By jeremyc | August 27, 2015
The US Food and Drug Administration (FDA) has approved a new drug called flibanserin (brand name Addyi) from Sprout Pharmaceuticals for treating generalized hypoactive sexual desire disorder in women. This is the first approved drug to treat the disorder in women, specifically pre-menopausal women.
However, the approval did come with a black box warning. Janet Woodcock, director of the Center for Drug Evaluation and Research, FDA, said, “Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies. Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.”
The black box warning indicates that patients taking the medication could experience loss of consciousness or severely low blood pressure, especially if they consume alcohol. Hypoactive sexual desire disorder is marked by a low sex drive and patients often feel anxiety and stress around their lack of sexual desire.
Woodcock said, “Today’s approval provides women distressed by their low sexual desire with an approved treatment option. The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”
The FDA is not yet clear about how the drug works in premenopausal women, but found that the drug did work in three large-scale studies. The drug is recommended to be taken once a day. Also, patients taking the drug felt less stress and anxiety tied to their disorder. Insomnia, dry mouth, nausea, fatigue, dizziness and tiredness were the most commonly reported side effects.
By jeremyc | August 26, 2015
According to a recent study, the drug liraglutide (brand name Victoza) may be linked to increased weight loss in overweight type 2 diabetes patients.
The study was led by Melanie Davies, of the Leicester Diabetes Centre at Leicester General Hospital in the UK, who said, “To our knowledge, this is the first study specifically designed to investigate the efficacy of liraglutide for weight management in patients with type 2 diabetes. Liraglutide, as an adjunct to a reduced-calorie diet and increased physical activity, was effective and generally well-tolerated and was significantly better than placebo.”
For this study, the researchers assessed 846 diabetes patients who were obese or overweight. The patients were administered 3mg of liraglutide per day, 1.8mg of liraglutide per day, or a placebo, for a period of 56 weeks. The patients also followed a lower-calorie diet and walked briskly for a minimum of 150 minutes per week.
On analysis, the group that took 2mg liraglutide lost 6 percent body weight, and the lower-dose group lost 4.7 percent of their body weight. The placebo group lost just 2 percent of their body weight. However, the highest-dose group did experience some gastrointestinal side effects.
Liraglutide’s manufacturer, Novo Nordisk, funded the study, and several authors serve on the company’s advisory board.
By jeremyc | August 25, 2015
A new study has found that beta blockers may be linked to a longer survival time among ovarian cancer patients. Beta blockers are a class of medicines generally indicated to treat high blood pressure. This new study, however, indicates that it could be an effective addition to the treatment regimen for ovarian cancer.
The study was led by Anil Sood, of the University of Texas MD Anderson Cancer Center. Sood and his team assessed the patient records of 1,425 ovarian cancer patients, of which 193 were also taking beta-1 blockers. Another 76 took broad beta blockers.
On analysis, the researchers found that those patients who took beta blockers lived 5.8 months on average longer than those patients who did not take the medicine. Broad beta blocker users had the longest increase in their survival time.
The researchers suggested that beta blockers may help by triggering stress hormones, which can encourage cancer cells to spread apart.
By jeremyc | August 24, 2015
A new form of a diabetes medication called metformin may change the game for some type 2 diabetes patients. The delayed-release form of the drug targets the gut and limits absorption in the bloodstream.
The study was led by John Buse, the director of the Diabetes Care Center, University of North Carolina. It focused on metformin-DR, a delayed-release form of the drug. It found that this form of the drug may primarily act within the intestines and not within the bloodstream.
Metformin is commonly prescribed to initially treat diabetes, but accumulated metformin may lead to kidney damage and the drug is not advised if a patient has kidney damage. This particular study had two trials.
In the first trial, healthy patients receive a form of metformin that released at different types. Metformin-DR users were found to have 50 percent less of the drug in their blood. In the second drug, type 2 diabetes patients were given metformin-XR (extended release), metformin-DR or a placebo. On analysis, metformin-DR had a 40 percent greater apparent potency than metformin-XR.
The researchers concluded that the delayed-release form was effective in lower blood sugar levels and could be less risky for patients who have kidney damage. The researchers disclosed ties to several pharmaceutical companies such as Elcelyx Therapeutics.
By jeremyc | August 23, 2015
A new review of multiple studies has found that the medication modafinil (brand name Provigil), which is generally meant to treat narcolepsy, could improve concentration and alertness even in non-sleep-deprived patients.
The review’s results show promise, but also raise ethical concerns over the use of the drug for non-medical needs. The review was co-authored by Ruairidh Battleday, of the University of Oxford and Anna-Katharine Brem, of Harvard Medical School. Battleday said, “This is the first overview of modafinil’s actions in non-sleep-deprived individuals since 2008, and so we were able to include a lot of recent data … It appears that modafinil more reliably enhances cognition: in particular ‘higher’ brain functions that rely on contribution from multiple simple cognitive processes.”
Modafinil was first developed to treat narcolepsy, a condition in which people sudden fall asleep, at times in the middle of what they are doing. It is approved by the FDA for treating excessive sleepiness from shift work disorder and obstructive sleep apnea.
However, the drug is sometimes used off-label for conditions like Parkinson’s disease and attention deficit hyperactivity disorder.
For this study, the researchers analyzed 24 studies from 1990 to 2014. They assessed the amount of the medicine consumed and memory, flexibility, decision-making and planning performance. The researchers found that the drug enhanced planning and decision-making, but did not seem to improve thought, flexibility or memory. The drug was linked to cognitive benefits consistently on longer and more complex tasks.
Most side effects were minor, such as headache, nausea, stomach ache and insomnia. Brem said, “So, we ended up having two main conclusions: first, that, in the face of vanishingly few side effects in these controlled environments, modafinil can be considered a cognitive enhancer; and, second that we need to figure out better ways of testing normal or even supra-normal cognition in a reliable manner. However, we would like to stress the point that with any method used to enhance cognition, ethical considerations always have to be taken into account: this is an important avenue for future work to explore.”
By jeremyc | August 22, 2015
A phase I trial of a new medication called guadecitabine (SGI-110) shows promise in treating bone marrow disorders (myelodysplastic syndromes) and blood cancer (acute myelogenous leukemia).
The researchers associated with the trial noted that a currently unpublished phase II trial has already been completed with more promising results, and the phase III trial is now underway.
The published phase I trial involved a small group of patients prescribed with the new medication. Subsequent phases involve larger patient groups. Lead author Jean-Pierre Issa, director of the Fels Institute for Cancer Research and Molecular Biology at Temple University School of Medicine, said, “The most exciting outcome of these studies is that this drug also started a new phase III clinical trial, and if successful, it can lead to US Food and Drug Administration approval to treat leukemia patients.”
The phase I trial saw the researchers administer the drug to 93 patients, of which 74 had blood cancer and 19 had bone marrow disorder. Issa said, “The goal was to measure the safety in patients diagnosed with MDS or AML and determine whether the drug changed the patients’ epigenetic bookmarks.”
SGI-110 appeared to be effective in treating both conditions and was easy to administer, without taxing the patients’ bodies significantly. Issa said, “This means that the drug is safe and those patients who had more changes of their epigenome responded more to the drug.”
By jeremyc | August 21, 2015
According to a new study, young breast cancer patients may be turning down tamoxifen, an important treatment drug, due to concerns that it may affect their fertility.
The study was led by Jacqueline Jeruss, a professor of obstetrics and gynecology-fertility preservation at Northwestern University Feinberg School of Medicine. She said, “Despite the importance of fertility to young breast cancer patients, availability of fertility preservation options, and relative safety of pregnancy among breast cancer survivors, fertility preservation is often underutilized and under-discussed in clinical settings.”
Tamoxifen, known by its brand names Nolvadex and Soltamox, is prescribed to lower the risk of breast cancer recurrence. However, it is not recommended to be administered to pregnant patients, as it may cause birth defects. Moreover, the length of treatment with this drug may narrow the time window for a woman to get pregnant.
For this study, the researchers looked at 512 cancer patients under 45 years of age, diagnosed with stage zero to three of hormone receptor-positive breast cancer. Tamoxifen is generally recommended for these cancers, and is recommended for at least five years. It may be continued for a maximum of ten years.
The researchers looked at data on treatment, disease and demographics, and interviewed patients who discontinued or refused the drug. These patients were also more likely to decline chemotherapy and radiation therapy, and were more likely to be smokers. Also, women were more likely to discontinue or decline the drug when they were diagnosed with ductal carcinoma in situ, a form of cancer that has not spread is not life-threatening.
The primary reasons for declining tamoxifen were the potential side effects associated with the drug and fertility concerns. The primary reasons for discontinuing the drug were also concerns related to the drug’s side effects, effects on pregnancy, and potential birth defects.
By jeremyc | August 20, 2015
The US Food and Drug Administration (FDA) has approved a new drug called eltrombopag (brand name Promacta) to treat low blood platelet counts in children diagnosed with a rare blood disorder called chronic immune thrombocytopenic purpura (ITP).
The drug, manufactured by pharmaceutical firm Novartis, was approved by the FDA for children older than one year whose condition did not improve from spleen removal surgery or other ITP medications. Eltrombopag was initially approved to treat adult ITP patients in 2008.
Richard Pazdur, director of the Office of Hematology and Oncology Products at the Center for Drug Evaluation and Research, FDA, said, “Today’s approval of Promacta emphasizes the FDA’s commitment to fully developing treatments in areas of pediatric hematology and oncology.
“This new use in ages one and up builds on a recent approval for ages six years and up, and fills an unmet need for young children whose disease has progressed after use of other available treatments.”
ITP leads to a low blood platelet count in patients, which could lead to dangerous bleeding. The new drug works by stimulating increased platelet production, according to the FDA. Its recommended dosage is once a day in tablet or powder form. The drug was tested to be safe and effective in two studies that involved a total of 159 ITP patients. Of the total patients prescribed the medication, 62 percent saw a platelet increase.
By jeremyc | August 19, 2015
A new Canadian study has found that trans fat could be linked to a greater risk of heart disease as well as death. On the other hand, saturated fats may not be associated with a risk of heart disease, death, stroke or type 2 diabetes.
The study was led by Russell de Souza, assistant professor of epidemiology at McMaster University in Ontario, Canada. He said, “For years everyone has been advised to cut out fats. Trans fats have no health benefits and pose a significant risk for heart disease, but the case for saturated fat is less clear.”
De Souza says that the current dietary guidelines recommending less than one percent trans fat and less than 10 percent saturated fat in the total calories consumed per day. Saturated fat is found in meat, cow milk, butter, egg yolk, salmon and other animal products, along with chocolate and palm oils. Trans fat is produced industrially through plaint oils via hydrogenation. It is generally found in packaged baked ite,s snack foods and margarine.
For this study, the researchers looked at 50 studies to find the link between types of fat and health outcomes. High saturated fat intake was not found to be linked to all-cause death, heart disease, diabetes or stroke. However, trans fat was linked to a 34 percent greater all-cause death risk, 21 percent greater heart disease risk and 28 percent higher risk of death due to heart disease. Still, it was not found to be linked to diabetes or stroke.
By jeremyc | August 18, 2015
According to a new study, aspirin may be linked to a reduced risk of colorectal cancer in obese Lynch syndrome patients with a genetic predisposition.
The study was led by John Mathers, of Newcastle University in the United Kingdom, who said, “The lesson for all of us is that everyone should try to maintain a healthy weight and for those already obese the best thing is to lose weight. However, for many patients this can be very difficult so a simple aspirin may be able to help this group.”
For this study, the researchers focused on Lynch syndrome patients. Lynch syndrome is a hereditary condition that increases colorectal cancer risk. A total of 937 patients were identified, half of which took 600mg aspirin every day for two years on average. The remaining took a placebo.
During the follow-up, 55 people were diagnosed with the cancer and obese patients had a 2.31 times greater risk of developing it over normal-weight patients.
Mathers said, “For those with Lynch syndrome, we found that every unit of BMI above what is considered healthy increased the risk of bowel cancer by 7 percent. What is surprising is that even in people with a genetic predisposition for cancer, obesity is also a driver of the disease. Indeed, the obesity-associated risk was twice as great for people with Lynch syndrome as for the general population.”
However, the increased risk among the obese was only seen in the group taking the placebo. Sir John Burn, study co-author, said, “This is important for people with Lynch syndrome but affects the rest of us too. Lots of people struggle with their weight and this suggests the extra cancer risk can be cancelled by taking an aspirin.”