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Alphs L.,Janssen Scientific Affairs LLC | Benedetti F.,University of Turin | Fleischhacker W.W.,Innsbruck Medical University | Kane J.M.,Zucker Hillside Hospital
International Journal of Neuropsychopharmacology

The effect of placebo observed in schizophrenia clinical trials represents a growing problem that interferes with signal detection for treatments, increases costs of development, discourages investment in schizophrenia research and delays the introduction of new treatments. This paper seeks to clarify key issues related to this problem and identify potential solutions to them. Differences between placebo effect and response are characterized. Recent insights into the central nervous system mechanisms of placebo effect are described. This is followed by a description of protocol/study design and study conduct issues that are contributing to a growing placebo effect in clinical trials. Potential solutions to these problems are provided. © 2012 CINP. Source

LaMori J.C.,Janssen Scientific Affairs LLC
Therapeutic advances in cardiovascular disease

This study examined comorbidity prevalence and general medication use among individuals with atrial fibrillation in the United States to convey a more comprehensive picture of their total disease burden. This was a retrospective, observational evaluation of responses to the 2009 wave of the annual Internet-based National Health and Wellness survey, which collects health data including epidemiologic data and information on medical treatment from a representative nationwide sample of adults in the United States. Responses were assessed to determine three measures of comorbidity: mean number of comorbidities, CHADS2 score reflecting stroke risk (0-6 points; low risk: 0; moderate risk: 1; high risk: ≥ 2), and scores on the Charlson Comorbidity Index, which is a measure of general comorbidity reflecting presence of a wide range of comorbidities. Of the overall sample, 1297 participants reported having been diagnosed with atrial fibrillation. Almost all (98%) of the predominantly male (65.1%) and older (≥ 65 years of age, 65.7%) population with atrial fibrillation had at least one additional comorbidity, and 90% had cardiovascular comorbidities. On the Charlson Comorbidity Index, 44.9% of the respondents had scores of 1-2 and 20.5% had scores of 3 or higher. High risk for stroke, demonstrated by a CHADS2 score of at least 2, was present in 45% and moderate risk (CHADS2 score 1) in 36%. Of the respondents with atrial fibrillation, 71% reported current use of medication to manage the condition, but only 48% of individuals at high risk for stroke reported use of anticoagulation therapy. Of those who reported having common risk factors for stroke, the majority reported receiving prescription therapy for these conditions. The health burden carried by patients often extends far beyond atrial fibrillation. Physicians should carefully consider comorbidities and concomitant medications when managing patients with atrial fibrillation. Source

Alphs L.,Janssen Scientific Affairs LLC | Schooler N.,New York University | Lauriello J.,University of Missouri
Schizophrenia Research

This article reviews key methodological considerations for clinical trials that utilize explanatory and pragmatic trial designs and relates these contrasting approaches to the interpretation of results from comparisons of oral versus long-acting injectable (LAI) antipsychotics in schizophrenia. Explanatory randomized controlled trials (RCTs) generally measure the efficacy of a treatment in a homogeneous population with intensive, frequent, and often clinical trial-specific assessments. In contrast, pragmatic trials measure effectiveness in routine clinical practice and frequently aim to inform choices between treatments. Comparative effectiveness outcomes with pragmatic designs in naturalistic settings for schizophrenia treatments are of increasing interest to healthcare providers because outcomes of treatment (both efficacy and safety) may vary significantly when identified in an explanatory setting compared with a naturalistic pragmatic setting. Indeed, it has been suggested that the inconsistent outcomes observed in trials comparing oral and LAI antipsychotic medications may be a function of the use of explanatory or pragmatic trial designs. In practice, clinical trial designs are seldom purely explanatory or pragmatic. To identify the predominant orientation of a trial, one must consider multiple features. This paper reviews the relative impact of these features when comparing LAI and oral antipsychotic treatments and makes recommendations for improving these comparative designs. © 2014 Elsevier B.V. Source

Frank Peacock W.,Baylor College of Medicine | Gearhart M.M.,Janssen Scientific Affairs LLC | Mills R.M.,Janssen Scientific Affairs LLC
Clinical Cardiology

As major prescribers of oral anticoagulants, cardiologists must be familiar with strategies to manage bleeding, the principal complication associated with all anticoagulants, and to reverse anticoagulant effects in acute-care settings. The purpose of this manuscript is to review currently available information regarding dabigatran and rivaroxaban, the 2 novel oral anticoagulants approved to date in the United States. Further, we suggest reasonable interventions for the clinician faced with a patient who suffers a major bleeding event while receiving one of these agents. Data sources were peer-reviewed publications, US Food and Drug Administration documents in the public domain, and approved US prescribing information for dabigatran (Pradaxa) and rivaroxaban (Xarelto). Strategies for management of bleeding and reversal of anticoagulant effects from warfarin include vitamin K, fresh frozen plasma, and prothrombin complex concentrates. For rivaroxaban and dabigatran, appropriate therapies include support and observation, which are likely to be effective for the majority of patients because of the short half-lives of these agents. In severe life-threatening hemorrhage, clotting-factor substitutes may be appropriate in certain situations. Validated protocols specific to each agent remain to be developed. © 2012 Wiley Periodicals, Inc. Source

Pandina G.,Janssen Research and Development LLC | Bilder R.,University of California at Los Angeles | Turkoz I.,Janssen Research and Development LLC | Alphs L.,Janssen Scientific Affairs LLC
Schizophrenia Research

Introduction: Cognitive impairment in schizophrenia and schizoaffective disorder is a major determinant of disability. This study explored the relationships among cognitive functioning, clinical symptoms, overall functionality, and demographic characteristics. Methods: This was a post hoc analysis of a 52-week, prospective, randomized, double-blind study (N. =. 323) comparing 2 doses of risperidone long-acting injectable (RLAI) in stable subjects with schizophrenia or schizoaffective disorder. Cognitive evaluations were performed and standardized using a healthy age- and sex-matched comparison group. Simple and multiple regression models were used to identify relationships among neurocognitive composite scores (NCS), clinical symptom end points (Positive and Negative Syndrome Scale [PANSS] total and factor scores), overall functionality (Personal and Social Performance [PSP] score), and demographics. Results: A simple regression model identified significant relationships between the NCS at end point and PANSS total score, PANSS disorganized thoughts factor score, functioning (PSP) and age. A 1-point decrease on PANSS total score and PANSS disorganized thoughts factor score corresponded to an increase in NCS of 0.126-point, and 0.81-point increases, respectively. A 1-point increase on the PSP corresponded to a 0.186-point increase in the NCS T-score. Among the demographic variables, only age correlated significantly with cognition (10-year increase in age corresponded to 1.1-point decrease in NCS T-score) in a multiple regression model. Conclusion: Improved cognition was associated with beneficial changes in functional status and clinical symptoms (particularly disorganization symptoms) in subjects with schizophrenia/schizoaffective disorder. Older subjects showed less overall cognitive improvement. Improved cognitive and functional outcome is correlated with symptom improvements in RLAI-treated patients with schizophrenia. © 2012 Elsevier B.V. Source

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