Clinical Studies of Long-Term Estrogen Therapy in Men with Myocardial Infarction

Marmorston, Jessie; Moore, Frederick J.; Hopkins, Carl E.; Kuzma, Oliver T.; Weiner, John M.

doi:10.3181/00379727-110-27531

Cited by 75 publications

(16 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…[14][15][16] Two of the trials were small and showed no clinical benefit from the reduced serum cholesterol levels obtained. The largest trial included 275 men with previous myocardial infarction randomly allocated to either placebo or mixed conjugated equine estrogens.…”

Section: Early Drug Trialsmentioning

confidence: 99%

The Success Story of LDL Cholesterol Lowering

Pedersen

2016

Circulation Research

View full text Add to dashboard Cite

Abstract:We can look back at >100 years of cholesterol research that has brought medicine to a stage where people at risk of severe or fatal coronary heart disease have a much better prognosis than before. This progress has not come about without resistance. Perhaps one of the most debated topics in medicine, the cholesterol controversy, could only be brought to rest through the development of new clinical research methods that were capable of taking advantage of the amazing achievements in basic and pharmacological science after the second World War. It was only after understanding the biochemistry and physiology of cholesterol synthesis, transport and clearance from the blood that medicine could take advantage of drugs and diets to reduce the risk of atherosclerotic diseases. This review points to the highlights of the history of low-density lipoprotein-cholesterol lowering, with the discovery of the low-density lipoprotein receptor and its physiology and not only the development of statins as the stellar moments but also the development of clinical trial methodology as an effective tool to provide scientifically convincing evidence. (Circ Res. 2016;118:721-731.

show abstract

Section: Early Drug Trialsmentioning

confidence: 99%

The Success Story of LDL Cholesterol Lowering

Pedersen

2016

Circulation Research

View full text Add to dashboard Cite

show abstract

“…The association between total mortality and cholesterol could be stronger in a subgroup of men with a more restricted age range. However, in logistic regression analyses of total mortality and serum cholesterol for men with age ranges of 40-59, 45-59, 30-54, and 55-64 [15][16][17][18][19][20] years may be required, depending on smoking intensity and duration, before those who quit smoking achieve the risk of a comparable group that has never smoked.28 29 (10) As noted earlier in the discussion, the trial design demands that we estimate as well as we can what risk reductions one could reasonably expect to achieve as the result of a specified intervention. The strict applicability of the risk function approach to answer this question rests directly on two assumptions: First, the risk function, a descriptive summary of the observed relationship between incidence and risk factors (in the absence of intervention) in a particular population is relevant to a different population (the trial population).…”

Section: Both Risk Factorsmentioning

confidence: 99%

Implications of findings in the coronary drug project for secondary prevention trials in coronary heart disease. The coronary; drug project research group.

Canner¹,

Halperin²

1981

Circulation

View full text Add to dashboard Cite

SUMMARY The associations observed in the Coronary Drug Project between two baseline factors serum cholesterol level and number of cigarettes smoked per day and 5-year mortality in men who had a history of myocardial infarction are used to derive required sample sizes for future risk factor intervention trials in the secondary prevention of coronary heart disease. Consider a trial in which it is anticipated that the baseline cholesterol level will be 250 mg/dl in the control group and that a 20% reduction in this level to 200 mg/dl will be experienced by the treated group. Let it also be assumed that this reduction in cholesterol level will have the effect of immediately reducing the mortality risk to that corresponding to a patient with a baseline level of 200 mg/dl. Given a type I error rate, a, of 0.05 for a two-sided test, a type II error rate, fi, of 0.10, and a follow-up period of 5 years, the required size of the trial would be over 10,000 patients. A similar sample size would be required for a single-factor trial focusing on cigarette smoking cessation. The sample size might be reduced to 6000 for a two-factor trial with intervention on cholesterol and cigarette smoking simultaneously. These numbers increase two-to threefold when dropout patients and "dropin" patients (i.e., those in the control group who decide on their own to begin the intervention therapy) are considered and when other assumptions are made concerning the anticipated time required for the treatment to achieve maximum benefit with respect to the mortality or morbidity end point.MANY FACTORS -demographic, historical, clinical, biochemical, electrocardiographic and hygienic -are associated with the development of first and recurrent events of coronary heart disease (CHD). Factors that can be modified by diet, drugs or other prophylactic or therapeutic measures have been the foci during the past 2 decades for clinical trials in the primary and secondary prevention of CHD. Although the rationale for such trials lies largely in the observed association between a particular risk factor and manifestation of the disease, rather infrequently has information on the strength of such an association been used in deriving the required sample size for the trial. Rather, it has been customary to assume that the intervention will produce a 25%, 35% or even 50% reduction in the rate of CHD events compared with the control group, and then to derive the sample size required to detect such a reduction.Data from the Framingham study on the relationship of serum cholesterol level to first events of CHD have been used to determine how large the sample sizes would have to be for trials of dietary intervention in the primary prevention of CHD

show abstract

“…The evidence outlined in the introduction suggests that the higher the serum lipid level, 27 found no relation between serum lipid levels and survival in patients with coronary heart disease who were treated with estrogens.…”

Section: Survival and Serum Lipoproteinsmentioning

confidence: 99%

Studies of Male Survivors of Myocardial Infarction

et al. 1965

View full text Add to dashboard Cite

This study examined life expectancy and serum lipids in 120 men with atherosclerotic coronary heart disease. Five-year survival from onset of infarction was 79 per cent. No relationship could be demonstrated between survival and the level of the total serum cholesterol, Std. S f 0-12, 12-20, 20-100, and 100-400 lipoproteins. Survival for patients with an infarct less than 6 months before entry into the study was shorter, despite serum lipid levels the same as the remainder of the group. Although the age of onset of coronary disease is influenced by serum lipid levels, survival subsequent to infarction is not. This paradox suggests that serum lipids affect rate of atherogenesis in the long preclinical stage but in the short clinical stage other factors determine survival.

show abstract

Clinical Studies of Long-Term Estrogen Therapy in Men with Myocardial Infarction

Cited by 75 publications

References 0 publications

The Success Story of LDL Cholesterol Lowering

The Success Story of LDL Cholesterol Lowering

Implications of findings in the coronary drug project for secondary prevention trials in coronary heart disease. The coronary; drug project research group.

Studies of Male Survivors of Myocardial Infarction

Contact Info

Product

Resources

About