Antimuscarinic use among individuals with urinary incontinence who reside in long-term care facilities.

PURPOSE: To assess appropriateness of antimuscarinic use in long-term care facilities (LTCFs) among treated and untreated urinary incontinence (UI) residents from 2007 to 2009. METHODS: We conducted a retrospective analysis using the AnalytiCare(SM) database consisting of minimum data sets (MDS) assessments and prescription records of 90,660 residents from 2007 to 2009. UI (MDS H1b ≥ 1) residents with ≥ 14-day LTCF stay were identified and categorized as treated if they had ≥ 1 antimuscarinic prescription and untreated if they had no antimuscarinics. A random sample of untreated residents was matched based on treated residents' type of MDS assessment. We defined appropriate antimuscarinic use if residents had adequate cognitive function [≤ 4 on the cognitive performance scale (0 = intact to 6 = very severe impairment)] and mobility [scoring <4 on mobility for toileting scale (MDS item G1iA 0 = independent to 4 = total dependent)]. Chi-square tests were used to detect statistical difference between cohorts. RESULTS: A total of 5,327 residents (2,840 treated; 2,487 untreated) were selected [mean age (standard deviation) 80 (8), 81 (8) years; female (76, 65 %), respectively]. On study-defined MDS assessment, 63 % of treated and 69 % of untreated residents had UI (P < 0.01). Approximately 84 % of treated and 74 % of untreated residents may have had cognitive function and mobility sufficient for appropriate antimuscarinic use (P < 0.01). CONCLUSIONS: Our study identified a high percentage of LTCF residents with UI who may have been candidates for antimuscarinics. However, due to the MDS limitation, we were unable to identify overactive bladder patients among these untreated residents with UI. It is possible that untreated control residents had UI due to other factors not amenable to treatment with antimuscarinic agents. Therefore, choice of treatment for each resident needs to be individualized and carefully monitored for efficacy and adverse effects. This retrospective analysis requires prospective confirmation. Proper patient selection for antimuscarinic treatment requires careful assessment of underlying physical status including cognitive function, mobility, and comorbidities.

Finding unrecognized information in overactive bladder clinical trial data: a new approach to understanding placebo and treatment effects.

AIMS: To identify combinations of variables among overactive bladder (OAB) clinical trial subjects that allow prediction of those who are more--or less--likely to respond strongly to placebo, or to medication. METHODS: Data from two Phase IIIb clinical trials of solifenacin in OAB were combined. Predictive models for placebo and treatment responses were constructed using baseline variables including individual items from the OAB questionnaire. These models were reduced to an essential subset of predictor variables. Two outcome measures are reported: urgency and incontinence. RESULTS: In placebo subjects, 14 selected variables permitted distinction between those who responded with significant reductions in urgency and those who did not. A subset of nine variables in treated subjects permitted distinction between those more--or less--likely to respond to medication. Data for urgency were combined from both placebo and actively treated subjects to identify those who had one of the previously identified clusters of variables. It was possible to predict, among all subjects, who would be likely to experience a strong placebo or active treatment response and who would not. This process was also applied to incontinence data. CONCLUSIONS: We have developed a new process to help understand placebo and treatment responses and their relationships to baseline conditions. The effectiveness of these methods was indicated using data from two solifenacin clinical trials and would benefit from future validation using other data sets. Methods used here are suitable for predicting the placebo effect in other clinical trials.

Efficacy of phosphodiesterase type 5 inhibitor treatment in men with erectile dysfunction and dyslipidemia: a post hoc analysis of the vardenafil statin study.

INTRODUCTION: Dyslipidemia occurs often in subjects with erectile dysfunction (ED), but there is little information about how this condition affects ED treatment responses. AIM: To determine whether low-density lipoprotein cholesterol (LDL-C) levels, total cholesterol (TC)/high-density lipoprotein cholesterol (HDL-C) ratio; or the presence of metabolic syndrome influenced efficacy of vardenafil in men with ED and dyslipidemia. METHODS: Post hoc subgroup analysis of a 12-week study of the influence of lipid levels and presence of metabolic syndrome on the efficacy of vardenafil as measured by International Index of Erectile Function-Erectile Function (IIEF-EF) domain score, responses to Sexual Encounter Profile (SEP) SEP2 and SEP3 questions, duration of erection leading to successful intercourse, and erection duration regardless of the answer to SEP3. Lipid values were obtained at study start, after patients had received at least 3 months of therapy with a statin. MAIN OUTCOME MEASURES: Outcomes in subjects with LDL-C < 100, > or = 100 to < 130, or > or = 130 mg/dL [< 2.59, > or = 2.59 to < 3.36, or > or = 3.36 mmol/L]; TC/HDL-C ratio < 3.5 vs. > or = 3.5, and presence or absence of metabolic syndrome. RESULTS: Vardenafil improved all endpoints evaluated compared with placebo in all subgroups, however, nominally significant treatment by subgroup interaction terms did not follow a distinct pattern. Increasing LDL-C (P = 0.033), but not TC/HDL-C ratio or metabolic syndrome, was associated with an increase in treatment response measured by the IIEF-EF domain score. Responses to SEP3 were nominally influenced by LDL-C levels (P = 0.019), but were not significantly influenced by TC/HDL-C ratio, or the metabolic syndrome. Only higher TC/HDL-C ratios (> or = 3.5) were associated with larger treatment differences in duration of erection leading to successful intercourse (P = 0.028). CONCLUSIONS: Vardenafil was effective in men with dyslipidemia regardless of LDL-C levels, TC/HDL-C ratio, and/or presence of metabolic syndrome. Despite the known presence of ED and dyslipidemia, other cardiovascular risk factors were apparently not aggressively managed.

Epidemiology of opioid pharmacy claims in the United States.

OBJECTIVE: To describe opioid pharmacy claims patterns in the United States among an insured population. DESIGN: Information was obtained from the US insurance claims database, IMS Lifelink, between 1997 and 2002. Descriptive statistics of opioid claims patterns were described with stratification by gender, age, and year of use. RESULTS: The prevalence of insured people with opioid claims increased from 17.1 percent in 1997 to 18.4 percent in 2002. Among people with an opioid claim, 24 percent had > or =30 days and 10 percent had > or =90 days of days supplied based on the insurance claims. Prevalence varied by type of opioid; 56 percent of people with a claim received propoxyphene, 43 percent received codeine, 23 percent received oxycodone, and 17 percent received hydrocodone. Sustained-release opioids were found among 6 percent of those with a claim. With respect to the dose of opioids in the pharmacy claims (expressed as morphine equivalent total daily dose), 71 percent had claims for <50 mg, 55 percent had claims for 50-99 mg, and 24 percent had claims for > or =100 mg. Women, individuals with cancer, and older patients had significantly more pharmacy claims as well as claims for higher doses of opioids (p < 0.05). Internal medicine and family practice specialists were responsible for 22.4 percent and 20.9 percent of all opioid claims. CONCLUSIONS: Opioid pharmacy claims increased slightly over time. Older patients, women and patients with a cancer diagnosis had significantly more opioid claims and claims for higher doses than the younger patients, men, and those without cancer.