. Design: Randomized, double-masked, placebo-controlled trial. Participants: We included 14 236 apparently healthy United States male physicians aged ≥50 years who did not report a diagnosis of AMD at baseline. Methods: Participants were randomly assigned to receive 400 international units (IU) of vitamin E or placebo on alternate days, and 500 mg of vitamin C or placebo daily. Participants reported new diagnoses of AMD on annual questionnaires and medical record data were collected to confirm the reports. Main outcome measures: Incident diagnosis of AMD responsible for a reduction in best-corrected visual acuity to ≤20/30. Results: After 8 years of treatment and follow-up, a total of 193 incident cases of visually significant AMD were documented. There were 96 cases in the vitamin E group and 97 in the placebo group (hazard ratio [HR], 1.03; 95% confidence interval [CI], 0.78-1.37). For vitamin C, there were 97 cases in the active group and 96 in the placebo group (HR, 0.99; 95% CI, 0.75-1.31). Conclusions: In a large-scale, randomized trial of United States male physicians, alternate-day use of 400 IU of vitamin E and/or daily use of 500 mg of vitamin C for 8 years had no appreciable beneficial or harmful effect on risk of incident diagnosis of AMD.
MeSH term(s)	Aged ; Ascorbic Acid/administration & dosage ; Dietary Supplements ; Double-Blind Method ; Drug Combinations ; Humans ; Incidence ; Macular Degeneration/diagnosis ; Macular Degeneration/epidemiology ; Male ; Middle Aged ; Physicians ; Risk Factors ; Surveys and Questionnaires ; United States/epidemiology ; Visual Acuity/physiology ; Vitamin E/administration & dosage ; Vitamins/administration & dosage
Chemical Substances	Drug Combinations ; Vitamins ; Vitamin E (1406-18-4) ; Ascorbic Acid (PQ6CK8PD0R)
Language	English
Publishing date	2012-04-13
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	392083-5
ISSN	1549-4713 ; 0161-6420
ISSN (online)	1549-4713
ISSN	0161-6420
DOI	10.1016/j.ophtha.2012.01.053
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Article ; Online: The VITamin D and OmegA-3 TriaL (VITAL): rationale and design of a large randomized controlled trial of vitamin D and marine omega-3 fatty acid supplements for the primary prevention of cancer and cardiovascular disease.

Manson, Joann E / Bassuk, Shari S / Lee, I-Min / Cook, Nancy R / Albert, Michelle A / Gordon, David / Zaharris, Elaine / Macfadyen, Jean G / Danielson, Eleanor / Lin, Jennifer / Zhang, Shumin M / Buring, Julie E

Contemporary clinical trials

2011 Volume 33, Issue 1, Page(s) 159–171

Abstract: Data from laboratory studies, observational research, and/or secondary prevention trials suggest that vitamin D and marine omega-3 fatty acids may reduce risk for cancer or cardiovascular disease (CVD), but primary prevention trials with adequate dosing ... ...

Abstract	Data from laboratory studies, observational research, and/or secondary prevention trials suggest that vitamin D and marine omega-3 fatty acids may reduce risk for cancer or cardiovascular disease (CVD), but primary prevention trials with adequate dosing in general populations (i.e., unselected for disease risk) are lacking. The ongoing VITamin D and OmegA-3 TriaL (VITAL) is a large randomized, double-blind, placebo-controlled, 2 x 2 factorial trial of vitamin D (in the form of vitamin D(3) [cholecalciferol], 2000 IU/day) and marine omega-3 fatty acid (Omacor fish oil, eicosapentaenoic acid [EPA]+docosahexaenoic acid [DHA], 1g/day) supplements in the primary prevention of cancer and CVD among a multi-ethnic population of 20,000 U.S. men aged ≥ 50 and women aged ≥ 55. The mean treatment period will be 5 years. Baseline blood samples will be collected in at least 16,000 participants, with follow-up blood collection in about 6000 participants. Yearly follow-up questionnaires will assess treatment compliance (plasma biomarker measures will also assess compliance in a random sample of participants), use of non-study drugs or supplements, occurrence of endpoints, and cancer and vascular risk factors. Self-reported endpoints will be confirmed by medical record review by physicians blinded to treatment assignment, and deaths will be ascertained through national registries and other sources. Ancillary studies will investigate whether these agents affect risk for diabetes and glucose intolerance; hypertension; cognitive decline; depression; osteoporosis and fracture; physical disability and falls; asthma and other respiratory diseases; infections; and rheumatoid arthritis, systemic lupus erythematosus, thyroid diseases, and other autoimmune disorders.
MeSH term(s)	Cardiovascular Diseases/prevention & control ; Dietary Supplements ; Double-Blind Method ; Fatty Acids, Omega-3/administration & dosage ; Female ; Fish Oils ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Neoplasms/prevention & control ; Primary Prevention/methods ; Retrospective Studies ; Treatment Outcome ; Vitamin D/administration & dosage ; Vitamins/administration & dosage
Chemical Substances	Fatty Acids, Omega-3 ; Fish Oils ; Vitamins ; Vitamin D (1406-16-2)
Language	English
Publishing date	2011-10-02
Publishing country	United States
Document type	Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural
ZDB-ID	2182176-8
ISSN	1559-2030 ; 1551-7144
ISSN (online)	1559-2030
ISSN	1551-7144
DOI	10.1016/j.cct.2011.09.009
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Article ; Online: Reduction in C-reactive protein and LDL cholesterol and cardiovascular event rates after initiation of rosuvastatin: a prospective study of the JUPITER trial.

Ridker, Paul M / Danielson, Eleanor / Fonseca, Francisco Ah / Genest, Jacques / Gotto, Antonio M / Kastelein, John Jp / Koenig, Wolfgang / Libby, Peter / Lorenzatti, Alberto J / Macfadyen, Jean G / Nordestgaard, Børge G / Shepherd, James / Willerson, James T / Glynn, Robert J

Lancet (London, England)

2009 Volume 373, Issue 9670, Page(s) 1175–1182

Abstract: Background: Statins lower high-sensitivity C-reactive protein (hsCRP) and cholesterol concentrations, and hypothesis generating analyses suggest that clinical outcomes improve in patients given statins who achieve hsCRP concentrations less than 2 mg/L ... ...

Abstract	Background: Statins lower high-sensitivity C-reactive protein (hsCRP) and cholesterol concentrations, and hypothesis generating analyses suggest that clinical outcomes improve in patients given statins who achieve hsCRP concentrations less than 2 mg/L in addition to LDL cholesterol less than 1.8 mmol/L (<70 mg/dL). However, the benefit of lowering both LDL cholesterol and hsCRP after the start of statin therapy is controversial. We prospectively tested this hypothesis. Methods: In an analysis of 15 548 initially healthy men and women participating in the JUPITER trial (87% of full cohort), we prospectively assessed the effects of rosuvastatin 20 mg versus placebo on rates of non-fatal myocardial infarction, non-fatal stroke, admission for unstable angina, arterial revascularisation, or cardiovascular death (prespecified endpoints) during a maximum follow-up of 5 years (median 1.9 years), according to on-treatment concentrations of LDL cholesterol (>/=1.8 mmol/L or <1.8 mmol/L) and hsCRP (>/=2 mg/L or <2 mg/L). We included all events occurring after randomisation. This trial is registered with ClinicalTrials.gov, number NCT00239681. Findings: Compared with placebo, participants allocated to rosuvastatin who achieved LDL cholesterol less than 1.8 mmol/L had a 55% reduction in vascular events (event rate 1.11 vs 0.51 per 100 person-years; hazard ratio [HR] 0.45, 95% CI 0.34-0.60, p<0.0001), and those achieving hsCRP less than 2 mg/L a 62% reduction (event rate 0.42 per 100 person-years; HR 0.38, 95% CI 0.26-0.56, p<0.0001). Although LDL cholesterol and hsCRP reductions were only weakly correlated in individual patients (r values <0.15), we recorded a 65% reduction in vascular events in participants allocated to rosuvastatin who achieved both LDL cholesterol less than 1.8 mmol/L and hsCRP less than 2 mg/L (event rate 0.38 per 100 person-years; adjusted HR 0.35, 95% CI 0.23-0.54), versus a 33% reduction in those who achieved one or neither target (event rate 0.74 per 100 person-years; HR 0.67, 95% CI 0.52-0.87) (p across treatment groups <0.0001). In participants who achieved LDL cholesterol less than 1.8 mmol/L and hsCRP less than 1 mg/L, we noted a 79% reduction (event rate 0.24 per 100 person-years; HR 0.21, 95% CI 0.09-0.52). Achieved hsCRP concentrations were predictive of event rates irrespective of the lipid endpoint used, including the apolipoprotein B to apolipoprotein AI ratio. Interpretation: For people choosing to start pharmacological prophylaxis, reduction in both LDL cholesterol and hsCRP are indicators of successful treatment with rosuvastatin.
MeSH term(s)	Aged ; Aged, 80 and over ; C-Reactive Protein/drug effects ; C-Reactive Protein/metabolism ; Cardiovascular Diseases/epidemiology ; Cardiovascular Diseases/metabolism ; Cardiovascular Diseases/prevention & control ; Cholesterol, LDL/blood ; Cholesterol, LDL/drug effects ; Disease-Free Survival ; Double-Blind Method ; Female ; Fluorobenzenes/pharmacology ; Fluorobenzenes/therapeutic use ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/pharmacology ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use ; Incidence ; Male ; Middle Aged ; Proportional Hazards Models ; Prospective Studies ; Pyrimidines/pharmacology ; Pyrimidines/therapeutic use ; Rosuvastatin Calcium ; Sensitivity and Specificity ; Statistics, Nonparametric ; Sulfonamides/pharmacology ; Sulfonamides/therapeutic use ; Treatment Outcome
Chemical Substances	Cholesterol, LDL ; Fluorobenzenes ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; Pyrimidines ; Sulfonamides ; Rosuvastatin Calcium (83MVU38M7Q) ; C-Reactive Protein (9007-41-4)
Language	English
Publishing date	2009-04-04
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	3306-6
ISSN	1474-547X ; 0023-7507 ; 0140-6736
ISSN (online)	1474-547X
ISSN	0023-7507 ; 0140-6736
DOI	10.1016/S0140-6736(09)60447-5
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Article ; Online: Science fiction inspires innovation.

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Article ; Online: Rationale and design of the Cardiovascular Inflammation Reduction Trial: a test of the inflammatory hypothesis of atherothrombosis.

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Article ; Online: Vitamins E and C and medical record-confirmed age-related macular degeneration in a randomized trial of male physicians.

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Article ; Online: The VITamin D and OmegA-3 TriaL (VITAL): rationale and design of a large randomized controlled trial of vitamin D and marine omega-3 fatty acid supplements for the primary prevention of cancer and cardiovascular disease.

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Article ; Online: Reduction in C-reactive protein and LDL cholesterol and cardiovascular event rates after initiation of rosuvastatin: a prospective study of the JUPITER trial.

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