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duminică, 5 august 2012

Researchers Develop First Potential Medicine For Patients With Most Severe Form Of Congenital Hyperinsulinism

A pilot study in adolescents and adults has found that an investigational drug shows promise as the first potential medical treatment for children with the severest type of congenital hyperinsulinism, a rare but potentially devastating disease in which gene mutations cause insulin levels to become dangerously high.

"There is currently no effective medicine for children with the most common and most severe form of hyperinsulinism," said study leader Diva D. De Leon, M.D., a pediatric endocrinologist at The Children's Hospital of Philadelphia. "Our new research shows that this investigational drug, a peptide called exendin-(9-39), controls blood sugar levels in people, a very promising result."

The study appears online ahead of print in the journal Diabetes.

In congenital hyperinsulinism (HI), mutations disrupt the insulin-secreting beta cells in the pancreas. Uncontrolled, excessive insulin levels thus sharply reduce blood glucose levels, a condition called hypoglycemia. If untreated, hypoglycemia may cause irreversible brain damage or death in children. Congenital HI occurs in an estimated one in 50,000 U.S. children, with a higher incidence among Ashkenazic Jews and certain other groups.

The standard treatment for some forms of congenital HI is diazoxide, a drug that controls insulin secretion by opening potassium channels in beta cells. However, this drug does not work in the most common types of HI, in which mutations prevent these potassium channels from forming.

When abnormal beta cells occur only in a discrete portion of the pancreas, precise surgery on the tiny organ can remove the lesion and cure HI. The Congenital Hyperinsulinism Center at The Children's Hospital of Philadelphia is a world leader in diagnosing such lesions and performing the curative surgery on newborns.

However, in roughly half of congenital HI cases, abnormal cells are diffused through the pancreas, and surgeons must remove nearly the entire pancreas. This leaves the majority of patients at high risk of developing diabetes.

The current study, which builds on previous research by De Leon and colleagues in animals, uses exendin-(9-39), which blocks the action of a hormone receptor, glucagon-like peptide-1 (GLP-1), in beta cells. The GLP-1 receptor is currently the target of drugs that treat diabetes, using the opposite effect from that investigated in this HI study.

The current pilot study included nine subjects, aged 15 to 47 years old, who had hyperinsulinism caused by mutations in potassium channels. None were being treated for HI at the time of the study, but all were at risk of hypoglycemia during periods of fasting.

In all nine subjects, the drug controlled blood glucose levels during fasting. Exendin also controlled insulin secretion in cell studies of beta cells taken from newborns with HI. The current research did not focus on the biological mechanisms that occurred, but De Leon said the results are encouraging enough to progress to a clinical study in children with HI over the next year.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our diabetes section for the latest news on this subject. Financial support for this study came from the National Institutes of Health (grant 1R03DK07835), the Lester and Liesel Baker Foundation, and the Clifford and Katherine Goldsmith Foundation. De Leon's co-authors, all from Children's Hospital, were Charles A. Stanley, M.D., Andrew C. Calabria, M.D., Changhong Li, M.D., and Paul R. Gallagher In addition to their positions at Children's Hospital, De Leon, Stanley and Li also are in the Perelman School of Medicine at the University of Pennsylvania.
"The GLP-1 Receptor Antagonist Exendin-(9-39) Elevates Blood Fasting Glucose Levels in Congenital Hyperinsulinism due to Inactivating Mutations in the ATP-sensitive Potassium Channel," Diabetes, published online Aug.1, 2012, to appear in print, October 2012. doi: 10.2337/db12-0166.
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joi, 15 decembrie 2011

An Acceptable Alternative To Surgery In Patients With Mild Trachomatous Trichiasis - Self-Epilation

Main Category: Eye Health / Blindness
Article Date: 15 Dec 2011 - 0:00 PST

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Self-epilation is an acceptable alternative to surgery in patients with mild trachomatous trichiasis

Teaching patients with mild trachomatous trichiasis - a leading cause of blindness in low resource countries in which chronic conjunctivitis leads to scarring causing the eyelids to turn inwards and the eye lashes to rub the eye causing pain, corneal damage, and visual impairment - to safely pull out the eyelashes touching their eye (epilation) using clean forceps, is an acceptable alternative to surgery to preserving vision. Furthermore, epilation may have additional advantages as surgical services are likely to remain unacceptable, inaccessible or prohibitively expensive for many people with the condition.

These findings from a large trial involving 1300 people in Ethiopia (the country with the highest rates of trachoma in the world) and published in this week's PLoS Medicine, leave the authors, led by Matthew Burton from the London School of Hygiene and Tropical Medicine, to conclude that although surgery should be performed for trachomatous trichiasis whenever possible, epilation should be considered when surgery is not available or is declined by the patient: in reality, a large majority of the approximately 8 million people who have trachomatous trichiasis are not receiving surgical treatment and given the enormous backlog of untreated cases, surgery is unlikely to be available to very large numbers of people living with trichiasis for at least the medium term.

The authors say "Where surgery is available and patients are willing to accept it, surgery should be performed, as the disease tends to progress, albeit quite slowly. However, we suggest that for individuals with minor trichiasis (who represent about half of all those with trachomatous trichiasis) epilation should be considered where surgery is either not available or declined by the patient."

In another study published in this week's PLoS Medicine, the same authors found that if surgery for trichiasis is performed, using absorbable sutures is as effective as silk sutures but has the added advantage of eliminating the need for patients to return to the clinic (often having to travel great distances) soon after their operation to have their sutures removed. The authors therefore suggest that trachoma control programs should now consider the potential logistical advantages of using absorbable sutures rather than silk sutures during trichiasis surgery despite the lack of any apparent clinical difference between the two suture types.

The authors say: "The logistical advantages of using absorbable sutures should be taken into consideration when considering the choice of suture material."

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our eye health / blindness section for the latest news on this subject. Surgery Versus Epilation for the Treatment of Minor Trichiasis in Ethiopia: A Randomised Controlled Noninferiority Trial
Funding: This study was funded by grants from the Band Aid Foundation (via Fight For Sight) and The Wellcome Trust (080741/Z/06/Z). Johnson & Johnson donated all sutures. Tweezerman donated all forceps. Tweezerman made a donation towards the production costs of a trichiasis surgery training DVD. No funding bodies had any role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing Interests: PTK is a member of the Scientific Advisory Boards for Alcon and Bausch & Lomb. All other authors have declared that no competing interests exist.
Citation: Rajak SN, Habtamu E, Weiss HA, Kello AB, Gebre T, et al. (2011) Surgery Versus Epilation for the Treatment of Minor Trichiasis in Ethiopia: A Randomised Controlled Noninferiority Trial. PLoS Med 8(12): e1001136. doi:10.1371/journal.pmed.1001136
Absorbable Versus Silk Sutures for Surgical Treatment of Trachomatous Trichiasis in Ethiopia: A Randomised Controlled Trial
Funding: This study was funded by grants from the Band Aid Foundation (via Fight For Sight) and The Wellcome Trust (080741/Z/06/Z). All the sutures (silk and polyglactin-910) were donated by the manufacturer, Ethicon, Johnson & Johnson. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing Interests: PTK is a member of the Scientific Advisory Boards for Alcon and Bausch & Lomb. All other authors have declared that no competing interests exist.
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marți, 13 decembrie 2011

Cancer Screening In Older Patients Very Common

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Academic Journal
Main Category: Cancer / Oncology
Also Included In: Seniors / Aging
Article Date: 13 Dec 2011 - 0:00 PST

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U.S. Preventive Services Task Force guidelines recommend against routine cancer screening, especially for breast, cervical, colorectal and prostate cancer, but adults 75 and older are still receiving regular cancer screenings. The report published in the December 12/26 issue of Archives of Internal Medicine, one of the JAMA/Archives journals, is a part of the journal's Less is More series, the aim is to educate healthcare professionals and patients alike in cuttings costs, but having a better service at the same time.

The authors write as background information in the article :

"In the United States, the number of adults 65 years or older, currently estimated at 36.8 million, is expected to double by the year 2030. Providing high-quality care to this growing population while attempting to contain costs will pose a significant challenge ...

While a great deal is known about cancer screening behaviors and trends in young and middle-aged adults, less is known about screening behaviors in older adults from different racial backgrounds."

Keith M. Bellizzi, Ph.D., M.P.H., of the University of Connecticut, Storrs, and colleagues analyzed data from the National Health Interview Survey, an annual in-person nationwide survey used to track health trends in U.S. citizens, to estimate the prevalence of cancer screening among older, racially diverse adults. The study population included 49,575 individuals, 1,697 of whom were 75 to 79 years of age and 2,376 were 80 years of age and older.

Percentages of those reporting cancer screenings are as follows : 62 percent Women age 75 to 79 - A mammogram within the past two years.50 percent of women age 80 and older - A mammogram within the past two years. 53 percent of women ages 75 to 79 - A Papanicolaou screen (also known as a pap smear or pap test) for cervical cancer within the past three years. 38 percent of women ages 80 and older - A pap smear within the past three years.57 percent highest of men and women 75 to 79 - Screenings for colorectal cancer. 57 percent of Men 75-79 - Prostate cancer screening.42 percent of Men 80 and older - Prostate cancer screening.40 percent of Men 50-74 and older - Prostate cancer screeningAnalysis showed large differences in breast, colorectal and prostate cancer screening among older adults, but the authors found that these differences were accounted for by low education.

Individuals without a high school diploma were significantly less likely to be screened for breast, cervical and prostate cancer, compared with adults older than 75 years with a college degree. Adults older than 75 years were also significantly more likely to be screened for breast, colorectal, and prostate cancer if a physician recommended the test.

The authors concluded :

"A high percentage of older adults continue to be screened in the face of ambiguity of recommendations for this group ... Prevalence results from this study can serve as a benchmark for progress as we move the science of cancer screening in older, diverse adults forward."

In additional commentary, Louise C. Walter, M.D., of the University of California, San Francisco and San Francisco Veterans Affairs Medical Center, writes that :

"There are no quality measures that address appropriate target rates for cancer screening in persons older than 75 years ...
While at extremes in older age the likelihood of surviving long enough to benefit from potential detection and treatment of asymptomatic cancer becomes quite small and the likelihood of harm becomes quite large irrespective of other factors, Bellizzi et al were not able to calculate screening rates in subgroups older than 85 years owing to the small number participating in the survey ...
Still, the data by Bellizzi et al raise the issue of whether quality measures should address the overuse of cancer screening."

Dr. Walter concludes :

"While it is useful to determine screening rates among persons in whom screening will likely result in net benefit or net harm, between these two groups is a large number of older persons in whom screening offers small or uncertain net benefit ...
For these persons, the decision about whether the potential benefits of screening outweigh the risks is a value judgment that requires informed decision-making ...
While arguments persists about what is the 'right' rate of cancer screening in older persons, it seems clear that the rate of informed decision-making should approach 100 percent."

Written by Rupert Shepherd
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today Visit our cancer / oncology section for the latest news on this subject. Arch Intern Med. 2011;171[22]:2031-2037.

Arch Intern Med. 2011;171[22]:2037-2038.

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Immune System Repaired In Leukemia Patients Following Chemotherapy

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Immune System / Vaccines
Article Date: 13 Dec 2011 - 0:00 PST

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A new treatment using leukemia patients' own infection-fighting cells appears to protect them from infections and cancer recurrence following treatment with fludarabine-based chemotherapy, according to new research from the Perelman School of Medicine at the University of Pennsylvania. The new process is a step toward eliminating the harsh side effects that result from the commonly prescribed drug, which improves progression-free survival in patients with chronic lymphocytic leukemia (CLL) but destroys patients' healthy immune cells in the process, leaving them vulnerable to serious viral and bacterial infections. The drug's effects on the immune system tend to be so violent that it has been dubbed "AIDS in a bottle."

At the 53rd American Society of Hematology Annual Meeting, the research team presented results showing how they use a patient's own T cells to repair his or her immune system after fludarabine treatment. With a restored immune system, patients can stop taking prophylactic antibiotics and may have prolonged progression-free survival.

"Fludarabine is a double-edged sword," says Stephen J. Schuster, MD, an associate professor in the division of Hematology-Oncology and director of the Lymphoma Program at Penn's Abramson Cancer Center. "Although it is very active at killing CLL cells, it is also very active at killing normal cells in the immune system, particularly T lymphocytes, which are the master regulators of the immune system. So you rid the patient of their disease, but you also rid them of a normal immune system."

Thirty-four patients enrolled in the multicenter study. Prior to chemotherapy treatment, the researchers isolated healthy T lymphocytes from each patient's blood. When the patient finished chemotherapy, the team grew the T cells in Penn's Clinical Cell and Vaccine Production Facility using a technique that induces them to proliferate rapidly. The researchers then infused the expanded T cells back into the patient. "What we showed was that by giving them back their own T cells after treatment, we can restore patients' immune systems," Schuster said.

"Within four weeks of the T cell infusion, their T cell counts were within the normal range."

After chemotherapy and prior to T cell infusion, the median CD4 T cell count for fludarabine-treated patients was 119 cells/ml blood and the median CD8 T cell count was 80 cells/ml. Thirty days after the patients received the infusion of their own T cells, the median cell counts were in the normal range, at 373 cells/ml and 208 cells/ml for CD4 and CD8 cells, respectively. The T cell numbers remained in the normal range beyond 90 days, leading Schuster and colleagues to conclude that the autologous T cell transfer repaired the immune system of patients.

Although all of the patients' T cell counts returned to the normal range after treatment, not all patients responded equally well to the T cell therapy. Patients who had a complete response to chemotherapy had a more robust T cell recovery than did patients who had only a partial response. "We believe that having a complete remission of CLL seems to create a larger space for the normal immune cells to expand into," Schuster says. "Somehow, the cancer seems to interfere with recovery of the immune system."

In addition to quashing the complications ordinarily associated with treatment, the team hopes that the restored immune system will help keep the cancer in check. At a median follow-up of 14 months after T cell infusion, two-thirds of the patients remain progression-free. Longer follow up will be needed to compare treatment results for patients receiving T cells with published results for patients receiving similar chemotherapy without T cell support.

What is clear from the small trial is that patients can safely stop prophylactic antibiotic therapy after their T cell numbers rebound. Physicians regularly keep CLL patients on extended prophylactic antibiotic therapy to help stave off infections. In this study, though, patients stopped taking antibiotics about a month after receiving T cells without developing significant infections.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our lymphoma / leukemia / myeloma section for the latest news on this subject. In addition to the Penn researchers, investigators from the MD Anderson Cancer Center, the Baylor College of Medicine, Texas Children's Hospital, and the Methodist Hospital in Houston also participated in the study.
The study was funded by the CLL Global Research Foundation.
This research was presented Sunday, December 11, 2011 between 6 PM and 8 PM in Hall GH of the San Diego Convention Center.
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Costly Diagnostic MRI Tests Unnecessary For Many Back Pain Patients

Main Category: Back Pain
Also Included In: MRI / PET / Ultrasound
Article Date: 13 Dec 2011 - 1:00 PST

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Johns Hopkins-led research suggests that routine MRI imaging does nothing to improve the treatment of patients who need injections of steroids into their spinal columns to relieve pain. Moreover, MRI plays only a small role in a doctor's decision to give these epidural steroid injections (ESIs), the most common procedure performed at pain clinics in the United States.

With greater focus on runaway health care costs, the study's findings, appearing online in the Archives of Internal Medicine, highlight one element of the problem: the indiscriminate use of an expensive imaging tool that shows little clinical benefit.

"Our results suggest that MRI is unlikely to avert a procedure, diminish complications or improve outcomes," says study leader Steven P. Cohen, M.D., an associate professor of anesthesiology and critical care medicine at the Johns Hopkins University School of Medicine. "Considering how frequently these epidural injections are performed, not routinely ordering an MRI before giving one may save significant time and resources."

Cohen adds that, "if we're trying to cut back on unnecessary medical costs, we should stop routinely doing MRIs on almost everyone who comes to us needing ESIs." A single MRI costs roughly $1,500.

The patients in Cohen's study were all treated at one of several pain clinics in the United States for sciatica, a condition in which the roots of the sciatic nerve that branches out from the bottom of the spinal column is pinched or compressed, causing severe pain and tingling in the lower back that shoots down the leg. The most common treatment in the United States and worldwide is an epidural steroid injection, which puts cortisone directly into the outermost part of the spinal canal in the lower back, delivering its anti-inflammatory benefits as close as possible to the source of pain.

Cohen and his colleagues treated 132 patients split into two groups. Both groups received MRIs, but the treating doctor only reviewed the films in one group. The first group received epidural steroids with the placement of the needle based solely on a physical exam and how and where the patient described his or her pain. The doctors who examined these patients did not review the MRI before giving the injections, but a physician not involved in the exams or treatments later did. In the second group, physicians determined treatment based on both an examination and imaging results, looking at the MRI to determine where to place the needle and whether to give an injection at all.

After three months, researchers reported no difference in how patients in both groups said they felt. In the group whose doctors didn't see the MRI, 23 (35 percent) reported "overall success" after three months. In the group whose doctors saw the MRI results before administering an injection, 24 (41%) reported a positive outcome.

In the first group, whose doctors were not privy to the MRI results, the independent evaluator agreed with the treating doctor in 66 percent of patients. In 18 of the other 22 cases, the independent evaluator believed an ESI was warranted, only in a different location along the bottom of the spine. Cohen says this discrepancy probably didn't change the outcome because research has shown that the steroid medication reaches across many levels as long as it is injected in the general vicinity. In every case, the doctor opted for some type of injection.

In the second group, the treating doctor who had the benefit of seeing the MRI results decided not to perform an epidural steroid injection in only five cases, only to have three of those patients get an ESI within the following six months anyway.

All in all, Cohen says, the treatment barely varied whether or not MRI was used to guide decision-making.

Cohen says that part of the problem in using MRI to diagnose lower back pain is that there is not a good correlation between abnormal findings and symptoms.

"If you look at 100 middle-aged people who have never had back pain, two-thirds of them would have abnormalities on MRI," he says. "This makes it difficult to use imaging to guide injections."

People who complain about back and leg pain but have a normal finding on an MRI and who go on to get an ESI anyway may not get relief because the pain may have originated somewhere besides the spine. Patients with abnormal MRIs who get ESI also may not receive benefit because their abnormal findings have nothing to do with their pain. In these cases, the abnormal findings are what doctors call a "red herring".

Overall, Cohen emphasizes, ESIs are not a magic bullet. Many studies affirm that they provide only short-term benefit to only a subset of people who get them.

Other Hopkins researchers involved with this study include Paul J. Christo, M.D., M.B.A.; Michael A. Erdek, M.D.; and David Cornblath, M.D.

Article adapted by Medical News Today from original press release. Source: Johns Hopkins Medicine
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How Patients Will Respond To Immunomodulator Therapy For Multiple Myeloma

Main Category: Lymphoma / Leukemia / Myeloma
Article Date: 13 Dec 2011 - 0:00 PST

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Research on the same protein that was a primary mediator of the birth defects caused by thalidomide now holds hope in the battle against multiple myeloma, says the study's senior investigator, Keith Stewart, M.B., Ch.B. of Mayo Clinic in Arizona. Dr. Stewart presented the results at the 53rd annual meeting of the American Society of Hematology in San Diego.

The drug thalidomide achieved infamy in the early 1960s as the cause of severe birth defects after being given to pregnant mothers for morning sickness. However, this drug, along with the highly related compounds lenalidomide and pomalidomide, also help to treat blood cancers, and are used worldwide as a cornerstone of therapy for the bone marrow cancer multiple myeloma. These drugs modulate the immune system and together are called immunomodulators or IMiDs.

The exact mechanisms and targets through which these therapies work to enhance immune response or kill cancer cells have been largely unknown. As a result, knowing which patients to treat and how to separate out the positive properties of these drugs from side effects has been impossible.

After recent research identified a protein known as cereblon as a primary mediator of the birth defects caused by thalidomide, researchers theorized that cereblon may also orchestrate the anti-tumor properties and be the primary therapeutic target for multiple myeloma.

In this study, researchers tested the theory and found a possible link between resistance to IMiDs and presence of cereblon. The researchers then found that lowering the level of cereblon allows the IMiDs to work properly.

"Interestingly, some resistant patients had normal cereblon levels, suggesting that while cereblon may be an absolute requirement for response, there are likely other mechanisms present that play a role in drug resistance," says Dr. Stewart. "These findings help us understand which patients may be more or less likely to respond to therapy and allow us to focus on other ways we can target cereblon as a possible biomarker to improve treatment and patient outcomes in multiple myeloma. This work also suggests that we can begin to dissect out the cause of birth defects from the anti-cancer properties and develop safer drugs in the future."

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our lymphoma / leukemia / myeloma section for the latest news on this subject. Other researchers involved in the study include Yuan Xiao Zhu, Esteban Braggio, Ph.D., Chang-Xin Shi, Jessica Schmidt, Laura Bruins, Steven Schuster, M.D., Rafael Fonseca, M.D. and, Leif Bergsagel,M.D., of Mayo Clinic and Chad Bjorklund, Ph.D. and Robert Orlowski, Ph.D., M.D., of MD Anderson Cancer Center.
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Increasing Number Of Imaging Visits Faced By Breast Cancer Patients Before Surgery

Main Category: Breast Cancer
Also Included In: MRI / PET / Ultrasound; Radiology / Nuclear Medicine
Article Date: 13 Dec 2011 - 1:00 PST

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Breast cancer patients frequently undergo imaging like mammograms or ultrasounds between their first breast cancer-related doctor visit and surgery to remove the tumor. Evaluations of these scans help physicians understand a person's disease and determine the best course of action. In recent years, however, imaging has increased in dramatic and significant ways, say researchers from Fox Chase Cancer Center. More patients have repeat visits for imaging than they did 20 years ago, and single imaging appointments increasingly include multiple types of imaging.

The researchers, led by Richard Bleicher, M.D., surgical oncologist at Fox Chase, found that between 1992 and 2005, the percentage of patients who had multiple (2+) imaging visits nearly quadrupled. Bleicher says additional visits present a burden to patients, many of whom are elderly, but the stress may be alleviated through better coordination and evaluation by physicians. Bleicher presented his group's findings at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium.

"The burden to the patient is increasing substantially," Bleicher says. "The number of days patients are having mammograms, MRIs, and ultrasounds is going up steadily year by year. They're having imaging done more frequently on separate dates during the preoperative interval than ever before. It's surprising."

The preoperative interval begins when a patient first reports to a doctor with a breast complaint and ends when the patient undergoes therapeutic surgery to resect a tumor. For the more than 65,000 patients involved in the study, the preoperative interval lasted 37 days on average. The Fox Chase researchers found that in 1992, roughly one in 20 cancer patients (4.9 percent) diagnosed with invasive, non-metastatic cancer underwent imaging twice or more during the preoperative interval. By 2005, that portion had climbed to about one in 5 (19.4 percent). In the extreme case, a small subset of 20 patients underwent mammograms on five or more visits during the preoperative interval.

The researchers also found that a single imaging visit increasingly includes multiple imaging types. In 1992, 4.3 percent of patients underwent multiple types of imaging; in 2005, that rate rose to 27.1 percent.

With the increased use of imaging, Bleicher says that for physicians, "the question becomes, 'How are we affecting patients overall with what we're ordering nowadays?'"

Previous studies have examined patient burden in terms of cost, but Bleicher says he hasn't seen studies that focus on the patient burden in terms of the patient's time. "I wanted to take a look at how things have been changing for patients and how many times they have to travel back and forth to get more imaging," he says. "Physicians need to keep in mind that it's hard enough for working people to take off from work and trek back and forth to appointments, but older people have infirmities, and it's harder to get around. The coordination of care is very important. We need to focus more on the burden to the patient."

Other studies have shown an increase in the cost of breast cancer care - but the cost of imaging is rising even faster. "We know the costs are going up, but we don't know why," he says. "One reason might be the frequency and amount of imaging."

He points out that when more than one set of imaging is done on the same day, "There are perversities of the reimbursement system that may foster these separate visits, although I don't know if that's why we're seeing this phenomenon."

The researchers discovered the climbing trend after studying data on Medicare patients from the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) program. Their results came from the records of 67,751 women who were treated for invasive, non-metastatic breast cancer with surgery and lymph node staging. The researchers omitted patients diagnosed with either metastatic disease or DCIS because those types of breast cancer require different approaches to imaging and treatment. The median age of the study participants was 75.

Bleicher says the patient's burden may be reduced if patients ask their providers why imaging is being done, and work together to make the process smoother. "If they do need imaging, then they might ask their physician, especially if they're of an older age, whether or not they think they're going to need additional types of imaging and if those can be scheduled together," he says.

The researchers are now diving deeper into their data to understand the trend and look for a better way to help breast cancer patients with imaging, Bleicher says. "We want to see whether or not there is a more efficient method of imaging the patients so that we're improving outcomes without increasing costs."

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our breast cancer section for the latest news on this subject. Co-authors include Karen Ruth, Elin R. Sigurdson, Kathryn Evers, Yu-Ning Wong, Marcia Boraas, and Brian L. Egleston from Fox Chase.
The study was supported, in part, by a US Public Health Services grant, an appropriation from the Commonwealth of Pennsylvania, an American Cancer Society grant, and by generous private donor support.
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luni, 12 decembrie 2011

Some Patients With Chronic Hepatitis C May Benefit From Boceprevir But Extent Of Added Benefit Still Unclear

Main Category: Liver Disease / Hepatitis
Also Included In: Cancer / Oncology
Article Date: 12 Dec 2011 - 1:00 PST

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The active ingredient boceprevir has been available since the middle of 2011 as a treatment for chronic hepatitis C of genotype 1. In an early benefit assessment pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined to establish whether boceprevir offers added benefit in comparison with the previous standard therapy. According to this assessment, the dossier submitted by the pharmaceutical company provides indications of added benefit for patients who have not yet developed liver cirrhosis. However, the extent of this added benefit cannot be classified.

The pharmaceutical company provided no data - or inadequate data - for two other indications - patients with liver cirrhosis and patients for whom prior treatment was totally ineffective (zero response to prior interferon-based therapy) - and therefore added benefit for these patients is not proven.

An addition to previous standard drug therapy

Hepatitis C viruses attack the liver and can trigger inflammation there. If this becomes chronic, cirrhosis can develop and liver function progressively deteriorates. Moreover, the risk of liver cancer (hepatocellular carcinoma, HCC) increases. Boceprevir (trade name Victrelis®, manufacturer MSD Sharp & Dohme) inhibits the reproduction of hepatitis C viruses. Experts assume that if no viruses are detectable in the blood over a sustained period after treatment (sustained virological response, SVR), the risk of secondary disease is reduced.

Boceprevir is administered in addition to the active ingredients peginterferon alfa and ribavirin, which are already on the market. In accordance with the approval status, different patient groups are treated for different periods, as was allowed for in the assessment. The dual combination of peginterferon alfa and ribavirin has been the standard therapy and this was compared with boceprevir given in a triple combination with the former two drugs.

Reduction in secondary diseases: extent cannot be classified

For the two indications of pretreated (treatment-experienced) and non-pretreated (treatment-naive) patients without cirrhosis, data from one approval study each (SPRINT-2 and RESPOND-2) were available. With the available studies, it is not possible to assess directly whether the new active ingredient influences secondary diseases, such as the development of liver cancer. This is partly because the studies have not lasted long enough for these patient-relevant outcomes to be recorded.

With respect to SVR, there was a clear advantage for boceprevir, both for pretreated patients and for non-pretreated patients without liver cirrhosis. However, SVR is not itself a patient-relevant outcome and cannot be equated with "cure", and there are no studies in which SVR is validated as a surrogate outcome in accordance with the usual criteria employed by IQWiG. Nevertheless, the Institute accepts SVR in the context of the assessment as a surrogate for the reduced incidence of liver cancer. This is because it is currently accepted that patients with no detectable hepatitis C virus in the blood are at lower risk of liver cancer. However, it is unclear how many cases of liver cancer can in fact be prevented by boceprevir.

For the outcome "secondary diseases", IQWiG recognizes an "indication" of a benefit for boceprevir. The requirements for a "proof" are not fulfilled, one reason being that the data are only derived from a single study each, with a comparatively small number of patients. Moreover, the scientific data do not permit a conclusive assessment of the number of patients in whom liver cancer is actually prevented. It is therefore unclear whether the added benefit is "minor", "considerable" or "major". For such a case, the corresponding legal ordinance specifies the assessment category of "unquantifiable".

Indication of greater harm for patients without prior treatment

The indication of greater benefit is in contrast to the indication of greater harm, but only in previously untreated patients. In these patients, boceprevir more often led to anaemia, although this was rarely serious. IQWiG classified the extent of this greater harm as "considerable". In contrast, in patients with prior treatment, anaemia was no more frequent than with standard treatment.

Effect on mortality unclear

IQWiG established that the approval studies contained inadequate data on quality of life for patients with or without prior treatment. There were no statistically significant differences in mortality between the treatment groups. It thus remains unclear if and how boceprevir influences mortality.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our liver disease / hepatitis section for the latest news on this subject. Please use one of the following formats to cite this article in your essay, paper or report:

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Institute for Quality and Efficiency in Health Car. "Some Patients With Chronic Hepatitis C May Benefit From Boceprevir But Extent Of Added Benefit Still Unclear." Medical News Today. MediLexicon, Intl., 12 Dec. 2011. Web.
12 Dec. 2011. APA
Institute for Quality and Efficiency in Health Car. (2011, December 12). "Some Patients With Chronic Hepatitis C May Benefit From Boceprevir But Extent Of Added Benefit Still Unclear." Medical News Today. Retrieved from
http://www.medicalnewstoday.com/releases/238995.php.

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Patients With Persistent Kidney Injuries Rarely See Specialists

Main Category: Urology / Nephrology
Also Included In: Primary Care / General Practice
Article Date: 12 Dec 2011 - 0:00 PST

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Most patients with an abrupt kidney injury that does not get better do not see a kidney specialist within a year, according to a study appearing in the Journal of the American Society Nephrology (JASN). The findings indicate that efforts are needed to identify and treat kidney injury patients who require subsequent care.

Acute kidney injury (AKI), an abrupt or rapid decline in kidney function, is an increasingly prevalent condition that can seriously affect individuals' health and survival. Sometimes AKI arises due to medical or surgical complications that deprive the kidneys of a normal blood flow for extended periods of time. That explains why AKI often arises in patients who are hospitalized.

Because the kidneys can often recover from AKI, most patients can resume a normal life after treatment; however, they often remain at increased risk of developing kidney disease in the future.

Edward Siew, MD, Michael Matheny, MD (Vanderbilt University Medical Center and Tennessee Valley Healthcare System Veterans Administration) and their colleagues wondered whether patients who experience AKI during hospitalization receive enough attention paid to their future risk of developing kidney problems.

From a US Department of Veterans Affairs database, the researchers identified 3,929 survivors of AKI who were hospitalized between January 2003 and December 2008 and who continued to have poor kidney function a month after their injury.

Among the major findings over a one-year surveillance period: 22% of patients died. Only 8.5% of patients were referred to a kidney specialist before dying, starting dialysis, or experiencing an improvement in kidney function. Patients' severity of AKI did not affect whether or not they were referred. "This study shows that only a minority of patients who do not recover their kidney function after an AKI event are seen by a kidney specialist, highlighting an important opportunity for a more integrated approach in maintaining the kidney health of these patients," said Dr. Matheny. "The findings also underscore the need for more research to help identify those patients who are at highest risk for persistent kidney problems and who might benefit from the input of a kidney specialist," he added.

Study co-authors include Josh Peterson, MD, Adriana Hung, Theodore Speroff, PhD (Tennessee Valley Healthcare System Veterans Administration and Vanderbilt University Medical Center); Svetlana Eden, and T. Alp Ikizler, MD (Vanderbilt University Medical Center).

Disclosures: The authors reported no financial disclosures.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our urology / nephrology section for the latest news on this subject. "Outpatient Nephrology Referral Rates after Acute Kidney Injury" online at http://jasn.asnjournals.org/ December 8, 2011, doi: 10.1681/ASN.2011030315.

The content of this article does not reflect the views or opinions of The American Society of Nephrology (ASN). Responsibility for the information and views expressed therein lies entirely with the author(s). ASN does not offer medical advice. All content in ASN publications is for informational purposes only, and is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. This content should not be used during a medical emergency or for the diagnosis or treatment of any medical condition. Please consult your doctor or other qualified health care provider if you have any questions about a medical condition, or before taking any drug, changing your diet or commencing or discontinuing any course of treatment. Do not ignore or delay obtaining professional medical advice because of information accessed through ASN. Call 911 or your doctor for all medical emergencies.

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