Ticagrelor : New hope for heart attack patients

A major drug trial has brought scientists closer to making a drug that could prevent thousands of deaths from heart attacks.

From the past six years, international clinical trials have been going on a new drug, ticagrelor.

The new findings have revealed that the platelet function in patients taking ticagrelor recovered much quicker after the drug is stopped, compared to the current gold standard drug, clopidogrel.

This study has also confirmed that breathlessness occurs as a side effect of ticagrelor but this is not associated with any harmful effects on lung or heart function.

The findings also include a new analysis of a previous trial looking at ticagrelor.

This new examination of the Plato trial, which was completed last year, showed that ticagrelor prevents 1 in 5 deaths after a heart attack, and patients who develop the adverse effect of breathlessness with ticagrelor still benefit from a lower risk of death compared to patients treated with clopidogrel for one year following a heart attack.

This has also confirmed that patients treated with clopidogrel, who have a genetic variant that reduces the effect of this drug have a slightly higher risk following heart attack but ticagrelor is not affected by this variant and is still more effective than clopidogrel, regardless of a patient's genetic make-up.

The study has previously shown for every 1,000 patients treated for one year with ticagrelor instead of clopidogrel, there would be 14 fewer deaths or 11 fewer heart attacks without an increase in bleeding problems.

"The latest results on ticagrelor reinforce the positive data from the PLATO trial and suggest that ticagrelor has the potential to improve the quality of care and save many lives in the year following a heart attack, regardless of adverse effects or genetic differences in the response to clopidogrel," said Robert Storey of the University of Sheffield.

The latest findings were presented at the European Society of Cardiology (ESC) Congress 2010 and appeared in the Lancet.

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Some patients with severe heart disease receiving wrong treatment, study finds

Tens or even hundreds of thousands of Americans are having coronary artery angioplasty and stenting every year when they should be having bypass grafts, and the result is an extra 5,000 or more deaths annually, researchers said Sunday.

Patients and cardiologists frequently prefer angioplasty and the insertion of a stent to keep arteries open because it is quicker and easier; patients go home sooner and return to work more quickly.

But new data from a major European-American study on more than 1,800 patients show that three years after the procedure, those who got stents were 28% more likely to suffer a major event, such as a heart attack or stroke, and 46% more likely to require a repeat procedure to reopen arteries. They were 22% more likely to die.

"This is one of the strongest studies yet demonstrating that, in advanced coronary disease, bypass has a real patient advantage," said Dr. Robert Guyton, chief of cardiothoracic surgery at the Emory University School of Medicine, who was not involved in the study.

"This will change practice," he said. "It may not reverse some of the use of stenting, but it is certainly going to slow it down and make people think. Stenting is a little bit easier on you and the return to work is quicker. But the benefits of surgery are more enduring and tend to emerge as time goes by."

Dr. Richard Shemin, chief of cardiac and thoracic surgery at UCLA's Ronald Reagan Medical Center, echoed that view. "Surgeons have had a strong feeling that, over time, surgery would be better for the most complex forms of heart disease," said Shemin, who also was not involved in the study.

The findings are "very strong, independent data that the public, payers and practitioners need to factor into how we make decisions in taking care of patients," he said.

"Any time that you compare angioplasty and surgery, the longer you go, the better surgery looks," said Dr. Michael J. Mack, first vice president of the Society of Thoracic Surgeons and a co-author of the study.

Coronary artery bypass grafts, commonly called CABG (pronounced cabbage), were the first treatment for blocked arteries. In the procedure, a blood vessel removed from elsewhere in the body, most often the chest or the leg, is used to bypass the blocked area, providing a new channel for blood to flow to the heart.

Hospital stays generally last five or six days, and the patient can return to work after a few weeks.

In recent years, however, cardiologists have turned more and more to balloon angioplasty, in which a catheter is threaded through a blood vessel in the groin to reach the blockage and a balloon is inflated at the site to compress the plaque. Originally, that was all that was done. Then physicians began inserting bare-metal stents, spring-like devices that hold the artery open.

More recently, doctors have begun using drug-eluting stents, which release a drug that helps prevent clot formation. Hospital stays are typically overnight, and the patient can return to work after a couple of days.

More than 1.3 million Americans now undergo angioplasty every year, compared with 448,000 who undergo bypass, according to the National Center for Health Statistics.

The new study, reported Sunday at a Geneva meeting of the European Assn. for Cardio-Thoracic Surgery, is the first large trial to compare stenting and CABG directly. Called SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery), the trial enrolled 1,800 patients at 85 centers in Europe and the United States.

Patients were randomized to receive either angioplasty with stenting or bypass.

Patients were considered to have mild disease if they had a single blocked artery. Their disease was considered moderate or severe if they had a blockage in the left main artery — the primary artery supplying blood to the heart — plus blockage in one of the other three arteries, or if they had blockages in all three other arteries. They were also considered severe if they had very long blockages, arteries that were totally blocked, or "very tortuous, curvy arteries" that make angioplasty difficult, Mack said.

For patients with mild disease, the two procedures produced equivalent results, so angioplasty might be preferred because it is easier on the patient. Previous studies have also shown that such patients can be successfully treated with medical therapy alone. But the differences were much more dramatic for those with more severe disease, which is present in about half of all patients undergoing angioplasty in the U.S.

Dr. John Conte, associate director of cardiac surgery at Johns Hopkins Hospital in Baltimore, noted that it is now incumbent on physicians to make sure patients have all the facts before they undergo any procedure. "It's absolutely amazing that the federal government and private insurers don't insist on it," he said. "Wouldn't it make sense to do the right procedure the first time, rather than do it over and over and drive up the cost of healthcare? To me, it's a no-brainer."

By Thomas H. Maugh II, Los Angeles Times

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Dutch study say that using Beta-Blockers is safe for Lungs

Medical tradition says that the beta blockers used to treat heart disease shouldn't be given to people who also have severe lung disease, but a new Dutch study suggests the tradition is wrong.

A study of more than 2,200 people with chronic obstructive pulmonary disease (COPD), a diagnosis that includes emphysema and chronic bronchitis, found better survival among those given beta blockers than those who did not get the drugs, claims a report in the May 24 issue of the Archives of Internal Medicine by physicians at University Medical Center Utrecht.

"To our knowledge, this is the first observational study that shows that long-term treatment with beta blockers may improve survival and reduce the risk of exacerbation of COPD in the broad spectrum of patients with a diagnosis of COPD," the researchers wrote.

"This is strikingly different from what our medical students are taught today," said Dr. Don D. Sin, a professor of medicine at the University of British Columbia in Vancouver, Canada, and co-author of an accompanying editorial. "Our traditional teachings are wrong."

The rap against beta blockers has been that while they improve heart function, they can cause airways to contract, a problem for people with COPD, Sin explained. "They demonstrate in this article that even people with COPD who use beta blockers did very well, better than people who didn't use beta blockers," he said.

Fears about beta blockers and COPD date back to the 1980s, when there were reports of "some nasty effects in patients with asthma, especially with high doses," said study author Dr. Frans H. Rutten, an assistant professor of medicine at Utrecht. The study demonstrates that the drugs can be handled safely for people with COPD, he noted.

"I know of no real problems now, especially when you start with a low dose so that the bronchial airways can adjust to the drug," Rutten said.

COPD was diagnosed in 560 patients at the start of the study in 1996, and 1,670 developed the condition by the end, in 2006. Of these, 665 were prescribed beta blockers for heart conditions, while 1,565 were not.

During an average follow-up time of 7.2 years, 27.2 percent of the people who took beta blockers died, compared to 32.3 percent of those not given the drug. The incidence of exacerbation -- severe flare-up -- of COPD was 42.7 percent among beta blocker users and 49.3 percent among nonusers.

The study isn't the final word on beta blockers and COPD, Sin said. That would have to come from a randomized, controlled study, which almost certainly will never be done, he said.

"If I had a heart attack, I wouldn't want to be in a clinical trial where there was a 50 percent chance I would get a sugar pill," Sin said. "So, this study may be the best evidence we get."

And the incentive of profit from increased use of beta blockers isn't there to have a drug company fund such a trial, since beta blockers are widely available in inexpensive, generic form, he added.

Sin acknowledged that he has been "an outlier" on the issue, already prescribing beta blockers for people with COPD. "But with this paper, I am much more confident that COPD patients can tolerate beta blockers," he said.

There are some exceptions, Sin noted. "For people with very bad asthma who have very reactive airways, I am much more cautious," he said. "I would start with the lowest dose possible, and then titrate upwards."

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Merck-Cardiome heart rhythm drug meets study goals

Merck & Co. and Cardiome Pharma Corp. said Friday that their drug candidate Brinavess met its goal in a late-stage clinical study, as it was better at restoring a steady heartbeat than an older drug use for the same purpose.

The trial compared Brinavess to the standard drug, amiodarone, as a treatment for atrial fibrillation. Atrial fibrillation is a condition in which the upper chambers of the heart beat rapidly and ineffectively. Merck and Cardiome said more than half the patients treated with Brinavess had a normal heart rhythm within 90 minutes, compared to about 5 percent of the amiodarone patients.

The companies said 51.7 percent of Brinavess patients had a normal heart rhythm within that time, and the median time to normal heart rhythm was 11 minutes. They said 5.2 percent of the patients who were treated with amiodarone met that goal. After 90 minutes, 53.4 percent of the Brinavess patients had no symptoms, compared to 32.8 percent of the amiodarone group.

Brinavess is an intravenous version of vernakalant, a drug Merck and Cardiome have been developing together. The companies have filed for approval in the U.S. and the European Union, and they are also working on an oral form of the drug. If approved, Brinavess would compete with Sanofi-Aventis' drug Multaq, which was approved in 2009.

A total of 232 patients were treated in the study, and Merck and Cardiome said the Brinavess patients also had a greater quality of life improvement based on a survey. The most common side effects of Brinavess were a bad taste in the mouth, coughing, sneezing, atrial fibrillation, nausea, dizziness, and high blood pressure.

Results from the trial were presented at a Heart Rhythm Society meeting in Denver.

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Sanofi-Aventis Begins Study Of Heart Drug Multaq In 10,000 Patients For Expanded Use

Pharmaceutical company Sanofi-Aventis Wednesday said it has initiated a Phase IIIb trial of Multaq in over 10 thousand patients with permanent atrial fibrillation or abnormal heart rhythm. The Paris, France-based company’s study is focused on assessing the potential clinical benefit of the drug in reducing major adverse cardiovascular events, and it expects first patient enrollment to begin in the third quarter of 2010.

Multaq, or dronedarone, an antiarrhythmic drug, has completed clinical trials in more than 7,000 patients and has met the primary endpoint by reducing cardiovascular hospitalization or death by 24%. The company added that the incidence of atrial fibrillation is growing worldwide in relation to aging populations, increasing the risk of stroke up to five-fold, worsening the prognosis of patients with cardiovascular risk factors and doubling the risk of mortality.

The Phase IIIb study, dubbed PALLAS, is conducted primarily to demonstrate a reduction in major cardiovascular events like stroke, systemic arterial embolism, myocardial infarction or cardiovascular death. In addition, the study aims to lessen cardiovascular hospitalization or death from any cause among patients with permanent atrial fibrillation and additional risk factors.

The company said the secondary objectives are to evaluate the efficacy of Multaq in preventing cardiovascular death and to check whether the drug is well-tolerated in this patient population.

Stuart Connolly, MD, Division of Cardiology, McMaster University, Hamilton, Canada, one of the trial’s principal investigators commented, “This is a trial of major significance since no anti-arrhythmic drug has ever been shown to reduce major morbidity and mortality in permanent AF patients in a large scale clinical trial. We designed the PALLAS trial to further assess the role of Multaq(R) to reduce cardiovascular outcomes in patients with AF.”

Sanofi-Aventis elaborated that PALLAS is a multinational, randomized, double-blind, parallel-group, placebo-controlled, multicenter trial comparing the efficacy of Multaq 400mg twice-daily with placebo in permanent atrial fibrillation patients. The study of Multaq is expected to be conducted on 10,800 patients enrolled in 43 countries at 700 sites.

Multaq, discovered and developed by sanofi-aventis, was granted marketing authorization by the European Commission in November last year to treat adult clinically stable patients with a history of, or current non-permanent atrial fibrillation to prevent recurrence of atrial fibrillation or to lower ventricular rate.

Multaq is currently available in the U.S., Canada, Switzerland, Germany, Denmark, Ireland, Norway, Finland and the UK and is also being launched in most European countries in 2010.

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Study sharpens focus on Glaxo's heart drug hope

A scientific study provided support on Friday for a way of fighting heart disease being pioneered by GlaxoSmithKline, likely to boost interest in drugs that target an enzyme involved in clogging arteries.

A study published in The Lancet medical journal suggests that the enzyme, known as lipoprotein-associated phospholipase A2, or Lp-PLA2, plays as much of a role in the risk of heart disease as high blood pressure and bad cholesterol.

Alex Thompson and John Danesh of Cambridge University, who conducted the research, said their findings would sharpen focus on an experimental drug called darapladib being developed by Glaxo and currently being studied in two large-scale clinical trials involving 27,000 patients worldwide.

"This reinforces interest in this enzyme, and reinforces the need to see the results from these clinical trials," Thompson said in a telephone interview.

Results of the trials are expected between 2012 and 2014.

Coronary heart disease is the leading cause of death worldwide, responsible for around 7 million deaths a year.

Smoking, diabetes, high blood pressure and high levels of "bad" cholesterol known as LDL are known to cause heart disease, but they do not entirely explain its incidence, so scientists and drug companies have been investigating other links.

Glaxo discovered darapladib through the use of gene technology from Human Genome Sciences, which has an agreement with Glaxo to receive clinical development milestone and royalty payments for such compounds.

It is the first in a new class of drugs targeting Lp-PLA2 and is designed to offer something beyond the hugely successful class of cholesterol-lowering statin drugs like Pfizer's Lipitor and AstraZeneca's Crestor.

Darapladib seeks to cut the risk of artery-clogging plaques rupturing, blocking blood vessels and triggering heart attacks. Thompson and Danesh looked at links between Lp-PLA2 and risk of heart disease, stroke and death in almost 80,000 people in 32 previous studies.

They found that higher blood levels of Lp-PLA2 were associated with increased risk. For heart disease, the size of the increased risk was similar to that from higher blood pressure or bad cholesterol, they said.

But they added that their analysis, which was mostly of data for people studied in North America and Europe, also showed weaker than expected links between heart disease and blood pressure and bad cholesterol.

"This enzyme in this study was as strongly associated with heart disease as blood pressure and cholesterol, but we need to be cautious in interpreting that because the associations of blood pressure and cholesterol were themselves substantially lower than we would have expected," Thompson said.

He said this may be because many patients in the studies were already taking heart medications that would alter their blood pressure or cholesterol levels.

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Good news for a new AstraZeneca drug

There is good news surfacing for pharmaceutical firm AstraZeneca this morning. Turns out a new drug produced by AZN helps reduce heart patients' chances of dying by more than 20% when compared to the standard treatment. The drug is designed to prevent blood clots in heart patients.

The study followed 18,624 patients from 2006 to 2008, with roughly half taking rival medicine Plavix and the other half taking AZN's Brilinta. The results show that patients taking Brilinta had a 4.5% chance of dying, compared to a 5.9% chance for patients on Plavix.

The results also showed that AZN's offering was safer for patients, as it was less likely to trigger bleeding problems, which is one of Plavix's side effects. Yes, Brilinta has its own side effects, including breathing and heart-rhythm abnormalities, but some will be willing to take these chances based on the drug's efficacy. Some experts believe Brilinta will be a best-selling drug if it receives regulatory approval, which could take "years".

One fact that could skew the results a bit is that AZN paid for the research, but this is a common practice in the pharmaceutical world.

Currently, the stock is treading along support in the $46 region as it waits for its 10-week moving average to come into the picture and push the stock higher. The question is whether or not the shares will be able to garner enough momentum to top past resistance in the $49-50 region. The stock has turned away from this region three other times in the past, and it could do so again. Will the news about Brilinta be enough to help puncture this resistance? I'm not sure, but history certainly suggests that it won't happen.

Source : www.bloggingstocks.com

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New drug could reduce prescription prices for heart patients

Heart patients who need to take a prescribed daily regimen of medicine to prevent blood clots might find lower prescription prices in an area that has been monopolized for years.

Dr. Shereif Rezkalla, an interventional cardiologist at Marshfield Clinic, recently took part in a worldwide, independent study that examined the effectiveness of a new drug, Prasugrel, which prevents platelets in the blood from sticking together.

The study found the medicine to be as effective as Plavix, the only similar drug on the market.

Rezkalla said Prasugrel's potency is important, but a major bonus is that it should help force down the price of Plavix, through competition for market share.

Plavix costs about $155 for 30 pills for a person without insurance.

"I know many patients of mine who needed (Plavix) and couldn't take it because of their financial budget," Rezkalla said. "It just became very expensive, and some patients truly have to pick between medications and their regular food."

Rezkalla said Prasugrel won't be cheap, particularly because the study found that it appears to be slightly more effective. Seven percent of patients taking Prasugrel had nonfatal heart attacks, compared to 9.1 percent taking Plavix.

Plavix is prescribed daily, Rezkalla said, but many patients struggle to afford it. While he's excited about the medical breakthrough, he said it's more important for patients if Prasugrel can lead to lower costs.

"I get more excited when I know to my patient it will be less of a burden on him financially," he said. "It's a problem I don't see once in a while or occasionally, but almost every day."

Both medicines are used to prevent clots that can lead to heart attacks or strokes and are necessary in patients undergoing angioplasty, Rezkalla said.

A small amount of the population is resistant to Plavix, making Prasugrel useful as another tool to combat clotting. Rezkalla said there are no firm data that estimate the number of people who are resistant to Plavix.

The most serious side effect, because of its potency, is that people who take Prasugrel are more prone to bleeding, Rezkalla said. Older people and those with a low body weight should avoid taking it.

The Federal Drug Administration recently approved the medicine and Rezkalla said Prasugrel, which he administered to patients at Saint Joseph's during the study, should be available within the next month. It will be marketed as Effient.

Source : www.wisconsinrapidstribune.com

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New Drug Could Reduce Heart Attack Damage

A new drug that targets a master disease-causing gene can dramatically reduce heart muscle damage after a heart attack and may lead to significantly improved patient outcomes, UNSW researchers have shown.

The drug, known as Dz13, specifically targets and neutralizes the gene responsible for inflammation and muscle death in the aftermath of a heart attack, preclinical trials have found.

The drug also reduces incidental cell and tissue death resulting from life-saving interventions such as balloon angioplasty and stent placements used to open blocked arteries, or from the delivery of clot-busting drugs.

Significantly, the heart’s pumping action is protected by the drug, dramatically improving the patient’s chances of a full recovery after a heart attack.

“While this drug doesn’t prevent the heart attack, it does reduce the damaging effects of the blockage on the heart once it’s happened,” said lead investigator Professor Levon Khachigian, from UNSW’s Center for Vascular Research.

“It’s a targeted therapy that can be used to complement other procedures and improve chances of a normal recovery,” he said.

The heart muscle suffers damage at two distinct times during a heart attack, Professor Khachigian said: first when the initial blockage occurs causing the chest pain; and second, when the patient undergoes a "revascularization" intervention, such as angioplasty or stenting, to reopen the blocked artery .

“At both these times a range of potentially damaging coordinated molecular responses kick in,” he said.

“We have been able to develop a drug to silence a disease-triggering gene. The drug improves heart function, regardless of whether it’s administered at the time of the heart attack, or at the time of the revascularization process."

Co-author on the study, interventional cardiologist Dr Ravinay Bhindi from Royal North Shore Hospital, said the technique represents an important potential advance in the treatment of heart disease, which is Australia’s number one killer.

“This drug not only structurally reduces heart attack size but it protects heart muscle function. Both those things in combination improve outcomes and give hope to patients,” Dr Bhindi said.

Safety trials of Dz13 are now underway ahead of Phase 1 human trials. A paper outlining the animal study appears this month in the high-impact cardiovascular journal Arteriosclerosis, Thrombosis and Vascular Biology.

Source : www.redorbit.com

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Asthma drug may increase risk of heart attack and stroke

After a post-marketing study suggested a disproportionate increase in heart attacks and strokes in patients treated with Xolair (omalizumab), compared to those who were not given the drug, the U.S. Food and Drug Administration (FDA) announced last week that it is conducting a safety review.

Xolair, a drug administered by injection every other week, is manufactured by Genentech and co-marketed by Novartis and was approved by the FDA in June, 2003 to treat patients at least 12 years old with moderate-to-severe persistent allergic asthma unresponsive to inhaled steroids.

The study, begun in 2004 and conducted by San Francisco-based Genentech Inc., is an observational study of 5000 patients who took Xolair and 2500 who did not. Because it is not a randomized trial, which is considered by researchers to be the gold standard in determining cause and effect, its conclusions may have built in bias. For example, there could be differences in underlying risk factors for heart attack and stroke between the two study groups, making it difficult for the FDA to ultimately decide how to act on the information. Patients and their doctors have to deal with even greater uncertainty since neither the drug company nor the agency is making public the data that generated the alert.

An FDA Early Communication available online states that it “is in keeping with the FDA’s commitment to inform the public about its ongoing safety reviews of drugs”. While the investigation is still under way, the agency is not telling doctors to stop prescribing Xolair and is not recommending any changes to the prescribing information for Xolair. However, doctors and patients are being advised to report side effects from the use of Xolair to the FDA's MedWatch Adverse Effects Reporting program. Once its review is completed, the finding should be communicated to the public along with any resulting recommendations.

This issue with Xolair points out some of the problems with newly approved drugs. While all new drugs go through clinical testing to demonstrate safety and efficacy prior to approval by the FDA for sale in the United States, these premarket clinical trials involve relatively small numbers of individuals compared to the actual numbers who will eventually take the drugs. As a result, it is impossible to really know how the drug might affect the general population until it is widely used. As more and more drugs have been getting accelerated approval, the FDA has required postmarketing study commitments in writing from drug manufacturers to learn additional information about the risks, benefits and optimal use of an approved drug. About half of new drug applications approved in fiscal years 1990 through 2004 involved at least one postmarketing study commitment, according to the Department of Health and Human Services Office of Inspector General (OIG). Postmarketing study results often lead to labeling changes, such as new warnings or dosing instructions. Xolair is one such drug and the manufacturer seems to be following through on its commitment.

However,despite their many promises, pharmaceutical companies often fail to submit required annual status reports to the FDA about postmarketing drug safety and efficacy studies and unfortunately, regulators lack the authority to punish those companies. In a 2006 report, the OIG attributed failed oversight to a lack of manpower and resources at the FDA.

According to OIG, 35% of the 336 annual status reports that were or should have been submitted by drug makers in fiscal year 2004 were missing entirely or contained no information on postmarketing study commitments. About 40% of these reports were missing one or more items of required information, investigators added.

FDA reported in the March 3 Federal Register that drug companies in fiscal year 2005 had missed the deadline for submitting 47% of their annual status reports. The agency also reported that 65% of open postmarketing studies had not been started as of September 2005.

After the 2006 report, the FDA promised to do better regulation of the postmarkeing process. Nevertheless, according to a Bloomberg report, data released by the agency in 2008, indicated that drugmakers had made little progress in beginning studies they had promised to conduct after their products were approved. According to the FDA 62 percent (1044), of incomplete studies for drugs and biotechs had yet to be started as of Sept. 30, 2008. At the same time in 2006, 63 percent (1026), of the unfinished studies hadn’t begun.

Source : www.examiner.com

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Approval of New drug for Heart patients

Here is the good news for all the heart patients of the world! The new anti-clotting drug of Eli Lilly & Co. and Daiichi Sankyo Co., named as Effient have been approved for sales by U.S authorities. This drug may take up one-fifth of the market from the second best selling drug- Plavix, which is largely sold out by Bristol-Myers Squibb Co. and Sanofi- Aventis SA.

Lilly’s medicine, prasugrel, which will be sold under the name of Effient got its clearance from Food and Drug Administration yesterday itself. This drug carries strict warning of increased risk of fatal bleeding in its label known as black box. Effient is available in markets in 5 and 10 milligram tablets for nullifying the chances of occurrence of heart attacks and strokes in a patient who are undergoing angioplasty treatment. But Tony Butler, who is an analyst at Barclay capital in New York expresses that the strict warning of this drug may affect its sales by $1.5 billion globally.

Seamus Fernandez, an analyst at Leerink Swann & Co. in Boston claimed in one of his meeting with clients on April 7 that Effient yearly sales will reach up to $1.9 billion by 2015. For New York based Bristol Myers and Paris based Sanofi, Plavix was an $ 8.2 billion seller last year.

Effient was out for sale in Europe in month of April and it captured nearly 20 percent of Plavix market. Tim Anderson, an analyst in Sanford C. Bernstein & Co. declared it to be the most preferred and prescribed drug for patients who suffers from acute coronary syndrome and are likely to undergo angioplasty procedure.

Initially the approval procedures for Effient face lot of hardships as one of the drug critic-Sanjay Kaul was removed from the panel of FDA advisors. FDA thought that the articles written by this critic related to the safety and effectiveness of the drug were biased. In a telephonic interview yesterday, the founder of Krensavage Asset Management LLC in New York said that FDA should go for another trail because the drug can cause tremendous bleeding in patients.

Effient has been designed to keep the blood platelets sticking from each other and form clot that can directly lead to strokes, heart attacks and finally death of a person. This drug was fully tested on patients suffering from heart attacks and who are undergoing angioplasty.

To persuade the doctors to make more use of Effient drug, it’s superiority over cheaper Plavix drug was made through various clinical trials. Consequently Plavix loses its patent rights with best seller of drugs company- Bristol-Myers in 2011.

Daiichi and Lilly carried out research involving 13608 patients in 30 countries for more than a year to check the effectiveness of their drug. The good news was that Effient was successful in preventing 23 more heart attacks than Plavix for every 1000 patients, but unfortunately it causes 6 more cases of excessive bleeding.

The American college of cardiologists in March 2008 founded that Effient was effectual in stopping blood clots in stent patients than the cheaper drug Plavix.

Recently Daiichi Sankyo and Lilly have started a new study known as trilogy to find out whether their drug is more suitable in treating patients from acute coronary syndrome along with other heart ailments than regular Plavix drug.

Very soon Daiichi Sankyo will be marketing the Effient drug in Japan and other countries as well. Lilly will booked the sales while Daiichi Sankyo will receive revenues from these sales.

Source : ub-news.com

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FDA Approves Heart Drug After New Trials

The FDA has approved the antiarrhythmic dronedarone (Multaq) for treatment of atrial fibrillation and atrial flutter, the drug's developer announced today.

Dronedarone is the first drug approved in the U.S. that has shown a clinical benefit to reduce cardiovascular hospitalization in patients with those conditions.

Calling the drug's approval "exciting," Stuart Connolly, MD, of McMaster University in Hamilton, Ontario, and a principal investigator in the ATHENA trial of dronedarone, suggested that the drug's reduction in hospitalizations "could change the way we approach the management of [atrial fibrillation and flutter]."

The FDA rejected the drug in 2005 following cancellation of the ANDROMEDA trial after enrollment of only 627 of 1,000 planned patients because of "worsening heart failure in the dronedarone group [n=25 versus 12 (placebo), P=0.027]," said a sanofi-aventis press release.

But the ATHENA trial, reported in the Feb. 12, 2009, issue of the New England Journal of Medicine, found a 25% reduced risk of the primary outcome of hospitalization for cardiovascular events or death (P<0.001)>

In ATHENA, 71% of at-risk patients had no heart failure, while 29% were in NYHA class I-III with stable heart failure, and 24% had a reduction in cardiovascular hospitalizations or death from any cause. Because of the ANDROMEDA findings, however, dronedarone is contraindicated, in patients with class IV heart failure or class II-III with recent decompensation needing treatment, said a sanofi-aventis press release.

Dronedarone is available in a 400 mg tablet that should be taken twice daily at morning and evening meals. Common adverse reactions include diarrhea, nausea, vomiting, abdominal pain, weakness, and rash.

Source : www.medpagetoday.com

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A cardiac arrest is quite a different diagnosis than that of a heart attack.

Blood vessel dilators and constrictors: Lidocaine, a local anesthetic has dual properties. It acts as a vasodilator or a vasoconstrictor depending on the sight and type of injection. Nitroglycerin is a blood vasodilator - a drug that opens the blood vessel by relaxing the muscular wall of the blood vessel. Nitroglycerin is usually given by pill under the tongue for rapid uptake or intravenously to prevent blood vessel spasm and to minimize the area of damage from the heart attack.

When paramedics are call to a life threatening situation or accident they rely on lidocaine in combination with other drugs to stabilize the injured until they are passed off to E.R. Lidocaine has gained the trust and safety properties of this agent. One must understand there is a clinical difference between a heart attack and cardiac arrest. In a word, there is more time to deal with a heart attack victim as opposed to a one who suffered cardiac arrest. Paramedics are never with out this drug because of its efficacious properties.

Clot busters. Most heart attacks are caused by a blood clot blocking a coronary artery. Using thrombolytic agents or "clot busters" that can break down blood clots and restore blood flow through the artery can limit heart muscle damage. Medications, if given early, also can be effective in reopening arteries. Clot-dissolving medications, also called thrombolytic agents or clot-busters, can open 80 percent of the blocked arteries within 90 minutes. There are many of these agents from which clinicians can use depending on the situation of the patient.

The most commonly used clot-dissolving drugs are tissue plasminogen activators (Activase and Retavase), streptokinase (Streptase and Kabikinase) Inohep and anistreplase (Eminase); all are given intravenously. The earlier these drugs are given, the better the chance of opening the artery quickly. If these drugs are given too late (more than 6 hours after the onset of chest pain), most of the damage to the heart muscle has already occurred.

There is another class of vasodilators, which are given orally after a heart attack to improve the heart muscle healing process. These medications reduce the stress on the heart, thereby allowing damaged muscles to recover.

Opening the artery quickly. If these drugs are given too late (more than 6 hours after the onset of chest pain), most of the damage to the heart muscle has already occurred. Clot-dissolving drugs may be combined with antiplatelet agents, such as aspirin and ReoPro, or anticoagulants, such as heparin and Coumadin. By reducing the tendency of blood platelets to clump and initiate clot formation, antiplatelet drugs lessen the possibility that the artery will reclose and improve chances of survival. An anticoagulant, such as heparin, often given intravenously in the hospital, thins the blood to prevent blood clots and to maintain an open artery during the initial 24 hours after a heart attack. The most serious complication associated with clot-dissolving drugs is excessive bleeding. A small number of patients who receive clot-busting drugs for a heart attack will experience some spontaneous bleeding. Such bleeding is most serious when it occurs in the brain.

A cardiac arrest , As reported what Michael Jackson suffered, also known as cardiopulmonary arrest or circulatory arrest, is the abrupt cessation of normal circulation of the blood due to failure of the heart to contract effectively during the pumping stage.

A cardiac arrest is different from (but may be caused by) a heart attack or, where blood flow to the still-beating heart, is interrupted as in cardiogenic shock. Cardiogenic shock is based upon an inadequate circulation of blood due to primary failure of the pumping valves (ventricles) of the heart to function. To put it bluntly the muscular integrity of the heart has failed due to possibly atrophy. Since this is a category of shock there is insufficient muscle mass tissue (i.e. the heart) to meet the required demand for oxygen and nutrients. This leads to cell death from oxygen starvation and nutrient starvation (e.g. hypoglycemia). Because of this it may lead to cardiac arrest.

"Arrested" blood circulation prevents delivery of oxygen to all parts of the body. Cerebral lack of oxygen supply to the brain causes victims to lose consciousness and to stop breathing, although breathing is abnormal or characterized as shallow may still occur. Brain injury is likely if cardiac arrest is untreated for more than 5 minutes.

by : Haynes Darlington M.SC.PharmD.
Source : www.amazines.com

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Prevent Heart Disease at Home

Dealing with heart disease is becoming more and more important. This hardening of the arteries or atherosclerosis can be caused or exacerbated by a number of different risk factors. The more of these factors you have, the more likely you?ll have to deal with heart disease at some point in your life.

Some of the most common risk factors are diabetes, high cholesterol, high blood pressure, obesity, stress, and genetics. You can also increase your risk of heart disease by living a very sedentary life or by smoking. Fortunately, many of these risk factors can be mitigated or even removed completely.

Of course, doing so will require a lifestyle change. One such change is to stop smoking and to start exercising. It can be difficult to do either, but both have many different benefits. If you stop smoking, you?ll not only reduce your chances of heart disease but you?ll also make your lungs healthier. Exercise, likewise, is a great way of keeping your heart healthy. You don?t even have to do major workouts or join a gym. Just do a few small things. Climb the stairs instead of taking the elevator. Learn deep breathing exercises. Take a walk around the block or, if possible, walk somewhere instead of driving. Yoga and swimming are also great ways of exercising our hearts. Remember, though, that you can over-exercise. If you have heart problems, discuss your exercise routine with your doctor before you start exercising.

Eating a healthy diet is another very, very important aspect to controlling heart disease. Those who eat greasy, fried foods are obviously in danger of blocking their arteries. People should try to avoid these types of food and instead focus on eating fresh vegetables and fruits. These foods are high in refined carbohydrates, which are healthy for you. Eating a diet that focuses on getting the daily recommended amount of fiber is also helpful. For those who already have heart disease, adding fish oil and fresh garlic is helpful.

Stress can have a major affect on heart attacks and heart problems. For those who deal with stressful situations on a daily basis, finding a healthy way of releasing this stress is very important. You may find yourself relaxing by spending time with others or going out somewhere, or you may enjoy curling up with a good book, watching television, or taking a hot bath. Either way, you must remember to relax every now and then or you may become so stressed you actually become unhealthy.

There are a number of other things we should remember to avoid: junk food, for example, is not good for our hearts. Neither is forgetting to take medication or multivitamins. Remember to follow your doctor?s orders when it comes to health or handling any health problems you already have. By reducing your cholesterol, reducing stress, and getting up and exercising, you can do a lot to prevent heart disease.

Source : www.amazines.com

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Stents no better than heart drugs in diabetics

Diabetics with stable heart disease do just as well taking drugs alone as getting quick angioplasty or bypass surgery to open blocked heart arteries, U.S. researchers said on Sunday.

They said patients advised to have angioplasty and a heart stent to restore blood flow and ease chest pain could safely wait and give drugs a chance to work.

But those with more severe disease sent for more invasive heart bypass surgery might be able to avoid a future heart attack if they have the surgery right away.

The study also found no difference in heart risks between two strategies for treating type 2 diabetes -- increasing the amount of insulin or lowering the body's resistance to its own insulin with drugs such as either metformin or GlaxoSmithKline's Avandia, also known as rosiglitazone, which had been thought to raise the risk of heart attacks.

"If you have diabetes and heart disease such that a bypass surgery is a recommended procedure, you should have that early rather than delaying it," said Dr. Trevor Orchard of the University of Pittsburgh, whose study appears in the New England Journal of Medicine.

Orchard said the study, also being presented at the American Diabetes Association meeting in New Orleans, offers evidence on how best to treat people with both type 2 diabetes and heart disease. More than 65 percent of people with diabetes die from heart disease or stroke.

For GlaxoSmithKline, the study represents a positive sign that Avandia may be safer than earlier analyses had suggested.

But it may be another blow for stent makers such as Boston Scientific Corp and Johnson & Johnson , whose U.S. sales plummeted after a similar study two years ago showed stents were no better than drugs at preventing death and heart attacks in all types of heart patients.

Stents are wire mesh tubes that prop open diseased arteries after they have been unclogged during angioplasty.

Questioning Angioplasty

In a commentary in the journal, Dr. William Boden of the University at Buffalo in New York said doctors should question why so many diabetics still get angioplasty.

"The continued high rate of use of (angioplasty) (1.24 million procedures per year in the U.S.) and the high rate of drug-eluting stent usage strongly suggests that we critically reassess our approach to revascularization, if needed, in diabetics with coronary disease," Boden wrote.

Diabetics with stable chest pain account for about 40 percent of all U.S. patients who get angioplasty, according to Wachovia analyst Larry Biegelsen, who said the findings could cut U.S. procedures by 3 percent.

The study involved 2,368 patients who either got treated right away with angioplasty, usually with a stent, and drugs or simply got drug treatment. It found no difference in the rates of death, heart attack or stroke after five years.

The study also looked at the risks and benefits of two strategies for controlling blood sugar in patients with type 2 diabetes, in which people lose the ability to use insulin.

One group took insulin injections or drugs known as sulfonylureas that boost the body's production of insulin. The other took insulin-sensitizing drugs like metformin or drugs known as glitazones, which include Avandia or Takeda Pharmaceutical Co's (4502.T) pioglitazone, brand name Actos.

Orchard said about 60 percent of patients in the insulin-sensitizing group took rosiglitazone or Avandia. He said there was no increased risk of heart attacks among patients in this group.

Source : www.reuters.com

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