Fludrocortisone (Florinef) is ineffective in Vasovagal Syncope

 Vasovagal syncope (common faint) is a common disorder responsible for many hospital admissions and significant utilization of resources.

During a late-breaking clinical trial at the Canadian Cardiovascular Congress 2011 earlier this month in Vancouver, B.C., the results of a randomized trial involving the use of Fludrocortisone (Florinef) in vasovagal syncope were presented.

This study was conducted at 17 centers around the world (including Canada and the US) and  enrolled 210 subjects, most of them young women in their late 20s and early 30s who had experienced anywhere from two to 15 syncope episodes in the past year, with a mean of three to four.

Patients were randomized 1:1 to either fludrocortisone (0.05-0.2 mg daily) or matching placebo for 12 months.

After one year, the syncope rate was numerically lower in the fludrocortisone group in both the intention-to-treat and on-treatment analyses, but the difference was not statistically significant.  Adverse events, however, were minor and rare, occurring in just 16 patients.

It has been concluded that fludrocortisone did not provide a statistically significant benefit in preventing the first recurrence of vasovagal syncope and is unlikely to provide a clinically significant benefit.


Citalopram Linked to Abnormal Heart Rhythm

A US Food and Drug Administration (FDA) alert now warns that citalopram has been associated, in a dose-dependent fashion, to prolonged QT interval, particularly in patients at risk for hypokalemia and hypomagnesemia. The drug label has been revised to include new drug dosage and usage recommendations.

The FDA warns that citalopram (Celexa, Forest Laboratories) should not be used in doses higher than 40 mg per day because of concerns that it can cause potentially fatal changes in heart rhythm.

An alert issued to healthcare professionals and patients cautions that the drug has been linked to prolonged QT interval in a dose-dependent manner. Patients at particular risk for developing the condition include those with underlying heart disease and individuals who are predisposed to low levels of potassium and magnesium in the blood.

Citalopram should not be used in patients with congenital long QT syndrome. Patients with congestive heart failure, bradyarrhythmias, or predisposition to hypokalemia or hypomagnesemia because of concomitant illness or drugs, are at higher risk of developing Torsade de Pointes, a rare type of ventricular tachycardia.

Risk of heart disease rises with COPD

A study presented here at the European Respiratory Society (ERS) 2011 Annual Congress shows that patients with chronic obstructive pulmonary disease (COPD) or reduced lung function are at a significantly increased risk of developing cardiovascular disease (CVD).

Data on 993 patients were drawn from the Obstructive Lung Disease in Northern Sweden (OLIN) studies, together with 993 gender- and age-matched reference subjects without COPD. The subjects were followed by annual examination.

The researchers found that CVD (heart disease, hypertension, stroke, claudication) was more prevalent in patients with COPD compared with controls with normal lung function (50.1% vs 41.0%, p<0.001). In addition, they found that the combined prevalence of angina pectoris, heart failure, and MI was 18.5% and 13.7% (p=0.006) in individuals with COPD and those with normal lung function, respectively. Having both conditions might lead to a far worse outlook for patients.

The finding that patients with COPD have a high risk of CVD fits in with previous studies. This comorbidity has also been shown previously to be associated with higher mortality. Probably there is a common causal factor, affecting both the lungs and the vessels, namely smoking.

Chocolate is good for the heart and the brain!!


In a presentation at the European Society of Cardiology (ESC), August  2011 Congress, British investigators are reporting that individuals who ate the most chocolate had a 37% lower risk of cardiovascular disease and a 29% lower risk of stroke compared with individuals who ate the least amount of chocolate.

In the study, published online August 29, 2011 in the British Medical Journal (BMJ) to coincide with the ESC presentation, Dr Adriana Buitrago-Lopez (University of Cambridge, UK) and colleagues state: “Although over consumption can have harmful effects, the existing studies generally agree on a potential beneficial association of chocolate consumption with a lower risk of cardio-metabolic disorders. Our findings confirm this, and we found that higher levels of chocolate consumption might be associated with a one-third reduction in the risk of developing cardiovascular disease.”

In this meta-analysis of six cohort studies and one cross-sectional study, overall chocolate consumption was reported. Chocolate in any form was included, such as chocolate bars, chocolate drinks, and chocolate snacks, such as confectionary, biscuits, desserts, and nutritional supplements. Chocolate consumption was reported differently in the trials but ranged from never to more than once per day. Most patients included in the trials were white, although one study included Hispanic and African Americans and one study included Asian patients.

Overall, the pooled meta-analysis results showed that high levels of chocolate consumption compared with the lowest levels of chocolate consumption reduced the risk of any cardiovascular disease 37% (RR 0.63; 0.44-0.90) and stroke 29% (RR 0.71; 0.52-0.98). There was no association between chocolate consumption and the risk of heart failure, and no association on the incidence of diabetes in women.

Buitrago-Lopez and colleagues concluded that these favorable effects seem mainly mediated by the high content of polyphenols present in cocoa products and are probably accrued through the increasing bioavailability of nitric oxide, which subsequently might lead to improvements in endothelial function, reductions in platelet function, and additional beneficial effects on blood pressure, insulin resistance, and blood lipids.


Apixaban: a new oral anticoagulant

In the trial (the ARISTOTLE trial), presented on August 28, 2011, at the European Society of Cardiology (ESC) 2011 Congress and simultaneously published online in the New England Journal of Medicine, apixaban was superior to warfarin in preventing stroke or systolic embolism (the primary end point) and was also associated with less bleeding and lower mortality than warfarin.

The results have been positioned as the most positive yet for one of the new oral anticoagulants in atrial fibrillation (AF) and appear to give apixaban the edge over its two major competitors, dabigatran (Pradaxa) and rivaroxaban (Xarelto). Both dabigatran and rivaroxaban have also shown benefits over warfarin in the RE-LY and ROCKET-AF trials respectively, but apixaban is the first of these three agents to have shown definite reductions in each of the major outcomes of stroke, bleeding, and mortality.

The ARISTOTLE trial randomized 18, 201 patients with atrial fibrillation to apixaban (5 mg orally twice daily) or warfarin (target INR of 2.0 to 3.0). After a median follow-up of 1.8 years, results showed that apixaban was associated with a 21% reduction in the risk of stroke or systemic embolism, a 31% reduction in bleeding, and an 11% reduction in all-cause mortality.

Addressing the question of whether these new oral agents will completely replace warfarin, Mega points out that that they overcome the need for monitoring with warfarin and have shown encouraging results in many different subgroups, but “switching to a newer agent may not be necessary for the individual patient in whom the INR has been well controlled with warfarin for years.”

The superior data for these new drugs presents a challenge for anyone to continue on warfarin. However, switching to a newer agent may not be necessary for the individual patient in whom the INR has been well controlled with warfarin for years. Another important issue that might prevent people from switching is cost. These new drugs will be much more expensive. It would be more reasonable to give these new drugs to new patients and switch over those not managing well on warfarin.


Real-Life Observations of Clinical Outcomes With Rhythm- and Rate-Control Therapies for Atrial Fibrillation: RECORDAF

Authors: Camm AJ, Breithardt G, Crijns H, et al.

Citation: J Am Coll Cardiol 2011;58:493-501.

Study Question: What are the outcomes of rhythm- and rate-control strategies for atrial fibrillation (AF) in clinical practice?

Data from 5,604 patients (mean age 66 years) enrolled in a longitudinal AF registry were analyzed upon enrollment and at 6 and 12 months of follow-up.

Results: The clinical outcomes that differed significantly between the rhythm- and rate-control groups were cardiovascular death (0.9 vs. 2.8%, respectively), stroke/transient ischemic attack (1.7 vs. 2.8%, respectively), hospitalization for arrhythmia/proarrhythmia (11.3 vs. 7.3%, respectively), and heart failure (2.4 vs. 4.8%, respectively). Adverse outcomes were related to renal disease, coronary disease, heart failure, prior stroke, and age, but not to the management strategy.

Conclusions: The authors concluded that adverse outcomes during follow-up in patients with AF are largely a function of age and comorbidities, not the management strategy.

Dronedarone trial suspended due to CV events in permanent atrial fibrillation

Sanofi, maker of dronedarone (Multaq), has suspended its phase 3b trial of its antiarrhythmic drug due to an increase in cardiovascular events seen in patients randomized to dronedarone. The PALLAS trial was testing the drug in patients with permanent atrial fibrillation (AF) and at least one other cardiovascular disease risk factor; at present, dronedarone is approved in patients with nonpermanent AF.

The trial’s operations and data monitoring committees made the decision to halt the study after seeing a significant increase in cardiovascular events among patients taking the study drug, as compared with patients on placebo, although details of just what those events are have not been released. In both arms of the trial, patients were also receiving antithrombotic and rate-control medications.

According to a press release issued by Sanofi on July 07, 2011, the company has informed regulators about the decision to stop the trial and asked trial investigators to get in touch with patients to tell them to stop taking the drug. Patients taking Multaq outside of the trial, however,

Of note, the press release states that the “decision to terminate the study was not related to any hepatic adverse event.” Liver injuries are a known side effect of the drug and have previously prompted warnings by both US and European regulators.

PALLAS was launched in July 2010 and was designed to enroll 10 800 patients, with an estimated completion date of August 2013. Only 3149 patients had been enrolled at the time the study was stopped. The study was to include over 585 sites, and according to Connolly, those included 185 sites in the US and at least 20 in Canada.

Dronedarone has faced a range of criticisms since its approval in the US in July 2009, including questions about its safety/efficacy tradeoff and the design and execution of the ATHENA study. Just last week, newspapers in France reported that French health authorities had concluded that the efficacy of dronedarone was “insufficient”—an opinion that could lead to the drug being dropped from the country’s drug reimbursement formulary.

Source: the heart.org

Smoking Cessation Aid Varenicline (Champix) Associated with Increased Risk for Cardiovascular Events

Smoking Cessation Aid Varenicline Associated with Increased Risk for Cardiovascular Events
On June 16th, 2011 the U.S. Food and Drug Administration (FDA) announced that the smoking cessation aid varenicline (Chantix in USA and Champix in Canada) may be associated with increased risk for adverse cardiovascular events, such as heart attack, in patients with pre-existing cardiovascular disease. In a clinical trial with 700 male and female smokers with cardiovascular disease, researchers found that those taking Champix had about double the risk of a cardiovascular event than those taking a placebo drug. However, the risk associated with Champix was still very low (1.4 – 2.3% increased risk for cardiovascular event). Therefore, the FDA announced these findings not to scare away patients but to inform them of the risks, which will now be added to the “Warnings and Precautions” section on the drug label.

Champix is the brand name for varenicline — a drug that helps people quit smoking by blocking the effects of nicotine from the brain. This drug was approved by the FDA in 2006 and has been widely used to aid patients in their struggle to quit smoking. Varenicline is typically taken for 12 weeks and can more than double likelihood of quitting smoking and abstaining from smoking long-term.

Based on the recent FDA announcement regarding varenicline, it is important that patients considering using or currently taking this drug consider the pros and cons of its use. Smoking is the number one most preventable cause of death in the United States and the most preventable risk factor for heart disease. Smoking increases risk for heart attack up to six times and greatly increases risk of death. Once smokers quit, however, they experience health benefits within just a few hours and greatly reduce risk for heart disease and other conditions over time. Therefore, the increased cardiovascular risk associated with varenicline (up to 2.3%) in patients with heart disease will often outweigh the many significant risks associated with continuing smoking. However, be sure to discuss all concerns with your doctor before using a smoking cessation aid to determine which is best for you.

Questions for You to Consider
Q: What should I do if I have heart disease and am currently taking varenicline (Chantix)?

A: If you are currently taking Chantix and have heart disease, contact your healthcare provider if you experience any new or worsening symptoms of heart disease, such as chest pain or shortness of breath. You should also discuss any concerns you may have regarding Chantix with your doctor.

Q: Are there alternative smoking cessation aids other than varenicline (Chantix)?

A: There are many smoking cessation aids other than Chantix that can help smokers fight nicotine withdrawal and tobacco cravings. Bupropion (Zyban) is another type of prescription drug, normally used to treat depression that helps people stop smoking. There are also various types of nicotine replacement therapy, including patches, inhalers, lozenges, gums and nasal sprays that can help wean smokers off of cigarettes.

Stress After Sleep Deprivation Increases Blood Pressure

Not getting enough sleep can affect us in many ways — worsening our mood, decreasing productivity and affecting our ability to concentrate. And stress? We all know how that can affect our daily lives. But what about the effects of sleep deprivation and stress that are less noticeable? Not only can stress and getting little sleep have negative effects on our body, they can also have more serious long-term effects on our health.

Studies have long suggested that sleep deprivation can increase risk for heart disease and even death. The exact cause of this relationship has remained a bit of a mystery, but recent findings may help explain why getting enough sleep is essential for our heart health. Researchers from the University of Pittsburgh’s Sleep Medicine Institute found that not getting enough sleep in addition to stress can have a serious impact on our blood pressure, and ultimately our cardiovascular health. In a study involving 20 healthy young adults, they found that stress in combination with sleep deprivation increases systolic blood pressure by 10 points in comparison with being stressed but well-rested.

These findings are very interesting, as they help clarify the relationship between stress, sleep, blood pressure and heart disease. Doctors know that chronic stress is a risk factor for heart disease, as it can raise blood pressure, putting a strain on the heart. They also know that getting enough sleep each night can help us live longer and improve our heart health. But knowing how these two factors in combination can affect blood pressure will prove helpful in the fight against heart disease.

Sleep deprivation and stress often come hand in hand as partners in a vicious cycle that, if not addressed, can become chronic conditions that can affect our health. However, these study findings may help people break this cycle. By getting enough sleep, we can help reduce the effect that stress may have on our blood pressure. In turn, this can reduce stress levels, lowering blood pressure and improving heart health.

Questions for You to Consider
Q: How much sleep is recommended each night for adults?

A: Although there is no magic number that is right for everyone, most adults require 7-9 hours of sleep each night. However, everyone is different. Some adults may need 7 hours of sleep each night to feel alert the next day, while others may require 9 hours to feel well-rested and awake.

Q: How does stress affect blood pressure?

A: When the body encounters stress, heart rate increases and blood vessels narrow, causing a temporary rise in blood pressure. When stress becomes a chronic condition, it can lead to hypertension (high blood pressure) — a risk factor for stroke, heart attack and heart disease.

Bupropion for Smoking Cessation in Patients With Acute Coronary Syndrome

Bupropion for Smoking Cessation in Patients With Acute Coronary Syndrome
First, what is Bupropion? Bupropion (marketed as Wellbutrin) is an atypical antidepressant and smoking cessation aid. Initially marketed as an antidepressant, bupropion was subsequently found to be an effective smoking cessation aid.
In a double-blind, randomized, controlled trial, the investigators compared the safety and efficacy of 8 weeks of treatment with bupropion SR or placebo for smokers hospitalized with acute coronary syndrome (ACS) as an adjunct to nurse-led hospital- and telephone-based support. Primary efficacy outcome was smoking abstinence at 1 year. Primary safety outcome was clinical events at 1 year.
A total of 151 patients were enrolled; all but two completed follow-up. Abstinence rates at 3 months were 45% versus 44% in the bupropion SR and placebo groups, respectively; 37% versus 42% at 6 months; and 31% versus 33% at 1 year.
Treatment with bupropion SR was not associated with an increase in clinical events or change in blood pressure or body mass index, but dizziness was more common compared with placebo
The authors concluded that in hospitalized patients with ACS who received continuous, intensive nurse counseling about smoking cessation, bupropion did not increase the rates of smoking abstinence.
The study results suggest that although bupropion SR is safe in patients hospitalized with ACS, it had no added value over placebo in this population when combined with intensive smoking cessation counseling. Based on this, adding bupropion to intensive counseling may be considered only in selected patients such as patients with post–myocardial infarction depression. Overall, the study emphasizes the unique opportunity to approach heavy smokers during hospitalization with ACS, in a forced nonsmoking environment, utilizing the effect of a life-threatening condition in order to achieve long-term high abstinence rates.

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