вторник, 5 июля 2011 г.

Lilly's Anti-clotting Drug Excess Bleeding Detected, But More Effective In Preventing Heart Attacks Than Plavix

Eli Lilly and Daiichi Sankyo Co's investigational anti-clotting drug, Prasugrel, was found to be more effective at preventing heart attacks than Plavix, but also caused excessive bleeding among patients in a clinical trial, according to a new report. This excessive bleeding may undermine its future success. However, Prasugrel was definitely better at reducing deaths from non-fatal heart attacks and strokes, compared to Plavix.

2.4% of patients in a trial involving 13,600 participants receiving Prasugrel experienced at least one major bleeding event - much higher than the 1.8% of those on Plavix.

Dr. Deepak Bhatt, Cleveland Clinic, author of the Editorial which accompanied the study, explained "When it comes to anti-clotting medications there is no free lunch. In order to reduce heart attack risk, there is a trade-off with increased bleeding."

You can read about this trial in the New England Journal of Medicine (NEJM). Results were also announced in Orlando, Florida, during the annual meeting of the American Heart Association.

In two small trials, Eli Lilly had stopped giving Prasugrel to patients without fully explaining its reasons for this. The word is that the excessive bleeding looks like a likely cause.

For Prasugrel to be approved by the FDA one day, its safety would most likely have to improve - i.e. the excessive bleeding risk would have to come down significantly. Eli Lilly and Daiichi have plunged enormous amounts of money into the development of Prasugrel, in the hopes it would become a serious challenger for Bristol Myers Squibb's and Sanofi's Plavix, which earns over $6.5 billion annually for the two companies. Plavix is known as a "blockbuster" (a super selling drug).

Dr. Deepak Bhatt explained that this trial has demonstrated, despite the excessive bleeding, that the more powerful oral anti-platelet drugs further reduce coronary complications.

In this latest trial 9.9% of patients receiving Prasugrel experienced a non-fatal heart attack or stroke, compared to 12.1% of those who were given Plavix.

"Intensifying Platelet Inhibition - Navigating between Scylla and Charybdis"

Deepak L. Bhatt, M.D.

NEJM - 10.1056/NEJMe0706859

Click here to read first 100 words online

"Prasugrel versus Clopidogrel in Patients with Acute Coronary Syndromes"

Stephen D. Wiviott, M.D., Eugene Braunwald, M.D., Carolyn H. McCabe, B.S., Gilles Montalescot, M.D., Ph.D., Witold Ruzyllo, M.D., Shmuel Gottlieb, M.D., Franz-Joseph Neumann, M.D., Diego Ardissino, M.D., Stefano De Servi, M.D., Sabina A. Murphy, M.P.H., Jeffrey Riesmeyer, M.D., Govinda Weerakkody, Ph.D., C. Michael Gibson, M.D., Elliott M. Antman, M.D., for the TRITON-TIMI 38 Investigators

NEJM - 10.1056/NEJMoa0706482

Click here to view Abstract online

Written by - Christian Nordvqist

View drug information on Plavix.

понедельник, 4 июля 2011 г.

St Jude Medical: Leading The Way In Pacemaker Technology To Improve The Lives Of Cardiac Patients

Approximately 25,000 people in the UK require an implantable cardiac device, more commonly known as a pacemaker, every year. Some pacemakers are specifically designed for the treatment of heart failure, a disease that affects 900,000 people in the UK alone. St Jude Medical's new Promote Quadra cardiac resynchronisation therapy defibrillator (CRT-D) and Quartet TM lead offers heart failure patients a quadripolar pacemaker that has fewer complications and that can potentially provide improvements in care for this debilitating and often fatal disease.

The Quartet TM lead provides additional connections with the heart muscle, allowing for more ways in which the heart muscle can be stimulated, thereby optimising the pacemaker's performance, improving quality of life and potentially avoiding common complications.

Ann Fraser, is a 74 year old chronic heart failure (CHF) patient who was wheelchair bound. She suffered with extreme shortness of breath, a racing heart beat and severe hiccups that would cause her to wake up in the night whenever she moved onto her side. These hiccups were caused by irritation of her diaphragm from the position of her pacemaker lead. This was extremely debilitating, leaving Ann exhausted and having great difficulties in walking more than 20-30 meters. 'Since having the new pacemaker and lead fitted my symptoms have improved dramatically. I can now sleep at night and I've noticed an improvement in my shortness of breath so that I can now walk for further without stopping, and can even visit the shops and local community centre, which is much better than before.'

Dr Chow, Cardiologist at The Heart Hospital, UCLH, said ''Pacemakers have traditionally had one lead designed to stimulate the heart from a fixed point. On this occasion, the lead was placed too close to the nerve that controls Mrs Fraser's diaphragm and as an unwanted side-effect was causing hiccups. These were so severe that the pacemaker had to be switched off, but this meant that Ann's heart failure became worse. At a time when it looked like the options had been exhausted, I was very excited to offer Mrs Fraser the opportunity to try the new Quartet TM lead technology. The new lead allows for many different options in pacing from different points on the lead and so potentially offers a solution to many patients currently experiencing problems with the standard pacemaker leads.'

воскресенье, 3 июля 2011 г.

Arterial Vascular Disease Underdiagnosed, Undertreated In Older U.S. Women

Though arterial vascular disease is widespread and often deadly among older American women, doctors too often fail to spot and treat it, according to a new report by a team of vascular surgeons from the Columbia University Medical Center and Weill Cornell Medical College campuses of NewYork-Presbyterian Hospital.

"Much of that is due to the fact that for years, cardiovascular research has focused almost exclusively on males, so in many cases we simply don't understand the true prevalence or level of threat women face from vascular disease," says the study co-author, Dr. Ageliki G. Vouyouka, assistant professor of surgery in the Department of Vascular Surgery at Weill Cornell Medical College, and a vascular surgeon at NewYork-Presbyterian Hospital. "Obviously, we need more trials focused on the vulnerability of women to these crippling and even lethal conditions."

She and co-author Dr. K. Craig Kent the Greenberg-Starr Professor of Surgery at Weill Cornell Medical College, professor of surgery at Columbia University College of Physicians and Surgeons, and chief of vascular surgery at NewYork-Presbyterian Hospital published their review, titled "Arterial Vascular Disease in Women," in a recent issue of the Journal of Vascular Surgery.

Arterial vascular disease is an umbrella term for diseases involving the gradual closure of arteries throughout the body, including carotid stenosis (blockage of the arteries that supply blood to the brain), aortic aneurysmal disease (plaque and blockages in the aortic artery leading from the heart to the lower body), and lower-extremity arterial occlusive disease, which involves poor blood flow within the legs.

For decades, these forms of vascular disease were thought primarily as "men's diseases."

"That's because the risk of vascular trouble increases greatly for women after menopause," Dr. Kent explains. "In years past when lifespans were shorter, women simply didn't live long enough to develop serious vascular illness. That's all changed because the average American woman now lives well into her 80s."

Other factors have conspired to keep women with arterial vascular disease off of doctors' radar. Women typically outlive their male partners and are then left alone either isolated at home or placed in nursing homes. They often have fewer financial resources and caregiver support to draw on, as well. "This means they often don't get the care they deserve," Dr. Vouyouka says.

In their paper, the two researchers pored over the existing literature on women and arterial vascular disease, breaking the findings down into the three main disease subtypes. Some of their findings:

For carotid stenosis:

-- Women's carotid and vertebral arteries are markedly smaller than those of men, so it takes less plaque buildup to cause severe restrictions in blood flow. However carotid plaque is more stable in women and therefore the risk of stroke becomes significant at higher degree of stenosis as compared to men.

-- Plaque composition within the artery appears to differ between the sexes, and certain risk factors such as high blood levels of C-reactive protein, use of hormone replacement therapy (HRT) and osteoporosis may be unique to women.

-- Women were under-represented in all major trials for carotid endarterectomy (surgery to correct the blockage of the neck arteries-CEA) and therefore the outcome of the procedure on women is not well analyzed. However it appears that carotid endarterectomy (CEA) probably carries a higher rate of complications for women, including stroke and therefore the procedure should be done for higher degree of stenosis in women, compared to men.

For aortic aneurysmal disease (AAA):

-- Because of hormonal and other factors, this condition develops much later in life in women, compared to men.

-- The U.S. Preventive Service Task Force currently recommends against screening for AAA in women. This may be misguided, the researchers contend, due to the fact that AAA is somewhat less common in women, compared to men. However there are certain groups of women with risk factors such as old age, smoking history and family history that have significantly higher likelihood of developing abdominal aortic aneurysms who deserve screening. Even more so, AAA appears to be more dangerous in women because they are more prone to rupture in smaller sizes and once they rupture are more fatal.

-- Women are less likely than men to be offered minimally invasive endovascular techniques to correct AAA, mainly because they have smaller arteries and the current endovascular devices are made to fit the male anatomy. At the same time, female patients are more likely than males to die following traditional "open" aneurysm surgery. However when they undergo endovascular repair, their likelihood of dying is almost as low as that of men; and once the endovascular repair is completed , they actually respond better than men, with more rapid shrinkage of their aneurysm

For lower-extremity arterial occlusive disease:

-- The risk for this type of restricted blood flow in the legs rises quickly for women after menopause. In fact, at age 70, males and females share identical odds for acquiring the potentially crippling condition.

-- Certain risk factors including osteoporosis and the probable use of HRT heighten women's risk for lower-extremity vascular illness. Women too often delay seeking medical help for the problem, leading to a higher rate of advanced disease at time of diagnosis. Because they seek medical help late, they are more likely than men to require amputation. Rates of wound complications when they undergo bypass surgery are also higher among women. There is not much information available, regarding the outcomes of minimally invasive procedures such as balloon angioplasty or stenting in women. A review of minimal invasive procedures performed by the Division of Vascular Surgery at NewYork-Presbyterian Hospital, a joint program between Columbia University Medical Center and Weill Cornell Medical College, has shown that women, although they come with more advanced disease, do equally well as men.

"Many of these findings remain tenuous, however, because we simply do not have enough women participating in clinical trials to firmly establish their risk factors, disease prevalence, indications for intervention or treatment outcomes," Dr. Vouyouka says. "For that reason, we urge the creation of more randomized trials focused on women, a closer look at the impact of risk factors such as osteoporosis and HRT on women's vascular health, and studies examining the role that social isolation plays in older women's ability to receive care."

Some of those efforts are already under way beginning in 2000, the U.S. National Institutes of Health authorized new funding and programs aimed at better understanding cardiovascular disease in women.

Older American women many of whom have spent their lives caring for others deserve no less, Dr. Vouyouka says.

NewYork-Presbyterian Hospital

NewYork-Presbyterian Hospital based in New York City is the nation's largest not-for-profit, non-sectarian hospital, with 2,242 beds. It provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine at five major centers: NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Columbia University Medical Center, Morgan Stanley Children's Hospital of NewYork-Presbyterian, NewYork-Presbyterian Hospital/Allen Pavilion and NewYork-Presbyterian Hospital/Westchester Division. One of the largest and most comprehensive health-care institutions in the world, the Hospital is committed to excellence in patient care, research, education and community service. It ranks sixth in U.S.News & World Report's guide to "America's Best Hospitals," ranks first on New York magazine's "Best Hospitals" survey, has the greatest number of physicians listed in New York magazine's "Best Doctors" issue, and is included among Solucient's top 15 major teaching hospitals. The Hospital is ranked with among the lowest mortality rates for heart attack and heart failure in the country, according to a 2007 U.S. Department of Health and Human Services (HHS) report card. The Hospital has academic affiliations with two of the nation's leading medical colleges: Weill Cornell Medical College and Columbia University College of Physicians and Surgeons. For more information, visit nyp.

Weill Cornell Medical College

Weill Cornell Medical College Cornell University's Medical School located in New York City is committed to excellence in research, teaching, patient care and the advancement of the art and science of medicine, locally, nationally and globally. Weill Cornell, which is a principal academic affiliate of NewYork-Presbyterian Hospital, offers an innovative curriculum that integrates the teaching of basic and clinical sciences, problem-based learning, office-based preceptorships, and primary care and doctoring courses. Physicians and scientists of Weill Cornell Medical College are engaged in cutting-edge research in such areas as stem cells, genetics and gene therapy, geriatrics, neuroscience, structural biology, cardiovascular medicine, AIDS, obesity, cancer, psychiatry and public health and continue to delve ever deeper into the molecular basis of disease in an effort to unlock the mysteries behind the human body and the malfunctions that result in serious medical disorders. The Medical College in its commitment to global health and education has a strong presence in such places as Qatar, Tanzania, Haiti, Brazil, Germany and Turkey. With the historic Weill Cornell Medical College in Qatar, the Medical School is the first in the U.S. to offer its M.D. degree overseas. Weill Cornell is the birthplace of many medical advances from the development of the Pap test for cervical cancer to the synthesis of penicillin, the first successful embryo-biopsy pregnancy and birth in the U.S., the world's first clinical trial for gene therapy for Parkinson's disease, and, most recently, the first indication of bone marrow's critical role in tumor growth. For more information, visit med.cornell.

Columbia University Medical Center

Columbia University Medical Center provides international leadership in pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, nurses, dentists, and public health professionals at the College of Physicians and Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. For more information, visit cumc.columbia.

NewYork-Presbyterian Hospital

425 East 61st St., Fl. 7

New York, NY 10021

United States


суббота, 2 июля 2011 г.

Discovery Of Gene Linked To Adult-Onset Obesity

Researchers at the University of Minnesota have discovered a gene that may provide a clue as to why obesity rates increase with age. The research was published in the Proceedings of the National Academy of Sciences.

Researchers in the lab of Kevin Wickman, Ph.D., associate professor of pharmacology at the University of Minnesota Medical School, removed a single gene from mice as part of an ongoing study to understand how the brain controls heart function. While some cardiac deficiencies were detected in these mice, the researchers unexpectedly found that these mice exhibited a predisposition to adult-onset obesity. "This was not an outcome we expected, but now we have an animal model that may provide new insight into human obesity," said Wickman, co-author of the article.

By examining closely where this gene, termed Girk4, is expressed in the body, the researchers found particularly high levels in the hypothalamus, a brain region involved in regulating food intake and energy expenditure. Wickman speculated that disruption of normal function in the hypothalamus may underlie the obesity seen in the mutant mice, but he acknowledges that more research is needed to understand where and how this gene works, and consequently, why mice missing this gene develop obesity.

The age-dependence of the obesity seen in this mouse model mimics human obesity patterns, researchers said. Indeed, the likelihood of people developing obesity more than doubles between the ages of 20 and 60.

"This is a novel finding that may provide important new insight to the underlying cellular mechanisms that influence obesity," said Catherine Kotz, Ph.D., co-author of the article, scientist at the Minneapolis VA Medical Center and adjunct professor in the Department of Food Science and Nutrition at the University of Minnesota.

This research was funded by the University of Minnesota Graduate School, a pilot award from the Minnesota Obesity Consortium, and a grant from the National Institutes of Health. The research was conducted in collaboration with the Department of Veterans Affairs.

пятница, 1 июля 2011 г.

UCSD Researchers Discover Variants Of Natural Tumor Suppressor - Could Lead To Therapy Targets For Diabetes, Heart Disease And Cancer

Building on their 2005 discovery of an enzyme that is a natural tumor suppressor, researchers at the University of California, San Diego (UCSD) School of Medicine have now identified two variants of that enzyme which could provide new targets for therapies to treat diabetes, heart and neurological disease. The findings, by Alexandra C. Newton, Ph.D., UCSD professor of pharmacology, and colleagues are published in the current edition of the journal Molecular Cell.

Previous research by Newton's lab, also published in Molecular Cell, described the discovery of an enzyme they named PH domain Leucine-rich repeat Protein Phosphatase (PHLPP, pronounced "flip") that turns off signaling of the Akt/protein kinase B, a protein which controls cell growth, proliferation and survival.

The new work describes a second family member, PHLPP2, which also inactivates Akt, inhibiting the cell cycle progression and promoting cell death. However, PHLPP1 and PHLPP2 control three different disease pathways. While both are important in cancer, PHLPP 1 impacts an important pathway in diabetes and PHLPP2 could be useful in fighting heart and neurological disease.

"We first discovered that PHLPP controls Akt, which is the driver on the pathway to tumor growth," said Newton. "PHLPP is like a brake that, when on, slows the driver but when 'off' allows the driver to move. In cancer, we want the driver to brake, to prevent cell proliferation leading to tumor growth. But in diabetes, heart or neurological disease, where we want to promote cell growth and survival, we don't want to slow the driver down."

The researchers have now found that PHLPP1 controls the driver along one pathway - Akt2, which is more closely involved in maintaining a constant level of glucose in the bloodstream. Therapies directed at inhibiting PHLPP1 could be used to treat diabetes; in essence, removing the 'brake' and allowing Akt2 to be more functional and allow better insulin regulation. PHLPP2, on the other hand, controls the driver on Akt1, the path involved with cell survival. Therapies directed at releasing the brake on this driver would allow cells involved in heart or neurological diseases to better survive.

"Both PHLPP variants are important in cancer; the loss of a brake to any of the three Akt pathways sends 'go, go, go' signals that promote the survival of tumor cells," said first author John Brognard. UCSD researchers had previously discovered that Akt is hyperactivated, or elevated, in most cancers and PHLPP provides a mechanism to reverse this activation.

Additional contributors to this paper include Brognard, Tianyan Gao and Emma Sierecki, UCSD Department of Pharmacology. Funding for the research was provided in part by the National Institutes of Health and a grant from the U.S. Army Medical Research Acquisition Activity.

Contact: Debra Kain

University of California - San Diego

четверг, 30 июня 2011 г.

12-Month Results With The Lifestent (Bard) For Popliteal Lesions Show It Is A Safe And Effective Option For Popliteal Lesions

Marc Bossiers, M.D., Head of the Department of Vascular Surgery at A.Z. St. Blasius Hospital in Dendermonde, Belgium, presented
the 12-months results on a test o the Lifestent (Bard) for popliteal lesions.

The objective was to determine the safety of treating
femoral-popliteal occlusive disease with the LifeStent NT (Bard) in everyday clinical practice. The results showed that all lesions were
successfully accessed and treated with the LifeStent NT.

No peri-procedural events (death, stroke, MI, distal embolization, surgical
revascularization and thrombosis) occurred and the safety profile of the procedure had a 4.6% death rate (none product related) at 30-

The 12-month primary unassisted patency rate was 70.2% with a 6-month fracture rate of 15.8%. In conclusion, the outcome of
MELOPEE shows that the LifeStent NT is a safe tool in the treatment of popliteal occlusive arterial disease.

VEITH SYMPOSIUM - New York, November 19th to 23rd

Now in its fourth decade, VEITH SYMPOSIUM provides vascular surgeons, interventional radiologists, interventional cardiologists and other vascular specialists with a unique and exciting format to learn the most current information about what is new and important in the treatment of vascular disease. The 5-day event features rapid-fire presentations from world renowned vascular specialists with emphasis on the latest advances, changing concepts in diagnosis and management, pressing controversies and new techniques.

VEITHsymposium is sponsored by Cleveland Clinic, Cleveland, OH.



Pauline T. Mayer


среда, 29 июня 2011 г.

Ranbaxy Granted Final FDA Approval To Market Simvastatin 5, 10, 20 And 40 Mg Tablets

Ranbaxy Laboratories Limited
(RLL), announced today that the Company has received approval from the U.S.
Food and Drug Administration (FDA) to manufacture and market Simvastatin
Tablets USP, 5 mg, 10 mg, 20 mg and 40 mg in the U.S. The FDA's Office of
Generic Drugs has determined Ranbaxy's Simvastatin Tablets USP, 5 mg, 10
mg, 20 mg and 40 mg to be bioequivalent, therefore, therapeutically
equivalent to the listed drug Zocor(R) Tablets, 5 mg, 10 mg, 20 mg and 40
mg of Merck Research Laboratories. Total annualized market sales for
Simvastatin were $4.8 billion, of which $4.2 billion were for the 5 mg, 10
mg, 20 mg and 40 mg tablets (IMS - MAT: September 2006).

Simvastatin tablets are indicated in the treatment of patients with
coronary heart disease (CHD) or at high risk of CHD, reductions in risk of
CHD mortality and cardiovascular events, patients with hypercholesterolemia
requiring modifications of lipid profiles and adolescent patients with
Heterozygous Familial Hypercholesterolemia (HeFH). A Simvastatin regimen
can be started simultaneously with diet.

"Ranbaxy has marketed the 80 mg tablets of Simvastatin on an exclusive
basis since the patent expired in June of this year. We are now in a
position to expand our product offerings to include the four additional
strengths of Simvastatin and can now offer the complete line of marketed
strengths for this product to our customers. Simvastatin has assumed a
prominent position in the management of patients with hypercholesterolemia,
and is now available as an alternative to the brand at an affordable price.
This undoubtedly will have a positive economic benefit to patients, as well
as to the U.S. healthcare system," according to Jim Meehan, Vice President
of Sales and Marketing for RPI.

Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is a
wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's
largest pharmaceutical company. RPI is engaged in the sale and distribution
of generic and branded prescription products in the U.S. healthcare system.

Ranbaxy Laboratories Limited, headquartered in India, is an integrated,
research based, international pharmaceutical company producing a wide range
of quality, affordable generic medicines, trusted by healthcare
professionals and patients across geographies. Ranbaxy's continued focus on
R&D has resulted in several approvals in developed markets and significant
progress in New Drug Discovery Research. The Company's foray into Novel
Drug Delivery Systems has led to proprietary "platform technologies,"
resulting in a number of products under development. The Company is serving
its customers in over 125 countries and has an expanding international
portfolio of affiliates, joint ventures and alliances, ground operations in
49 countries and manufacturing operations in 9 countries.

Zocor is a registered trademark of Merck Research Laboratories

Ranbaxy Laboratories Limited


View drug information on Zocor.