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Right Combination of Immunosuppressive Drugs May Lead to Less Organ Rejection and Long-term Benefits

Preventing organ rejection for kidney transplants without compromising other aspects of health requires a delicate balance of medications.  Finding this balance and the correct dosage of drugs has been difficult for physicians.  For example, immunosuppressive drugs that protect transplanted organs can also cause serious side effects, including compromising patients’ immunity to infection, cancer, and other threats.

A new multi-year study, conducted by Giselle Guerra, MD, and colleagues at the University of Miami has shown that using tacrolimus (TAC) and mycophenolate mofetil (MMF) in combination provided the vest long-term benefits and the least amount of side effects after a kidney transplant.  This was the longest randomized study to date that has analyzed transplant drugs.  The results provide valuable guidance to physicians who treat kidney transplant patients.  The study appears in an upcoming issue of the Journal of the American Society Nephrology (JASN), a publication of the American Society of Nephrology.

Guerra studied 150 kidney transplant recipients who received one of three common immunosuppressive treatment regimens: tacrolimus + MMF, tacrolimus + sirolimus, or cydosporine + sirolimus.  Tacrolimus and cydosporine are in a class of drugs called calcineurin inhibitors; they can prevent early organ reject but can be toxic to the kidneys.  Sirolimus and MMF do not damage the kidneys.  Often, patients receive low doses of calcineurin inhibitors plus sirolimus or MMF in order to gain the most benefit without serious risk to their kidneys.  The patients in the study also received another immunosuppressive drug, dadizumab, shortly after transplantation, and long term steroids.  All patients were followed for an average of eight years after transplantation.

The research team found that survival of transplanted organs was similar in all groups of patients.  Significantly fewer patients treated with tacrolimus + MMF (12%) experienced acute rejection, compared to those given tracrolimus + sirolimus (30%) or cyclosporine + sirolimus (28%).  Patients taking tacrolimus + MMF also had better kidney function during the first three years.  Patients given tacrolimus + MMf or cyclosporine + sirolimus were less likely to die with a functioning transplant (12% and 4% respectively), compared to those treated with tacrolimus + sirolimus (26%).  Patients who were given sirolimus were more likely to develop viral infections, discontinue treatment, and need cholesterol-lowering medications, compared to patients not taking sirolimus.  In conclusion, the results suggest that transplant patients do better long term with tacrolimus + MMG than with either tacrolimus + sirolimus or cyclosporine + sirolimus.

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How to Care for Urinary Incontinence

Urinary incontinence is a condition that results in the involuntary loss of urine.  It is a condition that affects millions of American men and women.  As we age, our body undergoes many changes.  Some of these changes involve the urinary tract and may lead to incontinence as men and women get older.

Both men and women may develop urinary incontinence, but several actions exist that women, specifically, can take to decrease or even limit involuntary release of urine.

The skin around the outside of the vagina in women is called the vulva.  This area includes the skin around the urethra and the vaginal lips, or labia.  Frequently, in incontinent women, this area is red, raw, and sore from urine irritating the skin.  These tips may help make women more comfortable and avoid irritation of the bladder, urethra, and surrounding skin.

Women who are incontinent should avoid synthetic or nylon underwear or synthetic pantyhose.  Instead, use full underwear made of cotton, also avoiding thongs and g-strings.  In addition, women may find that washing underwear in pure soap or soap flakes, instead of harsh detergents, may reduce irritation to the vulva.  Also, women should not wash the vulvar area no more than twice a day, using only plain water or mild soap.

Although bath oils, bubble baths, and bath salts feel nice, women with incontinence should avoid them.  The ingredients in relaxation baths can be very irritating to the already sensitive skin of the vulva.  Vaginal deodorants or douches should be avoided.  And tampons should not be used as they may irritate the bladder and urethra.

After bathing, gently dry the vulvar area with a towel.  Women may use a hair dryer on cool or low setting to dry the area completely.  If a powder is necessary, use corn starch and not talcum powder.

Finally, drink plenty of pure water.  Avoid caffeinated beverages such as coffee, tea, and cola.  Alcohol should also be avoided, especially excessive amounts of alcohol, as it also irritates the bladder and urethra.

Urinary incontinence can be helped and in many cases may be cured with proper treatment.  If you are experiencing any of the symptoms of urinary incontinence, contact your physician to discuss treatment options.

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Reprogrammed Kidney Cells Could Make Transplants and Dialysis Obsolete

A recently published article in the Journal of the American Society Nephrology (JASN) indicates that patients’ own kidney cells can be gathered and reprogrammed, which means that in the future, fewer patients with kidney disease would need complicated, expensive procedures that affect their quality of life.

Sharon Ricardo, PhD, from Monash University in Clayton, Austria and her colleagues took cells from an individual’s kidney and reprogrammed them into progenitor cells, allowing the immature cells to form any type in the kidney.  The team inserted several key programming genes into the renal cells that made them capable of forming other cells.

In another study, Miguel Esteban, MD, PhD, of the Chinese Academy of Sciences in Guangzhou, China and his colleagues found that kidney cells collected from the patients’ urine can also be reprogrammed in this way.  The use of urine cells is easy to implement in a clinical setting, and the urine cells can be frozen and later thawed before they are reprogrammed.

If researchers are able to expand the reprogrammed cells, known as induced pluripotent stem cells (iPSCs), and return them to the patient, these IPSCs may restore the kidneys’ health and vitality.  The breakthroughs might help investigators to study the causes of kidney disease and to screen new drugs that could be used to treat them.

Ian Rogers, PhD, from Mount Sinai Hospital in Toronto wrote in an accompanying editorial that the two studies “demonstrate the feasibility of using kidney cells as a source o iPSCs and efficient production of adult iPSCs from urine means that cells can be collected at any time.”

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Relationship Between Kidney Cancer and Arsenic Found

A new study in the Journal of Urology finds that people with moderately elevated levels of arsenic in their urine may have an increased risk of kidney cancer, especially if they have high blood pressure and kidney disease.  This does not necessarily mean that arsenic leads to kidney cancers.  Researchers report that one possibility is that kidney cancer leads to higher levels of arsenic in the urine.

While high levels of arsenic have been linked to many forms of cancer and some studies have linked moderately elevated levels of arsenic to high blood pressure and type 2 diabetes, the effects of low-level arsenic exposure are not yet fully known.

This new study was conducted in Taipei, Taiwan, where researchers looked at the arsenic levels in the urine of people who live in an area with low arsenic concentrations in the drinking water.  In Taipei, arsenic levels in tap water ranges from undetectable to 4 micrograms per liter, which is below the 10 micrograms per liter allowed by the U.S. Environmental Protection Agency (EPA).  Researchers compared 132 patients with kidney cancer to 260 cancer-free adults of the same age and sex.

In general, there was a relationship between higher arsenic levels in the urine and higher chances of kidney cancer.  This relationship was strongest for people who had high blood pressure or impaired kidney function, which have been established as risk factors for kidney cancer.  Study participants with both of these conditions and relatively high levels of arsenic in their urine were six times more likely than people with none of these risk factors to contract kidney cancer.  Participants with two of these risk factors had a quadruple rate of increase in risk of kidney cancer.

One possibility proposed by both researchers involved with the study and researcher who were not was that arsenic exposure led to high blood pressure or kidney disease in some people, which, in turn, contributed to their kidney cancer.

An estimated 13 million Americans live in areas where the public water supply exceeds the EPA’s limit of 10 micrograms per liter, and water from unregulated private wells may contain too much arsenic.

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Study Finds Another Risk of Fall in Blood Pressure During Dialysis

A recent study led by researchers at the Stanford University School of Medicine found that there is an increased risk of blood clotting at the point where the patient’s blood vessels are connected to the dialysis machine known as the point of vascular access.  Researchers from the University of Utah also contributed to the study.  The study was published in the Journal of the American Society of Nephrology. This is yet another diverse consequence associated with a fall in blood pressure during dialysis for patients

Dialysis is a life-extending procedure for patients with kidney failure.  It involves sitting in a chair three or more times a week connected to an artificial kidney machine.  The patient’s blood is cleansed by exchanging fluid and electrolytes across a membrane during each three to four-hour session.

The fistula is one of the most common forms of vascular access.  It is created surgically from the patient’s own blood vessels.  The tubes used to transport blood to and from the body to the dialysis machine are connected to the body at this access point.  Clotting is one of the problems of an access point and can lead to its closure.

This study was based on results from the Hemodialysis study, known as HEMO, a National Institutes of Health-sponsored randomized clinical trial that collected data from 1,846 patients on hemodialysis from 1995 to 2000.  This study included data from 1,426 of these patients.

The team found that patients who had the most frequent episodes of low blood pressure during dialysis were two times more likely to have a clotted fistula than patients with the least episodes.

Roughly $2 billion a year is spent on vascular access in dialysis patients in the United States. Low blood pressure during dialysis occurs in about 25 percent of dialysis sessions.

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Urinary Incontinence is More Frequent Among White than Black Women

Elisa R. Trobridge, MD, of the University of Virginia, and colleagues have found that urinary incontinence occurs in more than twice as many white women as black women.  The reasons are not known; neither frequency of symptoms nor risk factors explained the difference.  The results were reported in the April issue of the Journal of Urology and were based on a survey of about 3,000 women.

Black women, however, with incontinence experienced significantly more urine loss.  Half of black incontinent women described their urine loss as enough to wet their underwear or pads, compared with 37.7% of white incontinent women.  Also, while black women had more urge incontinence, white women had more stress incontinence.

Previous studies derived from surveys and clinical evaluations have suggested differences between black and white women in the prevalence and type of urinary incontinence, but those studies had problems with design, population, and other factors.

This study, on the other hand, was a population-based cross-sectional one.  Dr. Trowbridge and colleagues examined racial differences in prevalence, frequency, quantity, and type of urinary incontinence in community dwelling women ages 35 to 64.  They also investigated demographic, medical history, lifestyle, and obstretric/gynecologic factors that might influence continence status.  Estimates were weighted to reflect probability and nonresponse characteristics of the sample, and to increase generalizability of the findings.

The survey was conducted by telephone and included 1,922 black women and 892 white women living in three counties in southeast Michigan.  The overall prevalence of urinary incontinence was 26.5%.  White women had a significantly higher prevalence (33.1%) than black women (14.6%).  There were no differences in incontinence frequency (about 15 episodes each month).

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Hemoglobin Levels Linked to Severity of Incontinence in Older Women

Sei Lee, MD, Assistant Professor of Geriatrics at the University of California in San Francisco, and colleagues found that in older women in diabetes and urinary incontinence, very high hemoglobin A1c (HbA1C) levels are associated with patient reports of more severe limitations due to incontinence.  The data also showed, however, that in older women with diabetes, poor glycemic control does not predict the presence or absence of urinary incontinence.  The results were reported at the 71st Scientific Sessions of the American Diabetes Association.

They analyzed a large, diverse cohort of older women enrolled in the Diabetes and Aging Study, which is sponsored by the National Institutes of Health.  This five-year study examines medical care and outcomes in roughly 112,000 type 2 patients who are aged 59 years and older and enrolled in the Kaiser Permanente California Diabetes Registry.

Glycosuria has long been known to result from hyperglycemia.  Previous studies that have examined the relationship between poor glycemic control and urinary incontinence have found no association, but these studies included few patients with poor glycemic control and thus have had limited statistical power.

The outcome variables measured in this study were the presence/absence of incontinence and the severity of limitations due to incontinence.  The patients were asked “Do you experience occasional accidental urine leakage?” and “During the past 12 months, how much did the leakage of urine affect your day-to-day activities?”  The patients had the options of responding, “not at all,” “slightly,” “moderately,” “quite a bit,” or “extremely.”

The results from 3,916 older women with diabetes and urinary incontinence showed that HbA1C did not predict the presence or absence of urinary incontinence, after adjusting for age, ethnicity, education, income, parity, diabetes duration, diabetes treatment, co-morbid conditions, and body mass index.  Diabetic women with very poor control with an HbA1C greater than nine percent were about 50% more likely to be more severely limited by incontinence than women with excellent control with an HbA1C below six percent.  Dr. Lee recommended that clinicians routinely ask older female patients about incontinence.

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Weight Loss Increases Libido in Obese Men with Type 2 Diabetes

A small Australian clinical study showed that sexual function improved significantly and quickly in obese men with type 2 diabetes after weight loss with reduced-calorie diets.  For 31 men who lost five percent to ten percent of their body weight in eight weeks, erectile function, sexual desire, and urinary symptoms all improved significantly.  According to an article published in the Journal of Sexual Medicine, metabolic parameters, including blood glucose, insulin sensitivity, and lipid profile, also responded favorably to either a low-calorie, meal-replacement diet or a high protein-low carbohydrate diet.

The improvements were maintained during a year of follow-up.  Joan Khoo, MRCP, of Changi General Hospital in Singapore, and Australian co-authors wrote, “Further improvements during weight maintenance, using a high-protein low-fat diet, suggest that both nutrient quality and caloric restriction contribute to these benefits.”  Although the favorable effect of weight loss on sexual function is not new, this study may be the first to demonstrate an impact on sexual desire.

Another important finding was weight loss’ apparently favorable effect on systemic inflammation.  Obesity and type 2 diabetes increase the risk of erectile dysfunction and lower urinary tract symptoms (LUTS), which are associated with each other and with systemic inflammation and endothelial dysfunction.

Rapid weight loss through dieting can improve erectile dysfunction and LUTS. Previous studies also have shown improved endothelial function and reduced inflammation after weight loss, especially for people who lose at least 10 percent of body weight.  Not much data had been collected regarding the influence of macronutrient composition on associations between weight loss, endothelial function, systemic inflammation, sexual function, and LUTS in obese men.

All 31 men involved in the study had type 2 diabetes, a body mass index greater than 30, and a waist circumference of at least 102cm.  They were randomized to two dietary plans.  The first plan was a liquid meal-replacement consumed twice daily and one small, nutritionally balanced meal, providing a total energy of about 900 kcal/day (low-calorie diet).  The second plan was a low-fat, low-carbohydrate diet designed to reduce energy intake by about 600 kcal/day.

The first assessment occurred after eight weeks, and follow-up continued for an additional 44 weeks.  The participants who opted to stay in the study for long-term follow-up consumed the high-protein diet during the follow-up.

Men in the low-calorie diet group had about ten percent reduction in mean body weight and waist circumference at eight weeks, as compared with about five percent among men assigned to the high-protein diet.  Weight loss at eight weeks averaged 9.5kg with the low-calorie diet and 5.4 kg with the high-protein diet, both of which were statistically significant.

In general, inflammatory markers decreased significantly in the high-protein group but not the low-calorie group, but the men assigned to the high-protein diet had higher baseline levels of the markers.  About half of the men remained in the study for the entire 52 weeks. Of those who did, improvements were either maintained or increased.

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Increase of laparascopic radical nephrectomies for small renal tumors is alarming

Kidney cancer specialists reported that the use of radical nephrectomy for small renal masses remains “alarmingly high,” particularly among older patients.  Between 1995 and 2005, the use of radical nephrectomy decreased by 50 percent, but most of the decline was offset by a dramatic increase in the rate of laparascopic radical nephrectomies.

Use of laparascopic techniques to remove small renal masses increased by 35 percent overall.  Nephron-sparing surgery, on the other hand, increased by 15.5 percent.  These findings were presented at the American Urological Association meeting.

Marc Smaldone, MD, of Fox Chase Cancer Center in Philadelphia reported that in 2005, 77 percent of patients were treated with radical nephrectormy, either open or laparoscopic.

Investigators reported in another study that older patients were significantly more likely to have radical nephrectomy for small renal tumors compared with their younger counterparts.

James McKiernan, MD, of Columbia University in New York, said that this disparity is most common in patients with the smallest masses.  Over a third of small renal masses are less than 4cm, and incidental discovery of small masses has increased 244% since 1982.  The dramatic rise in the detection has coincided with the aging of the American population.

The AUA clinical guidelines for management of small renal masses emphasize disease control, nephron preservation, and use of minimally invasive techniques whenever appropriate.  Noting a potential to reduce the risks of chronic kidney disease, cardiovascular disease, and mortality, the guidelines cite nephron-sparing surgery as the reference standard.

Investigators reviewed the NCI Surveillance, Epidemiology, and End Results (SEER) Medicare-linked database from 1995 to 2005.  The team identified all patients treated for small renal masses and grouped the patients by type of surgical procedure: open radical nephrectomy, open partial nephrectomoy, laparoscopic radical nephrectommy, and laparascopic partial nephrectomy.  In 1995, radical nephrectomy accounted for 93% of all the procedures, 87% of which involved open surgery. In 2005, radical nephrectomy’s total share of procedures had declined to 73%, more than half (40.8%) performed laparoscopically.  During this time, the rate of open partial nephrectomy increased from 6.7% to 13.5%, and use of laparoscopic partial nephrectomy increased from 0.6% to 9.3%.

Mckiernan reported from a review of SEER data that identified 18,000 patients who had small (4 cm or less) localized tumors between 1998 and 2007 that the preference for radical versus nephron-sparing surgery has become even more pronounced among older patients.  The study analyzed trends in the use of radical nephrectomy by age and tumor size.  Two thousand seven hundred and thirty three patients were 27 or older, and 15,312 were younger than 75.

Overall, radical nephrectomy was the treatment of choice for both age groups, but was significantly greater among older patients: 66% of all surgical procedures compared with 59% among younger patients.  Stratification by tumor size showed that the age-related difference in use of radical nephrectomy increased as tumor size decreased. Although use of radical nephrectomy decreased with tumor size in both age groups, the magnitude of the difference between the groups increased.

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Botox Approved in Ireland for Treatment of Urinary Incontinence

The Irish Medicines Board has approved Botulinum toxin type A to treat urinary incontinence management in adults with neurogenic detrusor overactivity (NDO).

Neurogenic detrusor overactivity results from nuerogenic bladder due to multiple sclerosis or stable sub-cervical spinal cord injury.

Allergan Inc. has said that this step is important in securing national licenses in fourteen European countries that are involved in the Mutual Recognition Procedure.  The positive opinion came after the Irish regulatory agency evaluated Allergan’s successful global Phase III program.

Bladder dysfunction affects approximately 60 percent to 80 percent of people with multiple sclerosis (MS) and 75 percent to 80 percent of those with spinal cord injury (SCI), including urinary incontinence.

Both MS and SCI patients often have bladders which contract during the filling stage, during which time they should be relaxed.  This condition is known as neurogenic detrusor overactivity, which can result in uncontrolled urinary leakage, known as urinary incontinence.

When Botox is injected into the bladder muscle, the involuntary contractions subside and bladder activity increases, resulting in fewer urinary leaking incidents.  Sometimes the problem is completely resolved.

Urinary incontinence can often be a socially isolating and disabling condition. People who suffer from it frequently experience low self esteem, loss of independence, embarrassment, and depression.   MS and SCI patients with urinary incontinence are also more likely to develop skin irritations and ulcers, recurrent and kidney failure.

Douglas Ingram, President of Allergan in Europe, Africa and the Middle East, said that Allergan was pleased about the Irish Medicines Board’s decision.

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