Popular Statin Reduces Recurrent Stroke Risk

In people who have experienced a stroke, but who have no known history of coronary heart disease, beginning regular treatment with the cholesterol-lowering drug atorvastatin soon after the stroke can reduce the risk of recurrent stroke by 16 percent, according to a five-year study led by an international team that includes a researcher at Duke University Medical Center.

The results of the study, called the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial, appear in the August, 2006, issue of the New England Journal of Medicine. The study was funded by Pfizer, the manufacturer of atorvastatin.

“This is the first study to demonstrate that treatment with a statin, a type of cholesterol-lowering drug, can reduce the risk of strokes in patients who have had a recent stroke or a transient ischemic attack and who have no known history of coronary heart disease,” said Larry B. Goldstein, M.D., director of the Duke Stroke Center and a member of the SPARCL steering committee.

A transient ischemic attack is similar to a stroke, but is of shorter duration and severity. Often referred to as a ministroke, it is considered a warning sign or prelude for stroke.

“These results will have a major effect on how people are treated following a stroke,” Goldstein said. “The findings are very important for physicians and patients because they show that the addition of this drug to other treatments further reduces the risk of another stroke, which is a pretty big step in improving what we can do for stroke patients.”

Previous studies, Goldstein said, have demonstrated that atorvastatin and other drugs within the class of medications called statins could reduce risk of stroke in patients who have a history of coronary disease. Coronary heart disease is a narrowing of the small blood vessels that supply blood to the heart, usually due to a build-up of cholesterol. It is a leading cause of death for Americans, he added.

The study results showed that atorvastatin — sold as Lipitor — in addition to reducing recurrent stroke risk, can also reduce stroke patients’ risk of heart attack and other major coronary events by 35 percent; their risk of cardiovascular events such as unstable angina by 42 percent; and their need for coronary revascularization procedures, such as coronary artery bypass grafting or cardiac catheterization, by 45 percent, compared to treatment with an inactive placebo.

In the trial, the researchers enrolled 4,731 patients at 205 study sites in Africa, Australia, Europe, the Middle East, and North and South America. All of the patients had experienced either a stroke or a transient ischemic attack within six months of their enrollment. The patients averaged 63 years of age; 60 percent were male and 40 percent female. Patients were monitored for an average of five years following enrollment.

At the time of their enrollment, roughly 66 percent of the patients had experienced an ischemic stroke, which occurs when the blood supply to a part of the brain is suddenly blocked; 2 percent had experienced a hemorrhagic stroke, which occurs due to a leaking blood vessel in the brain; and 30 percent had experienced a transient ischemic attack.

Ninety-four percent of the patients enrolled were already being treated with aspirin or medications that reduce clotting of the blood, and 69 percent of the patients, most of whom had high blood pressure, were receiving treatment with blood-pressure lowering medications. Those treatments were continued during the patients’ participation in the SPARCL study.

The researchers randomly assigned patients to receive either 80 milligrams per day of atorvastatin or an inactive placebo. The study was double-blinded, meaning that neither the researchers nor the patients knew in advance which patients were receiving the active medication.

The study found that atorvastatin, compared with the placebo, reduced the risk of fatal and nonfatal strokes by 16 percent.

This overall reduction in the risk of stroke was present despite a small increase in the number of patients having one of the types of stroke, hemorrhagic stroke. Due to the small number of people recruited into the SPARCL trial with a previous hemorrhagic stroke, the researchers said that it is not possible to reach any meaningful conclusions regarding their risks and benefits with atorvastatin treatment.

The researchers suggest that the drug appears to exercise its overall protective effect by lowering the levels of low-density lipoprotein (LDL) cholesterol — popularly known as “bad” cholesterol — in patients’ blood. High levels of LDL cholesterol in the blood are known to increase the risk of coronary heart disease, a risk factor for stroke as well as heart attack.

Patients who received atorvastatin had an average LDL cholesterol level of 73 milligrams per deciliter of blood, compared with an average of 129 milligrams per deciliter for patients on placebo, the researchers said.


The SPARCL study, including the work of the steering committee, was supported by Pfizer. Goldstein also has consulted for Pfizer and other manufacturers of statin medications.

Other members of the SPARCL steering committee, who also were co-authors of the report, include Pierre Amarenco of Denis Diderot University, Paris, France; Julien Bogousslavsky of University of Lausanne, Switzerland; Alfred S. Callahan III of Neurologic Consultants, P.C., Nashville, Tenn.; Michael Hennerici of Universitat Heidelberg, Mannheim, Germany; Henrik Sillesen of University of Copenhagen, Denmark; Justin Zivin of the University of California at San Diego; and K. Michael A. Welch of the Rosalind Franklin University of Medicine and Science, Chicago, who chaired the steering committee. Other co-authors, who are not members of the steering committee, include Amy E. Rudolph, Lisa Simunovic and Michael Szarek, all of Pfizer.

Contact: Tracey Koepke
Duke University Medical Center

Life Expectancy Reaches Record High Of 78.1 Years, Report Finds

Life expectancy for U.S. residents reached a record high of 78.1 years in 2006, compared with a previous record high of 77.8 years in 2005, according to a preliminary report released on Wednesday by the National Center for Health Statistics at CDC, the Washington Post reports. For the report, Melonie Heron, a NCHS demographer, and colleagues analyzed 95% of the death certificates collected in the 50 states and Washington, D.C., in 2006.

According to the report, life expectancy was 80.7 years for women and 75.4 years for men (Brown, Washington Post, 6/12). Experts said that the disparity in life expectancy between women and men has decreased since 1979 as more women have become smokers (Stobbe, AP/Wichita Eagle, 6/12). The report found that white women had the longest life expectancy, at 81 years, followed by black women at 76.9 years, white men at 76 years and black men at 70 years (Washington Post, 6/12). The disparity in life expectancy between whites and blacks has decreased in recent years because of improvements in treatment for heart disease, which affects a higher percentage of blacks, experts said (AP/Wichita Eagle, 6/12).

The report also found that the overall mortality rate decreased to 776 deaths per 100,000 individuals in 2006 from 799 per 100,000 in 2005 (Sternberg, USA Today, 6/12). In addition, the report found the mortality rate for Hispanics was 550 deaths per 100,000 individuals, compared with 778 per 100,000 for whites and 1,001 for blacks (Washington Post, 6/12). The overall infant mortality rate decreased by more than 2% to 6.7 deaths per 1,000 live births in 2006, the report found (USA Today, 6/12). Black infants had a mortality rate of 13.3 deaths per 1,000 live births, more than double the rate for white infants, according to the report (Washington Post, 6/12).

Leading Causes of Death
In 2006, the two leading causes of death were heart disease and cancer, which accounted for 1.2 million of the 2.4 million deaths overall (Washington Post, 6/12). The mortality rate from heart disease was 210.2 deaths per 100,000 individuals, and the rate for cancer was 187.1 per 100,000, the report found (Washington Post graphic, 6/12). However, the number of deaths from heart disease decreased by more than 5% in 2006, according to the report (AP/Wichita Eagle, 6/12).

The third leading cause of death was stroke, which had a mortality rate of 45.8 deaths per 100,000 individuals, the report found (Washington Post graphic, 6/12). The report found that the number of deaths from stroke decreased by more than 6% in 2006 (AP/Wichita Eagle, 6/12).

According to the report, the remainder of the 10 leading causes of death included lung disease, accidents, Alzheimer’s disease diabetes, influenza and pneumonia, kidney disease and septicemia (Washington Post graphic, 6/12). In addition, the report found that the number of deaths from AIDS decreased for the 10th consecutive year (Washington Post, 6/12).

The report is available online (.pdf).

The Chicago Tribune blog “Triage” examined the report (Graham, “Triage,” Chicago Tribune, 6/11).

NBC’s “Nightly News” on Wednesday also reported on the study (Costello, “Nightly News,” NBC, 6/11).

Kids Count Report
The percentage of low-birthweight infants born in the U.S. in 2005 increased to the highest rate since 1968, according to the 2008 Kids Count report released on Thursday, the AP/Atlanta Journal-Constitution reports. The annual report, compiled by the Annie E. Casey Foundation, measures each state in 10 areas, which include the infant mortality rate, teen birth rate and rate of low-birthweight infants.

The report found that the percentage of infants who weighed less than 5.5 pounds at birth increased to 8.2% in 2005. According to the report, the rate of low-birthweight infants among blacks was 13.6%, compared with 7.3% for whites and 6.9% for Hispanics (Crary, AP/Atlanta Journal-Constitution, 6/12).

The report is available online.

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Vaxonco’s EP1300 Epitope-Based DNA Vaccine For Malaria Delivered By Ichor’s TriGrid™ Electoporation Enters Phase I Trial

Vaxonco Inc., a Korean company specializing in peptide-based vaccines and Ichor Medical Systems (Ichor), whose advanced TriGrid™ Delivery System (TriGrid™) is being tested worldwide for its ability to enhance delivery of DNA drugs and vaccines, announced the initiation of a Phase I clinical trial to evaluate a novel DNA-based polyepitope vaccine against malaria. The study is supported by the United States National Institutes of Health and Vaxonco, Inc.’s subsidiary Epimmune, Inc and EP1300 will be delivered using Ichor’s TriGrid™. The study will be conducted as a randomized, prospective, placebo-controlled, dose-escalating trial at the Emory Vaccine and Treatment Evaluation Unit in Atlanta, Georgia, and will be supported by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health.

The objectives of the study are to evaluate the safety, reactogenicity, tolerability, and immunogenicity of the DNA vaccine candidate when delivered in healthy adult volunteers using the TriGrid. Study participants will include 39 healthy adults aged 18-40 years who have no previous history of malaria exposure or infection.

“Epitope-based vaccines represent a very logical approach to treating a heterogeneous general population because they allow one to overcome restrictions associated with population heterogeneity in immune responses, thereby achieving a broader range of coverage. We are excited to be entering into the clinic with Ichor’s technology to address the major challenge of efficiently delivering DNA vaccines into cells,” stated Michelle Kim, Vice President from Vaxonco, Inc.

“We are delighted to be working with Vaxonco and NIAID to test this exciting epitope-based approach to treat this major disease. We anticipate the resulting human data will continue to position the TriGrid™ as a universal vaccine delivery platform for a multitude of infectious diseases,” said Robert Bernard, CEO from Ichor Medical Systems.

The proposed clinical trial will be the first to evaluate a DNA-based, polyepitope vaccine against P. falciparum malaria. Malaria is a mosquito-borne disease caused by protozoan parasites of the genus Plasmodium (P.falciparum). The World Heath Organization estimates that there are more than 250 million clinical cases of malaria per year, accounting for over 800,000 deaths. The majority of deaths occur among children under five years of age in Africa, especially in those areas with poor access to healthcare services.


Vaxonco Inc.

Non-invasive Methods To Detect Schistosome-based Bladder Cancer: Is The Association Sufficient For Epidemiological Use?

UroToday – Urinary schistosomiasis caused by the trematode parasite Schistosoma haematobium is endemic in most of Africa. This infection is one of the world’s great neglected diseases and it is a known carcinogen. The parasite is long lived, and causes sustained inflammation in the vesicular veins where the adults live for as long a 10 or 12 years. From the urological viewpoint, this prolonged inflammation as well as products of the parasite itself lead over time to the development of squamous cell carcinoma of the bladder.

In Africa, where the parasite occurs, bladder cancer is the most common form of cancer seen in populations, and the majority of these cancers are squamous cell carcinoma. The association is clear; we do not know much about the epidemiology and actual mortality of this condition because the only definitive diagnostic procedure is cystoscopy and biopsy. This cannot be done on a population wide study.

The paper we wrote is a review of some noninvasive techniques that can be applied on a population level in endemic areas. We propose that a battery of non-invasive tests, both cytological and biochemical should be sufficient to predict the serious nature of this infection. In Egypt it has been shown that reduction of this infection to very low levels and almost eliminated squamous cell carcinoma of the bladder. We feel that a sophisticated diagnostic center should be set up in Ghana from which a service could be provided to regional countries and societies where this parasite abounds. Prior studies in Ghana have demonstrated that:

1. A high incidence of abnormal bladder pathology (~40%) demonstrated in the four Ghanaian villages surveyed as assessed by portable ultrasound studies.
2. Digital image analysis (DIA) using Feulgen-stained urine cytology preparations could predict abnormal pathology by ultrasound.
3. About 60% of cases studies by DIA also had abnormal BlCa4 tumor-associated antigen present in their urine.
4. The application of DIA on captured transitional and squamous urine cytology preparations proved that both cell types could predict abnormal pathology but that squamous-type cells did so with greater accuracy.
5. In the future such non-invasive biomarker technology applied to an at-risk population should improve early detection and result in early intervention.


Shiff C, Veltri R, Naples J, Quartey J, Otchere J, Anyan W, Marlow C, Wiredu E, Adjei A, Brakohiapa E, Bosompem K. Ultrasound verification of bladder damage is associated with known biomarkers of bladder cancer in adults chronically infected with Schistosoma haematobium infection in Ghana. Trans. R. Soc. Trop. Med. Hyg. 2006; 100: 847-854.

Naples J, Isharwal S, Shiff C, Bosompem KM, and Veltri RW. Clinical Utility of Squamous and Transitional Nuclear Structure Alterations induced by Schistosoma haematobium in chronically infected adults with bladder damage verified by Ultrasound in Ghana. Anal Quant Cytol Histol 2009; 31:143-152.

Clive Shiff, MD and Robert W. Veltri, MD as part of Beyond the Abstract on UroToday

UroToday – the only urology website with original content global urology key opinion leaders actively engaged in clinical practice. To access the latest urology news releases from UroToday, go to:

Copyright © 2009 – UroToday

Anger And Hostility Hasten Decline In Lung Power

Longstanding anger and hostility compromise lung function and hasten the natural decline in lung power that is a normal part of aging, reveals research published ahead of print in Thorax.

The authors base their findings on a study of 670 men, taking part in the long term US Normative Aging Study. Their ages ranged from 45 to 86, but the average age was 62.

Their levels of hostility were measured in 1986, using a validated scoring system The average hostility score was around 18.5, but ranged from 7 to 37.

After this initial assessment, the men were monitored for an average of eight years, during which their lung function was measured on three separate occasions.

The men’s lung function at the start of the study varied according to their initial levels of hostility.

It was significantly poorer among those men deemed to exhibit high levels of anger and hostility compared with those who exhibited medium to low levels.

But it was also worse at each examination throughout the period of study.

Although the impact was lessened, the association held true even after taking account of factors likely to influence the findings, such as smoking and educational attainment.

Higher levels of hostility were also associated with a faster rate of the natural decline in lung function that occurs with aging.

Each point increase in hostility score was associated with a loss of FEV1 — the volume of air that can be forced out of the lungs in one second, and a measure of lung power — of 9 ml a year compared with men whose hostility levels were lower.

The authors point out that hostility and anger have been associated with cardiovascular disease, death, and asthma, and that previous research has suggested that changes in mood can have short term effects on the lungs.

Anger and hostility will alter neurological and hormonal processes, which in turn may disturb immune system activity, producing chronic inflammation, suggest the authors.

An accompanying editorial comments that the physiological components of anger and stress overlap, and stress is well known to affect the immune system.

“Indeed it is hard to find a disease for which emotion or stress plays absolutely no part in symptom severity, frequency, or intensity of flare-ups,” writes Dr Paul Lehrer of the University of Medicine and Dentistry in New Jersey, USA.

Chronic anger may permanently alter the normal body responses to and physical and psychological stressors, he suggests, and add to “wear and tear.”

But he cautions that associations do not necessarily equate to cause. “Personality, as well as physiology, can change over time, and deterioration in health and physical function can lead to negative emotion as well as vice versa, including for respiratory diseases.”


Contact: Emma Dickinson

BMJ Specialty Journals

China Blocks Pork Products From Alberta, Canada

All imports of pork products from Alberta province, Canada, have been banned by Chinese authorities. The Ministry of Agriculture says this is a precaution to stem the spread of swine flu, according to the Xinhua News Agency. The CFIA (Canadian Food Inspection Agency) found H1N1 flu virus (swine flu) in a swine herd in Alberta.

Canadian authorities stress that Canadian pork is safe to eat. Experts say the pigs were most likely infected by a human worker who had recently returned from Mexico. The worker has recovered. All the pigs have either recovered or are recovering well, authorities say.

Influenza viruses do not have an effect on the safety of pork and pork meat products, according to the World Health Organization (WHO) and the Food and Agriculture Organization of the United Nations (FAO). As with any uncooked meat, pork should always be correctly handled and cooked to get rid of a range of food safety concerns.
Mexico sends plane to pick up people from China
Mexico as chartered a plane to bring home 70 of its citizens who were seized and quarantined in China. Mexican authorities complained that the swine flu outbreak is no excuse for treating its citizens repressively and in such a discriminatory way.

Mexican authorities added that the swine flu epidemic appears to be waning. However, World Health Organization (WHO) officials say it is too early to lower our guard.

See our Map Of H1N1 Outbreaks
See our Mexico Swine Flu Blog

The Poppy Seed Test For Colovesical Fistulas

ORLANDO, FL (UroToday) – Most urologists at large referral centers have met a patients with a complex surgical history who presents with multi-microbial recurrent urinary tract infections. A fistula from the GI tract to the bladder is suspected, and after cysto/endoscopy, cross-sectional imaging, nuclear medicine imaging and fluoroscopic contrast studies, a fistula is finally found.

Can’t this be simplified? Yes, according to Kwon et al!

These investigators report an elegant and clinically very useful study that demonstrates that the “poppy seed test” reveals a colovesical fistula in 100% of patients, while Chromium-51 nuclear study and CT are much less impressive (BUT MUCH MORE EXPENSIVE).

The poppy seed test involves the microscopic examination of patients’ urine after an oral administration of poppy seeds. Sensitivity of the test was impressive (100%). The authors should be congratulated on this excellent report.

If these findings can be substantiated by others, poppy seed testing should enter ubiquitous routine clinical practice.

Presented by Eric O Kwon, MD, Noel A Armenakas, MD, Stephen C Scharf, MD, Georgia Panagopoulos, MD, and John A Fracchia, MD, at the Annual Meeting of the American Urological Association (AUA) – May 17 – 22, 2008. Orange County Convention Center – Orlando, Florida, USA.

Reported by UroToday Contributing Editor Alexander Kutikov, MD

UroToday – the only urology website with original content global urology key opinion leaders actively engaged in clinical practice.

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Copyright © 2008 – UroToday

Carbon monoxide: Poison gas or anti-inflammatory drug?

Carbon monoxide, a poisonous gas that kills thousands of Americans every year, could turn out to be a life-saver for patients recovering from organ transplants, strokes or heart attacks, according to new research from the University of Michigan Cardiovascular Center.

In a recent study, U-M scientists found that inhaling small amounts of carbon monoxide for several weeks after transplant surgery prevented the development of a lethal inflammatory reaction in experimental mice receiving transplanted trachea, or windpipes.

If carbon monoxide therapy works as well in human patients as it does in mice, it could prevent an inflammatory response, called obliterative bronchiolitis, which develops in nearly 50 percent of all patients who receive a lung transplant from an unrelated donor. OB is the most common complication following a lung transplant in humans and the most deadly. It occurs when the patient’s immune system rejects the transplanted lung and sends an army of T cells to attack and destroy the foreign tissue.

“No one is sure exactly how it happens, but the small airways in the lung swell and become progressively smaller until the patient cannot breathe,” says David J. Pinsky, M.D., the J. Griswold Ruth, M.D. & Margery Hopkins Ruth Professor of Internal Medicine and chief of cardiovascular medicine in the U-M Medical School, who directed the research. “Currently, we have no effective treatments for OB. Unless the patient receives a new lung transplant, the outcome is generally fatal.”

Results of the U-M study were published July 18 in the most recent issue of the Journal of Experimental Medicine (JEM).

Pinsky’s research team focuses on the relationship between carbon monoxide and nitric oxide – two poisonous gases produced by different types of cells in the body. U-M research findings suggest that a patient’s chances of living or dying after a lung transplant depend, in large part, on the outcome of an internal power struggle between two enzymes that control cellular production of these gases.

“Hmox, or heme oxygenase enzyme, is responsible for the synthesis of carbon monoxide,” Pinsky explains. “It was first identified as a heat shock protein induced under stress conditions to help protect cells from damage. Hmox expression increases in human lung transplant patients with OB.

“Nitric oxide synthase, or iNOS, is the enzyme responsible for the synthesis of nitric oxide,” Pinsky adds. “When it’s expressed in endothelial cells in blood vessels, it causes them to dilate and relax. But when it’s expressed in epithelial cells in airways, it generates a flood of leukocytes that trigger an inflammatory response. Expression of iNOS also increases during lung transplant rejection.

“We think that Hmox and carbon monoxide are the body’s way of trying to limit tissue inflammation and injury induced by iNOS and nitric oxide during transplant rejection,” Pinsky says. “Our data show that localized CO production provides critical protection against the OB induced by iNOS expression. It’s a balancing mechanism. When Hmox expression goes up, it reduces iNOS expression and suppresses a key signaling pathway involved in the immune response.”

To test their hypothesis, U-M scientists studied two types of experimental mice – one group lacked the gene for the Hmox enzyme and were unable to synthesize carbon monoxide. Another group produced unusually high levels of Hmox and CO. When U-M scientists transplanted windpipes from one type of mouse into the other, genetic differences between the two strains of mice triggered transplant rejection, inflammation and significant narrowing of the airway in the transplant recipients.

But U-M scientists discovered they could rescue the mice by having them inhale CO-enriched air (100 ppm) for two weeks after transplantation, or by giving them a drug that induces high levels of Hmox expression.

“We found that naturally occurring levels of the Hmox enzyme were not high enough to prevent airway occlusion in mice after transplant,” says Hiroaki Harada, M.D., a U-M research fellow and co-first author of the study. “We had to either use drugs to boost Hmox expression in the mice or boost its end-product with prolonged inhalation of carbon monoxide.”

“Carbon monoxide is lethal at certain doses, but the animals tolerated the 100 ppm level for two weeks with no apparent problems,” Pinsky says. “In human terms, it’s equivalent to the amount you’d receive sitting in a traffic jam in Mexico City.”

The next step was to analyze the amount of Hmox enzyme expressed in white blood cells and in epithelial cells lining the grafted trachea. “We did this to determine the source of CO,” Pinsky says. “Was it coming from infiltrating immune cells from the host or from donor epithelial cells lining the graft? In order to prevent airway rejection, our results show that Hmox expression and generation of carbon monoxide must occur in grafted tissue cells.”

The researchers also found that while both inhaled and internally produced carbon monoxide had a positive effect on transplant airway inflammation and narrowing, inhaled nitric oxide had no effect and internally produced nitric oxide made the inflammatory reaction worse.

Pinsky’s research team previously published evidence for the therapeutic efficacy of CO inhalation in mice recovering from the type of cardiovascular injuries caused by blood clots to the lungs. Pinsky maintains that the balancing act between CO and NO is an important factor in transplant rejection after heart transplants and in recovery after other types of damage to the cardiovascular system.

Pinsky believes that carbon monoxide may one day be as common in the hospital ICU as inhaled nitric oxide is today, but cautions that a great deal of additional research will be required to resolve important questions of dosing and toxicity.

“The therapeutic window for carbon monoxide is very small,” he says. “Small amounts are good, but a little more will kill you. So dosage will always be a serious issue in any future therapies.”

Columbia University, where Pinsky was a faculty member until 2003 when he joined the U-M’s Cardiovascular Center, holds several patents related to treating ischemic disorders using carbon monoxide. Pinsky recently became a consultant to iNOTherapeutics, a subsidiary of Aga-Linde Healthcare, a supplier of medical gases. The research study was supported by grants from the U.S. Public Health Service.

Kanji Minamoto, M.D., a former Columbia University research fellow now at Okayama University in Japan, was co-first author on the study. Other U-M collaborators included Vibha N. Lama, M.D., an assistant professor in internal medicine who specializes in research on lung transplantion and obliterative bronchonchiolitis; and Maksim A. Fedarau, M.D., a research fellow in internal medicine.

Sally Pobojewski

Kara Gavin

University of Michigan Health System

Predictors Of Hemorrhage Following Laparoscopic Partial Nephrectomy (LPN) – 24th Annual World Congress Of Endourology 2006 – VP 2-21

UroToday – In this report, the overall blood transfusion rate was 7% among 335 patients undergoing laparoscopic partial nephrectomy. The only risk factor that distinguished between the two groups was renal insufficiency (8.7% vs. 1.9% for patients with normal renal function) (p=.03). Hypertension, obesity, diabetes, and smoking history were not significant factors.

When transfusion was required, operative time and hospital stay became statistically significantly longer. The reader is cautioned to some extent as this study encompasses a 12 year experience with laparoscopic partial nephrectomy during which time, the authors’ technique has certainly evolved and improved.

While much controversy exists as to the “best” way to perform this procedure, from cutting cold to cutting “hot”, clamping artery and vein or just artery, use of Floseal or tissue glue, use of argon beam coagulator, closing or leaving the collecting system open, placement of simple or mattress sutures over bolsters, tying knots or using LaparaTy clips, I would submit that, especially for those embarking on this most challenging laparoscopic procedure, you can never have “too” much hemostasis.

By Ralph V. Clayman, MD

M. C. Ost, S. Montag, S. Permpongkosol, A. R. Rastinehad, and L. R. Kavoussi. North Shore-Long Island Jewish Medical Center, New Hyde Park, New York, U.S.A.

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bioMГ©rieux To Develop New Highly-Specific, Non-Invasive Test For Prostate Cancer, Reducing Unnecessary Biopsies

Prostate cancer is the most prevalent cancer in the United States and the 4th most common worldwide. The combination of a test for a new prostate cancer biomarker, Annexin 3, with the standard screening methods could potentially reduce the number of biopsies conducted by up to 75%, when compared with current screening methods alone. A world leader in the field of in vitro diagnostics, bioMГ©rieux has signed a license and development agreement with the German biotechnology company, ProteoSys, for Annexin 3, which will be used to develop a urine-based, confirmatory diagnostic test for prostate cancer. After a research phase, the new test should be developed on the VIDAS® platform, one of the most widely installed automated immunoassay instruments in the world.

“It was an obvious choice to partner with bioMГ©rieux because of its strategic focus on oncology, the market leadership of its VIDAS platform and its extensive commercial network,” stated AndrГ© Schrattenholz, Chief Scientific Officer of ProteoSys.

“We are very pleased to work with ProteoSys to bring such an innovative biomarker to urologists around the world,” declared StГ©phane Bancel, Chief Executive Officer of bioMГ©rieux. “This agreement is yet another building block in our high medical value test strategy.”

Annexin 3, also known as ANXA 3, was discovered by ProteoSys, a German biotechnology company based in Mainz, which specializes in the fields of cell biology and proteomics. Studies have shown that ANXA 3 quantification in urine is a novel, non-invasive test with high specificity for prostate cancer.1 Today, when the levels of PSA (Prostate Specific Antigen) are in the uninformative “grey zone”, a biopsy is used to provide definitive diagnosis. The ANXA 3 test would be used to provide better identification of patients with a high probability of prostate cancer, thereby reducing the number of unnecessary biopsies.

While complications are relatively rare, biopsies cause patient anxiety and discomfort as well as extra cost to the healthcare system. In the United States, only an estimated 15% of patients who undergo a biopsy actually are diagnosed with prostate cancer, while each biopsy costs over $1,000.

The first phase of research is beginning at bioMГ©rieux, which will be followed by the development of a diagnostic test for the VIDAS platform. While the confirmatory diagnostic application on VIDAS will be the initial focus, bioMГ©rieux is also considering the development of treatment decision and prognostic applications for ANXA 3, as described in a leading publication2. The financial details of the deal are not disclosed.

The ANXA 3 test will be complementary to the tPSA and FPSA tests available on VIDAS. bioMГ©rieux is developing a substantial panel of high medical value assays for the VIDAS system, which already include VIDAS B•R•A•H•M•S PCT for sepsis, VIDAS Clostridium difficile A & B, for healthcare-associated infections, and VIDAS D-Dimer Exclusion™, VIDAS Troponin I, VIDAS CK-MB and VIDAS NT-proBNP for cardiovascular emergencies.

About bioMГ©rieux

Advancing Diagnostics to Improve Public Health

A world leader in the field of in vitro diagnostics for 45 years, bioMГ©rieux is present in more than 150 countries through 38 subsidiaries and a large network of distributors. In 2007, revenues reached €1.063 billion with 84% of sales outside of France.

bioMГ©rieux provides diagnostic solutions (reagents, instruments, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are used for diagnosing infectious diseases and providing high medical value results for cardiovascular emergencies and cancer screening and monitoring. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products. bioMГ©rieux is listed on the NYSE Euronext Paris market (Code: BIM – Code ISIN: FR0010096479). Other information can be found at biomerieux.

About ProteoSys

ProteoSys AG in Mainz (proteosys) is a research venture with a focus on systems biology, employing proprietary technology platforms for integrating quantitative proteomic and cellular information. The key technology Proteotope delivers precise and statistically significant information about protein biomarkers as surrogates for modes of action in therapeutic approaches, diagnostics and in the analysis of toxicity. ProteoSys has successful projects on prostate and breast cancer, neurodegenerative diseases, and test systems for embryo toxicity. In the more than 8 years of its existence, ProteoSys has built up a portfolio of intellectual property, which led to license agreements with partners in diagnostic and pharmaceutical industries. Next to its own development projects, ProteoSys also works in cooperation with the life science industry and in a variety of national and international research projects funded by the European Union (FP6 & FP7) and the German ministry of research and technology (overview of projects and peer-reviewed publications at proteosys).


1. Annexin A3 in urine – a highly specific non invasive marker in prostate cancer early detection. Schostak et al., J. Urol. In Press

2. Expression and Prognostic Relevance of Annexin A3 in Prostate Cancer. Köllermann J, Schlomm T, Bang H, Schwall GP, von Eichel-Streiber C, Simon R, Schostak M, Huland H, Berg W, Sauter G, Klocker H, Schrattenholz A., Eur Urol. 2008 Jan 16