There has been considerable press recently on the cholesterol lowering medicine Zetia, also known as Ezetimibe, since the release of a recent study known as the ENHANCE study.  This study compared the cholesterol medication simvastatin, also known as Zocor, to the combination of Zocor and Zetia used together.  It looked out how effective each drug was in lowering cholesterol, how safe each drug combination was, and also measured the difference in the thickness of cholesterol blockages in arteries in the neck arteries during the study.  The aim was to see if the additional cholesterol lowering achieved by the addition of Zetia to Zocor could cause shrinking of the amount of cholesterol blockages as measured by ultrasound of these neck arteries.  The end result of the study was that the thickness of these blockages was not statistically different with either of these two drug treatments. 

However, this study looked at a very rare patient population who have a genetic disease where they have extremely high cholesterol levels that exist from a very young age.  This study lowered cholesterol to levels that are higher than most patients have prior to getting started on cholesterol medication.  Most patients with this disorder are on multiple drugs to lower there cholesterol, whereas the patients in this study were taken off their previous medications prior to being enrolled, and placed on only one drug.  Therefore, it is not at all clear what this study tells us, since most patients in this study acheived cholesterol levels that were still extremely higher than standard treatment targets.  What we can learn from this study is that the addition of Zetia to treatment with the statin Zocor lowered cholesterol an additional 17%.  Additionally, the rate of side effects was no different, and the rate of heart attack or stroke was similar in both groups.

Since no study ever done to date has ever shown that having higher cholesterol levels is more favorable, we cannot accept the conclusion being touted by the press.   In this case, they have been reporting that Zetia is not an effective drug and doctors are overprescribing it.  However, the applicability of this study to the general population is very limited, and the design of this trial has too many limitations to make any meaningful conclusions.   Future studies are needed to determine if the addition of Zetia to other therapy for high cholesterol can result in less heart attacks and strokes.

This is another crucial example of the need for patients to be getting medical advice from their physicians, rather than from the newspapers. 

Kastelstein et al: New England Journal of Medicine April 3, 2008

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health has stopped one treatment within a large, ongoing North American clinical trial of diabetes and cardiovascular disease 18 months early due to concerns about a higher risk of death seen in a trial called the ACCORD trial.   Prior studies suggested that reducing blood sugar to levels found in non-diabetic adults may reduce the rate of cardiovascular diseases among those with diabetes. However, a randomized clinical trial was needed to determine whether that hypothesis is accurate.

The ACCORD findings are important, but will not change therapy for most patients with type 2 diabetes. Few patients with high cardiovascular risk like those studied in ACCORD are treated to blood sugar levels as low as those tested in this study, to levels of hemoglobian A1C of less than 6.0.  However, this study data contradicts findings of another large ongoing trial called the Advance trial.  This trial which is still in progress, and is twice as large as the ACCORD trial, was recently scrutinized because of these findings.  They are using the same aggressive target levels for blood sugar lowering and did not find any evidence of danger at all in their study.  This study is more than 99% complete.

At the present time, most medical professionals are not sure how to interpret the findings of this study, and are not recommending any changes in diabetes management at the present time.

Reference: National Institute of Health Press Release February 6, 2008.

A recent study published in the journal Health Affairs reported what anyone who has recently gone to an emergency room already knows; waiting times to be seen are increasing. The average wait time has increased by 36 percent or 30 minutes per patient. Fully one quarter of patients wait 50 minutes or longer. This increase applies to patients with acute emergencies - such as heart attacks (where wait times have gone on average from 8 minutes to 20 minutes from 1997 to 2004) as well as for less urgent conditions. Blacks, Hispanics, and woman also wait longer. The main reason for the delays the authors say is the fact that hundreds of Emergency Departments across the country have closed - at the same time that the elderly population has increased. This in addition to a lack of inpatient bed space has created a log jam in the ER. The solution to the problem will not be simple - since so many factors come together to cause it. Interestingly, patients with insurance wait just a long as patients without it. The authors liken the ER to a NASCAR pit-crew - “We’re designed to immediately assess, stabilize and move patients [to treatment],” said Kellermann. Without the open space, he said, the ER health-care team wastes valuable time moving patients and equipment around to try to get to the next patient.”

Health Affairs Web Exclusive, January 15, 2008

Cognitive impairment is the decline in higher level thought processes of the brain, such as the ability to interpret information, make decisions or memory function.  The risk of cognitive decline increases with advanced age.  In the early stages of this process, this is only detected with careful testing with specially designed mental exams.

This population based study by investigators at Columbia University College of Physicians and Surgeons found that a history of high blood pressure is related to a higher risk of developing mild cognitive impairment.  Approximately 1 out of 100 elderly individuals without dementia develop mild cognitive impairment each year.  Of this group, about 10% progress each year to having full blown dementia.  This compares to about only 1 to 2% of elderly individuals without mild cognitive impairment on brain testing that develop full blown dementia each year. 

This study suggests that prevention and treatment of high blood pressure may provide important protection on the development of cognitive impairment and dementia.

Reference: Reitz C et al, Archives of Neurology 2007;64(12):1734-40.

Physical activity is a well accepted treatment when prescribed for patients after orthopedic surgery or for rehabilitation after a stroke.  Physical activity is also felt to reduce the risk of developing certain chronic diseases such as diabetes and cardiovascular disease.  However, despite these accepted benefits, the percentage of adults worldwide who are physically inactive remains very high.

This paper reviewed published studies in the medical literature from 2004 to 2007 to determine the amount of benefit that can be obtained from physical activity and exercise on the reduction of several major chronic diseases.  The strongest evidence existed for the reduction of colon cancer, breast cancer, diabetes and cardiovascular diseases.  The maximal magnitude of risk reduction reported was 75% for breast cancer, 49% for heart and cardiovascular related diseases, 22% for colorectal cancer and 35% reductions in diabetes.  Physical activity also provided significant reductions in weight gain that is associated with aging.  Additional findings that were discovered are that physical activity reduces fall-related injuries, depression and emotional distress.

The conclusion of this literature review showed that physical activity offers significant reductions on many chronic diseases, and as a result it correlates with living longer and healthier.

Reference: Kruk J. Asian Pacific Journal of Cancer Prevention, 2007 Jul-Sep;8(3):325-338.

Drugs known collectively as “statins” are widely prescribed for lowering cholesterol (for example, Lipitor) and their benefits in reducing the risk of heart attacks is generally well accepted. However, a recent study conducted in veterans showed that patients on such drugs had a 25% lower incidence of cancer. This was a large study (about 26,000 patients with an average age of 66.5 years in both the control (no statins) and the experimental (statins) groups) conducted over 2 years. “After adjusting the data for the effects of age, weight, other diseases, smoking, cholesterol levels, and history of colon cancer screening tests, the risk developing any type of cancer was reduced by 26 percent in the statin group.” The cancers reduced included colorectal, lung, and prostate. Higher dosage levels also correlated with lower cancer risk. The investigators conclude that more studies need to be preformed to confirm this association but it is clearly an encouraging result.

J Natl Cancer Inst. 2008 Jan 8

A recent study reported in the Journal of the American College of Cardiology has linked the incidence of heart attacks  to people with anxiety disorders.   It has been known  for some time that Type A personalities with personality traits of aggression and hostility have had a higher incidence of heart disease and heart attacks, but now researchers in the US found that fearful, anxious people were up to 40 % more likely to suffer a heart attack compared to the general population.  The findings were more common in older men with chronic symptoms of anxiety even after other variables such as smoking and obesity were factored in.   The findings were based on analysis of  data on 735 men who scored high in anxiety tests and who were followed over a 12 year period starting when they were healthy.     The researchers do point out that anxiety is treatable and that this risk may be mitigated.

 Reference:  Shen et al,  American Journal of Cardiology.   2008 Jan.

A recent study published in the journal, Epidemiology, suggests that people who live in certain neighbourhoods have an increased chance of developing insulin resistance and subsequent type 2 Diabetes. People who lived in neighbourhoods “more conducive” to exercise and healthy diet had less insulin resistance. These were hypothesized to be ones “with safe, walkable streets, or near gyms and parks”. Similarly, having neighborhood markets that sell high-quality fruits, vegetables and other healthy foods may promote healthier eating. 2026 adults living in the Baltimore, MD, New York, NY, and Forsyth County, NC were studied and were asked questions in two separate surveys. One about their medical history, weight, and family history, and the other about how exercise and healthy eating friendly their neighbourhood was. This study suggests that more farmers’ markets and restaurants serving healthier food need to be in poorer neighbourhoods as a well as sidewalks and parks more conducive to walking and exercising.

Epidemiology. 2008 Jan;19(1):146-157

Concerns regarding the link between childhood vaccinations and the development of autism have existed for some time.  It has been suggested that the preservative Thimerosal, which contains mercury, that had been prevalent in vaccines prior to 2000 may be a causative factor.  However, this relationship has never been proven, and no careful studies have been performed to substantiate this concern.

A careful observational study was performed by the California Department of Developmental Services where they studied trends in the diagnosis of autism from January 1995 to March 2007.  Since 1999, significant efforts to eliminate Thimerosal from vaccines occurred, allowing differences in the rate of development of autism to be evaluated.  This study found that in children ages 3 to 12, the rates of autism have continued to rise, despite the elimination of Thimerosal from vaccines.

This study supports the opinion of most experts that Thimerosal exposure from vaccines is not linked to the development of autism.  Additionally, it has been suggested that the rising incidence of autism may be merely due to the fact that it is a more recognized entity over the last decade, hence it is being diagnosed and reported with more frequency over this time.  This theory suggests that it may have been present in a similar frequency, but just underdiagnosed in earlier decades.

Reference: Schecter R et al, Archives of General Psychiatry 2008;65(1):19-24.

A recent study published in the Journal of General Internal Medicine found that almost 50% of internists polled in Chicago have prescribed their patients placebos during their career. Placebos are pill containing no actual medicine, just an inert substance like Dextrose (”sugar pills”). Many of those MD’s stated that they told their patients that they were prescribing them something that “may” help, and some others told them “it is a medication”. This study shows, the authors conclude, shows that MD’s believe in the mind-body relationship and the placebo affect as an adjunctive method to treat patients’ ailments. The hallmark of a placebo is that it may or may not work, but will do no harm. Although their ethical use in modern medicine is debated (except in controlled randomise trials), most of the 466 (96%) responding internists believed in the power of placebos to help patients - along with meditation, yoga, good social support, prayer, relaxation techniques, and others.

J Gen Intern Med. 2008 Jan;23(1):7-10. Epub 2007 Nov 10.