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Bulletin Board - January 2013
SLEEP DISORDER SPOTLIGHT
Sleep-Disordered Breathing Associated With Carotid Atherosclerosis in Elders
Abnormalities in respiratory pattern are characteristic of numerous sleep disorders that fall under the umbrella term sleep-disordered breathing (SDB). This group of disorders, which includes snoring, sleep apnea, and upper airway resistance syndrome, is associated with considerable morbidity. Recently, SBD has emerged as an independent risk factor for carotid atherosclerosis (CA) and cerebrovascular disease in middle-aged adults, but little is known about this relationship in elderly persons. In a new study published online ahead of print in Sleep Medicine, Emilia Sforza and colleagues, Department of Clinical Physiology and Exercise, Université Jean Monnet, PRES Université de Lyon, Saint-Etienne, France, set out to assess the impact of SDB on CA and other cerebrovascular diseases in a cohort of 755 healthy elderly persons who were 68 years old at study entry.
All subjects of the cross-sectional study underwent carotid ultrasonography and were assessed for risk factors of atherosclerosis, including smoking, metabolic syndrome, and hypertension. Carotid lesions were found in 35% of the study group, predominantly in men and overweight individuals. The most frequent alteration was arteriosclerosis present in 74% of cases, with stenosis greater than 50% found in only 9% of participants. There was no significant difference found in the frequency of carotid lesions between persons with and without SDB. However, individuals with a score of 30 or higher on the Apnea Hypopnea Index, indicating severe sleep apnea, had a slight increase in the occurrence of CA. According to a logistic regression analysis, the variables independently associated with carotid lesions were male sex (P<.001), hypertension (P=.009), and dyslipidemia (P=.003). This pattern was consistent even in severe cases.
Sforza and colleagues concluded that the occurrence of CA in healthy elderly persons has a greater association with sex, metabolic factors, and hypertension rather than the presence of SDB. However, further clinical studies, including an all-encompassing assessment of all atherosclerotic risk factors, are needed to clarify the predisposing role of SDB in cerebrovascular risk.
Pain Management Improves Sleep Quality for Elderly Patients Receiving Chemotherapy
In the absence of a cure for cancer, efforts are focused on providing the most comfortable care and quality of life to patients. In a new study, Thalyta Cristina Mansano-Schlosser, doctoral student, and Maria Filomena Ceolim, PhD, Universidade Estadual de Campinas, Brazil, evaluated the quality of sleep in elderly patients receiving outpatient chemotherapy treatment (Rev Lat Am Enfermagem. 2012;20[6]:1100-1108).
The cross-sectional study involved 140 elderly patients with either stage III or stage IV cancer (51.2% women; average age, 69.8 years). The exclusion criteria were patients with primary tumor or metastases in the central nervous system, those with a score of 60 or less on the Karnofsky Performance Status Scale, those within a 30-day postoperative period, and those with certain clinical and emotional conditions. The study group was monitored at a university hospital in São Paulo, and patient data was gathered using a sociodemographic and clinical characterization questionnaire, the Pittsburgh Sleep Quality Index (PSQI), the Piper Fatigue Scale, and a subjective pain measurement scale. The majority of participants (62.9%) had a score indicating poor sleep quality according to the PSQI. Almost 49% of participants reported taking longer than 30 minutes to fall asleep, with 30.7% sleeping for 5 hours or less per night. Only 8.6% of participants slept for 9 hours or longer. The average duration of sleep was 6.46 hours, with latency of 44.6 minutes, and efficiency of 83.8%. Some of the most common contributors to sleep disturbances were described by patients as “could not breath comfortably” (86.4%), “felt too hot” (76.4%), “had bad dreams” (65%), and “had pain” (59.3%). With every increase of one point on the pain intensity scale, the probability of poor sleep increased by 21%. Based on these results, Mansano-Schlosser and Ceolim concluded that pain management is critical when aiming to improve sleep in elderly patients receiving chemotherapy.
Restful Sleep Facilitates Better Stress Management
One of the links to developing cardiovascular disease (CVD) is psychosocial stress. Recently published in Tohoku Journal of Experimental Medicine (2012;229[1]:5-10), a study conducted by Seitaro Teraoka, CNS, Nagasaki University Graduate School of Biomedical Sciences, Japan, and colleagues suggests that the combination of a lower body mass index and restful sleep can lead to a better sense of coherence, or ability to cope with psychosocial stress.
Teraoka and colleagues conducted a study of 511 Japanese adults (185 men, 326 women) between the ages of 48 and 70 years old. Stress management capability and psychological conditions were evaluated using the Japanese version of the Sense of Coherence-13 Scale (SOC-13) supplemented by the General Health Questionnaire-12, which is a screening tool for minor psychiatric disorders. Patients who reported “having enough rest from sleep” had much higher SOC scores than those who answered no (P=.03 in men; P<.001 in women; P<.001 in all participants). Based on these results, Teraoka and colleagues concluded that weight control and proper sleep habits should be emphasized from a psychosocial stress-management point of view when working to prevent CVD in older adult patients.
FDA NEWS
FDA Approves Sirturo to Treat Multidrug-Resistant Tuberculosis
On December 28, 2012, the FDA approved Sirturo (bedaquiline) as part of combination therapy to treat adults with multidrug-resistant pulmonary Mycobacterium tuberculosis (MDR-TB). MDR-TB is caused by an organism that is resistant to at least isoniazid and rifampin, the two most common TB drugs. According to the Centers for Disease Control and Prevention, TB was diagnosed in more than 10,500 Americans and in more than 9 million individuals worldwide in 2011. The FDA approved Sirturo through its accelerated approval program based on the surrogate end point of time to sputum culture conversion. Sirturo has also been granted fast track designation, priority review, and orphan drug designation.
Manufactured by Janssen Therapeutics, Sirturo works by inhibiting mycobacterial ATP synthase, an important enzyme needed by MDR-TB to replicate and spread throughout the body. Two phase 2 trials involving a total of 440 patients were completed to establish the safety and efficacy of Sirturo. The first trial, a placebo-controlled, double-blind, randomized trial included two treatment groups: Sirturo versus other drugs approved for the treatment of MDR-TB (n=79); and placebo versus other drugs approved to treat MDR-TB (n=81). During the 24-week trial, Sirturo was administered as 400 mg once daily for 2 weeks, followed by 200 mg three times weekly for the remaining 22 weeks. Following the 24-week period, patients continued taking the other approved MDR-TB treatment drugs until total treatment duration of 18 to 24 weeks was achieved. The median time to culture conversion was 83 days in the Sirturo group versus 125 days in the placebo group. After 72 weeks, 70.1% of the Sirturo group was successfully treated compared with 56.1% of the placebo group. Similar results were seen in the second trial.
Before prescribing Sirturo, physicians should be aware of the required continual testing of Sirturo, as nine patients receiving Sirturo died compared with two deaths in the placebo group. Both placebo deaths and five of the Sirturo-group deaths were related to TB. The cause of the remaining deaths in the Sirturo group could not be consistently identified. Common side effects observed in patients taking Sirturo include nausea, joint pain, and headache. Sirturo can affect the heart’s electrical activity, causing potentially fatal arrhythmias. For full prescribing information, visit www.janssentherapeutics.com.
FDA Approves Eliquis to Reduce Stroke Risk in Patients With Nonvalvular Atrial Fibrillation
On December 28, 2012, the FDA approved Eliquis (apixaban), a factor Xa inhibitor anticoagulant, to reduce the risk of stroke and systemic embolism in patients with atrial fibrillation (AF) that has not been caused by a heart valve problem (nonvalvular). In the United States, approximately 5.8 million people have AF, and approximately 15% of persons who experience strokes also have AF.
Eliquis was tested in two phase 3 studies: ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) and AVERROES (A Phase 3 Study of Apixaban in Patients With Atrial Fibrillation). The ARISTOTLE trial compared Eliquis (5 mg twice daily) with warfarin in 18,201 patients (mean age, 69 years). During a median follow-up period of 89 weeks, the trial showed that patients taking Eliquis experienced fewer strokes than those taking warfarin (relative risk reduction, 21% [1.27% per year vs 1.6% per year]; hazard ratio=.79; P=.01).
The AVERROES trial evaluated the efficacy of Eliquis 5 mg twice daily over aspirin 81 mg or 324 mg once daily for preventing the composite outcome of stroke or systemic embolism in patients with nonvalvular AF who were not considered candidates for warfarin therapy. The AVERROES trial was stopped early because an analysis showed significant reduction in stroke and systemic embolism in patients taking Eliquis compared with a modest increased risk of major bleeding in the aspirin group.
Manufactured by Bristol-Myers Squibb, Eliquis is a tablet taken orally. Patients with prosthetic heart valves or those with valvular AF should not take Eliquis. The most serious side effect observed in patients taking Eliquis is bleeding. For full prescribing information, visit www.eliquis.com.
FDA Approves Signifor for Treatment of Cushing’s Disease
On December 14, 2012, the FDA approved Signifor (pasireotide diaspartate) to treat patients with Cushing’s disease who are ineligible for surgery or for whom surgical treatment has failed. Typically caused by a tumor or hyperplasia of the pituitary gland, Cushing’s disease is common in pediatric patients and adults aged 20 to 50 years, but it also occurs in elderly persons with certain risk factors, such as obesity, type 2 diabetes mellitus, poorly controlled hyperglycemia, and hypertension. Cushing’s disease is marked by the overproduction of adrenocorticotropic hormone, which if left untreated, can progress to Cushing’s syndrome (also known as hypercortisolism), the complications of which can be severe and even life-threatening. Cushing’s syndrome can lead to diabetes, hypertension, osteoporotic fractures, and increased susceptibility to infections. Signifor is an injectable somatostatin analog that works to suppress cortisol production in the adrenal glands.
Pituitary surgery has been considered first-line treatment for patients with Cushing’s disease, but in some cases, surgery is either unsuccessful or not an option. The safety and efficacy of Signifor as a viable alternative to surgery were demonstrated in a phase 3 randomized study that involved 162 patients with Cushing’s disease (78% women; mean age, 40 years). Approximately 83% of participants had persistent or recurrent Cushing’s disease despite undergoing surgery. Patients were divided into two groups and received different doses of Signifor for a period of 6 months. The first group (n=82) received Signifor 0.6 mg twice daily, while the second group (n=80) received Signifor 0.9 mg twice daily. As early as 1 month from the start of treatment, a decreased amount of cortisol in the urine was observed over a 24-hour period. By 6 months, normal urine cortisol levels were observed in approximately 20% of the participants. Of those on the 0.6 mg dose of Signifor, 34% saw a ≥50% reduction from baseline in urine-free cortisol. Of those in the 0.9-mg group, 40% saw similar results.
During the study, it was noted that Signifor was associated with hyperglycemia, and continued treatment with Signifor caused or worsened diabetes in some patients. The FDA is requiring three postmark studies of Signifor: a clinical trial to assess hyperglycemia management; a long-term prospective observational cohort study of patients treated with Signifor; and focused safety monitoring for reports of serious hyperglycemia, acute liver injury, and adrenal insufficiency. The most common side effects include hyperglycemia, diarrhea, nausea, abdominal pain, and gallstones. Signifor is manufactured by Novartis. For more information about Signifor, visit www.signifor.us.
LTC RESOURCES
As of 2010, there were more than 40 million Americans aged 65 years and older, and that number is projected to increase to 55 million by 2020. One of the biggest barriers to caring for this large population is physician-patient communication. Older patients may withhold health concerns from their providers if they consider them to be normal effects of aging or if they feel that physicians have less patience with them. To remedy this, the Gerontological Society of America has recently released Communicating With Older Adults: An Evidence-Based Review of What Really Works, a collection of recommendations for improving face-to-face communication with older patients. Supported by McNeil Consumer Healthcare, this publication is intended for all persons—physicians, nurses, social workers, caregivers, economists, and health policy experts—who are seeking to create the best possible interactions with older adult patients.
Experts in the field of gerontology and communications contributed all 29 tips, each accompanied by a brief explanation, advice for implementing them into practice, and a few selected references for further reading. These recommendations cover a broad field of communications, including tips for improving interactions with older adults, tips for improving face-to-face communication with older adults, tips for optimizing interactions between healthcare professionals and older patients, and tips for communicating with older adults with dementia. The guidebook also offers specific solutions for dealing with numerous obstacles to communication with elderly persons, including hearing and vision impairments. For nonmembers of the Gerontological Society, a copy of this resource can be purchased for $8 at the society’s Website at www.geron.org. The resource is free for members.
MEDICAL NEWS
Hand/Wrist Radiographs May Predict Risk of Hip Fractures
Each year, approximately 1.7 million hip fractures occur worldwide, with 10% to 20% of the patients dying of the complications of limited mobility following hip fracture, which include embolism, pressure ulcers, and urinary tract infections. Underscoring the importance of preventive measures, studies show that 1 in 3 women and 1 in 5 men older than 50 years will experience an osteoporotic fracture. In a recent study published online ahead of print in European Radiology, a Swedish study conducted by Michael Wilczek, doctoral student, and colleagues shows that digital X-ray radiogrammetry (DXR), which is used to measure bone density, can help identify patients at higher risk for hip fractures when used on standard hand/wrist radiographs obtained in emergency departments. This study was conducted to determine if DXR of radiographs could be used as selective screening for osteoporosis as well.
Between 2000 and 2008, more than 45,500 radiographs of the left hand were collected from the emergency departments of three hospitals in Sweden. After exclusions were made for radiographs including metacarpal bone, fractures in measurement regions, and presence of foreign material, 18,824 radiographs were analyzed using DXR to yield a calculated bone mass density (DXR-BMD). After further examination, a total of 8257 patients met the inclusion criteria (age ≥40, no prior hip fracture, and observation time >7 days). Age-adjusted hazard ratio per standard deviation (HR/SD) was calculated using Cox regression. Approximately 65.6% of the patients were women (average age, 60.5 years) and 34.4% were men (average age, 57.8 years). After the radiograph, 122 patients experienced a hip fracture. All of these patients had a significantly lower DXR-BMD than the nonfracture group when adjustments for age were made (DXR T-score, ≤-2.5). The highest number of fractures occurred in women between the ages of 75 and 89 years (43.4%). The HR/SD was 2.52 in women and 2.08 in men. The average follow-up period was 3 years and 3 months.
While there are no previous recommendations on when patients should receive treatment based on DXR measurements, this study supports a direct correlation between hand/wrist bone density and the predisposition to hip fractures, the authors concluded. Study limitations include the fact that the radiographs used where not intended for DXR analysis, there was no record of hand dominance (as DXR analysis is strictly meant for use on the nondominant hand), and some radiographs included for study were slightly suboptimal.
Positive Thoughts May Provide Positive Results
The phrase “mind over matter” may have a new meaning in long-term care settings. Recently published in the Journal of the American Medical Association (2012;308[19]:1972-1973), a study by Becca Levy, PhD, School of Public Health, Yale University, New Haven, CT, and colleagues suggests that older patients who have a positive outlook are not only more likely to recover from serious disabilities, but do so much more quickly than patients with a negative attitude toward recovery.
Between March 1998 and December 2008, more than 700 participants (age >70 years) were interviewed monthly and completed home-based assessments every 18 months. During this time, approximately 600 participants had been disabled for at least 1 month. Although their disabilities ranged from mild to severe, they required assistance to perform at least one activity of daily living (ADL). Investigators asked the participants questions about aging stereotypes, such as “When you think of old persons, what are the first five words or phrases that come to mind?” Responses were charted using a scale of 1 to 5 (1=most negative [ie, decrepit], 5=most positive [ie, spry]). ADL recovery transitions were measured from severe to no disability, severe to mild disability, and mild to no disability.
The results were collected and assessed using a competing risk Cox model for recurrent events to evaluate the likelihood of the positive age–stereotype group to experience each recovery transition compared with the negative age–stereotype group. The positive group was found to have higher recovery rates than the negative group, with 7.7% of the positive group progressing from severe to no disability (P=.04), 8.1% progressing from severe to mild disability (P=.02), and 1.1% progressing from mild to no disability (P=.02).
While the results demonstrate that patients with positive attitudes have a better chance of quick recovery, there is no definite reason as to why. Levy suggests that many factors can be at play, such as a positive attitude acting as a buffer against stress and lessening cardiovascular responses to challenges. There is also the possibility that participants who consider older adults to be stronger and healthier were more likely to participate in healthy behaviors, such as attending physical therapy.
RESEARCH NEWS
New MRI Methodology May Shed Light on Memory Loss
Scientists know that recently acquired knowledge is transferred into long-term memory while humans are in deep sleep. This occurs via widespread networks of neurons, but the exact processes for this mechanism have not been well understood. German scientists have developed a new methodology called neural event-triggered functional magnetic resonance imaging (NET-fMRI), which may enable researchers to map these networks of neurons. Functional magnetic resonance imaging (fMRI), which is used to distinguish diseased tissue from healthy tissue, has been used in clinical care settings to determine how well the brain is functioning after a stroke or when Alzheimer’s disease or other neurological conditions marked by memory impairment or loss are present. The NET-fMRI uses multiple-contact electrodes in combination with fMRI to map the entire brain, locating neurons that are activated by local, structure-specific neural events.
In fall 2012, the NET-fMRI was used on both anesthetized and awake, behaving monkeys. Nikos Logothetis, PhD, director, Department of Physiology of Cognitive Processes, Max Planck Institute for Biological Cybernetics, Germany, and his team characterized the brain areas that consistently increased or decreased their activity in relationship to a certain type of fast hippocampal oscillations known as ripples. Measured with electrophysiological methods, these ripples occur mainly during deep sleep, indicating they might have some responsibilities with memory transfer. The scientists were able to demonstrate that the short periods of aperiodic, recurrent ripples are closely associated with reproducible cortical activations that occur concurrently with extensive activity suppression in other brain structures. They also found that suppressed structure activities could interfere with the hippocampal-cortical dialog. For example, signals related to sensory processing were reduced when the activity in the thalamus was suppressed.
According to a news release by the Max Planck Institute about this technological development, these findings may provide great insights into the large-scale organization of memory and how widespread neural networks work. This multimodal methodology may help to elucidate processes responsible for such human mental capacities as perception, attention, learning, and memory, thereby heightening understanding of the pathophysiology of neurological diseases.
PRODUCT SPOTLIGHT
Mammotome Revolve: New Breast Biopsy Development
Developed by Devicor Medical Products, Inc, Mammotome Revolve, a dual vacuum-assisted biopsy system, was approved by the FDA on December 6, 2012. In 2011, approximately 1.4 million women in the United States underwent a breast biopsy procedure, 40% of which were vacuum-assisted. The Mammotome Revolve makes this process easier and more accurate with its patented DualVac vacuum technology, enabling clinicians to secure larger contiguous tissue samples and organize them in a management system that preserves tissue integrity. Clinicians are also able to adjust sample acquisition in response to procedural situations with the physician-controlled variable aperture. With the features of this system, “clinicians can be confident that patients are more likely to have a less painful and traumatic experience,” said Devicor President and CEO Tom Daulton, in a press statement.
Mammotome Revolve includes a select grip, enabling clinicians to select between one of three preferred hand positions. The single insertion, non-firing bladed tip facilitates easy movement through breast tissue while the 360-degree needle rotation permits orientation adjustment. The new product also includes a touchless collection system, allowing clinicians to view and transfer tissue without jeopardizing the quality of the specimen.
The Mammotome Revolve is currently available in limited market release in the United States, Canada, and Europe, with full market release expected in the spring of 2013. For more information about Mammotome Revolve and other Mammotome products, visit www.mamotome.com.
ALTC POLL RESULTS
Do you feel that your long-term care facility or clinic is adequately staffed to meet patients’ needs?
Current poll question
If you observe residents of your long-term care facility hoarding items, such as possessions or medications, how would you handle the situation?
Vote online at www.annalsoflongtermcare.com.
