Investigation of rivastigmine’s ability to manage gait in patients with Parkinson’s Disease

This article discussed a phase 2 trial that was conducted that studied rivastigmine’s ability to stabilize gait in individuals who have Parkinson’s disease. Before explaining the components and results of the trial, the article explained that Parkinson’s disease leads to gait variability (i.e. reductions in step length, loss of gait automaticity, etc.). Consequently, individuals with Parkinson’s disease and have developed gait are at a higher risk of falls. According to the article, gait characteristics are attributed to a loss of cholinergic function. The researchers therefore determined an acetylcholinesterase inhibitor would prevent falls by improving gait in patients with Parkinson’s disease.

The trial was performed at a hospital in the UK. Participants included those with moderate Parkinson’s disease and were stable on some type of antiparkinsonian treatment for at least 2 weeks prior to the study. They also had to be capable of walking a set distance without assistance and to have experienced at least one fall in the previous year. Patients who had already taken an acetylcholinesterase inhibitor were excluded. The trial was a 32-week long randomized placebo-controlled, double-blind, parallel-arm study. A total of 130 patients were either given rivastigmine or a placebo capsule. Participants were initially dosed at 3mg per day and eventually reached a maximum daily dose of 12 mg. Gait, balance, cognition, and mood were compared pre- and post-trial. Records of falls were also kept throughout by the patients.

The article says there was significant improvement in gait speed and controlled leaning balance in the rivastigmine group. However, fall risk, fear of falling, cognition, mood, disease severity, and quality of life measures were similar between the two groups. 23 of 65 participants stopped taking rivastigmine due to experienced adverse events. However, many of these were concluded to have not been due to rivastigmine treatment. The study found that rivastigmine participants reported more vomiting.

A discussion to conclude the article states that phase 3 trials need to be carried out in order to conclude that rivastigmine should be used to prevent falls in patients with Parkinson’s disease. The study confirmed improvement of gait in participants taking rivastigmine. However, considering the drug did not improve cognitive function in the participants, further research needs to be conducted to study if the treatment has cognitive benefit on non-cognitive impaired patients.

 

 

The Lancet Neurology. 2016;0: 1-9.

http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(15)00389-0/fulltext

The point that was made in the closing discussion about rivastigmine’s potential for improved cognitive function in individuals without decreased cognitive function was something that had come to mind when I read that the researchers were analyzing cognition in participants. If one already has adequate acetylcholine levels, can an acetylcholinesterase inhibitor really provide any benefit?

 

 

Increasing Medical Treatment for Hearing Loss

Hearing loss has become an increasingly prominent issue in the elderly population. Because current generations will live longer lives than previous generations, the problems associated with aging, such as heading loss, will and has become a larger problem in our society. There is a huge issue in regards to treatment and availability of treatment to these patients. Medicare does not cover the cost of hearing aids, which can be very expensive and is most likely the reason why only one in five people suffering from hearing loss use hearing aids. Additionally, there is a problem in the assessment of hearing. In most cases, patients must complain about their hearing in order for a hearing test to be implemented at a doctor’s appointment being that hearing is not usually included in primary care evaluations. The medical lapse in the field of hearing loss can be associated with the idea that hearing loss is natural in the aging process and it is not due to a biological error, therefore does not need medical intervention. However, the effects of medical treatment in hearing loss have increased the productivity, independence and quality of life for these elderly patients.

As a student pharmacist aspiring to enter the medical field, it is an obligation to help patient’s in need in order to increase their quality of life. An emphasis should be placed on improving the treatment availability for hearing loss in all ages, with a concentration on the elderly population. Over 40% of individuals over 60 suffer from hearing loss and the number doubles by the time the population reaches eighty years old with 80% having hearing impairments. Identifying the problem and monitoring yearly can increase the number of patients who receive treatment and possibly prevent the delay in availability of the hearing treatment. This article emphasizes the need for an improvement in areas such as research, treatment availability and insurance coverage.

Cassel, C, Penhoet E, et al. Policy Solutions for Better Hearing. JAMA Intern Med. 2016. Published online January 21, 2016.

JAMA. Published online January 21, 2016

Guidelines for the Zika virus in pregnant women

According to the CDC, the Zika virus is transmitted through a certain type of mosquito that also transmits other viruses that have been found in the United States. Although the Zika virus has not yet been identified in the United States, there have been infections reported throughout the world in people returning from travel to an area that has seen this virus, which could result in disease transfer from human to human rather than from mosquito and human. This increases the risk of the virus entering the United States.

Pregnant women are not thought to be more at risk for this disease or to have more serious symptoms. However, there is currently an outbreak of this virus in Brazil, and there has been an increase in infants born with microcephaly, which is a disease characterized by abnormal brain growth and an underdeveloped head size. Because of this, there are studies underway to see if the Zika virus is the cause, but until then, the CDC is recommending that all pregnant women hold off on traveling to areas that have a Zika virus outbreak, and if they do travel to this area, to wear long sleeved shirts and use insect repellants. There is no vaccine to prevent this infection and there is currently no cure, just the recommendation of rest, fluids and acetaminophen for fever and pain. In addition, if a woman has been tested positive for this virus, she should receive regular ultrasounds to monitor the growth of her baby and talk with a fetal medicine specialist.

MMWR Morb Mortal Wkly Rep. 2016;65(Early Release):1-4.

I thought this article was very interesting because it was proactive, discussing emerging health risks in other areas of the world before they hit the United States. I believe looking at health information from other areas of the world, especially those neighboring the U.S., and initiating studies based on that information should be done more often to help prevent large outbreaks that can turn into epidemics, which were seen with Ebola and the West Nile Virus. In addition, working on preventative measures, such as vaccines, as early as possible is one step that can be made to help prepare for potential disease outbreaks, because it is better to be over prepared than to be working against an epidemic.

Potential Risks to Mother and Fetus with Use of Psychotropic Medications

Chisolm and Payne conducted a literature review to summarize the known and unknown risks of using psychotropic drugs during pregnancy. 15% of pregnant women have a psychiatric illness and 10% to 13% of fetuses are exposed to a psychotropic medication. Studies showed that many women relapsed if their medications were discontinued during pregnancy. It was found that most classes of psychotropic drugs are relatively safe to the fetus during pregnancy. A risk-benefit analysis should be conducted to determine if the risks associated with the drug or untreated psychiatric disorder are worse.

CYP1A2 enzymes are down-regulated in pregnant women so medications such as olanzapine and clozapine require a lower dose. Additionally, these medications have an increased risk for maternal weight gain, increased infant birth weight, and gestational diabetes, so ultrasound monitoring of fetal size may be beneficial in late pregnancy. High potency first generation antipsychotics are recommended over low potency first generation antipsychotics to minimize maternal anticholinergic, hypotensive, and antihistamine effects. Second generation antipsychotics are no safer than first generation antipsychotics and may have an increased risk of high infant birth weight and hypoglycemia.

There is still an inadequate amount of literature on the safety of antipsychotic use in pregnant women. Focus should be emphasized on drug management during pregnancy, including before and after delivery. The psychotropic medications should not be suddenly discontinued, and a comprehensive treatment plan should be developed for women to ensure quality and safe care to the mother and developing fetus.

BMJ. doi: http://dx.doi.org/10.1136/bmj.h5918 (published 20 Jan. 2016).

There is still not enough evidence to completely decide which antipsychotics are safe during pregnancy. What other medications could potentially be safe during pregnancy but are often discontinued due to a lack of research? And why?

End of Life Infection Care

A lot of patients in the final stages of life face complicated decisions on their medical care and what should be treated. Infections are one of the most prevalent complications that these patients experience. A lot of clinicians prescribe antimicrobials in the weeks leading up to death. According to the article, 90% of cancer patients are prescribed these medications during the week prior to death. There are risks and benefits associated with prescribing antimicrobials to these patients when they are so close to death. Risks include drug reactions and interactions, the burden of treating more symptoms when the patient is terminally ill, and contributing to drug resistance. However, these medications can contribute to prolonged survival and symptom relief.

I think pharmacists can have a huge impact in these type of situations. Pharmacists, in my opinion, may be the best suited for these decisions and can help physicians make an informed decision. Will this drug be effective enough in relieving symptoms compared to the risks it poses to the patient? Do these medications interact with any treatment the patient is currently on? Pharmacists can weigh the risks and benefits of all of these questions and help other clinicians make informed decisions. This is an excellent article in showing how pharmacists need to be part of the health care team.

JAMA. 2015;314(19):2017-2018

Blog Officially Open: Safety of Off-Label Medication Use

Eguale and colleagues conducted a study to monitor and evaluate the off-label use of prescription medications and adverse drug events (ADE) in adults. The authors conducted a prospective cohort study of adult patients who visited a primary care physician in Quebec, Canada who participated in the Medical Office of the XXIst Century (MOXXI) research program and received a prescription for a medication between January 1, 2005 and December 30, 2009. The MOXXI physicians use an electronic health record (EHR) that integrates beneficiary, medical and pharmacy claims information together. The EHR requires that the physician document the indication for the medication, reasons for dose modifications and discontinuations and details related to any ADE. Indications were considered off-label if they were not approved by Health Canada (Canada’s FDA equivalent). A drug information database was used to classify the level of evidence supporting the use of the medications for the off-label indications. Strong evidence was defined as medication effective or favorable efficacy for off-label indication, medication is recommended for most patients with indication, and there are studies of efficacy, including at least one randomized controlled trial. In brief, the study included 46,021 patients who received 151,305 prescriptions of which 11.8% were prescribed off-label. The indication for use was not supported by strong evidence 80.9% of the time. The overall incidence of ADEs for all medications was 13.2 per 10,000 person-months. There was a 44% increase in risk of ADEs when medications were used off-label compared with on-label use. There were higher rates of ADE when the off-label use lacked strong evidence. The authors noted that the elderly and patients who frequent physicians may be overrepresented in their data. The authors concluded that the off-label use of medications is a risk factor for ADE.

JAMA Intern Med. 2016;176(1):55-63

Off-label use of medications is complicated. The editorial that accompanies the Eguale paper discusses some of in the issues, including the potential changes to off-label promotion of medications, the allowance of prescribers to write for off-label medication use, and the lack of surprise of the study’s results. How can EHRs in the US become more sophisticated and user friendly to allow for more clear documentation of off-label use of medications to allow for more thoughtful intervention? How can pharmacists help with the safe and effective use of medications, particularly when off-label use is being considered?

Adherence to preventative HIV infection therapies

Several studies have shown that actions to prevent HIV infection prior to exposure reduce HIV infection in men who have sex with men and transgender women by 44%. These preventative actions include tenofovir disoproxil fumarate and emtricitabine oral drug therapies. This study assessed adherence to these therapies, sexual behaviors, and STI and HIV infection in men who have sex with men and transgender women in STI clinics in San Francisco, Miami, and Washington, D.C. They tested the blood concentration of the drugs, number of sex partners, instances of unsafe sex, and HIV infection. At follow-up visits, 80% of participants had levels of the drug that would be sufficient to protect them from infection. African American populations and those in Miami were less likely to have sufficient blood concentration. Populations with stable housing and those who had more than two unsafe sex partners within the last three months were more likely to have sufficient blood concentration. The study concluded that the more a participant acts on risky behaviors, the more likely they are to be adherent to the preventative therapies.

I was pleasantly surprised by the results of the study. I was expecting the people who have risky behaviors to be less inclined to prevent infection simply because they were participating in the risky behaviors. It bodes well in regards to the HIV epidemic that these people are working to prevent infection, though in a perfect world, all people participating in these behaviors would be adherent to preventative therapies.

 

JAMA Intern Med. 2016;176(1):75-84.