An accelerated pathway for targeted cancer therapies.

A well-defined pathway for the accelerated development and approval of targeted cancer therapies and companion diagnostics would reduce uncertainty, improve efficiency in development and provide an effective incentive for developers.

An evaluation of recent federal spending on comparative effectiveness research: priorities, gaps, and next steps.

The American Recovery and Reinvestment Act of 2009 included new funding for developing better evidence about health interventions, with a down payment of $1.1 billion for comparative effectiveness research. Our analysis of funds allocated in the legislation found that nearly 90 percent of the $1.

Comparative effectiveness research: Policy context, methods development and research infrastructure.

Comparative effectiveness research (CER) has received substantial attention as a potential approach for improving health outcomes while lowering costs of care, and for improving the relevance and quality of clinical and health services research. The Institute of Medicine defines CER as 'the conduct and synthesis of systematic research comparing different interventions and strategies to prevent, diagnose, treat, and monitor health conditions. The purpose of this research is to inform patients, providers, and decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances.

Commentary: tackling the challenges of developing targeted therapies for cancer.

This article comments on the approaches to solving problems in the development of targeted drug therapies for cancer as outlined by expert collaborative panels and described in this issue by Amit et al., Abrams et al., and Clark et al.

Does a single-pill antihypertensive/lipid-lowering regimen improve adherence in US managed care enrolees? A non-randomized, observational, retrospective study.

Background: A previous study in 4703 patients suggested that a single-pill combination of amlodipine and atorvastatin is associated with greater adherence to therapy than a two-pill calcium channel antagonist (calcium channel blocker [CCB]) and HMG-CoA reductase inhibitor (statin) regimen. However, the impact of prior medication use on the potential adherence benefits of single-pill amlodipine/atorvastatin has not been studied.

Objective: To compare adherence to single-pill amlodipine/atorvastatin versus two-pill CCB + statin regimens in a large managed care population, stratified according to prior CCB and statin use.

A large observational study of cardiovascular outcomes associated with atorvastatin or simvastatin therapy in hypertensive patients without prior cardiovascular disease.

The objective of this study was to examine whether differences in effectiveness exist between statins in hypertensive patients seen in clinical practice. We assessed cardiovascular (CV) outcomes in hypertensive patients without cardiovascular disease who began therapy with atorvastatin (10 or 20 mg/d) or simvastatin (20 or 40 mg/d) between January 1, 2003, and September 30, 2005, using claims data from 92 US managed care plans in the PharMetrics database. A total of 98,471 hypertensive patients were identified, comprising 74,685 atorvastatin users (mean dose 13.

Comparing adherence and persistence across 6 chronic medication classes.

Background: The National Quality Forum recently endorsed the proportion of days covered (PDC)-a measure of medication adherence-as an indicator of quality in drug therapy management.

Objective: To inform initial efforts to improve the quality of drug therapy management, we compared PDC and persistence among new users of 6 commonly used chronic medication categories.

Methods: A retrospective analysis of pharmacy claims in a database of more than 64 million members enrolled in 100 health plans assessed persistence and adherence to drug therapy in 6 chronic conditions.

Difficult to swallow: patient preferences for alternative valproate pharmaceutical formulations.

Objective: To determine the degree to which swallowing valproate (VP) tablets is an issue, the proportion of patients who would prefer an alternative formulation, and the predictors of preference.

Methods: A quantitative telephone survey of eligible adults (n = 400, >/=18 years old) who currently take (n = 236) or previously took (n = 164) VP tablets within the past 6 months was conducted.

Results: More than half of the patients indicated that VP tablets were 'uncomfortable to swallow' (68.

Predictors of discontinuing overactive bladder medications.

Objective: To identify predictors of self-reported discontinuation of overactive bladder (OAB) medication using a three-phase survey.

Patients And Methods: In January 2005, a phase 1 survey was sent to 260 000 households in the USA to assess the prevalence of OAB symptom bother, treatment patterns and healthcare consulting behaviour. In July 2005, a detailed phase 2 follow-up survey was sent to 6577 phase 1 respondents who had used one or more OAB medications within the 12 months before phase 1; the phase 2 survey included questions about respondents' sociodemographic characteristics, general health status, OAB symptom bother, healthcare consulting behaviour, beliefs about OAB and treatment options, and medication usage.

Patient-reported reasons for discontinuing overactive bladder medication.

Objective: To evaluate patient-reported reasons for discontinuing antimuscarinic prescription medications for overactive bladder (OAB).

Patients And Methods: A phase 1 screening survey was sent to a representative sample of 260 000 households in the USA to identify patients using antimuscarinic agents for OAB. A detailed phase-2 follow-up survey was sent to 6577 respondents with one or more antimuscarinic prescriptions for OAB in the 12 months before the phase 1 survey.

Are high-risk hypertensive patients being prescribed concomitant statin therapy?: a retrospective cohort study.

Background: Treatment guidelines for dyslipidemic patients have focused on lipid levels and risk assessments. However, normolipidemic patients who have multiple risk factors for cardiovascular disease may also benefit from HMG-CoA reductase inhibitor (statin) therapy.

Objective: We examined the frequency of statin prescriptions in patients initiating antihypertensive drug treatment in a US managed-care setting.

Association between prescription burden and medication adherence in patients initiating antihypertensive and lipid-lowering therapy.

Purpose: The association between prescription burden and medication adherence in patients initiating antihypertensive and lipid-lowering therapy was studied.

Methods: Patients enrolled in managed care organizations who initiated antihypertensive therapy coincident with lipid-lowering therapy (no more than 90 days apart) between January 1, 1997, and April 30, 2000, were eligible for inclusion. Analysis was limited to new users of antihypertensive and lipid-lowering therapy.

Bother related to bladder control and health care seeking behavior in adults in the United States.

Purpose: We measured patient reported bother due to overactive bladder syndrome, patterns of physician consultation and prescription medication use for overactive bladder symptoms in adults in the United States.

Materials And Methods: A survey sample was derived from a consumer panel of 600,000 American households developed to match the United States Census of 260,000 adults. The survey included the Overactive Bladder-Validated 8 awareness tool, which includes 8 questions that measure the degree of bother due to specific bladder symptoms.

Generic and therapeutic statin switches and disruptions in therapy.

Background: The study objective was to compare dose-equivalence, adherence and subsequent switch rates among patients recently switched from a branded to generic version of the same statin (generic substitution, GS) vs. those switched from branded statin to generic version of a different statin (therapeutic substitution, TS).

Methods: In a retrospective cohort analysis among adult enrollees in over 90 US health plans, the authors identified adult patients who switched from a branded to generic statin from July-December 2006 (simvastatin became generic in June 2006).

Predictors of adherence to concomitant antihypertensive and lipid-lowering medications in older adults: a retrospective, cohort study.

Background: Many older individuals have concomitant hypertension and dyslipidaemia--two conditions that, together with age, increase the risk of adverse cardiovascular events. Adherence to antihypertensive (AH) and lipid-lowering (LL) therapy is therefore particularly important in older patients with concomitant hypertension and dyslipidaemia.

Objective: To determine patterns and predictors of adherence to concomitant AH and LL therapy among an older Medicare-eligible population.

The clinical and economic burden of nonadherence with antihypertensive and lipid-lowering therapy in hypertensive patients.

Objective: We sought to determine lifetime costs, morbidity, and mortality associated with varying adherence to antihypertensive and 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (statin) therapy in a hypertensive population.

Methods: A model was constructed to compare costs and outcomes under three adherence scenarios: no treatment, ideal adherence, and real-world adherence. Simulated patients' characteristics matched those of participants in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid-Lowering Arm and event probabilities were calculated with Framingham Heart Study risk equations.

A large observational study of cardiovascular outcomes associated with atorvastatin or simvastatin therapy in diabetic patients without prior cardiovascular disease.

Analysis of claims data from 46,076 diabetic patients without cardiovascular disease initiating atorvastatin or simvastatin therapy suggested that, after adjusting for demographic and clinical confounders, use of atorvastatin was associated with fewer cardiovascular events versus simvastatin at doses of similar potency (HR 0.88, 95% CI 0.80-0.