Friday, April 6, 2018

Health Benefits and Risks of Statins - Updated

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

World-renowned researchers from the Charles E. Schmidt College of Medicine at Florida Atlantic University as well as Harvard Medical School address the possible but unproven link between statins and diabetes, as well as the implications of prescription of statins for clinicians and their patients, in a commentary published in the prestigious American Journal of Medicine. The editor-in-chief of the journal published the commentary and an editorial he wrote online ahead of print.

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.


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.


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.
Some recent reports

Edit | View | Share | Delete






And my 2014 essay:

Health Benefits of Statins Updated

First, the negatives:

Statins may cause muscle pains:

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,
and may or may not increase the risk of cataracts:
and impair memory:


And to summarize:
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."

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.
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.


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


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.
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

No comments: