Lasix Linked to Secondary Hyperparathyroidism

Another interesting paper coming out of ASN this week seems to propose a link between the loop diuretic (Lasix) and secondary hyperparathyroidism. Tamara Isakova, MD, a research fellow at Massachusetts General Hospital in Boston, and her colleagues believe the calciuresis caused by Lasix may stimulate PTH. Accordingly, thiazide type diuretics do not exhibit such a relationship.

The researchers conducted a cross-sectional study of 3,612 subjects. Median PTH levels were almost twice as high in patients taking loop diuretics than in controls (81 vs. 44 pg/mL). After adjusting for age, race, BMI, BP, diabetes, and estimated glomerular filtration rate, subjects on loop diuretics had a 2.4 times increased risk of secondary hyperparathyroidism (PTH of 65 pg/mL or higher).

It must be said that these papers coming out of ASN are not published in peer reviewed journals and scrutinized to the same degree..  but, nevertheless it is an interesting hypothesis.

Hurray For the Young Nephrologists

I think (and hope) I can still be called a young nephrologist although, it is somewhat subjective and the clock is ticking. If not, I take exception to this erroneous study. Anyway, a nice paper was just presented at the ASN meeting in San Diego claiming younger nephrologists tend to send there patients for renal transplantation preemptively more frequently than the more senior nephrologists.

As reported in Renal Business Today : "The investigators found that doctors closer to completion of medical school were significantly more likely to refer their CKD patients in time for preemptive transplantation. It is conceivable that the reason for this finding is that younger physicians are more likely to have learned about the benefits of preemptive kidney transplantation during their education. Hence they might be more prone to refer CKD early in their disease process, the authors concluded".

Bodybuilding with Anabolic Steroids Causes Kidney Disease

According to a paper being presented at the American Society of Nephrology’s 42nd Annual Meeting and Scientific Exposition in San Diego bodybuilding supplemented by anabolic steroid usage can lead to kidney damage.

The researchers seem to believe that extreme increases in muscle mass require the kidneys to increase their filtration rate, placing harmful levels of stress on these organs. It may also be likely that anabolic steroids have direct toxic effects on the kidneys. “Athletes who use anabolic steroids and the doctors caring for them need to be aware of the potentially serious risks to the kidney,” said Leal Herlitz, MD, of Columbia University Medical Center.

Dr Herlitz and her colleagues recently conducted the first study describing injury to the kidneys following long-term abuse of anabolic steroids. The investigators studied a group of 10 bodybuilders who used steroids for many years and developed protein leakage into the urine and severe reductions in kidney function. Kidney tests revealed that nine of the ten bodybuilders developed a condition called focal segmental glomerulosclerosis, a type of scarring within the kidneys.

Although there has been a general feeling anabolic steroid use to increase muscle mass and strength has many deleterious effects, the link to kidney disease has been quite flimsy. This study seems to have strengthen the argument.

Urea Kinetics Website Launch

Introducing a new website: UreaKinetics.org
Taken from the website: "The purpose of ureakinetics.org is, first of all, to provide a home for Solute-Solver and related programs linked to urea kinetics and adequacy of hemodialysis. The site was begun and is maintained by Dr. John Daugirdas, a nephrologist from Chicago. Anyone is welcome to comment in the Forum section, about either Solute-Solver or other questions relating to hemodialysis adequacy."

Petition For Every Other Day Dialysis

To:  Congressional Kidney Caucus
 
We, the undersigned, ask the Congressional Kidney Caucus to advocate for the Centers for Medicare and Medicaid Services (CMS) to increase the number of routinely reimbursed hemodialysis treatments from three per week (156/year) to every other day (183/year).

We are people on dialysis, care partners, health professionals, family, and friends. Dialysis is not the end of life, but can and should be a new beginning. We believe that so-called “adequate dialysis” (three short treatments per week) merely allows people who need dialysis to hang onto life unproductively--in essence, many are prevented from living the life they were meant to live. This need not be the case! Research has proven that more treatments mean healthier lives, fewer hospitalizations, longer survival, increased productivity, and less overall cost to the healthcare system for people on dialysis.

The U.S has the worst dialysis outcomes of any industrialized nation. Supporting every other day treatments will allow those managing their illness with conventional hemodialysis to avoid the ‘long weekend’ with no treatment—which many studies have shown triples the risk of sudden death from a heart attack. Even this won’t allow the U.S. to catch up; that won’t happen until longer and more frequent treatments are made more widely available. But it’s a start! Please give this vital change your support!

Sincerely,
The Undersigned

Click here to sign the petition. I am #2162.  

Decline in Functional Status Seen in Nursing Home Patients After Dialysis

Nursing home residents with requiring renal replacement therapy with hemodialysis suffered "substantial and sustained" declines in functional status after the initiation of therapy, according to a New England Journal of Medicine study.

The authors of the study point out that because there was no control group, they could not conclude that dialysis caused the observed functional decline. This was a retrospective look at 3702 nursing home residents starting hemodialysis between 1998 and 2000 who had at least one measurement of functional status prior to the initiation of dialysis.

The editorialists write: "Prior to the initiation of dialysis, elderly patients must be informed about its modest benefit in their age group and the possibility of conservative therapy that does not involve dialysis." So, although dialysis will prolong life in this patient population it does not seem to lead to an improvement in functional status we would have hoped to have seen.

New Intravenous Thiazide, Coming to a Hospital Near You

I must admit, it is not readily obvious to me when or why I would use an intravenous thiazide over an IV loop diuretic... but nevertheless, it is pretty cool to have a new option.

The U.S. Food and Drug Administration has just approved APP Pharmaceutical’s Chlorothiazide Sodium (Diuril) for injection. The drug is approved for use in the treatment of high blood pressure , as well as fluid retention in people with congestive heart failure, cirrhosis of the liver, kidney disorders, or edema caused by taking steroids or estrogen.

APP is a subsidiary of Fresenius Kabi Pharmaceuticals, and they expect to launch the IV Chlorothiazide in the fourth quarter of 2009. It will come in single dose 500 mg vials. Maximum dose is 2000 mg / day.

AAKP Expresses Patient Concerns at CMS Town Hall Meeting

TAMPA, FLA. – The American Association of Kidney Patients (AAKP) took part in the Centers for Medicare and Medicaid Services town hall meeting today for the proposed bundled prospective payment system (PPS). Currently, Medicare pays dialysis services under a partial bundled rate which represent about 60 percent of total Medicare payments to end-stage renal disease (ESRD) facilities. The remaining 40 percent is made of separately billed items for dialysis services such as drugs, laboratory services, supplies and blood products. In 2006, Medicare paid $8.1 billion dollars for dialysis services and related drugs for 315,000 dialysis patients. CMS, through the Medicare Improvement for Patients and Providers Act (MIPPA), has been charged with creating a more efficient payment system that saves Medicare money and provides quality care to patients.

AAKP spoke of supporting the effort to shift Medicare payment systems to increasingly focus on high-value care. But, the Association is concerned that without thoughtful implementation and appropriate oversight, these changes may increase barriers to care for individuals with kidney disease. AAKP Board Member Paul T. Conway, former peritoneal dialysis (PD) patient/current kidney transplant recipient, spoke on behalf of the Association. “A patient who medically requires more previously unbundled biologicals, drugs and/or diagnostic studies may not be accepted for treatment in facilities trying to maximize their margin. Any system that links financial incentives or financial disincentives with limiting access to health care for certain types of patients is easily abused by cherry picking and requires meticulous validation of self reported performance measures.”

Conway also expressed the Association’s concern that patients have access to the best possible care. “ESRD health care has changed significantly since the initiation of the Medicare ESRD Program. We have witnessed many treatment modality and medication advances in ESRD care. It is essential that all patients have equal access to the best treatment available. AAKP urges CMS to initiate appropriate controls to guarantee these issues are addressed and minimized to ensure equal patient access to high-quality care.”

The Medicare Payment Advisory Commission (MedPAC) and the Government Accountability Office (GAO) have both recommended a fully bundled PPS for ESRD services – which include drugs, clinical laboratory tests and other items, and payments could be adjusted to reflect differences in the types of patients treated to ensure that payment to facilities would appropriately reflect the costs associated with treatment.

To read Mr. Conway’s full statement, visit www.aakp.org/public-policy/PPS/town-hall-mtg/. For more information about the American Association of Kidney Patients, call (800) 749-2257.

American Kidney Fund Testifies at CMS Town Hall Meeting

BALTIMORE (Oct. 23)—The American Kidney Fund (AKF) today submitted testimony at a Centers for Medicare and Medicaid Services town hall meeting on the End Stage Renal Disease Prospective Payment System Proposed Rule. LaVarne A. Burton, President and Chief Executive Officer of the American Kidney Fund, addressed the American Kidney Fund’s concern with three areas: drug bundling, cost sharing and disparities. Following is the full text of the American Kidney Fund’s testimony:

Good Morning.  My name is LaVarne Burton, and I am President and Chief Executive Officer of the American Kidney Fund. Thank you for convening this town hall meeting.  I am here to represent the voices of a vulnerable patient population—individuals with chronic kidney disease and kidney failure.
Our mission at the American Kidney Fund is to fight kidney disease through direct financial support to patients in need; health education; and prevention efforts. We provide treatment-related financial assistance to nearly 1 out of every 5 dialysis patients in the U.S. We help low-income patients maintain their health insurance coverage, and we help them to pay out of pocket costs for medications covered under Part D, as well as other treatment-related expenses not covered by their insurance.We applaud CMS for its commitment to promoting efficiency in the quality of care for individuals living with ESRD. We appreciate the opportunity to address three issues of particular concern to ESRD patients: drug bundling, cost sharing, and disparities.

Bundling of Drugs and Patient Cost Sharing
With regard to drug bundling, the American Kidney Fund has several serious concerns.
First, we are concerned that bundling will limit patient access to the most clinically appropriate drugs. Dialysis patients take numerous oral medications that do not have intravenous equivalents.  Each patient has a different health condition and could require a blend of multiple drugs. In addition, there are not adequate clinical metrics to monitor impacts of changes in drug regimen on patients. How do we ensure that patients will be administered the most clinically appropriate drug, versus simply the least costly?
Second, the administrative mechanisms for having patients receive their renal medications through one source and non-renal medications through a different source mean that we will not provide overall monitoring to protect patients against possible adverse drug interactions. 
Third, we are concerned that bundling will limit manufacturers’ incentives to develop new, innovative drugs to combat renal disease. If limiting costs becomes a primary driver of prescription decision-making, there will be little incentive for research and development of new drugs.  Are we expecting health outcomes for kidney patients to remain static?
Fourth, we are concerned that including Part D drugs in the bundle would eliminate patient access to support that assist with co-pays, such as the Medicare Low Income Assistance program as well as programs such as the American Kidney Fund’s Part D Bone Medication. Access to such assistance is vital. Let me share with you one example. A retired industrial firefighter in Louisville, Kentucky, recently wrote to us to let us know that he had been prescribed medication for treatment of secondary hyperparathyroidism at an out-of-pocket cost of $600 a month. “I couldn’t afford it,” he said. “I did what I could but occasionally I had to take half doses or share with friends on the same prescription.” Because he was not taking clinically appropriate doses of his medication, he was scheduled for a parathyroidectomy to treat his condition. But fortunately, he was able to enroll in the American Kidney Fund’s program that helps with costs under Part D—and as a result, he avoided surgery.  He is now taking his medication, as prescribed, because our assistance program helps him to afford it.
In short, we believe that including in the payment bundle Part D oral drugs that do not have intravenous equivalents will have an adverse impact on patients and we remain opposed to this provision until issues of quality and access have been addressed.

Patient Cost Sharing and Co-Insurance
We also have major concerns regarding patient cost sharing.  The proposed payment structure will be burdensome for patients.  The proposed rule imposes a patient co-insurance of 20 percent on the entire bundled ESRD payment.  When drug, laboratory, and other costs are added to the bundle, the out of pocket costs that patients must pay will be far greater than their current monthly co-pays and expenditures. For lab services, Medicare patients currently have no co-insurance obligations—and dialysis patients incur many lab costs on a routine basis.  The proposal will significantly increase patient out of pocket payments.   This is very troubling for a patient population that is already economically vulnerable and often unemployed because of the time demands of receiving dialysis treatment.

Case Mix Adjustors
Finally, we are concerned about the lack of adequate case-mix adjustors for race.  African Americans, Latinos, Native Americans and Asian Americans suffer disproportionately from ESRD.  African Americans represent 12 percent of the U.S. population, but are 30 percent of those on dialysis.  Despite the fact that CMS has historically acknowledged that African American patients require higher doses of ESA’s in order to control anemia, CMS does not account for race as a case mix adjustor for the payment structure.  CMS has repeatedly committed to developing such an adjuster and should move immediately to do so. 
While we recognize that there are challenges in the data used to evaluate race as an adjustor, The American Kidney Fund recommends that CMS refine its data sources and commit to a definite timeframe for completing this work so that a race/ethnicity adjustor may be factored into the reimbursement policy. In the meantime, CMS should not go forward with the proposed rule without some placeholder mechanism to recognize the impact of race on the cost of dialysis.

Conclusion
We trust that CMS will consider our positions and views as it relates to the Proposed Rule on the ESRD Payment System. Thank you for the opportunity to voice the concerns of the American Kidney Fund and the many patients we serve.

NKF Kidney Walk

Intensity of CRRT in the ICU, Does it Matter?

CRRT, or continuous renal replacement therapy (CVVHD/F continuous venovenous hemodialysis / hemodiafiltration) has been a great advance in the field of Nephrology. CRRT allows for a slow steady continuous form of dialysis that is much easier for a critically ill ICU patient to tolerate. Unlike conventional hemodialysis, CRRT is less taxing hemodynamically allowing use in the critically ill patients suffering with acute kidney injury and shock. Although CRRT (despite the issues with clotting) has many benefits, some of these benefits are theoretic and have not translated into an evidence based reality.

The NEJM this week reports on another somewhat disappointing study for CRRT enthusiasts (such as myself). This was a multicenter, randomized comparing two different intensities of CRRT and evaluating the 90 day mortality of both groups. Although we would have hoped that more aggressive and intensive CRRT would yield a better outcome... alas, it did not. The higher intensity CRRT prescription resulted in a lot more hypophosphatemia, but there was no reduction on the mortality rate.

Assault By Salt

This is a nice video I found that I will be adding to an upcoming lecture on hypertension.

Thoracic Kidney

Courtesy of the NEJM. This is an extraordinarily rare congenital anomaly. It is more common in men and usually found in the left thorax. It is also completely benign and does not require any intervention.

More Fish = More Diabetes?

A new study from Harvard, with unexpected results has made its way into the American Journal of Clinical Nutrition. Everyone knows fish is great for you and among the best protein one could eat. Increased intake of fish yields great health benefits.... right? Well, maybe not.

This particular study took a look at the risk of type 2 diabetes mellitus as it relates to long chain omega-3 fatty acid intake (in the form of fish). After adjusting for lifestyle and other dietary factors, plus body weight, family history of diabetes, and other confounding variables, researchers noted an increased diabetes risk "in all cohorts" consuming higher levels of omega-3 fatty acids. Contrary to popular belief, they found that eating two or more servings of fish a week may increase diabetes risk.

DOH! Although this data will undoubtedly be refuted, I guess I do not need to feel as guilt about the steak I am going to have tonight...

Alcohol and Albuminuria?

Researchers from Australia report a study in Nephrology Dialysis and Transplantation that reveals a link between alcohol intake and the risk for albuminuria. The study was detailed in Renal and Urology News.

Compared with subjects who drank 1 or less drinks a day, those who drank 3 or more drinks / day (30 grams ethanol/day) had a significantly higher risk of developing new onset albuminuria over a 5 year follow up. The study suggests the risk was increased nearly 60%.

Is alcohol intake an overlooked risk factor for renal disease? Does moderate-to-heavy alcohol consumption accelerate proteinuria and renal decline in patients who already have proteinuric renal disease? Further studies are indicated, but it is worthwhile to consider this possibly modifiable risk factor more carefully.

Is Coronary Angiogram Pre-Renal Transplant Safe?

A preemptive renal transplant is usually ideal for the appropriate candidate with advanced chronic kidney disease. The pre-transplant evaluation usually includes a cardiac work-up which culminates in a coronary angiogram. As we know, patients with advanced CKD are at risk for contrast induced nephropathy and therefore may hasten renal demise.

Contrary to the above fear, a study from the United Kingdom detailed in the Clinical Journal of American Society of Nephrology reveals data from a recent study that suggests coronary angiogram screening does not accelerate the decline in renal function in patients with advanced CKD prior to renal transplantation.

Community Lecture

For those of you who are local and interested....

I will be doing a community lecture this coming Tuesday, October 20th at:

MANHASSET DIAGNOSTIC IMAGING

Pathways Women's Health

1350 Northern Blvd. in Manhasset, NY

The talk is entitled: The Who, What, When, Where, How and Why of Renal Transplantation.

It will begin at 7:30 pm and last an hour.

Everyone is welcome, pre-registration is prefered (via the link above)

Kidney Public Policy Forum

The Renal Support Network has sponsored a forum dedicated to the CMS Proposed Rule for CKD / dialysis. Comments are due by November 16th. Please log on and contribute prior to this landmark ruling.

Pain Management in CKD

This has always been a controversial topic. Pain management in patients with CKD requires some unique considerations.

The Mid-Atlantic Renal Coalition (MARC) and the Kidney End-of-Life Coalition have teamed to produce an algorithm for treating pain in CKD patients.

Preferred medications in CKD:

• Fentanyl
• Methadone
• Dilaudid
• Acetaminophen
• Neurontin -up to 600 mg/day
• Lyrica - up to 100 mg/day

Use with Caution:

• Tramadol
• Hydyrocodone / Oxycodone
• Nortryptiline / Desipramine

Do Not Use:

• Morphine
• Codeine
• Demerol
• Darvon

Exercise Improves Life Expectancy in CKD Patients

From the easier said than done department... News flash: Exercise is good for you.

In the upcoming cJASN, there will be an article about about the benefit of exercise in CKD patients. The article uses data from the NHANES III. The conclusion was that physical inactivity leads to an increased mortality in CKD patients. Similarly, as in the non-CKD population, physical activity may therefore lead to a survival benefit in those with CKD.

Fosrenol Beats Renagel

OK, so Renagel is no longer on the market (the formulation has been changed and Genzyme has renamed it's offering Renvela). Yeah, it was only a 4 week study with a limited amount of ESRD patients. Sure, it barely reached statistical significance. Alright, it was sponsored by Shire, the maker of Fosrenol which always gives the whiff of some bias... But, it sure is nice to see a head-to-head studies of current competing drugs going at it.

Accordingly, Shire publishes the results of its study comparing Fosrenol to Renagel in the latest issue of Clinical Nephrology. The results not suprisingly favor Fosrenol as the superior phosphorous binder in this short four week trial. I am not sure it answers any significant question for nephrologists or dialyzors. Both medications work, getting the precise equivalent doses of the respective medications for the proper evaluation may be an exercise in futility.. but cheers for Shire for trying... go get em tiger.

A more mundane but important question in this debare and one I often ask my patients when choosing: Would you rather chew a (?tasteless) tablet or would you prefer swallowing an extra 3 pills or so with each meal three times a day, everyday?

Are You Getting your Flu Vaccines?

This is the most lively and debated flu season in memory. The seasonal influenza vaccine is something everyone in the healthcare field should get, and is not at all controversial. Yet, the H1N1 vaccine is creating quite a stir. Should everyone receive the vaccine? Is it safe? Is it being rushed to the market too soon? What is the downside to the vaccine? Do we really know?

This is a major public health initiative and dilemma. Physicians, epidemiologists, patients, administrators all vary in their opinions. It seems reasonable to vaccinate everyone against the seasonal flu and the H1N1 virus in theory, but it is realistic? Is it the right thing to mandate?

Fresenius is preparing to help dialysis patients in their facilities and clinical staff by offering the seasonal influenza vaccine and H1N1 flu vaccines when available. The company’s goal is to offer to vaccinate 100 percent of its patients and health care workers.

Most will get vaccinated, but not 100%. Are you getting vaccinated against both this season? If not, why?

Rethinking the Chronic Kidney Disease Staging System

OK, I am going to say it. Many within the nephrology community may not agree... but, I know I am not alone here... anyway.. here it goes... the CKD staging system sucks. There, I said it.

I was thinking about a more politically correct way to say it, but why sugar-coat it? Stage 1 and 2 are nearly meaningless. When we speak of CKD we are really speaking about only stages 3 through stage 5. So, why not just drop Stage 1 and 2 CKD? I believe they could easily be grouped together and renamed "Pre-CKD" in much the same way as we have "Prehypertension".

Moreover, I think there would be a psychological benefit of renaming stage 3 CKD as stage 1. Patients are often concerned that they are at stage 3. I have been told, "Why hasn't anyone told me about this when I was at Stage 1 or 2?" It can give the appearance the physician (PCP) is late to discovering a "disease" which has already "progressed" to this more advanced frightful stage 3. Patients and families alike are confused and upset by this arbitrary nomenclature.

This is an example of an email I just received, and it is a VERY common scenario:

My dad is almost 76 yrs. old. Due to other health concerns we got copies of all his medical records. In May of this year it was written down dads diagnosis of stage 3 ckd. This is the first we knew of this. The dr did not advise dad to go to a nephrologist. Mom called the drs office about this and she was told he has been stable since 07 but if they want a referral they would be glad to do this. So, my father has had this disease and his dr sits on it. Why?
Is this common practice for a physican? We certainly do not understand why he wasn't verbally told and then advised to seek specialized care. What is your opinion of this situation?
Thank you for your time and expertise
Sincerely
(name withheld)


I will give you another example.... There is a 60ish year old woman, let's call her Hilliary. Imagine Hilliary's BUN 14, Creatinine 1.1 mg/dL, and albumin 3.8 g/dL. Using the MDRD Eq, Hilliary's eGFR is 56 ml/min. She could now be considered by some to have stage 3 CKD. Well, does she really have Stage 3 CKD? Furthermore, I will tell you her urine is completely bland without a trace of proteinuria, cells or casts and she is neither diabetic or hypertensive. Now, is this really a pathologic entity deserving of the label stage 3 chronic kidney disease? Does a family member need to deal with the angst of deciphering the meaning of stage 3 CKD? Is it a productive use of time for the PCP to enbark upon a long discussion as to whether or not Hillary has stage 3 CKD, and its meaning? Is the anger directed towards a PCP that does not share this with Hillary or her family justified? Is the PCP obligated to work up Hillary further? Does she need to see a Nephrologist?

Additionally, another point I have made before is, all 'stage 3's' are not created equally. Please see my earlier post, 'Should all Stage 3 CKD Patients See a Nephrologist? What About Stage 3b?'

Is it time to rethink the staging system for CKD? I believe so.