Cardiovascular Outcomes During 6.8 Years of Hormone Therapy: Heart and Estrogen/Progestin Replacement Study Follow-Up (HERS II)

Grady, Deborah; Herrington, David; Bittner, Vera; Blumenthal, Roger S.; Davidson, Michael; Mark, Daniel B.; Hsia, Judith; Hulley, Stephen B.; Herd, Alan; Khan, Steven S.; Newby, L. Kristin; Waters, David D.; Vittinghoff, Eric; Wenger, Nanette K.

doi:10.1097/00006254-200210000-00020

Cited by 532 publications

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“…[115][116][117][118] A range of retrospective "explanations" were proposed for this apparent discrepancy with the results in the observational studies (e.g. that the wrong type of adjustment had been used or the timing of initiating treatment mattered), 119,120 but these were eventually refuted.…”

Section: Biases Due To Differences In Underlying Risks Of Health Outcmentioning

confidence: 99%

Interpretation of the evidence for the efficacy and safety of statin therapy

et al. 2016

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General rightsThis document is made available in accordance with publisher policies. Please cite only the published version using the reference above. Full terms of use are available: http://www.bristol.ac.uk/pure/about/ebr-terms SummaryThis review is intended to help clinicians, patients and the public make informed decisions about statin therapy for the prevention of heart attacks and strokes. It explains how the evidence that is available from randomized controlled trials yields reliable information about both the efficacy and safety of statin therapy. In addition, it discusses how claims that statins commonly cause adverse effects reflect a failure to recognise the limitations of other sources of evidence about the effects of treatment.Large-scale randomized trial evidence shows that statin therapy reduces the risk of heart attacks, ischaemic strokes and coronary revascularization procedures ("major vascular events") by about one quarter for each mmol/L reduction in low density lipoprotein (LDL) cholesterol during each year (after the first) that it continues to be taken. The absolute benefits of statin therapy depend on an individual's absolute risk of occlusive vascular events and the absolute reduction in LDL cholesterol that is achieved. For example, lowering LDL cholesterol by 2 mmol/L (77 mg/dL) with an effective low-cost statin regimen (e.g. atorvastatin 40 mg daily, costing about £2 per

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Section: Biases Due To Differences In Underlying Risks Of Health Outcmentioning

confidence: 99%

Interpretation of the evidence for the efficacy and safety of statin therapy

et al. 2016

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“…There was no difference in SCD events between the hormone replacement (E+P) and placebo arms (67 vs. 69, respectively), while there was a statistically significant doubling of NFVA in the E+P arm (33 vs. 17, p=0.02). 22 SNP analysis-There were no differences in baseline characteristics by β1AR49, β1AR389, β2AR16, or β2AR27 genotype (Tables 3A and 3B). Allele frequencies for each SNP are shown in Table 4.…”

Section: Hers Cohort Scd Studymentioning

confidence: 94%

“…The HERS randomized controlled trial was conducted over 4.1 years, after which women were observed for an additional 2.7 years on average (HERS II). 22 Records of all hospitalizations were reviewed, and an independent morbidity and mortality subcommittee blinded to treatment assignment adjudicated all suspected outcome events, including SCD and non-fatal VA requiring resuscitation (NFVA). SCD outcome was defined as an unexpected, non-traumatic, non-self-inflicted fatality in participants who died within one hour of the onset of terminal symptoms; NFVA was adjudicated as VF and unstable VT that required electrical cardioversion.…”

Section: Study Populationsmentioning

confidence: 99%

Common ß-adrenergic receptor polymorphisms are not associated with risk of sudden cardiac death in patients with coronary artery disease

et al. 2008

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“…9 At 6.8-year follow-up of HERS, HRT did not reduce cardiovascular events, insignificantly increased all-cause mortality 10%, significantly increased venous thromboembolism by 208% (95% CI: 1.28-3.40), significantly increased biliary tract surgery by 48% (95% CI: 1.12-1.95), and insignificantly increased any cancer by 19%. 10 The estrogen plus progestin component of the WHI (Women's Health Initiative) study included 16 608 healthy postmenopausal women age 50 to 79 years with an intact uterus who were randomized to estrogen plus progestin or to placebo. 11 At 5.2-year follow-up, this component of the WHI study was discontinued by the data safety and monitoring committee because the excess risk of events included in the global index was 19 per 10 000 person-years.…”

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Evidence‐Based Medicine Should Be Practiced for Primary Prevention and Secondary Prevention of Cardiovascular Disease

Aronow

2012

Clinical Cardiology

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Evidence-based medicine should be practiced for primary prevention and secondary prevention of cardiovascular disease. Randomized clinical trials have demonstrated, on numerous occasions, no difference or a worsening of clinical cardiovascular outcomes, whereas observational studies or studies relying on surrogate end points have shown a significant reduction in cardiovascular events by a therapeutic intervention. This editorial will discuss a few of these studies.Numerous studies have demonstrated that patients with complex ventricular arrhythmias associated with heart disease are at increased risk for new coronary events and for sudden cardiac death. 1 Antiarrhythmic drugs were used in widespread practice to suppress ventricular arrhythmias to prevent sudden cardiac death prior to CAST I (Cardiac Arrhythmia Suppression Trial I). 2 In fact, recruitment for this study was slowed because physicians were reluctant to allow their patients to be randomized because of a 50% chance of their patients being randomized to placebo.CAST I was a prospective, double-blind, randomized study in survivors of myocardial infarction with asymptomatic or mildly symptomatic ventricular arrhythmias, in which 730 patients were randomized to encainide or flecainide and 725 patients to placebo. 2 Adequate suppression of ventricular arrhythmias by encainide or flecainide was required before randomization. Despite adequate suppression of ventricular arrhythmias by encainide or flecainide, at 10-month followup encainide and flecainide significantly increased mortality from arrhythmia or cardiac arrest (relative risk [RR]: 3.5, 95% confidence interval [CI]: 1.7-8.5) and significantly increased all-cause mortality (RR: 2.5; 95% CI: 1.6-4.5). 2 Numerous studies have demonstrated that a low serum high-density lipoprotein (HDL) cholesterol is a risk factor for coronary artery disease (CAD). 3,4 We showed by multivariate analysis at 40-month follow-up of 664 older men and at 48-month follow-up of 1488 older women that there was a 1.70 times higher probability of developing new coronary events in men and a 1.95 times higher probability of developing new coronary events in women for a decrement of 10 mg/dL of serum HDL cholesterol. 4 However, does increasing serum HDL cholesterol by drug therapy reduce cardiovascular events? In aThe author has no funding, financial relationships, or conflicts of interest to disclose. randomized double-blind study of 15 067 patients at high cardiovascular risk, patients were randomized to torcetrapib plus atorvastatin or atorvastatin. 5 At 12-month follow-up, patients treated with torcetrapib had a 72% increase in serum HDL cholesterol. However, patients treated with torcetrapib had a 25% increase in cardiovascular events (P = 0.001) and a 58% increase in all-cause mortality (P = 0.006). 5 Compared with simvastatin plus placebo, the combination of fenofibrate plus simvastatin did not reduce the incidence of fatal cardiovascular events, nonfatal myocardial infarction, or nonfatal stroke at 4.7-year follow-up in 5518...

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Cardiovascular Outcomes During 6.8 Years of Hormone Therapy: Heart and Estrogen/Progestin Replacement Study Follow-Up (HERS II)

Cited by 532 publications

References 0 publications

Interpretation of the evidence for the efficacy and safety of statin therapy

Interpretation of the evidence for the efficacy and safety of statin therapy

Common ß-adrenergic receptor polymorphisms are not associated with risk of sudden cardiac death in patients with coronary artery disease

Evidence‐Based Medicine Should Be Practiced for Primary Prevention and Secondary Prevention of Cardiovascular Disease

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