Laura Petrillo

Eszopiclone improves insomnia and depressive and anxious symptoms in perimenopausal and postmenopausal women with hot flashes: a randomized, double-blinded, placebo-controlled crossover trial

OBJECTIVE Menopause-associated insomnia is commonly associated with other symptoms (hot flashes, depression, anxiety). Given frequent symptom cooccurrence, therapies targeting sleep may provide an important approach to treatment during midlife. STUDY DESIGN Peri/postmenopausal women (40-65 years old) with sleep-onset and/or sleep-maintenance insomnia cooccurring with hot flashes and depressive and/or anxiety symptoms were randomized to eszopiclone 3 mg orally or placebo in a double-blinded, crossover 11 week trial. Changes in the Insomnia Severity Index (ISI) scale and secondary outcomes (diary-based sleep parameters, depression/anxiety, hot flashes, quality of life) were analyzed using repeated-measure linear models. RESULTS Of 59 women, 46 (78%) completed the study. Eszopiclone reduced ISI scores by 8.7 + or - 1.4 more points than placebo (P < .0001). Eszopiclone improved (P < .05) all sleep parameters, depressive symptoms, anxiety symptoms, quality of life, and nighttime but not daytime hot flashes. CONCLUSION Eszopiclone treats insomnia and cooccurring menopause-related symptoms. Our results provide evidence that hypnotic therapies may improve multiple domains of well-being during midlife.

Paroxetine versus placebo for women in midlife after hormone therapy discontinuation.

OBJECTIVE Concerns about hormone therapy have led many menopausal women to discontinue hormone treatment. This study examines the efficacy of paroxetine controlled-release versus placebo for the treatment of women with vasomotor symptoms after discontinuing hormone therapy. METHODS Sixty-four perimenopausal and postmenopausal women without depression or anxiety but reporting vasomotor symptoms after hormone discontinuation entered a 1-week, single-blind, placebo lead-in phase, followed by a 6-week, flexible-dose, double-blind phase with paroxetine controlled-release (12.5-25 mg/d) or placebo. The primary outcome measure was a change in vasomotor symptoms. Other measures included changes in depressive symptoms and overall functioning. RESULTS Fifty subjects (paroxetine controlled-release, n=27; placebo, n=23) completed the study. At study entry, subjects had an average of 17 hot flushes per week, had used hormones for more than 5 years (median=66 months, interquartile range=18-120 months), and had discontinued treatment for less than 1 year (median=5 months, interquartile range=2-10 months) before study enrollment. Paroxetine controlled-release was more efficacious than placebo for the alleviation of vasomotor symptoms (mean reduction of 6.1 vs 2.8 hot flashes per week, respectively; P=.03). Depressive symptoms also improved with paroxetine (mean reduction of 3.6 points vs 0.4 points in Montgomery-Asberg Depression Rating Scale total scores; P=.01). CONCLUSION Treatment with paroxetine controlled-release may constitute an efficacious alternative for symptomatic perimenopausal and postmenopausal women after menopausal hormone discontinuation.

The challenges of symptom management for patients with multimorbidity in research and practice: A thematic review

Introduction: Multimorbidity, the presence of multiple coexisting diseases or conditions, afflicts the majority of older adults, and is associated with increased mortality and healthcare utilization. In addition, multimorbidity negatively impacts quality of life and increases symptom burden. Yet, there is a dearth of evidence on how to best manage symptoms in patients with multimorbidity. Methods: We conducted a thematic review of approaches to symptom management in multimorbidity. Results: Research in this area has been hampered by inconsistent definitions of multimorbidity and challenges in outcome measurement. Investigations of symptom management strategies in specific disease states, like cancer, typically exclude medically complex patients. In the absence of evidence, the American Geriatrics Societys recommendations for the care of adults with multimorbidity provide a useful starting point for clinicians. We present a case to demonstrate how the AGS recommendations can be tailored to the situation of symptom management in patients with multimorbidity. We also present suggestions for future research directions. Discussion: Multimorbidity is an incredibly common and overlooked problem in our healthcare system, and only stands to increase in relevance as patients live longer and have the opportunity to accrue a greater burden of chronic illness. A comprehensive approach to patients with multimorbidity includes focusing on patient preferences, carefully interpreting the available evidence (including both the benefits and potential harms), and thinking critically about the burden of any treatment. Taking time to elicit patient goals and preferences, and apprise patients of their prognosis if they want to know, are especially important in symptom management discussions with patients with multimorbidity.

California's End of Life Option Act: Opportunities and Challenges Ahead.

W hen the End of Life Option Act goes into effect in June of 2016, Californians will be able, for the first time, to ask their physicians for medication to end their lives. Many states introduced similar bills after Brittany Maynard’s highly publicized campaign for physician-assisted death in late 2014, but California’s End of Life Option Act is the first to pass and may signal a national shift. As the largest and most diverse state in the country, California’s response to the law will likely set a precedent that affects many Americans, not just the very few in California who will ultimately use the law to end their lives. Though the path to legalization of physician-assisted death in California was fraught with controversy, at this moment in time, healthcare providers must unite to achieve the best possible care of patients, regardless of whether or not they personally support the practice. Herein we describe the practical clinical, ethical, and policy issues that California, as an example for the country, must address in the wake of the law’s passage. A historical perspective of the first state to legalize physician-assisted death holds valuable lessons for California. When voters passed the Death with Dignity Act in Oregon in 1994, Oregonian healthcare providerssaw the event as a wakeup call that palliative care in Oregon fell short of dying patients’ expectations, and were invigorated to work toward change to address the shortcomings. In the ensuing years, hospice referrals increased 20 %. Hospitals created or expanded palliative care consult teams. The Oregon Health and Sciences University bolstered training in palliative care throughout the state. In a survey conducted two years after the Death with Dignity Act took effect, physicians reported very few requests under the law, and 46 % of patients who made a request changed their minds after physician interventions. Oregon continues to rank among the top states in the country in the provision of excellent palliative care, and utilization of the Death with Dignity Act remains low. It may be too soon to tell, but the legalization of physician-assisted death in California has not yet created a sense of urgency to improve care for the dying, as happened in Oregon in 1994. There is certainly room to improve in California; in a 2015 state-by-state report card on access to palliative care, California received a BB^ rating (61–80 % of hospitals have access to palliative care services). Palliative care uptake is particularly low in forprofit hospitals, small hospitals, and community hospitals that are the lone providers for their region. Most requests for physician-assisted death, however, occur in the outpatient setting. On par with the rest of the country, outpatient palliative care in California is even more limited than inpatient services. Outpatient and home-based palliative care programs in California have the capacity to serve only 24–37 % of patients in need, and 22 of 58 counties have no such services. Nationally, the majority of primary care providers receive no training in palliative care, nor do specialists like oncologists, cardiologists, or nephrologists, who routinely care for seriously ill patients. Why is access to palliative care important? Many more people support the general concept of physician-assisted death than seriously consider it for themselves; 68 % of people in the USA supported physician-assisted death in a 2015Gallup poll, but the Death with Dignity Act accounts for only 0.3 % of deaths in Oregon. There are many reasons that the actual rate of the law’s usage is low, but one critical factor is that aggressive symptom management, restoring patient control in decision-making, and the provision of hospice care help many people to have a dignified, comfortable death without the need for death-hastening medication. No matter where healthcare providers stand on physician-assisted death philosophically, all agree that maximizing multidisciplinary palliative interventions to address potentially reversible physical, psychological, and spiritual suffering should be standard of care for seriously ill people, and that physician-assisted death should be a last resort, if it is included in the spectrum of options at all. The BFast Facts^ guides to evaluating and responding to patient requests for hastened death are an excellent starting point for all clinicians (available at www.mypcnow.org). When Received January 25, 2016 Revised March 22, 2016 Accepted April 8, 2016 Published online April 25, 2016

Armodafinil for fatigue associated with menopause: an open-label trial.

Objective:This study aims to obtain preliminary data on the efficacy of armodafinil for improving menopause-related fatigue and quality of life. Methods:Women (aged 40-65 y) experiencing menopause-related fatigue received open-label armodafinil therapy (up to 150 mg/d) for 4 weeks. Changes from baseline in Brief Fatigue Inventory score and Menopause-Specific Quality of Life (MENQOL) physical domain score were examined using the Wilcoxon signed rank test. Exploratory analyses examined the effects of armodafinil on hot flashes, overall quality of life, insomnia, depression, anxiety, and perceived cognitive performance. After open-label treatment, participants were randomized to double-blind continuation of armodafinil versus placebo for 2 weeks to examine whether treatment discontinuation would precipitate symptom recurrence. Results:Of 29 eligible participants, 20 women (69.0%) completed the trial. During treatment with armodafinil (mean dose, 120 mg/d), median Brief Fatigue Inventory scores decreased by 57.7% from 5.2 (interquartile range [IQR], 4.6-6.2) to 2.2 (IQR, 1.1-4.4; P = 0.0002), and median MENQOL physical domain scores decreased by 51.3% from 3.9 (IQR, 2.3-4.8) to 1.9 (IQR, 1.3-2.7; P = 0.0001). Median hot flashes for 24 hours decreased by 48.3% from 2.9 (IQR, 1.1-4.6) to 1.5 (IQR, 0.4-2.4; P = 0.0005). Improvements in MENQOL total score (49%; P = 0.0001), cognitive function (59.2%; P = 0.0002), depressive symptoms (64.7%; P = 0.0006), insomnia (72.7%; P = 0.0012), and excessive sleepiness (57.1%; P = 0.0006) were noted. Randomized continuation (n = 10) or discontinuation (n = 10) did not indicate group differences. Armodafinil was well-tolerated; three women (12%) were withdrawn for adverse events. Conclusions:These preliminary results suggest a therapeutic effect of armodafinil on fatigue affecting quality of life during menopause, and a potential benefit for other menopause-related symptoms.

Older Adult and Surrogate Perspectives on Serious, Difficult, and Important Medical Decisions

To elicit decisions that diverse older adults and surrogates perceive as serious, difficult, or important and explore what helped them make those decisions.

Hypoglycemia in Hospice Patients With Type 2 Diabetes in a National Sample of Nursing Homes

This retrospective cohort study examines whether patients with type 2 diabetes on hospice are assessed for dysglycemia, receive insulin or oral hypoglycemic medications, or experience hypoglycemia and hyperglycemia in the nursing home setting.