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|Issue: #11 ||December 2010/January 2011|
|Greetings! |We are now entering 2011 and on behalf of myself, my group and all of our employees we wish you a "Happy and Healthy 2011!!!". I wish to thank our patron who requested I review the topic of chronic kidney disease and dialysis. The resulting newsletter article admittedly will improve the quality of care in our office and change some components of practice management as it relates to renal/kidney insufficiency. The second featured article discusses two recent medication topics relevant to our patients. The last article includes another tasty and healthy recipe as we all love to eat. Remember as you read the articles that if you scroll over the colored underlined fonts and then click your mouse you will be linked to articles, summaries and sometimes slides or videos to enhance your newsletter experience.Our website has been fully restyled- please visit it as I am sure you will find it more easy to navigate and get the information you are looking for quickly. The bulletin board has been modified into a blog site and thus patients can leave comments for us to consider posting. The bulletin board has been where prior opinion pieces by yours truly have been posted. It will have a totally different look and I hope you find it easier to navigate and more enjoyable to visit.
In addition to the revised website, we have increased our groups online presence by the creation of a new Twitter account and Facebook group. Please visit these pages to learn more about the services provided by our practice.
Please tell your friends to join our e-mail list if you think the site and our newsletter is worth reading. A new feature that is coming to our website (currently in development) is the option for established patients to use an Internet access option to contact our practice. This feature will also provide a HIPAA compliant way for patients to receive notice of some of their test results. It will require using a sign-on option which is unique to the patient (some computer skills required).
|Kidney Disease and Dialysis|
Stages of Chronic Kidney Disease
Chronic Kidney Disease (CKD) is classified according to the degree of functional impairment in the glomelular filtration rate of the kidney. The glomelular filtration rate refers to how well the kidney is doing its job- which is to filter our blood of waste products and excessive water/fluid. The classification scheme ranges the degree of kidney dysfunction from 1-5. Stage 1 is the earliest amount of dysfunction and might only be evident by an abnormal Xray or image test with totally normal blood findings. Stage 5 is full blown kidney failure and indicates the need for dialysis.
The prevalence of CKD in the United States is approximately 16%. This means when we look at patient data just under one in 5 persons have some degree of kidney insufficiency. The physicians or IMSWF usually refer to the diagnosis of renal insufficiency instead of Chronic Kidney Disease. The classification scheme is followed by the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative or (NKF KDOQI)™ and provides evidence-based clinical practice guidelines developed by volunteer physicians and health care providers for all stages of chronic kidney disease and related complications, from diagnosis to monitoring and management.
Physicians use a blood test call the creatinine level to help us screen for kidney insufficiency. This simple blood test is reported on any Basic Metabolic Profile or Comprehensive Metabolic Profile that we perform in our office. Knowing a patient's age, sex, and creatinine level allows us to apply a mathematical calculator to evaluate kidney function. This calculator provides an estimated Glomelular Filtration Rate (GFR) which is how the 5 stages of chronic kidney disease are defined. It is normal to have a high GFR. When the GFR falls under 15 ml/min, a patient is looking towards the inevitable need for a kidney transplant or dialysis.
The importance of identifying patients with kidney insufficiency is that there are many medical issues that need to be evaluated and followed. First the doctor seeks to rule out any chronic treatable reasons for the kidney disease. Diabetes and hypertension (high blood pressure) are the two most common causes of kidney insufficiency. There are also many primary kidney diseases that if identified could result in specific treatments that could delay or stop further deteriation of kidney function. Blood and urine testing, blood pressure measurement and renal/kidney ultrasound testing are typically done if the diagnosis is new or there is a significant change in kidney function.
If no primary kidney disease if found then optimizing blood pressure control and blood sugar control may minimize progression of kidney failure. Physicians need to monitor serum calcium, phosphate and creatinine levels along with monitoring urine protein excretion, bone health and nutritional issues. If we note that the condition is progressing despite our interventions then a referral to a Nephrologist (an Internist who specializes in the diagnosis and management of kidney disease) should be considered. If it looks like the 5th stage of disease is present then a nephrology referral is definitely in order as this specialist would coordinate both dialysis and or renal transplant if/when the GFR falls below 15 ml/min.
When the Kidney Totally Fails
Most patients still produce urine even when their kidney is failing. The problem is the quality of the urine is poor in that waste products aren't getting eliminated. When there is total kidney failure, kidney transplant is preferable to artificial dialysis. The overall mortality rate is significantly better if you can get a transplant. Being able to find a matched donor, along with being physically fit enough to tolerated not only the procedure but the chronic immune suppression medications for this procedure means not everyone can have a kidney transplant. Among the many potential contraindications to transplant, active cancer is one which disallows this option. The immunosupression medications would likely result in the patient's cancer progressing at a much more fulminant pace than the cancer will without immunosuppresion.
Dialysis is the process of artificially performing the kidney's job. There are two main methods of doing this: Hemodialysis or Peritoneal dialysis. Requiring dialysis is a very serious medical situation. Most persons requiring dialysis will not likely be able to hold a full time job due to the significant time commitment needed to have this procedure performed. There are ways to perform dialysis in your sleep at home but obviously this requires a very committed, capable patient and I suspect there are cost issues involved in being able to perform this function in the privacy of your home.
Hemodialysis involves taking a patient's blood and flowing the blood to a machine which then filters the blood of urea, potassium, phosphorous and other waste products while also extracting excessive water from the patient's blood. A recent review article in the NEJM titled Hemodialysis (authored by Dr.'s Himmelfarb and Ikizier) provides an excellent timeline slide explaining the evolution of this procedure.
Currently the standard of care is to have this procedure performed at a medical facility 3 times weekly. A recent study looking at more frequent dialysis showed some improvement in certain endpoints but there was a significant increase in vascular access complications. Since the patient undergoing hemodialysis requires frequent access to their blood circulation, they have to have an arteriovenous shunt surgically developed-usually in the patients non-dominant arm. If time allows a shunt is performed using the patient's own artery and vein. This type of shunt takes 6 months to mature and be able to be used. This is one reason that dialysis planning is preferred over waiting to refer a kidney patient to the specialist until the last minute.
According to my review, properly placed grafts can function up to 20 years without any significant complications or need for revision. On the other hand many patients have clotting problems, graft scarring, or infection issues that result in multiple revisions, need for repair using artificial grafts, etc.If a patient's arteries or veins are not suitable for a "natural tissue shunt" then a graft material is used to develop the shunt. Since the graft is made of synthetic material, there is a higher rate of infection problems and clotting risks in the graft. If a patient needs emergent dialysis before a shunt can mature, then a specialized catheter can be placed (usually in the jugular vein) and used until the shunt can be accessed.
Hemodialysis can be performed at home and in fact prior to Medicare covering it as a service this was the initial method of treatment. Since dialysis being covered (it was legislated under President Nixon's tenure) by Medicare, this service has rapidly and thoroughly become corporatized. The benefit of corporatization has been that this service is widely available and homogenized throughout the country. Dialysis is expensive and this of course was the impetus behind getting it covered. According to WiKipedia, renal transplantation is more cost effective. Transplants function 5 years or better and apparently under current costs a transplant is approximately the price of 3 years of dialysis. This seems paradoxical in that there is a shortage of kidneys and surgeons to perform the transplant yet there is a wide availability of dialysis ( I feel my price control theme rising at this point). I suspect as the health care system gets more taxed and the availability of good qualified physicians/nursing/staff for dialysis centers diminish the option of dialysis at home will increase.
Peritoneal dialysis is another option for end stage kidney patients. This method of dialysis is usually done at home and is one of the main appeals to it as a therapy. To be able to perform dialysis at home is a huge benefit for many patients as it frees their life up significantly. If done at night (there are peritoneal machines which will cycle your dialysis while you sleep), a person could potentially work full or part-time.
Peritoneal dialysis uses the lining of the patient's abdominal cavity for the dialysis membrane (in hemodialysis artificial tubing and filters perform this job). A peritoneal dialysis patient has a catheter surgically placed into their abdomen, usually just lateral to the belly button area. This catheter is partially tunneled in the abdominal fat and thus to improve it's security it is usually allowed to heal 2-4 weeks before being used. From the peritoneal catheter the patient has a prescribed amount of sterile fluid called dialysate placed into the abdominal cavity. This fluid is allowed to "stew" in the belly and the body disperses the waste products and electrolytes that the kidney normally would have handled into the dialysate fluid. After about one hour or so the fluid is then removed from the abdomen and flushed down the sewer system (just like your urine). The main complication of peritoneal dialysis is infection of the peritoneal cavity/lining. This situation is called peritonitis. Statistically this occurs once every 3 years in peritoneal dialysis patients. It is usually managed with intraperitoneal infusion of antibiotics. Sometimes IV or by mouth antibiotics are needed and sometimes the shunt itself is infected and will need to be changed out.
Dialysis patients do have additional complications besides those related to management. This includes the development of cysts on the kidneys. These cysts can hemorrhage or rupture (which can be painful). There is also a higher rate of kidney cancers in dialysis patients.
|Medications In The News|
| Two relevant medications|
Since the last newsletter there are two newsworthy items related to medications. In November the FDA recommended propoxyphene (Darvon, Darvocet N100, and others) be removed from the market. The second medication of note is dabigatran which just came to market under the name brand Pradaxa.
The propoxyphene issue has a long history based upon my review of the 32 page letter which resulted in the recommendation to remove this medication for safety reasons. The Office Of Surveillance and Epidemiology/Division of Epidemiology provided a long line of data mostly collected from Emergency room and Medical Examiner's data regarding the incidence of mortality as it related to medications. The medications studied often were taken in conjunction of other medications (multiple drug ingestion/overdose) The data was from patients presenting in the emergency room or evaluated at autopsy. This data did indicate that propoxyphene seem to have a significantly higher mortality relationship at autopsy than other narcotic type medications. Hydrocodone and tramadol were the other two analgesic/narcotics reported in these data sets. The letter recommending withdrawal was a follow-up to a Citizen's Petition Withdrawal first placed in 2006.
The final straw that resulted in the recommendation for withdrawal was the results of a multiple dose study looking at the effects that propoxyphene had on the electrical function of the heart. This study demonstrated that at a dose 300 mg above the maximal therapeutic dose recommended there was a significant and dangerous increase in what is known as the QT interval of the EKG tracing. Prior scientific study of other medications has shown that if the threshold that this study met was exceeded as it relates to the change in the QT interval, that potential for life-threatening rhythm changes could occur. The results of the multi-dose study was the threshold for increased life-threatening arrhythmia was met. The study's conclusion led to the final decision to recommend withdrawal of the medication.
Clinically neither I nor my colleagues had noted significant heart rhythm changes on our patient's EKG's or in their histories. Perhaps this is because we tended to maintain low dosing intervals for this medication and often asked patients to use it "only as needed" and with care and caution. Based upon my review, I do recommend patients not continue using this medication. If you feel you still need a prescription pain medication, I recommend you arrange an appointment with your main doctor.
The second medication of note is Dabigatran (Pradaxa) and it is potentially a "blockbuster" medication. It could change the game as it relates to preventing stroke in patient's with nonvalvular atrial fibrillation. This is its FDA approved indication. Atrial fibrillation is a condition whereby the heart does not beat in a synchronized fashion. It is not an uncommon condition and the prevalence of it rises with age. While atrial fibrillation can cause many cardiac and respiratory symptoms, physicians can usually resolve those complaints by using medications to control the heart rate. Is is very difficult and potentially dangerous to keep patients out of atrial fibrillation using medications.
A more serious and concerning long term effect of persistent atrial fibrillation is that of stroke. To date the drug of choice to minimize atrial fibrillation related stroke is warfarin (name brand Coumadin). Warfarin has been the drug of choice for stroke prevention related to atrial fibrillation for over 50 years! Warfarin is now generic and thus very inexpensive to purchase. Warfarin is, however, a difficult medication to manage. If you are placed on this medication, you must have frequent blood testing to monitor its effect. Too much effect places you at unacceptably high risk for bleeding and too little effect results in minimal or no benefit. Monitoring appointments must be made initially weekly and once a patient is stable on their customized dose they need to be checked at 1-2 month intervals. Nearly every other medication and various aspects of a typical diet can change the effect of warfarin. The appointments for monitoring increase the expense of managing chronic atrial fibrillation.
Internal Medicine of Southwest Florida was involved in a trial recently closed known as REAL-AF. We recently had just submitted our last patient cases for our small part in REAL-AF. This study is not yet reported but it will be analyzing the cost of warfarin management. The study was sponsored by the manufacturer of dabigatran- Boehringer Ingelheim Pharmaceuticals. I am sure they are hoping to prove that even if their medication cost a lot to fill, since their medication doesn't require frequent monitoring it will still be more cost effective than warfarin. The verdict is out on this still.
Until dabigatran's approval there was no medication that came close to reducing stroke risk to the degree warfarin does. The study which got the approval showed that this medication actually was slightly better at preventing strokes and was also associated with less significant bleeding outcomes. The medication was a bit harder to take than warfarin and thus the drop out rate for use was a bit higher. The most pronounced side effects were stomach and intestinal side effects- nausea and abdominal pains. Due to its brand new availability, to date we have no patients presently on this medication. Cost of prescription is going to be a major hindrance to its use-at least in the short term. It would appear that this medication will retail (actual cost to purchase) is going to be between 5-7 dollars a day at the pharmacy.
Another downside to using this medication is that it needs to be dose twice daily. Despite this inconvenience the study (RE-LY) showed that when dosed this way and blinded to both the patient's and the physicians, this medication routine was superior to the current warfarin program (at 150 mg twice daily). In the study the patient's on warfarin were in the therapeutic range for clot prevention 64% of the time. Perhaps the fact that the warfarin patients weren't therapeutic about a 1/3 of the time is why warfarin therapy has room for improvement and Pradaxa was able to beat it.
According to the medication package insert, if surgeries are going to be performed patients will be advised to hold the medication between 1-5 days prior to their surgery. The medication does have a relatively rapid clearance (especially relative to warfarin) and thus holding medication for very long prior to elective surgery won't be necessary. This also may explain the improved outcomes- since patients didn't need to hold medication and lose effectiveness as long as our current traditional recommendations for warfarin.
Patients will be seeing and hearing about this medication in 2011. The cardiologists are likely to recommend this therapy and as the information above indicates, it is a very good medication which is worth considering. As stated above the cost of the medication on a personal level to use is likely to be a major hindrance to its market success. If insurance plans cover the medication, I suspect it will be requested a lot.
| A Delicious Mexican Style Entree or Side Dish|
Black Bean Cakes
The typical American diet is estimated to provide about 12 grams of fiber per day. Nutritionists recommend a daily consumption of between 20-35 grams of dietary fiber daily. The recipe that follows is high in fiber, nutrition and taste. My family ranked this one as "excellent " when we first tried it August of 2010. I request this dish once a week now that I have had it.
The following recipe is from the fresh market & friends-a collection of recipes from the family and friends of The Fresh Market.2 15 oz cans black beans6Tbls salsa6Tbls sweet or green onion, finely diced3/4 cups red bell pepper, finely diced3Tbls fresh cilantro, chopped1&1/2 cups breadcrumbs1/4 cup pablano pepper, mild flavor or 1Tbls jalapeno,diced1 large garlic clove,minced2 tsp chipotle sauce or to taste 1/2 tsp hot sauce1&1/2Tbls lemon juice salt and pepper to tasteTortilla Chip Breading 1&1/2 cups tortilla chips, crushed (baked variety works well)1 tsp cuminPlace beans in colander and rinse in cold water. Drain well, for at least 10 minutes. Add drained beans and all other ingredients except the tortilla chip breading into a mixing bowl. Blend well, mashing some of the beans to form a thick mixture. Form into 6 patties and roll into tortilla breading. At this point you can cover and refrigerate until ready to heat. Heat skillet, saute in just enough oil to brown cakes and heat through. Serve with fresh tomato salsa.
As always, Internal Medicine of Southwest Florida appreciates your patronage. We continue to strive to be your Medical Home and maintain your confidence as we provide excellent medical care to the surrounding area of Fort Myers.
Raymond Kordonowy MD
Internal Medicine Of Southwest Florida