Chronic obstructive pulmonary disease in the long-term care setting: current practices, challenges, and unmet needs.

: Chronic obstructive pulmonary disease (COPD) is a prevalent and disabling disorder in the United States, especially affecting older individuals, women, and those with a history of smoking. Studies show that COPD may be underrepresented, underdiagnosed, and undertreated in elderly patients residing in long-term care (LTC) facilities. The quality of care for LTC residents with COPD is heterogeneous in regard to both the facility and the patient. For LTC facilities, care should be driven by staff education, interstaff communication, and interfacility communication. From the perspective of the LTC patient, choice of medication and device should be based on appropriate diagnosis, comorbidities, ability to perform treatment, and patient preferences. Nebulization is currently underutilized in LTC settings, although it would benefit older patients with low peak inspiratory flow, cognitive impairment, and/or physical impairment, which may preclude them from using other inhalation devices. Authors developed a COPD treatment algorithm that focuses on three primary patient aspects to consider when deciding on respiratory device in patients in LTC facilities: inspiratory flow, hand dexterity and coordination, and cognitive capacity.

Rivastigmine from capsules to patch: therapeutic advances in the management of Alzheimer's disease and Parkinson's disease dementia.

OBJECTIVE: To discuss the pharmacology, mechanism of action, and chemical properties of the cholinesterase inhibitor (ChEI) rivastigmine; to provide a rationale for transdermal delivery and supportive clinical data, along with practical guidance on rivastigmine patch use in Alzheimer's disease and Parkinson's disease dementia. DATA SOURCES: Pivotal studies of rivastigmine capsules and patch were identified using PubMed and the rivastigmine US prescribing information. PubMed searches were performed in 2013 using rivastigmine as a keyword. STUDY SELECTION: English-language articles related to rivastigmine considered of relevance to primary care physicians were included. DATA SYNTHESIS: Pharmacologic differences exist between rivastigmine and ChEIs. Clinical studies demonstrate symptomatic efficacy of oral rivastigmine across all stages of Alzheimer's disease and mild-to-moderate Parkinson's disease dementia. However, gastrointestinal adverse events limit access to optimal therapeutic doses. Strategies that lower maximum plasma concentrations (Cmax) and prolong time to Cmax, ie, transdermal delivery, may improve tolerability. Clinical registration studies have demonstrated improved tolerability of rivastigmine 9.5-mg/24-h patch versus 6-mg twice-daily capsules in mild-to-moderate Alzheimer's disease, and a positive benefit-risk profile of 13.3-mg/24-h versus 9.5-mg/24-h patch in patients needing enhanced efficacy. Clinical data comparing 13.3-mg/24-h versus 4.6-mg/24-h patch in severe Alzheimer's disease demonstrated efficacy on cognition and activities of daily living. These data led to approval of rivastigmine patch in severe Alzheimer's disease. Transdermal delivery also has practical advantages, including simple, once-daily administration and a visual indicator of compliance. Potential application site reactions can be minimized and need not be a barrier to treatment. CONCLUSIONS: In addition to practical advantages, rivastigmine patch may improve clinical outcomes throughout the course of Alzheimer's disease by providing access to high-dose efficacy without compromising tolerability.

Efficacy of 13.3 mg/24 h versus 4.6 mg/24 h rivastigmine patch on activities of daily living in severe Alzheimer's disease.

OBJECTIVE: Investigate efficacy of 13.3 mg/24 h rivastigmine patch in patients with severe Alzheimer's disease on Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale-Severe Impairment Version items and domains. METHODS: Retrospective analysis of the 24-week, randomized, double-blind ACTivities of daily living and cognitION (ACTION) study, using factor analysis to establish "best fit" for Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale-Severe Impairment Version items into domains. Treatment differences (13.3 vs 4.6 mg/24 h patch) on items and domains were assessed. RESULTS: Overall, 632 patients provided Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale-Severe Impairment Version data. Factor analysis yielded four domains. The 13.3 versus 4.6 mg/24 h patch demonstrated significantly greater efficacy on "Daily function" (p = 0.038), supported by greatest effect sizes on items within this domain, and trend toward greater efficacy on "Communication" (p = 0.052). No significant between-group differences were observed on "Independence" (p = 0.600) or "Environment" (p = 0.261). CONCLUSION: The 13.3 mg/24 h patch was superior to 4.6 mg/24 h patch on "Daily function" in severe Alzheimer's disease.

Safety and efficacy of duloxetine treatment in older and younger patients with osteoarthritis knee pain: a post hoc, subgroup analysis of two randomized, placebo-controlled trials.

BACKGROUND: Osteoarthritis (OA) knee pain is common in older patients and contributes to decreased quality of life. Older patients are generally at higher risk of adverse drug reactions due to age-related changes in physiology that affect drug disposition, metabolism, and response. These analyses examined efficacy and safety outcomes of older (≥65 years) versus younger patients from clinical trials of duloxetine in the management of OA knee pain. METHODS: This is a post hoc analysis of two 13-week studies, in which patients were randomized to duloxetine 60 mg/day or placebo. Both studies allowed potential dose changes after 7 weeks of dosing, with Study I re-randomizing duloxetine treated patients to either stay on 60 mg/day or increase to 120 mg/day; while Study II more closely mimicked clinical practice by escalating only non-responding patients to 120 mg/day. For all analyses patients were subgrouped by age: older (≥65 years) and younger (40-64 years). Overall efficacy and safety age-group comparisons of duloxetine versus placebo were performed using pooled data from both studies with all duloxetine dose levels combined. Safety analyses included discontinuation rates, treatment-emergent adverse events, and serious adverse events. To evaluate the effects of increasing the dose in non-responding patients, only Study II data were evaluated. Treatment arms were defined post hoc as placebo, duloxetine 60 mg/day, and duloxetine 60/120 mg/day. RESULTS: At study end, patients in each age group who were treated with duloxetine versus placebo had significantly greater improvement in pain (both, p<.05), and there was no significant effect of age on treatment (p=.72). Increasing the dose to 120 mg in non-responding patients was not found to have a significant advantage. Among treatment-emergent adverse events with duloxetine treatment, only dizziness had a significantly differential treatment effect (p=.02) with greater incidence over placebo in younger patients (6.6% versus 0.6%, p=.02), but not in older patients (1.0% versus 3.2%, p=.29). CONCLUSIONS: Duloxetine was efficacious and generally well tolerated for management of symptomatic knee OA in both older and younger patients, but increasing the dose to 120 mg in non-responding patients did not provide additional benefit.

Retrospective analysis of diabetes risk in elderly patients with dementia in olanzapine clinical trials.

OBJECTIVE: The objective of this study was to evaluate the association of established risk factors for treatment-emergent diabetes (TED) among patients over 65 years of age with dementia who received treatment with olanzapine. METHODS: This was a post hoc analysis of data pooled from seven olanzapine clinical trials, which included patients over 65 years of age with dementia. The association of established risk factors for TED was evaluated using categorical and time-to-event analysis. TED was defined as two casual (fasting or nonfasting) glucose values > or =200 mg/dL at any time after baseline or one casual glucose value > or =200 mg/dL at the final visit, initiation of antidiabetic medication, or new clinical diagnosis of diabetes. RESULTS: Elderly patients subsequently identified with TED (N = 29, 2.1%) had similar baseline body mass indices (24 kg/m(2)) and were similar in age (82 versus 80 years) to those who did not have TED. Cox proportional hazards model identified only elevated casual glucose (> or =140 mg/dL) measure at baseline to be significantly associated with the development of TED (hazard ratio [HR] = 11.2, p <0.0001) in this elderly cohort. Other clinical risk factors, like body mass index > or =25 (HR = 0.86), 7% weight gain (HR = 2.26), and antipsychotic treatment (HR = 1.36) were not significant. CONCLUSION: In elderly patients with dementia enrolled in olanzapine clinical trials, an elevated casual glucose (> or =140 mg/dL) at baseline was the only risk factor significantly associated with subsequent development of TED. Risk of diabetes in these studies was not significantly associated with antipsychotic treatment group assignment.