Simvastatin 10mg is deemed so safe it is sold over the
counter in Great Britain
In July 2004, simvastatin 10mg (which I
take) was reclassified in the UK from a Prescription-only medicine (PoM) to a
Pharmacy (P) medicine and launched as Zocor Heart-Pro (Johnson &
Johnson.MSD Consumer Pharmaceuticals). It is the first statin in the world to
be sold without prescription. Zocor Heart-Pro is licensed to reduce the risk of
a first major coronary heart disease (CHD) event in people likely to be at
"moderate risk" of such problems. Here we review the rationale and
process for reclassifying simvastatin 10mg as an over-the-counter product.
Experts urge for wider prescription of statins in
treatment and prevention
Charles H. Hennekens, M.D, Dr.P.H., the first Sir Richard Doll professor and senior academic advisor to the dean, the Charles E. Schmidt College of Medicine at FAU; Bettina Teng, BA, a recent pre-med honors graduate of the Harriet L. Wilkes Honors College at FAU; and Marc A. Pfeffer, M.D., Ph.D., the Dzau professor of medicine at HMS, emphasize to clinicians that the risk of diabetes, even if real, pales in comparison to the benefits of statins in both the treatment and primary prevention of heart attacks and strokes.
"The totality of evidence clearly indicates that the more widespread and appropriate utilization of statins, as adjuncts, not alternatives to therapeutic lifestyle changes, will yield net benefits in the treatment and primary prevention of heart attacks and strokes, including among high, medium and low risk patients unwilling or unable to adopt therapeutic lifestyle changes," said Hennekens.
In the accompanying editorial, Joseph S. Alpert, M.D., editor-in-chief and a renowned cardiologist and professor of medicine at the University of Arizona School of Medicine, reinforces these important and timely clinical and public health challenges in treatment and primary prevention.
"There is no threshold for low density lipoprotein cholesterol below which there are no net benefits of statins either in the treatment or primary prevention of heart attacks and strokes," said Alpert.
The authors and editorialist express grave concerns that there will be many needless premature deaths as well as preventable heart attacks and strokes if patients who would clearly benefit from statins are not prescribed the drug, refuse to take the drug, or stop using the drug because of ill-advised adverse publicity about benefits and risks, which may include misplaced concerns about the possible but unproven small risk of diabetes.
"These public health issues are especially alarming in primary prevention, particularly among women, for whom cardiovascular disease also is the leading cause of death, and for whom there is even more underutilization of statins than for men," said Hennekens.
At its national meeting in November 2013, the American Heart Association, in collaboration with the American College of Cardiology, presented and published its new guidelines for the use of statins in the treatment and primary prevention of heart attacks and strokes, in which the organizations also recommended wider utilization in both treatment and prevention.
According to the United States Centers for Disease Control and Prevention, heart disease is the leading killer among men and women, causing approximately 600,000 deaths each year.
USPSTF
issues recommendations regarding use of statins for the prevention of
cardiovascular disease
The U.S. Preventive Services Task Force (USPSTF) has issued a recommendation statement regarding the use of statins for primary prevention of cardiovascular disease in adults. The report appears in the November 15 issue of JAMA.
Recommendations
The USPSTF recommends initiating use of low- to moderate-dose statins in adults ages 40 to 75 years without a history of cardiovascular disease (CVD) who have 1 or more CVD risk factors (dyslipidemia, diabetes, hypertension, or smoking) and a calculated 10-year CVD event risk of 10 percent or greater (B recommendation, indicating that there is high certainty that the net benefit is moderate, or there is moderate certainty that the net benefit is moderate to substantial).
The USPSTF recommends that clinicians selectively offer low- to moderate-dose statins to adults ages 40 to 75 years without a history of CVD who have 1 or more CVD risk factors and a calculated 10-year CVD event risk of 7.5 to 10 percent (C recommendation, indicating this should be selectively offered or provided to individual patients based on professional judgment and patient preferences. There is at least moderate certainty that the net benefit is small).
The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of initiating statin use in adults 76 years and older (I statement, indicating that evidence is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined).
To update its 2008 recommendation on screening for lipid disorders in adults, the USPSTF reviewed the evidence on the benefits and harms of screening for and treatment of dyslipidemia in adults 21 years and older; the benefits and harms of statin use in reducing CVD events and mortality in adults without a history of CVD events; whether the benefits of statin use vary by subgroup, clinical characteristics, or dosage; and the benefits of various treatment strategies in adults 40 years and older without a history of CVD events.
The USPSTF is an independent, volunteer panel of experts that makes recommendations about the effectiveness of specific preventive care services such as screenings, counseling services, and preventive medications.
Importance
Cardiovascular disease is a broad term that encompasses a number of atherosclerotic conditions that affect the heart and blood vessels, including coronary heart disease, as ultimately manifested by myocardial infarction (MI; heart attack), and cerebrovascular disease, as ultimately manifested by stroke. Cardiovascular disease is the leading cause of illness and death in the United States, accounting for 1 of every 3 deaths among adults. Statins are a class of lipid-lowering medications that reduce levels of total cholesterol and low-density lipoprotein cholesterol (LDL-C).
Potential Benefits of Statin Use
The USPSTF found adequate evidence that use of low- to moderate¬ dose statins: reduces the probability of CVD events (heart attack or ischemic stroke) and mortality by at least a moderate amount in adults ages 40 to 75 years who have 1 or more CVD risk factors and a calculated 10-year CVD event risk of 10 percent or greater; and reduces the probability of CVD events and mortality by at least a small amount in adults ages 40 to 75 years who have 1 or more CVD risk factors and a calculated 10-year CVD event risk of 7.5 to 10 percent. The USPSTF found inadequate evidence to conclude whether initiating statin use in adults 76 years and older who are not already taking a statin is beneficial in reducing the incidence of CVD events and mortality.
Potential Harms of Statin Use
The USPSTF found adequate evidence that the harms of low- to moderate-dose statin use in adults aged 40 to 75 years are small. The USPSTF found inadequate evidence on the harms of initiating statin use for the prevention of CVD events in adults 76 years and older without a history of heart attack or stroke.
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And my 2014 essay:
Health Benefits of Statins Updated
First, the negatives:
Statins may cause muscle pains:
Musculoskeletal
conditions, injuries may be associated with statin use
Potency of Statins Linked to Muscle Side Effects
Research Finds Link Between Statin Use and Progressive Muscle Disease
Potency of Statins Linked to Muscle Side Effects
Research Finds Link Between Statin Use and Progressive Muscle Disease
and Diabetes:
But taking Coenzyme Q10 may eliminate or minimize these risks:
and taking Coenzyme Q10 has other benefits as well:
and the overall risk of Diabetes may be worth it:
Patients taking
statins who were not at risk for diabetes had a 52 percent lower risk of
developing heart disease and no increased risk of developing diabetes.
Statins may cause fatigue,
depression,
and may or may not increase the risk of
cataracts:
Statin
Use Tied to Possible Boost in Cataract Risk
Statins cut cataract risk in men by 40%
Statins prevent cataracts
Statins cut cataract risk in men by 40%
Statins prevent cataracts
and impair memory:
But:
Statin
medications may prevent dementia and memory loss with longer use
High dose statins prevent dementia
High dose statins prevent dementia
And to summarize:
Statins
can lead to an increased risk of liver dysfunction, acute renal failure,
myopathy (musclepain) and cataracts.
But:
Statin use linked to few side effects
But:
Statin use linked to few side effects
Statins -- the
popular class of cholesterol-lowering drugs used widely to prevent recurrent
heart disease or stroke as well as risk for having a first cardiac or stroke
event -- appear to cause few side effects, according to new research reported
in Circulation: Cardiovascular Quality and Outcomes. Researchers conducted the
largest meta-analysis on statin side effects to date, reviewing data from 135
previous drug studies to evaluate the safety of the seven statins on the
market. They concluded "as a class, adverse events associated with statin
therapy are not common."
And:
Few symptomatic side effects reported for statins are actually attributable to statins
At
a time when the wider prescription of statins is under renewed public scrutiny,
a substantial analysis of placebo-controlled randomized trials of statins has
found that only a small minority of side effects reported by those taking the
cholesterol-lowering drugs are actually attributable to them. Almost all the
side effects reported in these trials "occurred anyway when patients were
administered placebo," say the investigators.The study, a meta-analysis
involving more than 80,000 patients and reported today in the European Journal
of Preventive Cardiology,
Now the benefits
(Red Yeast Rice -may be an alternative to statins)
Statins are available over the counter in Great Britain, without a prescription. Some advocate for even wider distribution:
Free statins with fast food could neutralize heart risk, scientists say
Wider Utilization of Statins in Prevention and Treatment of Heart Attacks and Strokes?
The available data
suggest that there is no threshold for low density lipoprotein cholesterol
below which there are no net benefits of statins. Therefore, there are new and
emerging clinical challenges to healthcare providers suggesting the need for
wider utilization of statins in the prevention of heart attacks and strokes.
A new analysis suggests
that broader statin use among adult patients may be a cost-effective way to
prevent heart attack and stroke.
But others advise caution (Although I'm not quite sure why after reading what they have to say:)
Combined data from
eight trials involving 28,161 patients that provided data on deaths from all
causes showed that statins reduced the risk of dying from 9 to 8 deaths for
every 1000 people treated with statins each year. Statins reduced fatal and
non-fatal events, including heart attack, stroke and revascularization surgery,
as well as blood cholesterol levels. However, the researchers say that the
conclusions of their review are limited by unclear, selective and potentially
biased reporting and that careful consideration should be given to patients'
individual risk profiles before prescribing statins.
Rolling back
suggestions from previous studies, a Johns Hopkins study of 950 healthy men and
women has shown that taking daily doses of a cholesterol-lowering statin
medication to protect coronary arteries and ward off heart attack or stroke may
not be needed for everyone.
General Benefits:
Conclusions: Statin
therapy is associated with significant decreases in cardiovascular events and
in all-cause mortality in women and men. Statin therapy should be used in
appropriate patients without regard to sex.
Coronary Heart Disease
People whose
cholesterol improved after one month on cholesterol-lowering drugs called
statins reduced their risk of stroke and heart attack. For each 10-percent
decrease in LDL, or low-density lipoprotein “bad” cholesterol, the risk of
stroke was reduced by four percent and the risk of heart attack was reduced by
seven percent. The average decrease in LDL cholesterol after one month on
atorvastatin was 53 percent.
Combination of statin and omega-3 fatty acid provides cardioprotective effects
Coronary
atherosclerosis – a hardening of the arteries due to a build-up of fat and
cholesterol – can lead to heart attacks and other forms of coronary heart
disease (CHD). Lowering low-density lipoprotein (LDL), or "bad"
cholesterol, reduces the risk of CHD, and researchers found that lowering LDL
beginning early in life resulted in a three-fold greater reduction in the risk
of CHD than treatment with a statin started later in life, according to
research presented today at the American College of Cardiology's 61st Annual
Scientific Session.
Over the long term,
treatment with cholesterol-lowering statins reduces the rate of mortality and
cardiovascular events such as heart attack, for people with and without heart
disease. Still, it is unclear whether these drugs take effect rapidly when the
risk of these dire events is highest. A systematic review of randomized
controlled trials found that death, stroke and heart attack did not decline
significantly in the first few months after starting the drugs, but indicated
that statins might reduce the likelihood of severe chest pain during this
period and are quite safe in any case. Adverse effects were “very rare” in both
statin and control groups, Briel said. Signs of muscle damage—the most severe
risk of statin therapy—were limited to patients in a single study who received
a particular statin, simvastatin, at a dosage known to carry a relatively high
risk of this side effect.
Statins reduce CV events in CAD patients with very low LDL-C
Statins accelerate depletion of plaque in arteries
Statins: Reduced Risk of Recurrent Cardiovascular Events in Men, Women
Most At-Risk Patients Don’t Adhere To Statin Treatment, Despite Real Benefits
A new study from
North Carolina State University shows that the vast majority of patients at
high risk for heart disease or stroke do a poor job of taking statins as
prescribed. That’s especially unfortunate, because the same study shows that
taking statins can significantly increase the quality and length of those
patients’ lives.
“We found that only 48 percent of patients who have been prescribed statins are taking their prescribed dose on a regular basis after one year – and that number dips to approximately 27 percent after 10 years,” says Jennifer Mason, a Ph.D. student at NC State and lead author of a paper describing the study. Statins are a component of many current cardiovascular medical treatment guidelines. They lower cholesterol levels and may significantly reduce the risk of heart attack and stroke, particularly in patients that are considered to be at high risk.
The researchers also found that, for high-risk patients, high adherence to a prescribed statin regimen may increase quality-adjusted life years (QALYs) by as much as 1.5 years compared to low adherence – and up to two years compared to not taking statins at all. Low adherence means a patient is taking the statins irregularly or at less than the prescribed dosage. QALYs are established metrics for measuring the effect of health conditions, such as heart disease and stroke, on quality of life.
“We found that only 48 percent of patients who have been prescribed statins are taking their prescribed dose on a regular basis after one year – and that number dips to approximately 27 percent after 10 years,” says Jennifer Mason, a Ph.D. student at NC State and lead author of a paper describing the study. Statins are a component of many current cardiovascular medical treatment guidelines. They lower cholesterol levels and may significantly reduce the risk of heart attack and stroke, particularly in patients that are considered to be at high risk.
The researchers also found that, for high-risk patients, high adherence to a prescribed statin regimen may increase quality-adjusted life years (QALYs) by as much as 1.5 years compared to low adherence – and up to two years compared to not taking statins at all. Low adherence means a patient is taking the statins irregularly or at less than the prescribed dosage. QALYs are established metrics for measuring the effect of health conditions, such as heart disease and stroke, on quality of life.
Cancer:
Prolonged statin use may lower risk of lung cancer death
Lung cancer patients who used statins in the year prior to a lung cancer diagnosis or after a lung cancer diagnosis had a reduction in the risk of death from the disease.
Journal in Which the Study was Published: Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research
Background:
Recently there has been much interest in the potential for exploring new therapeutic uses for existing drugs, in part, because existing medications are relatively inexpensive and have known side effect profiles, according to Cardwell. This study investigated whether lung cancer patients who received statins had improved cancer outcomes.
How the Study Was Conducted: Cardwell and colleagues used data from nearly 14,000 patients newly diagnosed with lung cancer between 1998 and 2009 from English cancer registry data. They gathered the patients' prescription records from the U.K. Clinical Practice Research Datalink and mortality data up to 2012 from the Office of National Statistics.
Results: Among patients who survived at least six months after a diagnosis, those who used statins after a lung cancer diagnosis had a statistically nonsignificant 11 percent reduction in lung cancer-specific deaths. Among those who used at least 12 prescriptions of statins there was a statistically significant 19 percent reduction in lung cancer-specific deaths, and among those who used lipophilic statins such as simvastatin there was a 19 percent reduction in lung cancer-specific deaths as well.
Among all patients in the study, those who used statins in the year before a lung cancer diagnosis had a statistically significant 12 percent reduction in lung cancer-specific deaths.
Cardwell noted that the outcomes were not different between non-small cell lung cancer patients and small cell lung cancer patients in this study.
Author Comment:
In an interview, Cardwell said, "Our study provides some evidence that lung cancer patients who used statins had a reduction in the risk of death from lung cancer. The magnitude of the association was relatively small and, as with all observational studies, there is the possibility of confounding--meaning that simvastatin [a type of statin] users may have differed from simvastatin nonusers in other ways that could have protected them from death from cancer, for which we could not correct. However, this finding is worthy of further investigation in observational studies. If replicated in further observational studies, this would provide evidence in favor of conducting a randomized, controlled trial of simvastatin in lung cancer patients. We hope to conduct a similar analysis in a large cohort of lung cancer patients from Northern Ireland."
Statins Tied To
Reduced Cancer Deaths
A new study from Denmark found that people who regularly used statins to lower cholesterol and then received a cancer diagnosis were 15% less likely to die from cancer or any other cause than cancer patients who had never used statins.
Statins
may protect against esophageal cancer
Men who take statins are less likely to die from prostate cancer
Statin and Aspirin Use Linked to Improved Survival in Women with Endometrial Cancer
Statins = improved survival in inflammatory breast cancer
Statin use associated with statistically significant reduction in colorectal cancer
Statins associated with lower cancer recurrence following prostatectomy
Low Cholesterol=Lower Prostate Cancer Risk
Statins Can Help Prevent Skin Cancer
Men who take statins are less likely to die from prostate cancer
Statin and Aspirin Use Linked to Improved Survival in Women with Endometrial Cancer
Statins = improved survival in inflammatory breast cancer
Statin use associated with statistically significant reduction in colorectal cancer
Statins associated with lower cancer recurrence following prostatectomy
Low Cholesterol=Lower Prostate Cancer Risk
Statins Can Help Prevent Skin Cancer
Two large
cardiovascular clinical trials have demonstrated a significant reduction in
skin cancer among patients taking lipid-lowering drugs. Although clinical data
do not consistently show a decreased risk of skin cancer with statin use,
various human trials and preclinical studies suggest that statins may have
chemopreventive activity against skin cancer.
Other Specific Benefits:
Many Statin Benefits
Fitness + Statins Lowers Mortality Risk
Benefits of statin therapy include eliminating blood clots as well as lowering lipids
Pneumonia Death Rate Lower Among People Who Take Statins
Reduced glaucoma risk in patients who take statins
Statin significantly reduces lung damage in severe abdominal sepsis
Statin therapy associated with lower risk of pancreatitis
Statin use appears associated with modest reduction in Parkinson's disease risk
Statins = reduced mortality in flu patients
Statins May Boost Your Gums' Health, Too
Statins may prevent pneumonia
Statins may slow human aging
Statins may slow prostate growth
Statins reduce deaths from infection and respiratory illness
Those taking statins when admitted to the hospital with serious head injuries were 76 percent more likely to survive
Chronic Statin Therapy Associated With Reduced Postoperative Mortality
Cholesterol-lowering statins boost bacteria-killing cells
Regular statin use is associated with a reduced risk of developing rheumatoid arthritis
Statins decrease risk of clot-related diseases
Statins may slow progression of multiple sclerosis
Statins fight gallstones
More Evidence Statins Fight Parkinson's
Statin drugs may have a protective effect in the prevention of liver cancer and lead to a reduction in the need for gallbladder removals
Statins can protect against Alzheimer's disease
Statins reduce loss of lung function, keeping old lungs young - even in smokers
Statin Use Benefits Multiple Areas of Urologic Health
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