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Muscle Pain with Statins Likely the Result of Expectations

Statins are one of the most commonly prescribed medications. Studies have repeatedly demonstrated that the benefits of statins greatly outweigh any side effects, there is an ongoing concern that some patients may stop taking the drug after experiencing muscle pain or soreness. Interestingly, a new study has found that patients taking statins report no increase in muscle problems – if they are unaware that they are taking the drug.

Published in the The Lancet, the study out of Imperial College London, analyzed data from a large randomized clinical trial which looked at lowering cholesterol in more than 10,000 patients in the UK, Ireland and the Nordic regions over three years. What the researchers found suggests that cases of muscle pain and weakness in patients are unlikely to be directly caused by statins, but rather by the so-called “nocebo” effect, where the very expectation of side effects can make patients more likely to report them.

Quick to acknowledge that patients can experience very real pain because of the nocebo effect, lead author Peter Sever, MD, PhD, said that he hopes the study’s data will help persuade physicians and patients that exaggerated concerns about statins are not supported by the available scientific evidence. “We know there is a significant emergence of heart attacks, strokes and deaths in people who have stopped taking statins, who would benefit from them,” he said. “It’s a huge problem affecting tens if not hundreds of thousands of patients worldwide.”

[This article originally appeared in The Beat.]

Cognitive Decline Not Impacted by Cholesterol or Blood Pressure Drugs

With populations aging in much of the world, the decline of mental capacity in later years  is of increasing concern. There has been hope in the medical community that effectively treating hypertension and atherosclerosis could slow or delay this decline.brain

In the HOPE-3 clinical trial, a study of people over the age of 70 taking either blood pressure medication or statins for the prevention of heart disease, neither drug slowed cognitive decline during treatment. These results, presented at the American Heart Association 2016 Scientific Sessions, were disappointing for researchers looking to delay or even prevent the cognitive decline that comes with aging.

However, the findings were encouraging in one respect. There have been persistent concerns among patients and regulators that the use of statins to control cholesterol could negatively impact cognitive function and memory. The trial found that the patients taking statins did not have a larger decline in cognitive ability than other participants.

Patients were randomly assigned to receive either one of three drug regimens (combination blood pressure medication, a statin, or both) or to corresponding placebo groups. At the beginning and end of the study, 1,626 older adults completed several questionnaires and tests of mental processing speed and cognitive function.

While participants in all groups experienced a decline in cognitive function over the time of the study, there was no difference in the amount of this decline between treatment or placebo groups.

Data from the trial seemed to suggest that there might be some prevention of cognitive decline in patients with the highest blood pressure and LDL cholesterol levels at the start of the study, but this would need to be confirmed in other trials, said Jackie Bosch, PhD, of McMaster University, who presented the study results at AHA.

Dr. Bosch indicated that the results of this and other recent studies should put to rest concerns about statins and cognitive decline. “We have the data…that show that there is no adverse effect of statins” on cognition, she concluded.

[This article originally appeared in The Beat.]

The Importance of Best Practices for Successful Smoking Cessation

Cigarette smokers face twice the risk of heart disease compared with non-smokers, and most of them—more than 60%—want to quit. Unfortunately, the likelihood of success for those who attempt to quit on their own is dismal: fewer than 5% will remain tobacco-free one year later.smoking-cessation

But “with effective treatments, we can quadruple or quintuple or even sextuple the success rate,” explained Robert Reid, PhD, deputy division head of Prevention and Rehabilitation at the Ottawa Heart Institute. “There are opportunities to intervene with smokers and offer treatment that are not being taken advantage of at this point in time.”

With the goal of highlighting recent advances in treatments to aid smoking cessation, as well as pointing out persistent myths about cessation that might be preventing doctors from providing the most effective tools to their patients, Dr. Reid and colleagues at the Heart Institute published the first review of smoking cessation treatment in the Canadian Medical Association Journal in over a decade.

The issues discussed in the review include:

  • Effectiveness: Combining smoking cessation aids is more effective than any single treatment alone. For example, combining a nicotine patch with a nicotine gum, lozenge, inhaler or oral spray is more effective than any single nicotine replacement (NRT) aid. Adding a nicotine patch to the oral cessation drug varenicline (Chantix®) works better than varenicline alone.
  • Safety: Contrary to earlier concerns, a recent large clinical trial showed that varenicline does not increase the risk of suicide, depression or other mental health issues. And NRT is both safe and effective for patients who already have heart disease.
  • Goals: Even though some smokers might not be ready to quit right away, many are interested in reducing their tobacco use, either as a step towards quitting or as a goal in itself, and many of the treatments for cessation can also be used to help people minimize their smoking.

The authors also address the fact that reliable systems are needed at every level of care “to make sure that all smokers are identified and offered assistance when you come into contact with them,” said Dr. Reid. “There’s a gap in that clinicians don’t seem to address this very routinely in their practice.” Many barriers keep this gap open, including competing medical priorities during visits and knowledge of what it is that patients need to help them quit, he explained.

“A cigarette is a finely tuned instrument of addiction,” added Dr. Reid. “People are generally smoking, particularly if they’ve been at it a while, out of compulsion and addiction, not as a choice.”

The practice setting itself must be changed “to make it easy for clinicians to intervene with smokers that they come into contact with. That’s everything from having materials close to hand, to having reminders and cues in the environment and in the electronic medical record, to having easy access to referral for follow-up,” he explained.

“Smoking is really the most preventable cause of why people are being hospitalized, why they’re accessing the healthcare system in the first place,” said Dr. Reid. “So it doesn’t make sense if we don’t address the root the cause of why people are coming to see us.”

[A longer version of this article originally appeared in The Beat.]

Changes in Blood Pressure Medication Temporarily Increase Risk of Serious Falls

Elderly patients who start taking blood pressure medication or change their prescription or dosage have a temporarily increased risk of serious fall-related injury. The findings, published in Circulation: Cardiovascular Quality and Outcomes, included more than 90,000 patients in the United States aged 65 years and older.BP medicine

Between 2007 and 2012, researchers found that 272 of the patients began taking drugs for high blood pressure, 1,508 added a new drug to their existing blood pressure regimen, and 3,113 had the dose of at least one blood pressure drug increased. The likelihood of a serious fall-related injury went up 36% for patients starting a medication regimen, 16% for patients adding a new drug and 13% for patients increasing a dose.

This increased risk dissipated after two weeks following the medication changes. The authors of the study stressed that, due to its observational nature, the research could only show an association between medication changes and fall risk, not determine cause and effect. However, it identifies a time period during which elderly patients may need closer monitoring for short-term side effects.

Aortic Valve Replacement: What’s Next for TAVI?

Aortic stenosis affects more than 100,000 Canadians over the age of 65. Until recently, surgical replacement was the only treatment option, but over the last several years, TAVI, or transcatheter aortic valve implantation (often referred to as transcatheter aortic valve replacement (TAVR) in the US), has emerged as a viable alternative with advantages over surgery. Because the TAVI valve is inserted through a catheter, the incision is small and recovery times can be much shorter than for the open heart surgical procedure.

First introduced in the early 2000s, TAVI is approved in Canada mostly for use in patients who are inoperable or whose condition makes surgery a high risk. As evidence for TAVI’s safety and durability grows and advanced technology comes on the market, the procedure is poised to become much more common.

Extending TAVI to Lower Risk Patients

“We do patients for whom surgery would be high risk, often higher risk patients than at other centres in the province,” said Interventional cardiologist Marino Labinaz, head of the TAVI heart team at the Ottawa Heart Institute.TAVI

The older and sicker high risk patients require hospital stays similar to surgical patients. In Europe, where TAVI is used in a broader range of patients, the time in hospital can be much shorter.

“In low risk patients, we are seeing expedited discharge. There is a trial underway in Vancouver where they are looking at 24-hour discharge,” he said. “Where I see the sweet spot for TAVI in the low-risk patient is in rapid recovery. You’re going to come in, get your TAVI and go home the next day. In our patients, we haven’t reaped the benefit of early discharge yet.”

“The use of TAVI in these patients will be, in part, patient choice. It may also become a societal choice,” he continued, “Because, if you can send a patient home in 24 hours, then TAVI could become very cost effective when compared to a five- to seven-day stay for surgery. This will particularly be true if the cost of the valves comes down.”

TAVI is currently a more expensive option than surgery due to the cost of the valves, but as demand for TAVI grows and as new vendors enter the market and increase competition, costs are expected to decline.

Conscious Sedation Over General Anesthetic

Another emerging benefit of TAVI over surgery is the use of conscious sedation.

“Currently, we give patients a general anesthetic and they are intubated. Conscious sedation means we give them short-acting medication,” he explained. “They are conscious, and they are never intubated. The patient doesn’t have the issue of the anesthetic to recover from, and it saves time so you can do more patients in a day.”

Given the Heart Institute’s emphasis on high-risk patients, conscious sedation is only just getting started in Ottawa.

Improved Technology

One of the limitations of TAVI is the size of the catheter. To fit the valve inside, the catheter has to be larger around than those used in angioplasty for delivering stents.

“From a patient perspective, one of the biggest changes is that the valves are becoming smaller in size,” said Dr. Labinaz. “The first generation devices were very large calibre and we would see higher rates of dissections or occlusions in the arteries. Smaller tubes mean fewer vascular complications.”

Another important advancement is retrievability. Until recently, the cardiologist had only one shot to position and deploy the valve. Poor positioning can impact the seal of the valve and cause leaking—known as paravalvular aortic regurgitation—as well as complications that can require a pacemaker. A retrievable valve allows for real-time adjustments to be made.

“They aren’t yet commercially available here, but there are three valves available on special access from Health Canada that have the ability to be retrieved,” he said. “With two of them, you can deploy the valve to 80% to get an idea how it is positioned and functioning, and then retrieve it. The only completely deployable valve that can be retrieved is the new Lotus valve. We will begin using it this spring.”

“Another advance related to leaking is the addition of flexible sleeves on the outside of the valves that provide a better seal with the calcium and nodules and crevices that can create an uneven surface. Preliminary data is positive.”

One complication of aortic valve replacement that’s common to surgery and TAVI is stroke. Material from the calcium deposits in and around the valve can break away during the procedure and travel up the bloodstream to the brain. For both surgery and TAVI, the rate of stroke is 5 to 10%. On the horizon for TAVI is the use of protective filters in the blood vessels to capture that material. Results so far have been mixed.

Looking Ahead

“TAVI has been a real game changer,” concluded Dr. Labinaz. “We’re getting lots of data now on the durability of the valves in people who have had them for five and 10 years. They have low failure rates and seem to be comparable to the surgical valves.”

“It’s my prediction that TAVI will become a standard way of doing aortic valve replacement in the next five years. In Germany, it already is. Sixty per cent of aortic valve replacements in Germany are now TAVI. That’s the way it’s going. In Canada, cost and funding are the limiting factors.”

Heart Health Infographics

Heart Health Infographics

This series of heart health infographics, developed by the Prevention & Wellness Centre at Ottawa Heart Institute, are good tools for reminding patients about the importance of staying healthy.

Download them, share them, and print them to use with your patients. More health information and resources are available at the Prevention & Wellness Centre.

(Click on the images below to enlarge and download.)

Blood Pressure Cholesteral Depression Diabetes


Weight MgtSmoking

Major Statement on Heart Attack in Women

Every year for more than three decades, cardiovascular disease has killed more women than men in North America. While that gap has been narrowing, it still remains. On January 26, the American Heart Association (AHA) issued its first scientific statement on heart attack in women in the journal Circulation.

The AHA released the statement as a comprehensive summary of what the cardiovascular community knows about heart attack in women: its causes, presentation, treatment and outcomes. No matter their age, more women than men die within a year of their first heart attack (26 per cent of women compared with 19 per cent of men). However, women are on average older at the time of first heart attack: 71.8 years compared with 65 for men. This difference explains, in part, the higher mortality that continues to be seen in women five to 10 years after a heart attack.

Although risk factors for heart disease are shared between men and women, some factors—such as high blood pressure, and diabetes in younger women—seem to confer greater risk to women than men. Symptoms of a heart attack can also differ between women and men, a fact that many Canadian women are unaware of.

Women in general seek treatment later for a heart attack than men, which may contribute to poorer outcomes. Women are less frequently referred for appropriate treatment during a heart attack compared with men and, following a heart attack, are less likely to use guideline-recommended medical therapies. Less than 20 per cent of women eligible for cardiac rehabilitation have participated over the last three decades, and even with a referral to rehabilitation, women participate and complete it less frequently than men.

More Information

Prescribing Physical Activity: A Call to Action

The health benefits of regular physical activity are well documented and hard to overstate, but too often they are left out of the doctor–patient conversation. In December 2015, JAMA, the Journal of the American Heart Association, published the Viewpoint “Making Physical Activity Counseling a Priority in Clinical Practice: The Time for Action Is Now.” In it, the authors issue a call to action advocating the use of physical activity prescriptions and treating a patient’s level of activity as a vital sign.

In a related commentary at, JoAnn Manson, MD of Harvard Medical School and co-author of the article stated, “A prescription for increased physical activity… could be one of the most important prescriptions that a patient receives.”

This is a topic of great interest to Andrew Pipe, MD, Chief of Prevention and Rehabilitation at the Ottawa Heart Institute, one that he is passionate about and has spoken on publicly. (See “Don’t Fear the Exercise Prescription” for coverage of his talk on this subject at the Canadian Cardiovascular Congress in 2013.)

“I’m very pleased to see this call to action in JAMA,” said Dr. Pipe. “It puts a spotlight on something we have known for a very long time: that regular physical activity is one of the most fundamental elements of good health and a powerful way to forestall the development of preventable disease.” The benefits apply not just to heart disease, but to a broad range of diseases and chronic conditions that include diabetes, cancer, stroke, dementia and many others.

Dr. Pipe is a well known advocate for health promotion and smoking cessation and is active in sports medicine with Canadian national teams.

“We have to be clear, though, that participating in physical activity does not mean people need to become athletes. It doesn’t mean that they need expensive equipment or access to special programs or facilities,” he explained. “It can be as simple as regularly walking most days of the week at a level that lets you still carry on a conversation.”

“I like to talk about the three Fs: fun, feasibility and forever,” said Dr. Pipe. “What kind of activity do you like to do the most, and how can you easily make it a part of your daily routine? If you can satisfy both of those questions, then it’s much more likely you will continue to be active for the rest of your life.”

Too Much Sitting Impacts the Health of Heart Patients Even If They Exercise

Patients with heart disease who sit a lot have worse health even if they include exercise in their lives. That is the conclusion of new findings that looked at the activity levels and corresponding health indicators of patients with coronary artery disease.

“Limiting the amount of time we spend sitting may be as important as the amount we exercise,” said lead author Stephanie Prince, PhD, post-doctorate fellow in the Division of Prevention and Rehabilitation at the University of Ottawa Heart Institute. “Sitting, watching TV, working at a computer and driving in a car are all sedentary behaviours and we need to take breaks from them.”

Previous research has shown that being sedentary increases the risk of cardiovascular disease, but until now, its effect on patients with established heart disease was unknown.

The current study, published in November in the European Journal of Cardiovascular Prevention, investigated levels of sedentary behaviour and the effect on health in 278 patients with coronary artery disease. The patients had been through a cardiac rehabilitation programme which taught them how to improve their levels of exercise in the long term.

Patients wore an activity monitor during their waking hours for nine days. The monitors allowed the researchers to measure how long patients spent being sedentary, or doing light, moderate or vigorous levels of physical activity.

The researchers also assessed various markers of health including BMI and cardiorespiratory fitness to determine whether the amount of time a person spent being sedentary (mainly sitting) was related to these markers.

The patients spent an average of eight hours each day being sedentary. “This was surprising given that they had taken classes on how to exercise more,” said Dr. Prince. “We assumed they would be less sedentary but they spent the majority of their day sitting.”

Men spent more time sitting than women—an average of one additional hour each day. This difference was primarily because women tended to do more light-intensity movement—things like light housework, walking to the end of the drive, or running errands.

Dr. Prince said: “Women with coronary artery disease spend less time sitting for long periods, but we need to do more research to understand why. There is some research which suggests that at around the age of 60 men become more sedentary than women and may watch more TV.”heart patient sitting

The patients who sat more had a higher BMI and had lower cardiorespiratory fitness. This was assessed using their aerobic capacity. This is the maximum rate at which the heart, lungs and muscles use oxygen during an exercise test.

“These relationships remained even when we controlled for an individual’s age, gender or physical activity levels,” said Dr. Prince. “In other words, people who sat for longer periods were heavier and less fit regardless of how much they exercised.”

Dr. Prince emphasized that sitting less was not a replacement for exercise. “It’s important to limit prolonged bouts of sitting and in addition to be physically active,” she said. “Sedentary time may be another area of focus for cardiac rehabilitation programmes along with exercise.”

Intensive Blood Pressure Treatment Shows Benefits

How low should treatment targets for blood pressure be? Major medical groups, including the American Heart Association (AHA), recommend maintaining systolic blood pressure below 140 mm Hg. But results from the large randomized Systolic Blood Pressure Intervention Trial (SPRINT) show that, for some patients at risk of cardiovascular disease, bringing systolic blood pressure below 120 mm Hg saves lives with manageable side effects.

Released simultaneously at the AHA 2015 Scientific Sessions and in the New England Journal of Medicine, SPRINT included over 9,000 volunteers, half of whom were assigned to standard therapy (to bring systolic pressure below 140 mm Hg) and half to intensive therapy (below 120 mm Hg). Medication regimens were individualized and relied on standard, widely available drugs: mostly diuretics, ACE inhibitors, calcium channel blockers, and angiotensin receptor blockers, with other drugs used as needed to meet the blood pressure targets.

All participants were at least 50 years old and bphad high blood pressure and at least one other risk factor for heart disease. The trial included older patients (75 years or older), people with chronic kidney disease, and people with a history of cardiovascular disease. The participants were also diverse: about 36 per cent were women, 30 per cent African American, and 11 per cent Hispanic. People with diabetes, prior stroke or advanced kidney disease were excluded.

SPRINT was scheduled to run for five years but was stopped after less than three and a half because of the strong benefits seen in the intensive therapy group: those participants had a 43 per cent decrease in risk of death from cardiovascular disease and a 27 per cent decrease in overall mortality compared with the standard treatment group. This was true across all subgroups, including older participants.

The benefits seen in the intensive therapy group did come with an increase in side effects: more patients showed an increased indication of kidney damage and an increased risk of low blood pressure episodes and fainting, though not of falls leading to injury. Overall, 4.7 per cent of patients in the intensive therapy group and 2.5 per cent in the standard therapy group experienced a serious adverse event. “Our impression overall is that the beneficial effects [in the intensive therapy group] seem to be much, much more important,” said Paul Whelton, MD, chairman of the SPRINT steering committee. Additional data on kidney function and cognitive performance will be published in 2016.

A concurrent paper, published in the Journal of the American College of Cardiology, estimated that 16.8 per cent of U.S. adults would meet the SPRINT eligibility criteria.

More news from AHA 2015, including updates on cardiac resuscitation, salt intake and the clinical use of genetic risk scores, is available at now at The Beat.