Tuesday, December 29, 2009

Risk of ESRD from Diabetes Continues to Decline


Diabetes mellitus is the most common cause of end stage renal disease (ESRD). Diabetes was listed as the primary cause of kidney failure in 44 percent of newly diagnosed ESRD patients in 2006. In fact, the incidence of ESRD as a consequence of diabetes mellitus has risen steadily in diabetics for decades. That is until 1996. Since 1996, the rate of diabetes-related ESRD finally began to decline. 


Since that time, the incidence has dropped steadily. The decline is currently about 3.9 percent a year, a new government study finds.

"The incidence had decreased for all age groups and for both men and women," noted study author Nilka Rios Burrows, an epidemiologist with the U.S. Centers for Disease Control and Prevention.

"The findings from this study increase hope by showing that by intervening and being diligent, we have the opportunity to change what needs to be changed -- managing blood pressure and blood sugar, controlling obesity, participating in reasonable aerobic activity -- to have dramatic impacts on health and quality of life," Burrows said.


I'd like to think it has a lot to do with the great nephrology care given in the USA and the increased awareness of CKD. Is this a trend? Can it continue? Will it start to rise up again? Only time will tell. For, now all the efforts to slow the progression of diabetic nephropathy seem to be working. Kudos to all. 

The Top 10 Leading Causes of Death 2006-2007


No change was seen in a primary renal cause of death which remains at number 9 in the top 10.

Saturday, December 26, 2009

Daytime Napping and Diabetes


An interesting study published by the American Diabetes Association, Diabetes Care journal reports an association between daytime napping and diabetes.

This was a prospective study of hours of daytime napping and night sleeping assessed in 1996-1997 in relation to diabetes diagnosed between 2000 and 2006.

Day napping and short night sleeping were found to be associated with a higher risk of the development of diabetes. The association between sleep duration and diabetes may be modified by napping habit. 

Still Holding Your Breath for Roche's Mircera?


From Renal Business Today: After Roche admitted that it infringed on rival Amgen’s patents, they will finally be able to market its anemia drug Mircera in the United States sometime in mid- 2014.

Roche admitted that “the five Amgen EPO patents involved in the lawsuit are valid, enforceable and infringed by Roche's pegylated-erythropoietin (peg-EPO) product, Mircera,” according to Amgen.
As a result, the U.S. District Court in Boston entered a final judgment and issued a permanent injunction barring Roche from selling Mircera in the United States.

However, Roche will be allowed to sell Mircera in the United States in mid-2014 under terms of a limited license agreement, according to Amgen. The settlement terms do not include any financial payments between the parties.

Amgen filed a lawsuit in November 2005 in the U.S. District Court of Boston to stop Swiss drugmaker Roche from making or importing Mircera into the United States. Amgen said that Mircera violated EPO patents related to Amgen’s anemia drugs Epogen and Aranesp.

In October 2007, a jury ruled that Roche’s anemia drug infringes on Amgen’s existing patents. The U.S. Federal District Court in Boston issued a preliminary injunction barring Roche from selling Mircera in the United States. That ruling was upheld by a federal judge.

"We are very pleased with this agreement, a victory for Amgen that reaffirms the validity of our patents and brings to an end this long-standing legal dispute," said David Scott, senior vice president and general counsel for Amgen. "The settlement provides certainty to both companies and allows Amgen to focus intently on investing in innovative research and delivering medicines that treat grievous, unmet medical needs."

CEO's Corner: Why Health Care Reform Makes Dialysis Firm DaVita 'Nervous'


Now that President Obama's landmark health-care legislation has cleared both the U.S. Senate and House, many patients and businesses are seeking clues on how the final outcome could hit their wallets. With key differences in each bill, the legislation must be merged before Obama can sign off on it.

The wait has some businesses on pins and needles. According to the 2009 Business Leaders Survey by research firm Business Forward, nearly 9 out of 10 business leaders already rank health-care costs as their biggest business concern. Whatever the outcome of the health care overhaul, there is sure be a significant economic impact that could affect companies' bottom lines.

DailyFinance chatted with Kent Thiry, CEO of dialysis service provider DaVita (DVA), to discuss his view on the current legislation and the company's explosive stock growth. Here are excerpts of the conversation:

DailyFinance: For our readers who may not be familiar with DaVita, can you describe your business model?
Kent Thiry: Most of have a couple of kidneys. These kidneys are amazing organs -- some of the most complex, sophisticated organs in the human body, which is why they've been so difficult to replicate compared to other organs like the heart and lung and others. And when the kidney fails, you need to go on dialysis, unless you're one of the fortunate few to get a transplant. And we operate the centers that people come to if their kidney fails and they can't get a transplant.

And what do in our centers is take care of these people typically three times a week -- four hours each time -- where we take their blood out of their body, clean out all the toxins that they would normally clean out themselves through the act of urinating. But you don't do that anymore once you've lost your kidney function. And we take that part out, take the toxins out and then put the blood back in with some other nutrients.

We do that at 1,500 centers across America for 115,000 patients every single week.

As a health care service provider, what's your view on the health care legislation currently being debated in Congress?
For us, 85% of our patients are in Medicare and the government doesn't cover the full cost of care. So the other 15% have to pay extra in order to subsidize and make up for the government deficit. So, if a Medicare extension means that human beings who are not getting good care today can get good care, that's great. But in our particular community -- the dialysis community -- we already take care of everybody and for us it could be quite economically dangerous.

In the health-care legislation, the parts that are very exciting for us are the parts that have to do with the government allowing us to provide more integrated care. Because we have done a number of experiments with the government over the last three years and proven that by providing more integrated care, we can simultaneously dramatically reduce the total cost of care and improve quality. And so that's the positive part.

The negative part? To the extent that we end up with more patients at Medicare rates, then we have a lot of centers that are at risk of being closed.

Your company has had a string of positive earnings results and you recently boosted your guidance. Could the outcome of the legislation hurt your outlook?
Depending on what they put in or take out the legislation could be very bad for our patients and caregivers or neutral, or there is a small chance that it could even be good. But we are quite nervous about the whole thing. Congress is appropriately so focused on hospitals and physicians and insurance companies because those segments are much, much bigger than dialysis is. But sometimes when they write a few pages to cover one of those big segments, they do some serious damage or disrupting of our little community.

What are you most concerned about?
What we're most concerned about is if they pass legislation which leads to a reduction in the number of private patients and an increase in the number of Medicare patients. Because we rely on our tiny percentage of private patients to offset the deficit traded by the big majority of Medicare patients for which the government does not cover the costs.

It's kind of ironic, when people talk about private insurance premiums going up and that being a sign that private insurance can't work right. In many cases the private insurance premiums go up because the private patients are being charged to make up for the Medicare deficit. So that's the part that scares us the most.

On the flip side, what we would be happiest about is if the government allows us to operate more out an integrated care model. Right now, most of American health care, including most kidney care, is reimbursed on a very fragmented basis.

We've proven that we can be the general contractor for taking care of these dialysis patients, not just doing their dialysis, but also trying to keep them out of the hospital; trying to make sure that they get to the right cardiologist or the right endocrinologist because more than half of our patients also have diabetes; more than a third have hypertension and more than half have cardiovascular disease.

So we can become the kind of coordinator that most Medicare beneficiaries don't have. These poor people trying to coordinate their own care is not feasible and very scary for them and it ends up being very expensive for the taxpayer because they end up going to the hospital far more often than they should.

So the part of the legislation than excites us the most are the parts that will allow us to do more of the integrated care for patients across all of their conditions instead of just providing dialysis care.

Q: DaVita's stock has shown explosive growth over the past decade. What would you attribute that to?

DaVita 10-year chart
I think it's four things. The first one is probably just dumb luck. But numbers two, three and four are loyalty, choice and value.

Loyalty is because we have created in many of our 1,500 centers a special kind of work environment where there is a higher level of mutual emotional commitment between staff and them and the patients and between them and the physicians. Because of that we have unusually high retention rates that patients and physicians that get exposed to us tend to want to keep working with us and/or being taken care by us. So the loyalty factor has played out very strongly over the last three, five or 10 years.

The second category is choice. For physicians or patients looking to make a new choice or patients making a new choice where they go on the web and look at www.davita.com where they talk to other patients where they go the public databases and check out clinical outcomes, where they will see that in every category that DaVita is among the best or is in fact the best category after category. You put all of that together and a disproportionate percentage of physicians and patients are making their first big decision or renewal decision about who they are going to primarily work with or be taken care of by. We're winning a lot of those battles.

The final category is value is quality. DaVita has been a successful innovator. I'll give you two examples. If you're going onto dialysis, you need to have an access created. What that means is that we have to have a way -- a hole, if you will, to take the blood out of your body and putting it back in. Once you do that those things can get clotted, they can get tired, they can get used up; things can go wrong.

We're one of the first organizations to start doing focused access centers where we have 70 operations that just take care of these patients and those all important access points for taking their blood in and out. And in that area, we're by far the biggest in America -- three times bigger than the nearest dialysis company. And this gives patients a higher quality, more focused result that saves taxpayers a lot of money because it's far cheaper than hospitals or most surgical sites.

A second example is pharmaceuticals. Our typical dialysis patient -- if you can imagine every day having to take eight different drugs because again our patients have cardiovascular disease, diabetes, hypertension, all on top of kidney failure. And these poor human beings have no one helping them try to coordinate that all. We started our own specialized kidney-care pharmacy. It's by far the largest in the world. It's about 20 times bigger than the nearest competitor. And in that pharmacy we now provide all the drugs that our patients need -- for 20,000 of our patients.

Q: What advice would you give to someone who is at risk of kidney disease?
This is so important. See you physician regularly and get your blood tested but also ask to have your kidney health measured as well.

Tuesday, December 22, 2009

Exercise Hypertension: Good or Bad?


Looking through the most recent issue of the Journal of the American Society of Hypertension lying on the side of my desk, I came across an interesting article. It was a review article on exercise hypertension.

This was a retrospective look at fourteen studies. Six studies were of healthy volunteers or hypertensives. Eight studies were in subjects with known or suspected heart disease. The purpose was to clarify the prognostic importance of an “exaggerated” or “hypertensive” systolic blood pressure response to exercise during an exercise test.

Studies in subjects with known or suspected heart disease, exercise hypertension predicted fewer cardiac events and lesser mortality. However conversely, in a healthy population, a higher exercise blood pressure may indicate hypertension or prehypertension, instead of normal vascular function, and an associated long-term adverse prognosis. In a population with a high burden of heart disease, the highest risk subjects with the most extensive cardiac disease may not be capable of generating pressure or workload to allow the manifestation of exercise systolic hypertension. By comparison, therefore, those with exercise hypertension have a better prognosis.

So is exercise hypertension good or bad? The answer is... it depends. If the subject has known or expected heart disease exercise hypertension is actually good. If the subject is healthy, exercise hypertension can be bad.

Saturday, December 19, 2009

Prognostic Significance of Nocturnal Dip with ABPM Questioned


This is interesting.. despite the difficulties in getting reimbursed with 24 ambulatory blood pressure monitoring (ABPM), I use them all the time for my patients. I think they are invaluable in managing hypertension. One thing of note when reviewing a 24 ABPM is whether or not the patient is a "nocturnal dipper". Conventional wisdom is that the blood pressure should go down in the middle of the night ("nocturnal dip") and the lack of such a decrease in the blood pressure is a poor prognostic sign.

An article in the recent Clinical Journal of the American Society of Nephrology addresses the challenges of interpreting the 24 hour ABPM in regards to the nocturnal dip phenomena. They found that people who use the ambulatory monitor are less physically active during the day and exhibit a sleep disturbance from the apparatus that may dampens the patient's ability to show their normal nocturnal dip and mitigate its prognostic significance. Surely, something to keep in mind while reviewing the results of this important clinical test.

Transplant Found on Facebook


From the Chicago Tribune: CEDAR RAPIDS, Iowa - A lifesaving operation for a Cedar Rapids man was scheduled after a Facebook friend of his son's answered a post on the social networking Web site.

John Burge has suffered from polycystic kidney disease for 16 years, and was told two years ago he needed a transplant. When no donor had been found by mid-September, Burge's son, Matthew, turned for the second time to Facebook.

Less than 30 minutes after making his post on Sept. 18, a 24-year-old friend, Nick Etton, responded. Tests showed that John Burge and Etton were a match.

Etton and Matthew Burge met at Kirkwood Community College several years ago and stayed in touch, but Etton had never met John Burge until he came to Cedar Rapids for blood tests.

30 Rock's Grizz Chapman Opts for Dialysis over Transplant


Gizz Chapman, half of Tracy Morgan's entourage on NBC's hit show 30 Rock, has stage 5 CKD. He has been on hemodialysis, but is not so sure a transplant is the right way to go for him.

"Whatever I can do for the longevity of my life, I'm going to do," Chapman says. "I'm afraid to get one because of all the unknown things. You can put a kidney in your body — and somewhere down the line your body might reject it. I'm not saying I don't want to go through with it but it's a little scary. It's a big decision."

The etiology of his kidney disease seems to be hypertensive nephrosclerosis. The 35 year old actor will be on an upcoming episode of the popular Dr. Oz show, to discuss his battle with CKD and bring awareness to the silent killer, hypertension.

Thursday, December 17, 2009

RPA Public Policy in a Minute

UKidney.com


I just happened to find this website, ukidney.com and I was impressed. It is a great resource and I highly recommend you check it out. The registration is quick, simple and free.

The description from the website:

UKidney is a provider of educational tools for the study and practice of nephrology, hypertension management, and kidney transplantation. This site features essential educational contributions from major opinion leaders in nephrology. We hope that you will return to this site as an emerging internet school for nephrology education and kidney information. UKidney uses the latest web technology to deliver the best content in the field of nephrology education.

A great resource I found while navigating around the site is the free blood pressure log. This is useful for anyone with hypertension to keep an online log of their blood pressure readings with the added ability of conveniently being able to email your BP log to your physician.


Higher Hemoglobin Benefit with ESA?


As reported by Renal and Urology News from a study presented at ASN's Renal Week, a higher hemoglobin level was associated with a significant 26% reduced risk of death or the initiation of dialysis.

The study was led by Derek Larson, MD, of the North Shore University Health System's Evanston Hospital in Evanston, Ill. They studied 208 patients with CKD and anemia, hypothesizing that higher epoetin (EPO) doses would be associated with an increased risk of death or end stage renal disease (marked by the initiation of dialysis). Subjects were followed for three years. The investigators compared average quarterly EPO doses and hemoglobin levels in those who died or started dialysis (52 patients) and those who did not (156 patients).

The researchers observed no significant difference in average quarterly EPO dosage and baseline hemoglobin levels between the two groups. They also found no increased risk of death or dialysis initiation between patients who received EPO doses greater or less than 25,000 units per week. In both groups, hemoglobin level was negatively correlated with EPO dose.

Dr. Larson noted that the findings challenge those of the well noted Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR) study.

Clevidipine Recalled

FROM THE FDA FOR IMMEDIATE RELEASE - December 16, 2009 - Parsippany, N.J. - The Medicines Company (NASDAQ: MDCO) announced today that it is voluntarily recalling eleven (11) lots of Cleviprex ® (clevidipine butyrate) injectable emulsion due to the potential presence of visible particulate matter which has been observed in some vials during a routine annual inspection.

The affected Cleviprex lots are 61-978-DW, 61-979-DW, and 61-980-DW, Exp. 01/2010; 68-404-DJ, 68-405-DJ, and 68-406-DJ, Exp. 08/2010; 69-830-DJ, 63-385-DJ, 63-386-DJ, and 63-266-DJ, Exp 03/2011; and 64-453-DJ, Exp. 04/2011. No other lots are affected by this recall.

The Medicines Company has not received any product complaints or reports of adverse events related to this issue. The Company is cooperating with the U.S. Food and Drug Administration on this recall.

The particulate matter comprises sub-visible inert stainless steel particles of around 2.5 microns. When present in low numbers as observed, particles of this size are not known to constitute a health hazard. Experimental animal and human data indicate that they are scavenged by macrophages and other cells of the reticuloendothelial system without adverse effects. Although aggregates have not been observed, if the sub-visible particles were to aggregate, or if larger particles were present, then they could become visible and could theoretically reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions. Reduced blood supply to tissues may lead to ischemia or organ insufficiency in the brain, kidney, liver, heart or lungs.

Anyone with inventory from the affected lots of Cleviprex should arrange for its return through their pharmaceutical wholesaler/distributor. Unaffected product from lots 68-407-DJ, 68-408-DJ, 71-101-DJ and 71-106-DJ is being shipped to wholesalers and can be ordered by hospitals.

For medical inquiries, adverse event reporting or quality issues related to Cleviprex, please contact The Medicines Company Medical Information at 1-888-977-6326 Monday to Friday 8:00am-5:30pm EST or cleviprexrecall@themedco.com.

Any adverse reactions associated with the use of Cleviprex may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Tuesday, December 15, 2009

Animal Transplants Coming Soon...


Australia has lifted its five-year ban on the transplantation of animal cells and organs into humans. Transplantation from animals to humans (xenotransplantation) was banned in 2004 because of concerns that pig endogenous retrovirus could spread to humans.

The National Health and Medical Research Council made its decision despite pleas from animal rights activists and transplant specialists that the procedure had not been proven safe and could result in the creation of deadly viruses.

''It is proposed as being unlikely, improbable, but there is literally no way to predict this. What this means is the potential for another SARS or AIDS, another viral pandemic, much more dangerous than the recent bout of swine flu,'' a Sydney cardiologist and former president of the International Society for Heart and Lung Transplantation, Professor Anne Keogh said.

This is something that is quite controversial and will be monitored closely. Due to the worldwide organ shortage, some seemingly unattractive solutions are being considered out of necessity. Lets hope for the WAK (wearable artificial kidney) sooner than later.

Carotid Endarterectomy Beneficial in Chronic Kidney Disease


Carotid endarterectomy (CEA) is recommended for symptomatic high grade stenosis (70-99%) of the internal carotid artery. Whether or not the CKD population benefits similarly is not clear. Thankfully, the Journal of the American Society of Nephrology (JASN) has recently published a study that shows the benefit of CEA in CKD patients.

Among medically treated patients with high-grade carotid stenosis, the risk for ipsilateral stroke at 2 years was 31.6% in patients with stage 3 CKD vs 19.3% in those with preserved renal function (P = .042). Carotid endarterectomy was associated with a significant decrease in this risk by 82% and 51%, respectively.

The number needed to treat with endarterectomy to prevent 1 ipsilateral stroke was 4 for patients with CKD and 10 for patients with preserved renal function. Rates of perioperative stroke and death were similar in patients with CKD vs in patients with preserved renal function, but rates of cardiac events were higher in those with CKD.

"Patients with stage 3 CKD and symptomatic high-grade carotid stenosis gain a large benefit in stroke risk reduction after endarterectomy," the study authors write.

The benefit was greater than what was seen in patients with preserved renal function. This coupled with the increased morbidty of angioplasty with stenting of the carotid (another recognizes alternative therapy for symptomatic carotid stenosis), this makes the case for CEA in patients with CKD even stronger. My sincere apologies to all my invasive interventionalist colleagues. 

Thursday, December 10, 2009

FDA Approves Extended Release Clonidine


I have to admit this one snuck up on me. I use clonidine frequently. It is clearly not a first line therapy, but in cases of resistant stage 2 hypertension it can be very effective. Until now there were two formulations. There is the oral clonidine tablets and the transdermal Catapres patch. The oral clonidine is cheap and effective but short acting (commonly prescribed three times daily) and often limited by side effects (fatigue and dry mouth). The Catapres patch is useful (although more expensive) and I have found has somewhat better tolerated by patients. The patch is worn for a week at a time and it helpful as add on therapy.

Now, seemingly out of nowhere, I found out today the FDA has approved Tris Pharma’s clonidine extended-release tablets and suspension for the treatment of hypertension. The suspension is the first available 24-hour liquid sustained-release doseform, allowing physicians to customize dosing options through titration. The new doseform will also help patients who have difficulty swallowing pills, such as young children and the elderly.

"The suspension represents a true leap forward for drug delivery in that it is the first-ever FDA approved 24 hour sustained release liquid formulation," noted Ketan Mehta, chief executive officer and president of Tris Pharma, in a company news release.

I look forward to adding this new option soon.

Anabolic Steroid Use and Renal Failure

Yesterday, The New York Times posted online an article with an accompanying video about the link between anabolic steroid use and progressive renal disease.

The video was compelling and detailed the story of Patrick Antonecchia who competed in powerlifting and strong man events for more than 25 years. He was forced to quit when he received a diagnosis of severe kidney damage after years of using anabolic steroids.

This article follows up the research offering published by the Journal of the American Society of Nephrology earlier this year. The JASN paper identified an association between focal segmental glomerulosclerosis (FSGS) and proteinuria in a cohort of 10 bodybuilders who abused anabolic steroids. One of the ten progressed to end stage. The authors warn that this may be an under-recognized phenomena since many bodybuilders have elevated serum creatinine which is often attributed soley to the increased muscle mass. Perhaps, a higher degree of suspicion is in order to catch FSGS early in this patient population.

Wednesday, December 9, 2009

An Unacceptable Amount of Dialysis Patients Receiving Wrong Antithrombotics for PCI


A new study published in the Journal of the American Medical Association (JAMA) shows that more than 1 in 5 dialysis patients who had a percutatenous coronary intervention (PCI) received a contraindicated antithrombotic.Antithrombotics are commonly used by interventional cardiologists performing PCI, but due to their renal clearance, enoxaparin (Lovenox) an anticoagulant and eptifibatide (Integrilin) an antiplatelet agent are relatively contraindicated due to bleeding concerns.

This retrospective study examined antithrombotic use in 22,778 dialysis patients from 829 US hospital between Janurary 1, 2004 and August 31, 2008.

In total, 5,084 dialysis patients (22.3%) received a contraindicated antithrombotic (enoxaparin 46.7%, eptifibatide 64.1%, and 10.9% receieved both).

The use of these drugs in this patient population resulted in a significant increase in the risk of a major in-hospital bleeding event. These agents should remain contraindicated in dialysis patients, as well as those with advanced CKD.

Coffee Cuts Prostate Cancer Risk


As an avid coffee drinking male... I was happy to see and now report on the recent press release by The American Association for Cancer Research. Data presented at the AACR's Frontiers in Cancer Prevention Research Conference revealed a strong inverse association between coffee consumption and the risk of lethal and advanced prostate cancers.

Translation: More coffee =Less risk of advanced prostate cancer.

In a prospective investigation, Kathryn M. Wilson, Ph.D. and her colleagues found that men who drank the most coffee had a 60 percent lower risk of aggressive prostate cancer than men who did not drink any coffee. This is the first study of its kind to look at both overall risk of prostate cancer and risk of localized, advanced and lethal disease.

"Few studies have looked prospectively at this association, and none have looked at coffee and specific prostate cancer outcomes," said Wilson. "We specifically looked at different types of prostate cancer, such as advanced vs. localized cancers or high-grade vs. low-grade cancers."

Caffeine is actually not the key factor in this association, according to Wilson. The researchers are unsure which components of the beverage are most important, as coffee contains many biologically active compounds like antioxidants and minerals.

Regardless of the mechanism, seems to me this may be one more reason to not bother skipping the second... or third cup of coffee.

Tuesday, December 8, 2009

Transplanting Kidneys with Renal Masses?


According to an article in BJUI, a new class of kidney donor organs is being considered. Surgeons at the University of Maryland School of Medicine in Baltimore have transplanted five kidneys from which they had removed small masses, three of which were cancerous. Four of the five patients have survived between nine months and 41 months so far without any evidence of recurring tumors. The fifth transplant patient died about a year after the operation because of a fall in an accident.

“Transplanting a living donor kidney which has been affected by a renal mass is controversial and considered a high risk” urologist Michael W Phelan, co-author of the study, said in a statement. “However the ongoing shortage of organs from deceased donors, and the high risk of dying while waiting for a transplant, prompted five donors and recipients to push ahead with surgery after the small masses were found in the donor kidneys.”

This would not be the first choice for me,or my patients , but sounds interesting for others.

FDA Recommends Everolimus in Kidney Transplant


A federal advisory panel recommended the Food and Drug Administration approve a new anti-rejection drug from Novartis, everolimus.

From Dow Jones Newswires: The panel of outside medical experts voted 11 to 1 in favor of a question that asked if the drug, everolimus, should be approved. The FDA typically follows its panels' advice but is not required to.


The drug was approved in March at a different dose to treat advanced kidney cancer and is sold under the brand name Afinitor. Novartis is seeking approval for everolimus in combination with two other drugs for kidney transplant patients.

FDA said a study comparing two doses of everolimus to Myfortic, another Novartis drug used in kidney-transplant patients, showed both drugs worked equally as well at preventing the body from rejecting a new kidney in a study that involved 1,335 patients.

However, the agency said there was a higher failure rate among women being treated with everolimus compared to Myfortic.
The agency said mortality rates were similar "with more deaths attributed by FDA to the study drug" in the lower-dose everolimus group. The agency said there were three times as many kidney rejections attributed to blood clots in the everolimus group compared to the Myfortic group.

But, the agency said there were fewer cases of cytomegalovirus infections and cancer in the everolimus group compared to the Myfortic group. Cytomegalovirus is a common infection associated with organ transplants that can lead to other infections and cause the body to reject the transplanted organ.

In its briefing document, Novartis said everolimus is a "meaningful alternative" therapy for kidney-transplant patients.





Sunday, December 6, 2009

D-Dimer Utility Diminished in CKD


The work up for a patient with a suspected pulmonary embolism often begins with a D-dimer test.

An article in the American Journal of Medicine suggests this measurement is less accurate in the setting of a decrease in the GFR. The specificity of D-dimer testing decreased as the GFR worsened. The authors conclude that the D-dimer test should still be used and the algorithm does not need to be altered. 

Proscar Linked to Breast Cancer in Men


An analysis detailed in UK's Telegraph, 53 men worldwide have developed breast cancer while taking finasteride (Proscar). Finasteride is commonly used for benign prostatic hypertrophy (BPH). Gynecomastia has been a known complication of the medication, but the link to breast cancer has been less certain.

"Patients using finasteride products should be advised to promptly report to their doctor any changes in their breast tissue such as lumps, pain or nipple discharge because these may be signs of a serious condition, such as breast cancer.

"On the basis of the review, it was recommended that a warning on the risk of breast cancer should be included in the product information for all medicines containing finasteride."

Thursday, December 3, 2009

Link Between Stress and Hypertension Strengthened


An interesting article was just published in the Journal of Clinical Investigation. This article may be another step forward in the long debated issue of the correlation between stress and hypertension.

Does stress cause hypertension? A simple question, that unfortunately does not yield a simple response. Well, the link between emotional stress and hypertension seems to exist. But how? Why? To what degree is the correlation? Through what mechanism does it occur?

New research presented in this article has for the first time established a link between a novel gene, phosducin, and the blood pressure response to stress in mice as well as humans. The studies were directed by scientists at the University of Freiburg and Muenster in Germany, and the Medical College of Wisconsin in Milwaukee, in collaboration with other institutions in Europe and Canada.

The investigators used mice lacking the phosducin gene and compared them with normal mice. Under various conditions of stress, the mice lacking the phosducin gene developed high blood pressure. The mechanism of this gene's action appears to be directly involved with specific sympathetic nerve cells The cells show a distinct increase in their activity leading to an increase in systemic blood pressure.

In an accompanying commentary, Dr. Guido Grassi, at the Clinica Medica, Italy, notes that "the approaches employed in the present study, along with the nerve traffic recording technique, represent the most sophisticated and sensitive methodologies currently available to assess neuroadrenergic function in different experimental animal models." He further emphasizes the need for additional studies to determine the therapeutic implications.

For quite some time it has seemed almost intuitive to many that there was a link between stress and hypertension, now we may be finally closing in on a plausible mechanism.

Medicare Fraud By DaVita and Fresenius?


As reported in the Beaumont Enterprise this morning, a former regional sales manager for Amgen, Inc., has filed a lawsuit in Beaumont federal court, alleging that salesmen dictated dosages of Epogen to increase the bottom line of pharmaceutical maker.

From the report:

"According to the suit filed in a Beaumont federal court, salesmen worked in cahoots with dialysis clinics nationwide to pump the maximum amount of the drug Epogen into the bloodstreams of terminally ill patients - an amount just below the threshold that would raise the suspicion of Medicare auditors.

Woodard, who now works as a nurse practitioner in Tennessee, has filed a False Claims Act case. In such a lawsuit, a person files on behalf of the federal government, but the government does not have to intervene in the case.

He accuses Davita Inc. and Fresenius Medical Care, the nation's two leading dialysis clinic companies, of prescribing excessive doses of Epogen in order to bilk the government out of millions of dollars."

A lawyer for Davita said Woodard's charges are "without merit"