By jeremyc | June 18, 2013
Dr. Athanasios Nikolakopoulos recently spoke at the European Society of Ophthalmology about a novel technique to remove strongly resistant cortical vitreous adhesions with little trauma. The suggested technique involved hydro-lifting after initially removing as much vitreous as possible using triamcolone (brand name Nasacort).
At present, the surgical procedures followed to remove resistant vitreous adherence are complicated and there is a high risk of triggering irreversible iatrogenic trauma. Dr. Nikolakopoulos said, “Our hydrolifting technique uses the new controlled reflux system of the Constellation (Alcon). After triamcinolone-assisted removal of as much vitreous as possible, we create a gentle current, directed away from the fovea, that gently lifts the sides of the residual attached cortical vitreous. The fluid slowly detaches all vitreous adhesions.”
To prevent trauma, forceps or suctions can be used for removal of the vitreous adhesions. Dr. Nikolakopoulos suggested that if surgeons do use Constellations, they can create the fluid current using a 2cc syringe with a soft-tip flute needle. This can be done with the help of an assistant, but it does require careful fluid control and attention to prevent it from causing mechanical damage. He said, “Ocriplasmin injection will be a further weapon, but hydrolifting will still have a role in dealing with strong adhesions.”
By jeremyc | June 17, 2013
A recent peer-reviewed article on AIDS Patient Care and STDs discussed the representation of women and women of color in studies, and how the GRACE study can help get a more equal representation of patients in such studies. Around the world, more than half the people with HIV are women, but they have not been represented equally in most HIV-related trials. In the period from 2000 to 2008, 18 randomized controlled trials related to HIV medications were submitted to the FDA. In these trials, only 15 percent of the patients were women.
Non-white women were especially under-represented, even though they form a significant portion of newly infected patients. Apart from the stigma related to HIV, these patients may also face discrimination on racial and gender lines, resulting in a greater number of mental health problems. Sex-based statistical conclusions and analyses are limited and less conclusive when the number of female patients is low, so female representation has to be increased to reflect the infected population in general for more effective HIV clinical trials.
The recent GRACE study conducted between 2006 and 2008 was based on a combination therapy with darunavir and norvir (generic name- ritonavir). Around 67 percent of the participants were female with an average age of 43 years. Of this, 62 percent were black, 22 percent Hispanic, and 15 percent Caucasian. Around 37 percent reported tobacco use, 35 percent alcohol use, 14 percent recreational drug use, and 39 percent were diagnosed with stage C HIV.
More than half the participants of the study responded to a survey done in 2010-2011 to evaluate their experienced and outcomes. In this survey, 76 percent of the participants reported that the study changed their feelings about HIV care and general healthcare. Around 82 percent were more focused on their health and 87 percent continued their treatment after their treatment. The most positive aspect of the treatment reported was access to medications and treatment facilities. They also cited support from staff as the main reason for continuing and completing the study. Acknowledging these characteristics and implementing them in future HIV-based trials may help improve the response rate and achieve equal representation from the population.
By jeremyc | June 16, 2013
A recent Canadian study found a link between statins like pravastatin and the risk of diabetes. It indicated that powerful statins like Lipitor and Crestol increase the risk of diabetes by 22 percent when compared to weak statins like Pravachol (generic name- pravastatin). Other studies in the past have also hinted at the link between statins and risk of type 2 diabetes. The new study confirms the connection to a greater extent, so doctors and patients may need to be careful about the dosage being taken.
The study involved the analysis of data from 500,000 patients in Ontario over the age of 66 years with no history of diabetes. After 14 years, it was found that patients who took stronger statins had a higher risk of diabetes as compared to those patients who took pravastatin. The researchers, however, did state that the results of this study do not mean statin usage needs to be stopped. Moreover, significant variations like family history, ethnicity, and weight were lacking. The authors concluded, “Our findings suggest that older patients treated with certain statins are at increased risk for incident diabetes.” They further said, “Regardless of dose or whether treatment is used for primary or secondary prevention. The risks seems to be greatest with atorvastatin, rosuvastatin, and simvastatin….Clinicians should consider this risk when they are contemplating statin treatment for individual patients.”
By jeremyc | June 15, 2013
Pfizer, the manufacturer of menopause relief medication Prempro, recently recalled several batches due to quality issues. The company also recalled Norpace and Cleocin Phosphate. The former is a medicine for heart rhythm disorder treatment and the latter is an antibiotic. The voluntary recall was done on five batches of Prempro after scheduled tests on the medicine suggested that they do not meet necessary potency levels. Reduced potency can change the way the medicine reacts and affects the body.
According to MacKay Jimeson, a spokesperson for Pfizer, taking tablets from the recalled batches is not likely to trigger severe side effects. However, the company ordered the recall as a cautionary measure. The recall does not affect a significant number of tablets since the batches affected were due for expiry by the end of June. Most pharmacists remove medicines that are due to expire within six months and return them to the company, so most of the tablets to be recalled are already back with Pfizer.
Prempro is a hormone replacement medication used to provide relief from menopause symptoms like hot flashes and prevent the onset of osteoporosis. The use of the medication was reduced significantly, however, when a study last decade showed that it increase breast cancer risk. This study triggered several personal injury claims against the then-marketer, Wyeth. Pfizer acquired the company in 2009 and covered $1.6 billion in settlements and verdicts for 95 percent of the lawsuits. Nevertheless, Prempro and drugs related to it generate a revenue over $1 billion per year for the company.
By jeremyc | June 14, 2013
A recent study indicates that children using Proventil and steroidal inhalants for asthma treatment do not grow as tall as children who are not on such medications. Asthma is a chronic condition that affects five percent of children. Almost five million asthma patients are below the age of 18 years according to the Asthma and Allergy Foundation of America.
This study was done by Robert C. Strunk and colleagues from the Washington University School of Medicine. Over 1,000 children participated in the study that aimed at analyzing the impact of asthma treatment on a child’s growth pattern. All the participants involved were between the ages 5 and 12 years. They underwent treatment for four or more years as per the Asthma Management Program clinical trial.
Apart from Proventil, the patients were also prescribed with budesonide, nedocromil, and Placebo. They were divided into three groups according to the medications prescribed to them. By the end of the study, researchers saw that the patients in the budesonide group were an inch and a half shorter than those in other groups. Dr. Strunk said, “This was surprising because in previous studies, we found that the slower growth would be temporary, not affecting adult height. But none of those studies followed patients from the time they entered the study until they had reached adult height.”
He concluded, “If a child is not growing as they should, we may reduce their steroid dose. We will use the lowest effective dose to control symptoms to minimize concerns about effects on adult height.”
By jeremyc | June 13, 2013
According to the Department of Health, Ireland, a new pricing system will be introduced for generic drugs by the last quarter of 2013. The new system will significantly lower the cost of drugs and will include 20 active substances, including rabeprazole. However, the department is sketchy as to reference pricing it plans to introduce to cut the drugs bill that takes up €2 billion per year.
A recent legislation was approved by President Higgins last week, and it will force pharmacists to substitute costly branded medication for cheaper generic medications. The current rules require pharmacists to provide a branded drug when it is prescribed by the doctor. However, the savings gained by the patient is still only 10 percent since generic drugs cost 90 percent of the cost of branded ones in Ireland. In contrast, generic drugs in the UK cost 24 times less than the same drug in Ireland.
The Irish Medicines Board has already started creating lists of medications that are interchangeable with the 20 most commonly prescribed active substances. Apart from rabeprazole, the first 20 medications to be affected will include valsartan, simvastatin, rosuvastatin, risperidone, ramipril, quetiapine, pravastatin, perindopril, pantaprazole, omeprazole, olanzapine, losartan, lercanidipine, lansoprazole, esoprazole, clopidrogel, candesartan, anastrazole, and atorvastatin.
By jeremyc | June 12, 2013
Salix Pharmaceuticals has recently announced positive results from two late-stage studies with budesonide foam for treating mild to moderate cases of active ulcerative proctitis or proctosigmoiditis (UP or UPS). Budesonide is also the generic name for rhinocort, the nasal spray indicated for treatment of asthma, rhinitis, and other breathing conditions.
The two studies were double-blind, randomized, multicenter, and placebo-controlled, and they show that budenoside foam help a majority of the participants achieve remission from the condition, as compared to the placebo control group. The data from these studies were statistically significant. Salix Pharmaceuticals hopes to use the positive data from these studies to file for FDA approval of their medicine by the end of the third quarter of 2013.
If approved, Salix’s medication would be the first foam product approved in the United States for treatment of UP and UPS. Ulcerative proctitis is a form of ulcerative colitis that affects up to 10cm from the rectum. UPS extends to 40cm from the rectum. Salix is already part of a licensing agreement with Dr. Falk Pharma since 2008. The agreement gives Salix permission to exclusively develop and sell budesonide foam in the United States.
Along with this new foam version of Rhinocort, Salix is also working towards the development a new HIV/AIDS treatment drug that prevents and stops diarrhea. This medication gained approval from the FDA in early 2013 for providing relief from non-infectious diarrhea in patients diagnosed with HIV/AIDS.
By jeremyc | June 11, 2013
A recent survey of participants of the Gender, Race, and Clinical Experience (GRACE) trial shows that a majority of the participants would recommend taking part in a clinical trial to others. The GRACE trial was the largest study involving female adult HIV patients who experienced treatment. The trial aimed to examine differences in HIV therapy responses in different genders. The HIV therapy in this trial was based on ritonavir, and 429 patients took part in it.
Researchers of the GRACE trial survey assessed patient characteristics, and collected their opinions and experiences of the trial. A total of 151 patients responded that support from the study staff and access to treatment were the most important factors for enrolling in and completing the trial. The survey was conducted by Janssen Therapeutics, which also conducted the GRACE trial.
The GRACE study itself evaluated differences in ritonavir-based HIV therapy outcomes based on sex and race. A total of 65 sites through the U.S., Canada, and Puerto Rico were included in the Phase 3b trial, which achieved 67 percent and 33 percent enrollment of women and men, respectively. During the recent participant survey, 41 percent of the respondents replied that access to treatment was the best part of the trial. Around 82 percent were more focused on their health and 87 percent continuing treatment after the trial.
Kathleen Squires, MD, is the Director of the Division of Infection Disease, Thomas Jefferson University. She was also the primary investor in the study and lead other of the survey manuscript. She says, “As researchers, we spend much time analyzing the data points pulled from a clinical trial. The results of the GRACE participant survey provide us with the unique opportunity to view the clinical trial experience through the eyes of a patient. The survey has the potential to help shape how future studies are conducted, as it further addresses some of those barriers that may prevent individuals from participating in clinical research. We now can begin to understand how to better anticipate the barriers and help patients in overcoming them.”
By jeremyc | June 10, 2013
A Japanese study suggests that sporanox, a medicine indicated for fungal infection treatment, may raise the risk of peripheral neuropathy in multiple myeloma patients undergoing treatment with bortezomib. Peripheral neuropathy is a side effect associated with bortezomib and characterized by tingling or pain in the extremities. It is caused by nerve damage. Researchers of this study recommend that sporanox not be prescribed for multiple myeloma patients undergoing bortezomib treatment.
The study was done by researchers at the Keio University Hospital. They assessed the bortezomib-induced peripheral neuropathy (BIPN) severity in 48 patients diagnosed with refractory or relapsed multiple myeloma. These patients were treated with bortezomib for the first time between 2007 and 2011, and 13 patients experienced early-onset BIPN, and the risk factors identified were the simultaneous use of sporanox and a proton-pump inhibitor.
The researchers completed a multivariate analysis of the results as well, during which they discovered that sporanox usage was the only risk factor significant enough to develop early-onset severe peripheral neuropathy. The concomitant usage of sporinax with bortezomib significantly raised the incidence of severe peripheral neuropathy as well in the study population. The researcher concluded that administration of sporinox in multiple myeloma patients receiving bortezomib should be avoided.
By jeremyc | June 9, 2013
Psychiatric conditions can be dangerous for patients and those around them, but anti-psychotic medications play a significant and positive role in their successful treatment. The strength of anti-psychotic medications like ziprasidone also makes them a risk when prescribed wrongly. Unfortunately, ziprasidone seems to be increasingly prescribed for low-level conditions, according to a study done by Dr. Dina Panagiotopoulos., an endocrinologist at the BC Children’s Hospital, Canada.
According to Dr. Panagiotopoulos, the unnecessary prescription of ziprasidone and other second-generation antipsychotics (SGAs) has increased to an extent where doctors seeing the side effects of these medications do not bother reporting to Health Canada. The medicine is being prescribed for children as young as two to three years of age. The side effects of SGAs can magnify at such young ages, resulting in muscle spasms, uncontrolled twitching, massive weight gain, and even diabetes.
Recent data compiled by IMS Brogan, a prescription drug research firm, shows that the rate of antipsychotic prescription drug prescriptions has increased significantly. In 2012, more than 74 million prescriptions for psychiatric drugs were filled. In 2008, this number was only 58 million. The growing popularity of these drugs may be due to marketing hype that they cure more conditions than they are approved for. In case of ziprasidone, the prescription for this medicine alone rose by 700 percent from 2008 to 2012. Another drug called paliperidone saw a 30-fold increase in prescriptions in the same period.