Harmful Effects of NSAIDs among Patients with Hypertension and Coronary Artery Disease

Among patients with high blood pressure and heart disease, researchers  sought to determine if use of anti-inflammatory  (NSAIDS such as Motrin, Advil, Aleve, Naproxyn) medications cause and increase risk of adverse events during long–term follow–up.

This was a post hoc analysis from the International Verapamil Trandolapril Study (INVEST), which enrolled patients with hypertension and coronary artery disease. During each office visit, the patients were asked if they were currently taking NSAIDs.

Patients who reported NSAID use at every visit were defined as chronic NSAID users, while all others (occasional or never users) were defined as non- NSAID users.

The primary composite outcome was all–cause death, nonfatal myocardial infarction, or nonfatal stroke.

There were 882 chronic NSAID users and 21,694 non-NSAID users.

At an average follow–up of 2.7 years, the primary outcome occurred at a rate of 4.4 events per 100 patient–years in the chronic NSAID group, versus 3.7 events per 100 patient–years in the group not taking NSAIDs. The elevated death rate  was due to an increase in cardiovascular mortality.

Source: American Journal of Medicine

Is Anything Possible at Any Age?

If you’re feeling down and tired, worried about your age, whatever the case may be, watch this inspiring video:

Special Report Part 2: Statin Drugs: Do They Increase Your Risk of Serious Side Effects?

Statin drugs are one of the most frequently prescribed medications.  Millions of Americans take these drugs to lower cholesterol levels.

Despite the belief that because they lower cholesterol levels, and provides protection against cardiovascular disease, a new study discovered they have very real, and very significant risks, and a not appropriate or safe, for everyone.  The new study found that statin drugs actually  the risk of having a certain type of stroke, caused by bleeding in the brain if you’ve already had one before. In fact, it increased the risk of a second stroke by  22 percent among patients who took cholesterol lowering drugs compared with 14 percent in those who did not.

There are two reasons why this might happen: the drugs may either lower your cholesterol too much, to the point that it increases your risk of brain bleeding, or they may affect clotting factors in your blood, increasing the bleeding risk.

While the benefits of statins for reducing the risk of heart disease and stroke appear to be well established, widespread use of statin therapy remains controversial, according to background information in the article. “A particular group of patients for whom the advisability of statin use is unclear are those at high risk for intracerebral hemorrhage,” (a stroke caused by bleeding within the brain).  The authors added,  “The reason for added concern is the increased incidence of intracerebral hemorrhage observed among subjects randomized to statin therapy in a clinical trial of secondary stroke prevention.”

“Because intracerebral hemorrhage sufferers commonly have co-morbid [co-occurring] cardiovascular risk factors that would otherwise warrant cholesterol-lowering medication, it is important to weigh the risks and benefits of statin therapy in this population,” write M. Brandon Westover, M.D., Ph.D., of Massachusetts General Hospital and Harvard Medical School, Boston, and colleagues. The researchers used a Markov decision model to evaluate these benefits and risks.

Due to the results of earlier research, simulated patients were assigned to states that correspond to disease risk and could then experience any combination of events which may lead to the increased risk of stroke or heart disease, change in quality of life or death.

“Our analysis indicates that in settings of high recurrent intracerebral hemorrhage risk, avoiding statin therapy may be preferred,” the authors write. “For lobar intracerebral hemorrhage [bleeding in the cerebrum] in particular, which has a substantially higher recurrence rate than does deep intracerebral hemorrhage, statin therapy is predicted to increase the baseline annual probability of recurrence from approximately 14 percent to approximately 22 percent, offsetting the cardiovascular benefits for both primary and secondary cardiovascular prevention.”

In the case of deep intracerebral hemorrhage, a type of stroke due to bleeding deep within the brain that has a lower risk of recurrence, the benefits and risks of statin use were more evenly balanced. “Consequently, the optimal treatment option may vary with specific circumstances,” the authors write.

The mechanism by which statins might increase the risk of hemorrhagic stroke are unknown, the authors note. The association may be due to an increased risk of brain bleeding among those with lower cholesterol levels, or potential anti-clotting properties of statins.

“In summary, mathematical decision analysis of the available data suggests that, because of the high risk of recurrent intracerebral hemorrhage in survivors of prior hemorrhagic stroke, even a small amplification of this risk by use of statins suffices to recommend that they should be avoided after intracerebral hemorrhage,” the authors conclude. “In the absence of data from a randomized clinical trial (ideally comparing various agents and doses), the current model provides some guidance for clinicians facing this difficult decision.”

Editorial: Do No Harm With Statin Treatment

“The question prompting the decision analysis model reported by Westover et al epitomizes a common conundrum faced by clinicians — the need to make a therapeutic decision for a given patient in the absence of guidance from specific, high-quality clinical trial data,” writes Larry B. Goldstein, M.D., of Duke University and Durham VA Medical Center, Durham, N.C.

“In this case, exploratory data from two clinical trials (Heart Protection Study and SPARCL) suggest, but do not prove, a statin-associated increased risk of brain hemorrhage that may reduce the overall benefit of treatment in patients with a history of cerebrovascular disease.”

The available data are “generally consistent with the conclusion of the decision analysis — the risk of statin therapy likely outweighs any potential benefit in patients with (at least recent) brain hemorrhage and should generally be avoided in this setting.”

Dr. Goldstein writes. “Until and unless there are data to the contrary, or warranted by specific clinical circumstances, the use of statins in patients with hemorrhagic stroke should be guided by the maxim of nonmaleficence — Primum non nocere.”

Statins  Protection Against Heart Attacks Question

Originally, statin drugs were prescribed for secondary prevention, meaning the prevention of a second heart attack or stroke if you’d already suffered one and had clear signs of heart disease.

However, with the 2008 publication of the Jupiter Study, in the New England Journal of Medicine the results prompted doctors to prescribe these drugs for to a majority of for primary prevention, and supposedly help lower those with certain risk factors of heart disease — although otherwise healthy — from having a heart attack or stroke in the first place.

The study claimed that statin drugs could lower the risk of heart attack by 54 percent, the risk of death from all causes by 20 percent,  the risk of needing angioplasty or bypass surgery by 46 percent, and the risk of stroke by 48 percent.

The study was funded by the maker of the drug Crestor, Astra-Zeneca.

Findings contradicted

In 2010, three reports  were published in the Archives of Internal Medicine, that contradicted and refuted the claims of the Jupiter study.

One of these studies, Cholesterol lowering, cardiovascular diseases and the rosuvastin-JUPITER controversy: a critical reappraisal,  carefully reviewed the methods and the results of the JUPITER trial and concluded that the trial was flawed. The authors wrote,  “The results of the trial do not support the use of statin treatment for primary prevention of cardiovascular diseases and raise troubling questions concerning the role of commercial sponsors.”

In part 3 we’ll take a look at other harmful side effects of these drugs.

Sources:

http://archneur.ama-assn.org/cgi/content/full/archneurol.2010.356

M. Brandon Westover; Matt T. Bianchi; Mark H. Eckman; Steven M. Greenberg. Statin Use Following Intracerebral Hemorrhage: A Decision Analysis. Archives of Neurology, 2011; DOI: 10.1001/archneurol.2010.356

Larry B. Goldstein. Statins After Intracerebral Hemorrhage: To Treat or Not to Treat. Archives of Neurology, 2011; DOI: 10.1001/archneurol.2010.349

http://www.nejm.org/doi/full/10.1056/NEJMoa0807646#t=articleTop

http://www.ncbi.nlm.nih.gov/pubmed/20585068

Special Report Part 1: Are These Frequently Prescribed Drugs Increasing Your Risk of Having A Stroke, Heart Failure, Liver Damage?

A study found that cholesterol lowering drugs, also known as statin drugs, are associated with decreased heart muscle function.

These drugs are linked to muscle damage,  weakness and a breakdown of muscle fibers resulting in the release of muscle fiber contents into the bloodstream.

Statin drugs are highly toxic because they stop the cells from producing a key vitamin, CoQ10, which is the cause of the side effects.  Relatively low doses of statin drugs such as Lipitor and Zocor effectively reduce plasma cholesterol levels. These drugs function by halt an enzyme that changes the chemical HMG-CoA to mevalonate, which is an early and rate-limiting step in cholesterol production. A branch of the mevalonate cholesterol pathway in mammalian cells leads to the formation of CoQ10. Also, high levels of statin drugs can reduce CoQ10 in the liver and compactin reduces LDL-bound CoQ10 at doses prescribed by physicians.

Unfortunately, most doctors are unaware of the cause of these complications, and could recommend taking CoQ10 supplements to their patients when prescribing these drugs.   Pharmaceutical company even has a patent on the drug and CoQ10 combination, since but never released it.

A Unique Drug Vitamin Patent

In 1989, Merck& Co., makers of lovastatin was awarded patent #4,933,165.  Tthe reasons for the combination of statin drug plus CoenzymeQ10 are as follows:

Coenzyme Q10 is a redox component in the respiratory chain and is found in all cells having mitochondria. It is thus an essential co-factor in the generation of metabolic energy and is particularly important in muscle function.

Researchers, led by Dr Karl Folkers, have measured the levels of Coenzyme Q10 in heart tissue biopsy samples taken from patients with varying stages of damage to the heart muscle.  These researchers observed decreasing tissue levels of CoQ10 with increasing severity of the symptoms of cardiac disease.

No FDA Warning

Unfortunately, the FDA doesn’t warn consumers of this dangerous and reversible side effect.

There are no official warnings in the U.S. regarding CoQ10 depletion from taking statin drugs, and many physicians fail to inform you about this problem as well. Labeling in Canada, however, clearly warns of CoQ10 depletion and even notes that this nutrient deficiency “could lead to impaired cardiac function in patients with borderline congestive heart failure.”

The majority of people who use statin cholesterol-lowering drugs are doing so because they believe lowering their cholesterol will prevent heart attacks and strokes. However, new research shows they are linked to heart muscle damage and an increased risk of having  stroke!

A study published in Clinical Cardiology determined that the heart muscle function in the control group, the participants who didn’t take a statin drug was much better compared to those who did.

Also, the usefulness of statin drugs has received tough scrutiny in recent months, and that scrutiny is well deserved.  A study published in Clinical Cardiology found that heart muscle function was “significantly better” in the control group than in those taking statin drugs! The researchers concluded:

“Statin therapy is associated with decreased myocardial [heart muscle] function.”

What’s often the end result when your heart muscle function is weakened or decreased? Heart failure!

How Statin Drugs Damage the Heart

The Clinical Cardiology study did not address causes, because statin drugs damage muscle, it is completely logical to see how the heart can be damaged by this drug, since it is a specialized muscle.

In addition to halting CoQ10 production, these drugs,  also reduce the blood cholesterol that transports CoQ10 and other fat-soluble antioxidants.

The loss of CoQ10 leads to loss of cell energy and increased free radicals which, in turn, can further damage your mitochondrial DNA, effectively setting into motion an evil circle of increasing free radicals and mitochondrial damage.

As your body gets more and more depleted of CoQ10, you may suffer from fatigue, muscle weakness and soreness, and eventually heart failure, so it is imperative if you take statin drugs that you take CoQ10 or, if you are over the age of 40, the reduced version called ubiquinol.

In our next issue, we’ll take a look at its role in increased stroke risk and other diseases.

Source:

Clinical Cardiology December 2009; 32(12):684-9

Does Zinc Help Type 2 Diabetes?

The mineral zinc, may protect diabetics (type 2-adult onset), according to a recent study conducted by researchers at the University of Michigan suggests.

According to Ayyalusamy Ramamoorthy, a professor of chemistry and of biophysics,  amylin,  a protein forms dense clumps that shut down insulin-producing cells in the pancreas, and disrupts the body’s ability to control  blood sugar levels. Zinc  may help prevent this disruption that amylin causes.

Healthy people with normal zinc levels, in the pancreas, this protein helps to regulate blood sugar leves.  It’s analog, a chemical compound similar to a nature substance — of amylin called symlin works together with  insulin to manage blood sugar levels in diabetics, Ramamoorthy says.

Amylin is helpful because zinc acts to regulate and modify it’s destruction properties.  However, when type 2 diabetics  are zinc deficient,  But in a zinc-starved cellular environment of a patient with type 2 diabetes, amylin is missing a critical regulator to  rein it in and it is free to clump together with other amylin molecules, and cause damage.

Source: Journal of Molecular Biology.

Read more: http://www.upi.com/Health_News/2011/07/01/Zinc-may-help-with-type-2-diabetes/UPI-15051309573358/print/#ixzz1R3A1lviU

Is Vitamin C A Natural Stress Buster?

A study finds in addition to benefits related to the common cold and cancer, vitamin C helps reduce both the physical and psychological effects of stress on people.

Research studies have found that vitamin C recently helps reduce both the physical and psychological effects of stress on people.

People who have high levels of vitamin C do not show the expected mental and physical signs of stress when subjected to acute psychological challenges. What’s more, they bounce back from stressful situations faster than people with low levels of vitamin C in their blood.

Earlier studies showed that vitamin C stopped cortisol release in stressed animals. It is  a hormone created by our adrenal glands in response to stress. Cortisol stimulates our “fight or flight” response to stress. That allows us to spring into action when we sense danger. Once it gets into the circulatory system, it is responsible for triggering a protective response to the entire body.

German researchers subjected 120 people to a well known stressor, public speaking, combined with solving math problems. Half of those studied were given 1,000 mg of vitamin C. Indicators of stress, include elevated levels of the stress hormone cortisol and high blood pressure were much higher in those who did not receive the vitamin supplement. The participants taking  vitamin C experienced feeling less stress when they got the vitamin.

Our bodies easily recover from a short term release of this hormone.  But continuous high levels of cortisol,  overstimulates our cells and can lead to tissue and organ damage. Thus making us more susceptible to memory loss, learning impairment, the development of chronic diseases, including heart disease, high blood pressure, diabetes, depression and cognitive impairment.

In the animal studies, vitamin C fed to rats undergoing stress not only maintained normal cortisol levels, it also stopped the  animals from exhibiting the known signs of physical and emotional stress, including loss of body weight. Those that did not receive vitamin C had t a three -fold increase  of stress hormones.

The current recommended daily amount (RDA) for vitamin C for adults is 60 milligrams—a fraction of the 1,000 mg given and found helpful in the new stress study.  Many believe, the  RDA for vitamin C is vastly underestimated.  It was set several decades ago and is based on the minimum on the amount of the vitamin needed to ward off scurvy (vitamin C deficiency disease).

Current thinking looks at vitamin C from the opposite direction: The amount needed to promote health under varying environmental conditions. That appears to be a lot greater than the amount needed to prevent deficiencies.

There’s also evidence suggesting that our ancient ancestors had a tropical diet  fruit rich diet that allowed the consumption of  large amounts of vitamin C in a.  If so, the physiological constitution we have inherited may require far larger daily doses of vitamin C than the current RDA, perhaps as high as 1,000 mg.

Vitamin C is found in fresh, uncooked fruits and vegetables, especially citrus fruits and red and green peppers. It’s also found in papayas, cantaloupes, strawberries, broccoli, Brussels sprouts, tomatoes, asparagus and parsley. Vitamin C is not present in meats, and a small amount in raw fish.

Source:

http://clinicalstudiespublishing.com/pdf/supplemental/intjsptmed2001_22.pdf

Does A Diet Rich In A Certain Oil Lower Stroke Risk?

Senior citizens consuming diet rich in olive oil have  lower risk of developing  stroke, compared to those who  do not.   For five years, French researchers at the National Institute of Health and Medical Research in Bordeaux, France studied more than 7,000 people over 65 residing in three cities, Bordeaux, Dijon and Montpellier.

The participants were divided into groups, according to their olive oil consumption, ranging from those who did not use it at all to those who used it in cooking, dressings and on bread.

During the course of the study 148 participants experienced a stroke.

When the researchers analyzed the data, after adjusting for factors such weight, physical activity, and diet, they determined that the “intensive” olive oil users had a 41 per cent lower risk of having  stroke compared to those who had no olive oil consumption.

The findings were published in Neurology, the medical publication of the Academy of Neurology.

Study author, Cecilia Samieri noted, “Our research suggests that a new set of dietary recommendations should be issued to prevent stroke in people 65 and older.

“Stroke is so common in older people and olive oil would be an inexpensive and easy way to prevent it.”

Source: Yahoo news

Can An Ancient Technique Improve Stroke Patient’s Balance and Endurance?

Researchers at  Indiana University conducted a study that taught veterans who’d experienced a stroke yoga that produced promising results.

This pilot study involved 20 participants, 1 woman and 29 men, with an average age of 66 years.  During the 8 week study, twice each week, they took part in a 1 hour yoga class,  that was significantly altered to meet the veteran’s needs.

Their balance was measured using a standard scale (Berg Balance Scale and Fullerton Advance Balance Scale), and it improved by 17 percent and 34 percent respectively by the end of the study.  Equally exciting to the study’s lead researcher Arlene Schmid, assistant professor of occupational therapy in the School of Health and Rehabilitation Sciences at Indiana University-Purdue University Indianapolis was the measurable gain in confidence the study participants had in their balance.

Dr. Schmid noted, “It also was interesting to see how much the men liked it.  They enjoyed it so much partly because they weren’t getting any other treatment.  They had already completed their rehabilitation but felt there still was room for improvement.”

The study participants performed yoga poses while seated in chairs and then progressed to standing and seated poses.  By the end of the study, they all performed poses on the floor, an achievement Dr.  Schmid  characterized as significant because many senior citizens are reluctant about working on the floor.

The therapeutic use of yoga is really taking off, according to Dr. Schmid.  She notes she has observed a small trend among occupational therapists  and physical therapists receiving yoga therapy training.

Source:

Indiana University

Can Green Tea Boost Your Immune System?

A green tea compound was recently found to have a powerful ability to increase the number of T cells that play a regulatory role, a key participant in the immune system function.

Emily Ho, of the Linus Pauling Institute, located at Oregon State University, says that this finding may be one of the reasons that green tea is beneficial in controlling inflammation, improving  immune system function and preventing cancer.

Drugs with a similar function, have be the source of great interest and research among pharmaceutical companies, but they have toxicity problems.

Dr. Ho notes, “This appears to be a natural, plant-derived compound that can affect the number of regulatory T cells, and in the process improve immune function.

“When fully understood, this could provide an easy and safe way to help control autoimmune problems and address various diseases.”

In this study, the researchers experimented with the green tea compound, EGCG, a powerful polyphenol, antioxidant with known health benefits.  EGCG is believed to be responsible for many of green tea’s beneficial properties. It possesses anti-cancer and anti-inflammatory characteristics.

The researchers found that EGCG caused a larger number of regulatory T cells to be produced.  While it’s effects weren’t as potent as drugs, but had fewer concerns about toxicity or long term use.

“EGCG may have health benefits through n epigenetic mechanism, meaning we aren’t changing the underlying DNA codes, but just influencing  what gets expressed, what cells get turned on, Dr. Ho says.

Laboratory studies done with mice, Ho said, showed that treatment with EGCG significantly increased the numbers and frequencies of regulatory T cells found in spleen and lymph notes, and in the process helped to control the immune response.

“Epigenetic regulation can be potentially exploited in generating suppressive regulatory T cells for therapeutic purposes, and is of significant clinical importance for the suppression of autoimmune diseases,” the researchers said in their study.

The research was done by scientists from OSU, the University of Connecticut, and Changwon National University in South Korea. The work was supported by the National Institute of Environmental Health Sciences and the Oregon Agricultural Experiment Station.

The study was published in Immunology Letters.

Source:

http://oregonstate.edu/ua/ncs/archives/2011/jun/mechanism-discovered-health-benefit-green-tea-new-approach-autoimmune-disease

FDA Warns of High-Grade Prostate Cancer Risk With BPH Drugs

WASHINGTON — The FDA has issued a warning of an increased risk of high-grade prostate cancer with the 5-alpha reductase inhibitors finasteride (Proscar) and dutasteride (Avodart), currently approved to treat benign prostatic hypertrophy.

The agency announced Thursday that it has updated the Warnings and Precautions section of labels for the class of drugs — which includes branded products Propecia and Jalyn under which finasteride and dutasteride are marketed for other indications — to reflect the increased risk.

“This risk appears to be low, but healthcare professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men,” the agency wrote in its safety announcement.

Avodart, Jalyn, and Proscar are approved to treat symptoms of an enlarged prostate. Propecia, at a 1-mg dose, is approved to treat hair loss in men.

The announcement follows the FDA’s Oncologic Drugs Advisory Committee’s vote of 17-0 in December that GlaxoSmithKline’s dutasteride and Merck’s finasteride should not be used to prevent prostate cancer because the drugs are linked to a higher incidence of high-grade tumors.

GlaxoSmithKline was seeking to expand dutasteride’s indication to include reducing the risk of prostate cancer in men who have had a prior negative biopsy and who have an elevated PSA.

Merck hadn’t been seeking an expanded indication, but the company wanted to update the label of finasteride to detail positive results of the Prostate Cancer Prevention Trial (PCPT), which demonstrated the drug’s chemopreventive potential.

Although the 5-alpha reductase inhibitors were shown to prevent low-risk cancers better than placebo, two large clinical trials painted a disturbing link between both drugs and an increased incidence of higher-risk prostate cancers.

Taken together, data from the trials — the PCPT and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial — showed the 5-alpha reductase inhibitors both provided a statistically significant reduction in the cumulative incidence of prostate cancer after four years (REDUCE) and seven years (PCPT) of treatment with dutasteride and finasteride, respectively.

But both trials also found an unexpected increase in the incidence of high-grade prostate cancers among men receiving the 5-alpha reductase inhibitors.

In the REDUCE trial, 29 high-grade tumors were found among patients being treated with dutasteride compared with 19 in the placebo group.

In the PCPT, there was a 26% decrease in all prostate cancers but an absolute increase of 1.3% in the incidence of high-grade tumors.

According to an FDA statistician who spoke at the December advisory committee meeting, if 200 men are treated with the drugs, it is expected that there will be one additional tumor with a Gleason score of 8 to 10.

How to handle low-grade prostate cancer is controversial in the urology community, in part because it is unknown if the low-grade tumors would ever develop into high-grade tumors, and also because the method used to originally detect prostate cancer — the PSA test — is inexact.

About five million men received a prescription for a 5-ARI between 2002 and 2009, according to the FDA.

Source:

http://www.medpagetoday.com/HematologyOncology/ProstateCancer/26977