An update on Ulipristal Acetate 5 mg Tablet for treating Uterine Fibroids has been published at the website of European Medicines Agency (EMA):
European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of Ulipristal Acetate 5 mg, following reports of serious liver injury. Committee has now concluded that new patients can start treatment in line with the below recommendations to minimize the risk of liver injury.
Previous Recommendation: Do not initiate new treatment courses of Ulipristal Acetate 5 mg including in women who have completed one or more treatment courses previously.
New Recommendation: Treatment can be initiated even after liver enzyme levels are 2 times the upper limit of normal.
Previous Recommendation: Do not re-start treatment.
New Recommendation: Re-start of treatment can be initiated and can be used for two treatment course.
Previous Recommendation: Stop Ulipristal Acetate 5 mg in any woman who develops transaminase levels more than 2-times the upper limit of normal.
New Recommendation: Ulipristal Acetate 5 mg can only be stopped if any woman who develops transaminase levels more than 3-times the upper limit of normal.
Ref.: European Medicines Agency
A new norovirus strain caused most of the outbreaks of the contagious intestinal illness in the United States between September and December last year, but it is not known if this strain will lead to an overall increase in outbreaks, researchers report. Norovirus is highly infectious and is the leading cause of what is commonly called ‘stomach flu,’ a gastrointestinal illness with symptoms such as diarrhea, abdominal pain, vomiting, headache, fever and chills. For the study, U.S. Centers for Disease Control and Prevention (CDC) researchers analyzed data collected through CaliciNet on norovirus strains linked to U.S. outbreaks and found that 141 of the 266 outbreaks reported during the last four months of 2012 were caused by the GII.4 Sydney strain. This strain was first detected in Australia in March 2012 and caused outbreaks in that country and several other nations. The new strain spread rapidly across the United States from September to December 2012. The proportion of reported outbreaks caused by this strain increased dramatically from 19 percent in September to 58 percent in December, said the researchers. New strains of GII.4 have emerged every two to three years over the past decade. Investigator found that the new GII.4 Sydney strain replaced the previously predominant GII.4 strain. Right now, it's too soon to tell whether the new strain of norovirus will lead to more outbreaks than in previous years. However, CDC continues to work with state partners to watch this closely and see if the strain is associated with more severe illness. More than 21 million people in the United States contract norovirus infections each year and about 800 die. Young children and seniors are most likely to develop severe illness. Norovirus spreads primarily from infected people to others through direct contact, but also spreads through contaminated food, water and surfaces. The illness has often made the news when outbreaks have occurred on cruise ships. The best ways to prevent norovirus infection include washing hands with soap and water, rinsing fruits and vegetables, disinfecting surfaces, cooking shellfish thoroughly and not preparing food or caring for others while ill, the CDC suggests.
SOURCE: HealthDay News, Jan. 2013
A large new study indicates that lifetime smokers cut 10 years off their life expectancy-a decade they can gain back if they quit before age 35. Using data from more than 200,000 Americans, researchers also found that the death rate for current smokers is three times as high as those who never smoked, with most of the extra deaths caused by smoking-related conditions such as cancer, heart disease, stroke and respiratory diseases. This is really striking -a combination of good news for nonsmokers, but much higher death rates among smokers, said study author. Researchers found a tripling of the mortality rate and men and women are now very similar. Women smoke like men and die like men. According to the U.S. Centers for Disease Control and Prevention, tobacco use accounts for nearly 200,000 deaths annually in the United States-more than HIV infection, drug or alcohol use, car accidents, suicides and murders combined. American, Canadian and British scientists examined data on smoking status from nearly 217,000 adults from the U.S. National Health Interview Survey between 1997 and 2004 to determine the hazards of smoking and benefits of quitting. Nonsmokers are twice as likely to live to age 80 compared to smokers-indicating that smoking isn't just killing people in old age, but in middle age, the study found. Another startling find was that adult smokers who quit at ages 25 to 34, ages 35 to 44 or ages 45 to 54 gain about 10, nine and six years back, respectively, compared to those who continue to smoke. Even quitting after age 55 should net former smokers extra years. It's never too late to quit. Even if anyone quit by age 60, he/she get four years back. That's a fair proposition-and four good years of life is probably worth it. The numbers are very, very compelling, and it points out that smoking prevention and cessation is still the most important public health challenge we have in the United States. Efforts to eliminate smoking in public places and place higher taxes on cigarettes have all helped cut the prevalence of smoking, but more research is still needed to help understand the science behind nicotine addiction and steer adolescents away from tobacco.
SOURCES: HealthDay News, Jan. 2013
For people with type 2 diabetes, the key to living a long and healthy life may lie in avoiding kidney disease, now that new research finds the combination is particularly lethal. The study found that 10-year mortality rates for people with both type 2 diabetes and kidney disease is more than 31 percent. But for people with only type 2 diabetes, the death rate after a decade was 12 percent. For those with neither condition, the 10-year death rate was about 8 percent. Type 2 diabetes is bad thing but it's particularly bad when one get kidney disease, too. On the other hand, investigators found that type 2 diabetes may not affect mortality as much if the people don’t get kidney disease. People with type 2 diabetes do not produce or properly use insulin, a hormone needed to convert food into energy. In the United States, about 26 million people have diabetes and the number is growing. Type 2 diabetes has long been associated with an increased risk of death, especially from cardiovascular disease. And kidney disease is common in people with type 2 diabetes. To better understand how the two diseases behave together, the researchers reviewed 10 years of data from the U.S. National Health and Nutrition Examination Survey, involving more than 15,000 people. About 42 percent of people with type 2 diabetes had kidney disease, they found. When the researchers controlled the data to account for factors such as age, sex and body-mass index- a calculation based on height and weight-as well as duration of diabetes, the rates of death remained high for people with kidney disease and diabetes at about 23 percent. The 10-year mortality for those with only type 2 diabetes was 9 percent when the data was adjusted for such factors, while the rate of death for people without diabetes or kidney disease was about 3 percent. Prevention efforts should focus on people who have diabetes but not kidney disease. Try to control risk factors to prevent kidney disease and the biggest risk factor is uncontrolled blood sugar. However, there also is a genetic component to developing kidney disease. So, if anyone have those genes, they may develop kidney disease even if blood sugar is well-controlled. But for most people with type 2 diabetes, controlling blood sugar levels can help prevent kidney disease, or at least slow its progression, researcher said. Researchers always have to emphasize much more on prevention. There's a nice correlation between A1C (a long-term measure of blood sugar control) and kidney disease. And people without high blood pressure tend to do better. At the time of diagnosis people are often undertreated previously which leads to uncontrolled diabetes. People who have both type 2 diabetes and kidney disease should be monitored more closely by their physicians. It's important to remember that it's much easier to prevent kidney disease than to stop it once it's begun, said the investigator.
SOURCES: HealthDay News, Jan. 2013
The U.S. Food and Drug Administration approved three new products Nesina (alogliptin) tablets, Kazano (alogliptin and metformin hydrochloride) tablets and Oseni (alogliptin and pioglitazone) tablets, for use with diet and exercise to improve blood sugar control in adults with type 2 diabetes. Alogliptin is a new active ingredient, while metformin hydrochloride and pioglitazone are already FDA-approved for the management of type 2 diabetes. As the most common form of the disease, type 2 diabetes affects about 24 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. People with type 2 diabetes are either resistant to insulin or do not produce enough insulin, resulting in high blood sugar levels. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness and nerve and kidney damage. Controlling blood sugar levels is very important in the overall treatment and care of diabetes. Alogliptin helps stimulate the release of insulin after a meal, which leads to better blood sugar control. Alogliptin, Alogliptin plus metformin and Alogliptin plus pioglitazone were studied as stand-alone therapies (monotherapies) and in combination with other type 2 diabetes therapies, including sulfonylureas and insulin. They should not be used to treat people with type 1 diabetes or those who have increased ketones in their blood or urine (diabetic ketoacidosis).
Alogliptin was demonstrated to be safe and effective in 14 clinical trials involving about 8,500 patients with type 2 diabetes. It resulted in reducing glycosylated hemoglobin (HbA1c) of 0.4 percent to 0.6 percent compared with placebo after 26 weeks of use. The FDA is requiring five postmarketing studies for alogliptin: a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for liver abnormalities, serious cases of pancreatitis and severe hypersensitivity reactions and three pediatric studies under the Pediatric Research Equity Act (PREA), including a dose finding study and two safety and efficacy studies, one with Alogliptin as a monotherapy and one with Alogliptin plus metformin. The most common side effects of Alogliptin are stuffy or runny nose, headache and upper respiratory tract infection.
The safety and efficacy of Alogliptin and metformin were demonstrated in four clinical trials involving more than 2,500 patients with type 2 diabetes. It resulted in additional reductions in HbA1c of 1.1 percent over Alogliptin and 0.5 percent over metformin after 26 weeks of use. The FDA is requiring two postmarketing studies for Alogliptin and metformin: an enhanced pharmacovigilance program to monitor for liver abnormalities, serious cases of pancreatitis and severe hypersensitivity reactions and a pediatric safety and efficacy study under PREA. Alogliptin and metformin carries a Boxed Warning for lactic acidosis associated with metformin use. The most common side effects of Alogliptin plus metformin are upper respiratory tract infection, stuffy or runny nose and sore throat, diarrhea, headache, high blood pressure, back pain and urinary tract infection.
Alogliptin and pioglitazone was demonstrated to be safe and effective in four clinical trials involving more than 1,500 patients with type 2 diabetes. It resulted in additional reductions in HbA1c of 0.4 percent to 0.6 percent over pioglitazone monotherapy and 0.4 percent to 0.9 percent over alogliptin monotherapy. The FDA is requiring an enhanced pharmacovigilance program for Alogliptin and pioglitazone to monitor for liver abnormalities, serious cases of pancreatitis and severe hypersensitivity reactions. Alogliptin and pioglitazone carries a Boxed Warning for heart failure associated with pioglitazone use. The most common side effects of Alogliptin and pioglitazone are stuffy or runny nose and sore throat, back pain and upper respiratory infection.
SOURCES: FDA News Release, Jan. 2013.
Researchers at the Utrecht University Medical Center, the Netherlands, and the Hubrecht Laboratory, also in Utrecht, have succeeded in growing cardiac muscle cells from adult human hearts. This major step forward in experimental cardiology is big news, if only because heart problems are the number one cause of death in the Western world.
Up to now heart muscle cells - or cardio myocytes could only be grown from embryonic stem cells. The newly developed heart muscle cells behave exactly like natural heart cells and in the future will help repair damaged hearts. The scientists are hopeful that human testing can begin within three years.
Crucial in this case is the fact that the stem cells are not embryonic, which means the whole ethical debate about the use of human embryos for scientific research can be avoided. But there are clinical advantages as well. Embryonic stem cells come with their own immune system and this can be incompatible with the immune system of the patient. The patient's body may identify the foreign stem cells as being alien and attack them, so the treatment is ineffective.
It's also extremely difficult to grow high-quality cardiac muscle cells from embryonic stem cells, and even a single faulty one can produce tumors - the patient gets cancer on top of heart failure. But the Utrecht scientists use the patient's own cells to grow their cardiac muscle cells, so there is no problem with rejection. And they are cardiac cells to begin with, which greatly reduces the possibility of one of them turning cancerous.
Another advantage of the approach taken by the Utrecht University cardiologists is that they don't need any donors for their scientific research. During regular heart surgery, such as bypass surgery or valve replacement, the oracle, a little bit of heart tissue that doesn't serve any purpose, is normally just thrown away. Now the researchers are standing by to take this bit of flesh to their laboratory in order to harvest the precious cardiac stem cells as quickly as possible.
Source: Radio Netherlands Worldwide, April 2008
A research team from Edinburgh University has developed the new method, which enabled them to grow hundreds of eggs in a laboratory, the first time such a feat has been achieved.
The process works by removing a piece of ovary from the woman, which contains hundreds of immature eggs. These are then frozen, to be thawed at a later date and exposed to a chemical treatment to encourage growth. Once the eggs reach full growth, then they can be fertilised, and the embryo implanted in the womb.
The study has the potential to revolutionize fertility treatments due to the multitude of eggs that were successfully frozen, which amounts to many more than allowed by traditional IVF techniques. It also takes younger eggs, which were found to survive freezing more effectively than mature eggs.
Not only could the research prove beneficial to women left infertile by medical treatment, it could also be used for women who want to wait and have children in later life.
'Women who face infertility as a result of chemotherapy, or who want to put their biological clock on hold, could benefit from this system. However, there is a lot more research to be carried out before this technique could be safely applied within a clinical setting,' the researcher adds.
Source: Business Wire, San Francisco, USA, April 2008
InSightec Ltd. has developed the only FDA approved MR Guided Focused Ultrasound Surgery (MRgFUS) device, which has been used to treat uterine fibroids non-invasively, minimizing trauma, morbidity and recovery time. In addition to enhancing patient care, the procedure has a significant economic impact reducing overall medical costs when compared to conventional surgery. Uterine fibroid is a pervasive condition that impacts up to 70% of women of childbearing age and can lead to serious symptoms.
The company's device is the world's first non-invasive surgery system to combine focused ultrasound and magnetic resonance imaging. It received its European CE Marking in 2002 and U.S. Food and Drug Administration approval in 2004 for treating uterine fibroids
The MRgFUS procedure takes between two to four hours depending on the size of the fibroids treated. Patients are able to go home the same day and return to normal activities within a day or two. Hysterectomy is the most common treatment for uterine fibroids, and is a major surgery requiring hospitalization and significantly longer recovery times. Many women have chosen to suffer from the severe symptoms that fibroids cause rather than undergo hysterectomies or other invasive surgical procedures.
Uterine fibroids carry a significant economic burden in terms of the cost of treatment, hospitalization and work absenteeism. Since the MRgFUS procedure is performed on an outpatient basis without any hospitalization and allows the patient to return to normal activity within one to two days, it offers cost and comfort advantages to patients, healthcare providers and employers as compared with other treatment modalities.
InSightec is carrying out an extensive research program to conduct clinical trials using this technology in various cancerous applications including breast, bone metastases, liver, brain and prostate, while continuing clinical trials in uterine fibroids.
About the device
This is the first system to use the breakthrough MRgFUS technology that combines MRI – to visualize the body anatomy, plan the treatment and monitor treatment outcome in real time – and high intensity focused ultrasound to thermally ablate tumours inside the body non-invasively. MR thermometry, provided uniquely by the system, allows the physician to control and adjust the treatment in real time to ensure that the targeted tumor is fully treated and surrounding tissue is spared. This has been recognized for its innovation and potential to serve mankind and has been awarded the 2004 European Union's Information Society Technologies grand prize, The Wall Street Journal's 2004 Technology Innovation Awards, Advanced Imaging's 2005 Solutions of the Year, the Red Herring 100 Europe 2007 Award and currently one of the World Economic Forum Technology Pioneer 2008.
Source: Business Wire, San Francisco, USA, April 2008
A revolutionary cancer treatment using microscopic magnets to enable 'armed' human cells to target tumours has been developed. A new study shows that inserting these nanomagnets into cells carrying genes to fight tumours, results in many more cells successfully reaching and invading malignant tumours.
Using human cells as delivery vehicles for anti-cancer gene therapy has long been an attractive approach for treating tumours, but these cells usually reach tumours in insufficient numbers to effectively attack them. Now, a new 'magnetic targeting' method has been developed to overcome this problem by the researchers at the University of Sheffield, the University of Keele, and at the University of Nottingham.
The technique involves inserting nanomagnets into monocytes - a type of white blood cell used to carry gene therapy - and injecting the cells into the bloodstream. The researchers then placed a small magnet over the tumour to create a magnetic field and found that this attracted many more monocytes into the tumour.
The head of the laboratory in which the work was done, explains: "The use of nanoparticles to enhance the uptake of therapeutically armed cells by tumours could herald a new era in gene therapy - one in which delivery of the gene therapy vector to the diseased site is much more effective. This new technique could also be used to help deliver therapeutic genes in other diseases like arthritic joints or ischemic heart tissue."
The team are now looking at how effective magnetic targeting is at delivering a variety of different cancer-fighting genes, including ones which could stop the spread of tumours to other parts of the body.
Source: ScienceDaily, April 2008