The Observatory

July 25, 2017

In kidney disease, the kidneys are damaged and cannot filter blood the way they should. This damage can cause wastes to build up in the body. Chronic kidney disease (CKD) is any condition that causes reduced kidney function over a period of time.

14 percent
Is the overall prevalence of chronic kidney disease (CKD) in the United States.

661,000
Is the number of Americans who have kidney failure.

468,000
Is the number of Americans who are on dialysis.

193,000
Is the number of Americans living with a functioning kidney transplant.

47,000
Is the number of Americans who will die from kidney disease this year.

16 percent
Is the prevalence of women who have stages 1 to 4 CKD.

13.5 percent
Is the prevalence of men who have stages 1 to 4 CKD.

14 percent
Is the percent of Caucasians who have CKD.

17 percent
Is the percent of African Americans who have CKD.

$1,700
Is the per-person annual Medicare expense attributable to stage 2 CKD.

$3,500
Is the per-person annual Medicare expense attributable to stage 3 CKD.

$12,700
Is the per-person annual Medicare expense attributable to stage 4 CKD.

Source: https://www.niddk.nih.gov/health-information/health-statistics/Pages/kidney-disease-statistics-united-states.aspx and http://jasn.asnjournals.org/content/24/9/1478.full

Zika Virus

NIH launches prospective study of Zika and HIV co-infection during pregnancy. The National Institutes of Health (NIH) has launched a study to determine the potential risks that infection with the Zika virus might pose for pregnancies in which the mother is also infected with HIV. At this point, little is known about whether Zika virus infection poses additional risks for maternal or infant health in pregnancies already complicated by HIV. Researchers hope the new study will provide information on whether infection with one of these viruses might increase the risk for infection with the other.

Other concerns include whether Zika might interfere with medications that prevent HIV from being passed from a pregnant woman to her fetus and whether infection with the two viruses might increase the risk of damage to the fetal brain, as seen with Zika virus.

The researchers plan to enroll pregnant women who are infected with HIV only, with Zika virus only, and with HIV and Zika, as well as women who are not infected with either virus. The study is enrolling participants in Puerto Rico and will soon recruit volunteers at sites in the continental United States and Brazil. Study participants will be provided with appropriate treatment. Women will be monitored throughout their pregnancies and for six months after giving birth. Infants will be observed for a year after birth.

The study will be conducted in two parts: In the initial phase, the researchers aim to recruit roughly 200 pregnant women; if their efforts are successful, they will then try to enroll 1,800 additional pregnant women. The study is expected to run from four to six years.

Infectious Diseases

Cases of recurrent Clostridium difficile infection are soaring. Intestinal infection with the bacterium Clostridium difficile is the most frequent healthcare-linked infection in the United States. Each year it afflicts about half a million Americans, causes tens of thousands of deaths, and costs the nation’s healthcare system an estimated five billion dollars. Now researchers from the Perelman School of Medicine at the University of Pennsylvania have found evidence that the most difficult C. difficile cases, known as multiple recurring C. difficile infections (mrCDI), are rapidly becoming more common.

In an analysis of a large, nationwide health insurance database, the Penn researchers determined that the annual incidence of mrCDI increased by almost 200 percent from 2001 to 2012. During the same period, the incidence of ordinary CDI increased by only about 40 percent. The study results were published in the Annals of Internal Medicine.

The precise mix of reasons for the sharp rise in mrCDI’s incidence is so far unknown. But the authors say the finding clearly points to an increased burden on the healthcare system, including increased demand for new treatments for recurrent CDI. The most promising of these new treatments, fecal microbiota transplantation—the infusion of beneficial intestinal bacteria into patients to compete with C. difficile—has shown good results in small studies, but hasn’t yet been thoroughly evaluated.

Cases of CDI were considered to have multiple recurrences when doctors treated them with at least three closely spaced courses of CDI antibiotics. Compared to CDI patients whose infections cleared up after just one or two courses of therapy, patients with mrCDI were older (median age 56 vs. 49), more likely to be female (64 percent vs. 59 percent), and more likely to have been exposed, before their CDI, to medications such as corticosteroids, proton-pump inhibitors, and antibiotics.

The rapid rise in the incidence of mrCDI may be due in part to Americans’ increasing use of such drugs. However, according to study authors, it is likely that other causes are also involved. One of these drivers may be the recent emergence of new strains of C. difficile.

Drugs of Abuse

On-site ecstasy pill-testing services may reduce user risks at concerts and raves. Johns Hopkins scientists report that data collected over five years by volunteers who tested pills free of charge at music festivals and raves across the United States suggest that at least some recreational users of illegal drugs may choose not to take them if tests show the pills are adulterated or fake.

Their findings, published online last month in the Journal of Psychopharmacology, also revealed that pills purported to be a purer and safer version of the illegal stimulant drug MDMA known as Molly contained as many harmful additives as the version known as Ecstasy. And, unlike older analyses that found different results, the most common adulterants in this study were chemicals commonly known as “bath salts.“ The researchers say their study adds critical evidence that on-site pill-testing services may be a valuable public health and safety tool.

Between July 2010 and July 2015, volunteers for the nonprofit DanceSafe tested samples of pills or powder believed by music festival and rave attendees to be MDMA. The testing was free and advertised by word of mouth.

To test the pills, the volunteers were equipped with chemical kits and a means of scraping about one milligram off the pill or collecting it out of a capsule. The sample was added to multiple chemicals that changed color in the presence of specific pill components.

The resulting colors of the tested sample were matched up with a color chart of 29 known substances, such as cocaine, caffeine, or sugar. Those not matching a listed substance were reported as unknown, and the color test isn’t sensitive enough to detect minute quantities of chemicals. The tests also can’t provide information on concentration.

Of the 529 total samples collected, 318 actually contained MDMA or the closely related drug MDA. The chemical adulterants weren’t identifiable using the color test in 90 of the 211 adulterated samples, but the most common ones found bath salts, specifically methylone in 35 and other cathinones in 21 of the adulterated samples. After these, methamphetamine was the next most common additive in 13 of the adulterated samples. Three samples contained a dangerous form of amphetamine known as PMA, which is associated with overdoses and death.

After the volunteers reported the results of the test to the festival-goers, the participants were asked if they still intended to take the pill or powder. Of the 168 participant responses, 46 percent of those whose substances contained MDMA said they intended to take their drug, compared with 26 percent of participants whose substances tested negative for MDMA.

Diabetes

Diabetes complications are a risk factor for repeat hospitalizations, study shows. For patients with diabetes, one reason for hospitalization and unplanned hospital readmission is severe dysglycemia (uncontrolled hyperglycemia, or high blood sugar; or hypoglycemia, or low blood sugar), says new research published in the Journal of General Internal Medicine.

People who were previously hospitalized for severe hypoglycemia or hyperglycemia are at highest risk for recurrent dysglycemic episodes in the short term (within 30 days of the prior episode) and over the long term. In addition, having multiple diabetes complications significantly increased the risk of readmission not only for severe dysglycemia, but also for all causes that are seemingly unrelated to diabetes.

Using the OptumLabs Data Warehouse, a database of de-identified, linked clinical and administrative claims information, researchers examined administrative data of 342,186 adult patients with diabetes who were hospitalized for various reasons nearly 600,000 separate times between Jan. 1, 2009, and Dec. 31, 2014.

The researchers determined that patients with diabetes are admitted to the hospital and experience unplanned readmissions for a wide range of reasons, similar to patients without diabetes. The most common reason (5.5 percent) for these initial, or index, hospitalizations, was congestive heart failure. Severe dysglycemia caused 2.6 percent of the initial hospitalizations for these patients.

When their initial condition was treated or stabilized, and the patients were discharged, 10.8 percent of them found themselves back in the hospital within 30 days. Of these 68,212 readmissions, 2.5 percent were for severe dysglycemia, regardless of the initial reason for hospitalization. But if their index hospitalization was also for severe dysglycemia, the risk of a recurrent episode requiring hospitalization was nearly ninefold higher after a severe hyperglycemic event and fivefold higher after a severe hypoglycemic event.

The research also found that younger patients (18-44) were twice as likely to be readmitted for severe dysglycemia than were older patients and that a severe dysglycemic episode was a strong predictor of readmission for another dysglycemia event. The study helps providers identify patients at highest risk for readmission, allowing intervention and prevention.

Fasting blood sugar and fasting insulin identified as new biomarkers for weight loss. Researchers from the University of Copenhagen announced the findings from a weight loss biomarker study published in the American Journal of Clinical Nutrition (AJCN). The study found that fasting blood sugar and/or fasting insulin can be used to select the optimal diet and to predict weight loss, particularly for people with prediabetes or diabetes.

The research analyzed data from three diet trials which collectively looked at more than 1,200 individuals. The findings suggest that for most people with prediabetes, a diet rich with vegetables, fruits, and whole grains should be recommended for weight loss and could potentially improve diabetes markers. For people with type 2 diabetes, the analysis found that a diet rich in healthy fats from plant sources would be effective for achieving weight loss. These diets could also be effective independent of caloric restriction.

“Recognizing fasting plasma glucose as a key biomarker enables a new interpretation of the data from many previous studies, which could potentially lead to a breakthrough in personalized nutrition,” says Arne Astrup, MD, Head of Department of Nutrition, Exercise and Sports at University of Copenhagen. “The beauty of this concept is its simplicity. While we are looking into other biomarkers, it is quite amazing how much more we can do for our patients just by using those two simple biomarkers. We will continue to participate in and support research to explore additional biomarkers such as gut microbiota and genomics approaches, which may offer more insights and help to more effectively customize the right diet for specific individuals.”

Cancer

Simple test predicts return of bladder cancer. Scientists have devised a simple test for an earlier and more accurate warning of returning bladder cancer than existing methods, according to research recently published in the British Journal of Cancer.

Researchers from the University Hospital of Lyon tested the urine of 348 bladder cancer patients for a faulty protein called TERT, and this was able to predict when the cancer was about to return in more than 80 percent of patients. Standard cytology testing detected the return in only 34 percent of patients.

The new test detected bladder cancers that had not spread to the muscle wall, earlier than cytology, potentially helping doctors to start treatment sooner and before symptoms appear. A further benefit is that the new test distinguished cancer from urinary tract infections.

“The standard cytology test needs a doctor to look down a microscope to read the results, but the TERT test is read by a machine, which is simpler, more accurate and available to use straightaway,” says Professor Alain Ruffion, a researcher based at the University Hospital of Lyon’s Oncology Institute. “While the TERT test costs slightly more than standard cytology, it is likely to become cheaper over time.”

The discovery also suggests that further research is needed to understand more about the role TERT faults play in bladder cancer.

Anna Perman, senior science information manager at Cancer Research UK, says: “This promising study suggests a new and more accurate early warning system to detect whether bladder cancers are likely to return. Larger trials are now needed to see if this information could help more people survive by catching bladder cancer’s return at its earliest stage.”

Transplant Medicine

Biopsy tests may lead to inappropriate discards of donated kidneys. Researchers have found that discarding donated kidneys on the basis of biopsy findings may be inappropriate. The findings, which were published last month in the Journal of the American Society of Nephrology (JASN), may help address the organ shortage by keeping valuable organs from being thrown away.

Discard rates for deceased donor kidneys in the United States are at an all-time high, and transplant centers frequently cite biopsy findings as the reason for not accepting kidneys obtained from donors for transplantation. The importance of biopsy results in determining how well a kidney will function post-transplant remains unclear, however.

To assess the true impact of biopsy results on long-term outcomes, Sumit Mohan, MD, MPH, and colleagues analyzed nearly 1,000 kidney biopsy samples that were processed under ideal circumstances and read by experienced renal pathologists.

The investigators found that biopsy results did not appear to impact long-term patient outcomes following transplantation of kidneys from living donors. Also, living donor kidneys with suboptimal biopsy results had better outcomes than deceased donor kidneys with optimal results.

Outcomes following kidney transplantation using deceased donor kidneys were influenced by biopsy findings; however, the team estimated that even transplantation with kidneys with the worst biopsy findings would result in several additional years of life for a patient compared with remaining on dialysis.

“Also, 73 percent of deceased donor kidneys with suboptimal biopsy results were still functioning at five years, suggesting that discards based on biopsy findings may be inappropriate, says Mohan. “This merits further study.”