Relative and attributable diabetes risk associated with hyperuricemia in US veterans with gout.

BACKGROUND: Hyperuricemia is known to be a risk factor for incident type 2 diabetes mellitus, but the absolute magnitude of the association is not known. We aimed to evaluate the strength of association between hyperuricemia and the risk of developing diabetes among the US veterans with gout. METHODS: Patients (age ≥ 18 years) with ≥2 clinical encounters with gout diagnoses, no history of inflammatory diseases or diabetes and two serum urate (sUA) measurements between 1 January 2002 and 1 January 2011 were selected. Diabetes was identified using International Classification of Disease-9-Clinical Modification codes, use of anti-diabetic medications or HbA1c ≥6.5%. sUA levels were assessed at 6-month cycles (hyperuricemia: sUA >7 mg/dl). Accumulated hazard curves for time to first diabetes diagnosis were derived from Kaplan-Meier (KM) analysis. Risk of diabetes associated with hyperuricemia was estimated using a Cox proportional hazards model. Population attributable fraction (AF) of new-onset diabetes within 1 year was estimated using logistic regression. RESULTS: Among 1923 patients, average age was 62.9 years, body mass index was 30.6 kg/m(2), and follow-up time was 80 months. Diabetes rates from KM were 19% for sUA ≤ 7 mg/dl, 23% for 7 mg/dl < sUA ≤ 9 mg/dl and 27% for sUA > 9 mg/dl at the end of follow-up period (P < 0.001). Hyperuricemia was associated with a significantly higher risk of developing diabetes, after adjusting for confounding factors (hazard ratio: 1.19, 95% confidence interval: [1.01-1.41]). Approximately, 8.7% of all new cases of diabetes were statistically attributed to hyperuricemia. CONCLUSIONS: Among veterans, hyperuricemia was associated with excess risk for developing diabetes. Approximately, 1 in 11 new cases of diabetes were statistically attributed to hyperuricemia.

Treatment retention with risperidone long-acting injection: 24-month results from the Electronic Schizophrenia Treatment Adherence Registry (e-STAR) in six countries.

OBJECTIVE: To assess treatment retention on risperidone long-acting injection (RLAI) and outcomes in schizophrenia patients for whom 24 months of follow-up data in the electronic Schizophrenia Treatment Adherence Registry (e-STAR) were available. RESEARCH DESIGN AND METHODS: e-STAR is an ongoing, international, multicenter, prospective, observational registry assessing use of antipsychotics in patients with schizophrenia or schizoaffective disorder in a normal clinical practice setting. Parameters were assessed prior to and post-initiation of RLAI. Data presented are from six European countries that enrolled patients in e-STAR after they initiated treatment with RLAI. MAIN OUTCOME MEASURES: Clinical and demographic information were collected at baseline and treatment-related data, including RLAI discontinuation, psychiatric hospitalization and medication utilization, were collected prospectively every 3 months. Data collection continued for 24 months, even for patients who discontinued RLAI therapy. Hospitalization and medication utilization were also collected retrospectively by chart review for the 12-month period prior to RLAI initiation. RESULTS: A total of 1659 patients (mean age, 39.2; 18.3% inpatients) completed the study. Twenty-four months after initiating therapy (initial RLAI dose = 33.6 mg) 85% of patients (n = 1410) remained on RLAI (completers) while 15% discontinued therapy. The main reasons for discontinuation were insufficient response (28.5%), patient/family choice (26.1%), adverse events (9.6%) and unacceptable tolerability (6.0%). At baseline, compared to completers, discontinuers were younger (37.4 vs. 39.6 years, p = 0.01), had schizophrenia for a shorter time (10.2 vs. 11.9 years, p = 0.02), had lower Global Assessment of Functioning (GAF) scores (43.5 vs. 48.0, p = 0.0001), higher utilization of benzodiazepines (56.5 vs. 43.3%) and more initiated therapy as inpatients (30 vs. 16%). With RLAI therapy GAF scores improved significantly (p < 0.001) for both groups but the 24-month value for discontinuers was lower than that of completers (55.4 vs. 67.2). Compared to the pre-RLAI initiation period, at 12 months post-initiation completers had greater reductions than discontinuers in the percent of patients hospitalized (66.2% reduction vs. 29.2%) and in the length (68% reduction vs. 0%) and number (80.0 vs. 14.3%) of hospital stays, differences that remained at 24 months. The most common adverse events while patients were taking RLAI were nervous system disorders (6.8%), psychiatric disorders (5.6%), weight increase (3.2%), reproductive system and breast disorders (2.5%) and gastrointestinal disorders (2.1%). CONCLUSIONS: These observational data confirm that RLAI is an effective treatment in schizophrenia and high levels of adherence to therapy offers an opportunity for effective long-term disease management and significant sustained decreases in hospitalization.

Clinical and resource-use outcomes of risperidone long-acting injection in recent and long-term diagnosed schizophrenia patients: results from a multinational electronic registry.

BACKGROUND: Non-adherence to pharmacological treatment leading to frequent relapses and rehospitalizations is a major issue of concern among schizophrenia patients, especially those who are recently diagnosed. Risperidone long-acting injection (RLAI) has been shown to be efficacious, improve compliance, and increase long-term retention rate on therapy. OBJECTIVE: To determine clinical outcomes and hospitalizations before and after the initiation of RLAI among schizophrenia patients with recent (< or =2 years) diagnosis relative to those who had long-term (> 2 years) diagnosis. RESEARCH DESIGN AND METHODS: The electronic Schizophrenia Treatment Adherence Registry (e-STAR) is an observational study of patients with schizophrenia who start treatment with RLAI. Data were recorded at baseline, retrospectively for the 12 months prior to baseline, and prospectively every 3 months for 24 months. Data on patients with a defined length of diagnosis were pooled from eight countries. MAIN OUTCOME MEASURES: Clinical Global Impression of Illness Severity (CGI-S), Global Assessment of Functioning (GAF) scores, and hospitalization data were key outcomes. RESULTS: The magnitude of improvement in CGI-S scores was greater in the recent versus long-term diagnosis group [Delta -1.48 vs. Delta -0.95 (12 months); Delta -1.6 vs. Delta -1.09 (24 months)]. There were parallel improvements in GAF scores [Delta 19.4 vs. Delta 13.7 (12 months); Delta 22.3 vs. Delta 16.8 (24 months)]. The decline in the proportion of patients hospitalized from the retrospective to the prospective period was greater in the recent versus long-term diagnosis group (Delta -36.0 vs. Delta -19%, respectively) at 12 months. This was also true for the number of hospital stays (Delta -0.6 vs. Delta -0.3, respectively) and length of stay (days) (Delta -20.9 vs. Delta -6.9, respectively) at 12 months. Common adverse events in both groups included psychiatric, gastrointestinal, musculoskeletal and reproductive system and breast disorders. CONCLUSIONS: Treatment with RLAI is associated with improved outcomes in recently diagnosed and chronic patients. However, the magnitude of improvement was higher in recently diagnosed patients.

Discontinuation of antihypertensive drugs due to adverse events: a systematic review and meta-analysis.

We conducted a systematic review of randomized, controlled, monotherapy trials since 1990 of oral antihypertensive agents in patients with essential hypertension. Our objective was to quantify the frequency of discontinuation of antihypertensive agents due to adverse events from a meta-analysis of the studies. A total of 190 studies met inclusion criteria. The highest frequency of discontinuations due to adverse events (DAEs) occurred with calcium channel blockers (6.7%) and alpha-adrenergic blockers (6.0%); the lowest with diuretics and angiotensin receptor blockers (each 3.1%). Only in calcium channel blocker studies was the frequency of DAEs greater in treated patients than in patients receiving placebo, but the difference was not significant. This systematic review suggests that the frequency of DAEs in monotherapy antihypertensive trials varies across drug classes and should be considered when choosing drugs for patients with essential hypertension.

Clinical and economic outcomes of coronary angioplasty alone or in combination with stents in academic health centers: a retrospective database analysis.

OBJECTIVES: Indications for the use of stents are evolving and their optimal place in therapy remains to be defined. The objective was to compare the 1-year clinical and economic outcomes of percutaneous transluminal coronary agioplasty (PTCA) with and without the use of stents. METHODS: This retrospective database analysis was conducted using data from 60 US academic medical centers in 1996 and 1997. Outcomes of interest included in-hospital mortality (both on sentinel and readmission visits), readmission rates, revascularization procedures, length of stay, and the cost of sentinel and readmission hospitalization. RESULTS: A total of 27,020 patients either did (n = 13,254) or did not (n = 13,766) receive coronary stents in conjunction with PTCA. The median cost of hospitalization for the stent group was about dollar 1,409 higher (mean, dollar 1,200) than the no-stent group and the length of stay was similar (4.3 days vs. 4.5 days, respectively, P = .2628). Mortality rates on readmission (0.9% stent vs. 0.8% no-stent, P = NS) did not differ. However, patients in the stent group had better mortality rates compared to the no-stent group during the sentinel visit (1.7% vs. 2.7%, P < .001). Stent use was not associated with a significantly lower risk of a revascularization procedure on readmission to the same institution (OR 0.95, 95% CI 0.87-1.04, P = .28). CONCLUSIONS: Stents were associated with a 1% decrease of inpatient mortality during the sentinel visit without impacting length of stay or readmission rates. This advantage was associated with a dollar 1,409 higher median cost of hospitalization in the stent group.

Health-related quality of life in the treatment of angina.

The objectives of this study were to review the literature on health-related quality of life (HRQOL) in patients with angina pectoris (AP), provide suggestions for future research, and propose practical considerations for the selection and use of HRQOL instruments in AP clinical trials. A MEDLINE search was conducted of literature published between January 1980 and April 1999 using MeSH terms "quality of life" and "heart disease." Sixty articles were eligible for inclusion. General and disease-specific instruments were used in 55% and 57%, respectively. Findings were inconsistent with respect to which disease-specific or generic aspects of HRQOL were affected by treatment or which measures were sensitive to treatment changes. Disease-specific measures were more sensitive to treatment than general measures. Evidence suggests that HRQOL effects of surgical and medical treatments are similar over the long term. HRQOL is an important outcome measure to consider. Both disease-specific and generic measures should be used, and a variety of dimensions should be addressed when evaluating HRQOL of patients with AP. Further research is needed to assess the long-term effect of various treatments on HRQOL and the predictive power of HRQOL in clinical outcomes.

Review of the development, validation, and application of predictive instruments in interventional cardiology.

Within the last few years, risk assessment has become an integral part of clinical practice, particularly for thoracic surgery and interventional procedures. Risk assessment statistical models are being used in medical decision making, quality improvement tools, and as aids to patient counseling. This literature review was conducted to evaluate the types of predictive models and outcomes measures that have been examined, and methods used in development, validation, and application of these models. A Medline search performed to identify articles (limited to human studies) published in English from 1980 to 1999 resulted in 89 articles, of which 71 were evaluable. Populations studied for model development included patients undergoing coronary artery bypass graft (CABG), percutaneous transluminal coronary revascularization (PTCR), cardiac catheterization, or stenting procedures and patients with angina or stroke. The models were equally developed from a single center versus multicenter and from retrospective databases versus prospective studies. In terms of model perspectives, only three of the models measured cost or cost-effectiveness as the outcome; the remainder considered only clinical outcomes. The most commonly reported types of predictive models were developed using logistic regression and Bayesian techniques, followed by neural networks, rule-based artificial intelligence, simultaneous equation system, and multiple linear regression. Factors to consider when developing or evaluating a predictive model include uniformity of definitions of outcomes, uniformity of definitions of variables, completeness of data, number and frequency of variables, timeliness and source of data, development population characteristics, development and testing (validation) cohorts, and calibration and discrimination. Application of these models to an individual patient can spur quality improvement efforts that can lead to dramatic, system-wide improvements in outcomes.

1993 Bibliography: a 32-year literature review on the value and acceptance of ambulatory care provided by pharmacists.

OBJECTIVE: To review the published literature on the value and acceptance of pharmaceutical services provided by pharmacists in ambulatory care settings. DATA SOURCES AND METHODS: Articles published between 1960 and 1992. A MEDLINE search of the English-language literature was conducted using the terms pharmacists, services, and ambulatory settings. Studies were selected for inclusion if they addressed services provided by pharmacists in ambulatory settings and dealt with the cost of patient care, quality of care, or attitudinal surveys. Original research reports were summarized according to objectives, sample size, duration of study, methods, and findings. Summaries were categorized according to reported positive impact, negative impact, or investigational reports with no outcome. RESULTS: One hundred seventy articles were identified; 104 of them reported research data and were summarized. The 1970s was the most prolific decade for publication of articles reporting positive, negative, or no impact, which numbered 47, 20, and 37, respectively. Positive correlation was found among studies conducted according to predetermined protocol and reporting positive impact. Moreover, academic interest in pharmacy varied for the different decades. CONCLUSIONS: Collectively, this article provides references of the published reports on pharmacy professional services in ambulatory care settings, and a summary of the articles reporting research data. Additional and more focused research on pharmaceutical services in the community is needed. Emphasis is required on practicing pharmacists' attitudes toward nondispensing, patient-oriented pharmaceutical services; the impact of educational changes on the practice of pharmacy and consumers' attitudes and willingness to pay for services; and the link between patient outcome and pharmaceutical services.