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Search Results: 1 - 10 of 300610 matches for " Bruce J. Kinon "
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Discontinuation of treatment of schizophrenic patients is driven by poor symptom response: a pooled post-hoc analysis of four atypical antipsychotic drugs
Hong Liu-Seifert, David H Adams, Bruce J Kinon
BMC Medicine , 2005, DOI: 10.1186/1741-7015-3-21
Abstract: A post-hoc, pooled analysis was made of 4 randomized, double-blind clinical trials, 24–28 weeks in duration, involving 1627 patients with schizophrenia or a related disorder. Analyses combined all the atypical antipsychotic treatment groups in the studies.The majority of patients (53%) stopped their treatment at an early stage. Poor psychiatric response along with worsening symptoms was the most frequently given reason for discontinuing the course (36%), which was substantially more common than discontinuation due to poor tolerability of the medication (12%). This phenomenon was corroborated by less improvement in patients who discontinued treatment compared with those who completed, based on the PANSS total scores. Discontinuation due to poor response was, apparently, more predominantly linked to patient perception than to physicians' conclusions alone (80% vs. 20%). Discontinuation due to patient perception of poor response appeared to occur particularly early in the course of treatment. Patients who discontinued due to poor toleration of the medication responded in a more comparable manner with completers.Discontinuing treatment may lead to exacerbation of symptoms, undermining therapeutic progress. In these studies, poor response to treatment and worsening of underlying psychiatric symptoms, and to a lesser extent, intolerability to medication were the primary contributors to treatment being discontinued. Our findings suggest that adherence may be enhanced by effective symptom control, as objectively measured and as subjectively perceived. Such strategies may improve patients' willingness to undertake long-term therapy and increase the likelihood of a better prognosis.Adherence to a drug regime is a significant issue in the clinical management of schizophrenia. Early treatment discontinuation on the part of patients with schizophrenia or schizophrenia-like disorders is strikingly common, with estimates of its prevalence in antipsychotic drug trials ranging from
Sexual dysfunction in patients with schizophrenia treated with conventional antipsychotics or risperidone
Hong Liu-Seifert, Bruce J Kinon, Christopher J Tennant, Jennifer Sniadecki, Jan Volavka
Neuropsychiatric Disease and Treatment , 2009, DOI: http://dx.doi.org/10.2147/NDT.S4766
Abstract: al dysfunction in patients with schizophrenia treated with conventional antipsychotics or risperidone Original Research (4673) Total Article Views Authors: Hong Liu-Seifert, Bruce J Kinon, Christopher J Tennant, Jennifer Sniadecki, Jan Volavka Published Date January 2009 Volume 2009:5 Pages 47 - 54 DOI: http://dx.doi.org/10.2147/NDT.S4766 Hong Liu-Seifert1, Bruce J Kinon1, Christopher J Tennant2, Jennifer Sniadecki1, Jan Volavka3 1Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA; 2CJT Biomedical Consulting, South Lake Tahoe, CA, USA; 3New York University, New York, NY, USA Objective: To better understand sexual dysfunction in patients with schizophrenia and its associations with prolactin and reproductive hormones. Methods: This was a secondary analysis of an open-label, one-day study (N = 402). The primary objective of the study was to assess the prevalence of hyperprolactinemia in patients with schizophrenia who had been treated with conventional antipsychotics or risperidone. Other atypical antipsychotics available at the time of the study were not included due to a more favorable prolactin profile. Results: The majority of patients (59% of females and 60% of males) reported impairment of sexual function. In postmenopausal females, risk of impaired sexual interest was increased by 31% for every 10 ng/ml increase in prolactin (p = 0.035). In males, lower testosterone was associated with higher prolactin (p < 0.001) and with orgasmic (p = 0.004) and ejaculatory dysfunction (p = 0.028). Conclusion: These findings suggest that hyperprolactinemia may be associated with sexual dysfunction. They also provide more information on the relationships between prolactin, reproductive hormones, and sexual dysfunction. Sexual dysfunction is an understudied yet important consideration in the treatment of schizophrenia. More attention is warranted in this area as it may provide opportunities for improved quality of life and adherence to treatment for patients.
Sexual dysfunction in patients with schizophrenia treated with conventional antipsychotics or risperidone
Hong Liu-Seifert,Bruce J Kinon,Christopher J Tennant,Jennifer Sniadecki
Neuropsychiatric Disease and Treatment , 2009,
Abstract: Hong Liu-Seifert1, Bruce J Kinon1, Christopher J Tennant2, Jennifer Sniadecki1, Jan Volavka31Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA; 2CJT Biomedical Consulting, South Lake Tahoe, CA, USA; 3New York University, New York, NY, USAObjective: To better understand sexual dysfunction in patients with schizophrenia and its associations with prolactin and reproductive hormones.Methods: This was a secondary analysis of an open-label, one-day study (N = 402). The primary objective of the study was to assess the prevalence of hyperprolactinemia in patients with schizophrenia who had been treated with conventional antipsychotics or risperidone. Other atypical antipsychotics available at the time of the study were not included due to a more favorable prolactin profile.Results: The majority of patients (59% of females and 60% of males) reported impairment of sexual function. In postmenopausal females, risk of impaired sexual interest was increased by 31% for every 10 ng/ml increase in prolactin (p = 0.035). In males, lower testosterone was associated with higher prolactin (p < 0.001) and with orgasmic (p = 0.004) and ejaculatory dysfunction (p = 0.028).Conclusion: These findings suggest that hyperprolactinemia may be associated with sexual dysfunction. They also provide more information on the relationships between prolactin, reproductive hormones, and sexual dysfunction. Sexual dysfunction is an understudied yet important consideration in the treatment of schizophrenia. More attention is warranted in this area as it may provide opportunities for improved quality of life and adherence to treatment for patients.Keywords: sexual dysfunction, schizophrenia, hyperprolactinemia, antipsychotics, risperidone
Clinical and economic ramifications of switching antipsychotics in the treatment of schizophrenia
Douglas E Faries, Haya Ascher-Svanum, Allen W Nyhuis, Bruce J Kinon
BMC Psychiatry , 2009, DOI: 10.1186/1471-244x-9-54
Abstract: Data from a 1-year randomized, open-label cost-effectiveness study involving typical and atypical antipsychotics were assessed. The study protocol permitted switching of antipsychotics when clinically warranted. The risk of crisis-related events, use of acute-care services, and the time to the initial use of such services were determined in outpatients who switched antipsychotics compared with those who continued with their initial medications. Health care resource utilization data were abstracted from medical records and other sources (e.g., patient self-report), and direct costs were estimated using previously published benchmarks.Almost one-third of patients (29.3%) underwent a switch from their initial antipsychotic agent, with an average duration of 100 days before such treatment alterations. Compared with their counterparts who remained on their initial therapies, individuals who switched antipsychotics experienced a significantly higher risk of acute-care services, including hospitalization (p = .013) and crisis services (p = .011). Patients undergoing medication switches also used acute-care services significantly sooner (p = .004) and accrued an additional $3,000 (a 25% increase) in annual total health care costs per patient, most of which was due to acute-care expenditures.Switching antipsychotic medications was found to be associated with considerably poorer clinical and economic outcomes, as reflected by, more frequent and more rapid use of acute-care services compared with persons remaining on their initial treatments.Trial ID 2325 in LillyTrials.com (also accessible via ClinicalStudyResults.org).Antipsychotic medications are mainstays in the management of schizophrenia, yet many patients experience suboptimal improvement (or even worsening) in the core symptoms of their disease or intolerance to their initially prescribed treatments [1-3]. Under such conditions, a clinically indicated change (i.e., switch) in antipsychotics represents a viable treatmen
Predictors of switching antipsychotic medications in the treatment of schizophrenia
Allen W Nyhuis, Douglas E Faries, Haya Ascher-Svanum, Virginia L Stauffer, Bruce J Kinon
BMC Psychiatry , 2010, DOI: 10.1186/1471-244x-10-75
Abstract: This post-hoc analysis used data from a one-year randomized, open-label, multisite study of antipsychotics in the treatment of schizophrenia. The study protocol permitted switching of antipsychotics when clinically warranted after the first eight weeks. Baseline patient characteristics were assessed using standard psychiatric measures and reviews of medical records. The prediction model included baseline sociodemographics, comorbid psychiatric and non-psychiatric conditions, body weight, clinical and functional variables, as well as change scores on standard efficacy and tolerability measures during the first two weeks of treatment. Cox proportional hazards modeling was used to identify the best predictors of switching from the initially assigned antipsychotic medication.About one-third of patients (29.5%, 191/648) switched antipsychotics before the end of the one-year study. There were six variables identified as the best predictors of switching: lack of antipsychotic use in the prior year, pre-existing depression, female gender, lack of substance use disorder, worsening of akathisia (as measured by the Barnes Akathisia Scale), and worsening of symptoms of depression/anxiety (subscale score on the Positive and Negative Syndrome Scale) during the first two weeks of antipsychotic therapy.Switching antipsychotics appears to be prevalent in the naturalistic treatment of schizophrenia and can be predicted by a small and distinct set of variables. Interestingly, worsening of anxiety and depressive symptoms and of akathisia following two weeks of treatment were among the more robust predictors of subsequent switching of antipsychotics.Antipsychotic medications are mainstays in the clinical management of schizophrenia. Although generally effective in ameliorating core manifestations of the disease, some patients experience only suboptimal responses or are intolerant of the medication. This may include insufficient improvement or even worsening of symptoms, as well as a var
Involvement in the US criminal justice system and cost implications for persons treated for schizophrenia
Haya Ascher-Svanum, Allen W Nyhuis, Douglas E Faries, Daniel E Ball, Bruce J Kinon
BMC Psychiatry , 2010, DOI: 10.1186/1471-244x-10-11
Abstract: This post-hoc analysis used data from a prospective one-year cost-effectiveness study of persons treated with antipsychotics for schizophrenia and related disorders in the United States. Criminal justice system involvement was assessed using the Schizophrenia Patients Outcome Research Team (PORT) client survey and the victimization subscale of the Lehman Quality of Life Interview (QOLI). Direct cost of criminal justice system involvement was estimated using previously reported costs per type of encounter. Patients with and without involvement were compared on baseline characteristics and direct annual health care and criminal justice system-related costs.Overall, 278 (46%) of 609 participants reported at least 1 criminal justice system encounter. They were more likely to be substance users and less adherent to antipsychotics compared to participants without involvement. The 2 most prevalent types of encounters were being a victim of a crime (67%) and being on parole or probation (26%). The mean annual per-patient cost of involvement was $1,429, translating to 6% of total annual direct health care costs for those with involvement (11% when excluding crime victims).Criminal justice system involvement appears to be prevalent and costly for persons treated for schizophrenia in the United States. Findings highlight the need to better understand the interface between the mental health and the criminal justice systems and the related costs, in personal, societal, and economic terms.Individuals with severe mental illness are over-represented in the criminal justice system when compared with the larger US population. In the United States each year, approximately 1 million detentions in county jails involve persons with serious mental illnesses. These individuals are imprisoned about 8 times more frequently than they are admitted to state mental hospitals [1] and are incarcerated for significantly longer time than other inmates [2].Although persons with schizophrenia are know
Predictors and correlates for weight changes in patients co-treated with olanzapine and weight mitigating agents; a post-hoc analysis
Virginia L Stauffer, Ilya Lipkovich, Vicki Hoffmann, Alexandra N Heinloth, H Scott McGregor, Bruce J Kinon
BMC Psychiatry , 2009, DOI: 10.1186/1471-244x-9-12
Abstract: Data were obtained from 3 randomized, double-blind, placebo-controlled, 16-week clinical trials. Included were 158 patients with schizophrenia or bipolar disorder and a body mass index (BMI) ≥ 25 kg/m2 who had received olanzapine treatment in combination with nizatidine (n = 68), sibutramine (n = 42), or amantadine (n = 48). Individual patients were analyzed for categorical weight loss ≥ 2 kg and weight gain ≥ 1 kg. Variables that were evaluated as potential predictors of weight outcomes included baseline patient characteristics, factors of the Eating Inventory, individual items of the Eating Behavior Assessment, and the Visual Analog Scale.Predictors/correlates of weight loss ≥ 2 kg included: high baseline BMI, low baseline interest in food, and a decrease from baseline to endpoint in appetite, hunger, or cravings for carbohydrates. Reduced cognitive restraint, increase in hunger, and increased overeating were associated with a higher probability of weight gain ≥ 1 kg.The association between weight gain and lack of cognitive restraint in the presence of increased appetite suggests potential benefit of psychoeducational counseling in conjunction with adjunctive pharmacotherapeutic agents in limiting weight gain during antipsychotic drug therapy.This analysis was not a clinical trial and did not involve any medical intervention.In adult patients with serious and persistent mental illnesses such as bipolar disorder or schizophrenia, obesity is a common comorbidity. [1] Many antipsychotic medications used to treat these diseases are associated with an increased risk of weight gain. A meta-analysis by Allison and colleagues showed a significantly greater incidence of weight gain in patients treated with clozapine or olanzapine compared with patients treated with other atypical antipsychotics. [2] Since 1996, the United States (US) prescribing information for olanzapine has advised clinicians of the potential for significant weight gain in more than 1/4 of patients durin
Acute weight gain, gender, and therapeutic response to antipsychotics in the treatment of patients with schizophrenia
Haya Ascher-Svanum, Michael Stensland, Zhongyun Zhao, Bruce J Kinon
BMC Psychiatry , 2005, DOI: 10.1186/1471-244x-5-3
Abstract: Data were drawn from the acute phase (first 6-weeks) of a double-blind randomized clinical trial of olanzapine versus haloperidol in the treatment of 1296 men and 700 women with schizophrenia-spectrum disorders. The associations between weight change and change in core schizophrenia symptoms, depressive symptoms, and functional status were examined post-hoc for men and women and for each medication group. Core schizophrenia symptoms (positive and negative) were measured with the Brief Psychiatric Rating Scale (BPRS), depressive symptoms with the BPRS Anxiety/Depression Scale and the Montgomery-Asberg Depression Rating Scale, and functional status with the mental and physical component scores on the Medical Outcome Survey-Short Form 36. Statistical analysis included methods that controlled for treatment duration.Weight gain during 6-week treatment with olanzapine and haloperidol was significantly associated with improvements in core schizophrenia symptoms, depressive symptoms, mental functioning, and physical functioning for men and women alike. The conditional probability of clinical response (20% reduction in core schizophrenia symptom), given a clinically significant weight gain (at least 7% of baseline weight), showed that about half of the patients who lost weight responded to treatment, whereas three-quarters of the patients who had a clinically significant weight gain responded to treatment. The positive associations between therapeutic response and weight gain were similar for the olanzapine and haloperidol treatment groups. Improved outcomes were, however, more pronounced for the olanzapine-treated patients, and more olanzapine-treated patients gained weight.The findings of significant relationships between treatment-emergent weight gain and improvements in clinical and functional status at 6-weeks suggest that patients who have greater treatment-emergent weight gain are more likely to benefit from treatment with olanzapine or haloperidol regardless of gende
Effectiveness and medication acceptance of olanzapine disintegrating tablets compared to standard olanzapine tablets in acutely treated psychiatric patients
J rg Czekalla, Thomas Wagner, Alexander Schacht, Michael Kluge, Bruce Kinon
Patient Preference and Adherence , 2007, DOI: http://dx.doi.org/10.2147/PPA.S2300
Abstract: tiveness and medication acceptance of olanzapine disintegrating tablets compared to standard olanzapine tablets in acutely treated psychiatric patients Original Research (4433) Total Article Views Authors: J rg Czekalla, Thomas Wagner, Alexander Schacht, Michael Kluge, Bruce Kinon Published Date December 2007 Volume 2007:1 Pages 19 - 27 DOI: http://dx.doi.org/10.2147/PPA.S2300 J rg Czekalla1, Thomas Wagner2, Alexander Schacht2, Michael Kluge3, Bruce Kinon4 1Department of Psychiatry and Psychotherapy, RWTH Aachen University, Germany; 2Medical Department, Lilly Deutschland GmbH, Bad Homburg, Germany; 3Max Planck Institute for Clinical Psychiatry, Munich, Germany; 4Lilly Research Laboratories, Indianapolis, USA Background: This study compared effectiveness and acceptance of orally disintegrating olanzapine tablets (ODT) with standard-coated tablets (SOT) in acutely ill psychiatric patients admitted to psychiatric hospitals for emergency treatment. Methods: Large, prospective, observational study at hospital emergency units across Germany in patients with a diagnosis or tentative diagnosis of acute schizophrenia treated with ODT or SOT. Clinical (CGI-S and CGI-I) outcomes, attitudes towards medication (Nursing Assessment of Medication Acceptance, NAMA) scale, suicidal ideation, and adverse events were assessed at start of treatment and after 2 weeks. Results: Both olanzapine formulations, ODT (N = 247) and SOT (N = 207), showed similar effectiveness after 2 weeks. CGI-I improved in 92.1% of patients (ODT: 91.8%, SOT: 92.3%). In patients receiving both formulations suicidal ideations were reduced (ODT from 53.9% to 20.6%, SOT from 51.2% to 22.7%). ODT was preferably given to severely ill (SOT: 49.8%, ODT: 64.4%) and aggressive patients. Adverse events were reported for 6.5% of ODT- and 2.9% of SOT-patients. This difference was possibly caused by the characteristics of patients receiving ODT. Conclusions: This non-randomized, observational study shows comparable outcomes and tolerability in patients treated with both olanzapine formulations. In an acute treatment setting, orally disintegrating tablets were preferably used for more severely ill and aggressive patients with low medication acceptance.
Pomaglumetad Methionil (LY2140023 Monohydrate) and Aripiprazole in Patients with Schizophrenia: A Phase 3, Multicenter, Double-Blind Comparison
David H. Adams,Lu Zhang,Brian A. Millen,Bruce J. Kinon,Juan-Carlos Gomez
Schizophrenia Research and Treatment , 2014, DOI: 10.1155/2014/758212
Abstract: We tested the hypothesis that long-term treatment with pomaglumetad methionil would demonstrate significantly less weight gain than aripiprazole in patients with schizophrenia. In this 24-week, multicenter, randomized, double-blind, Phase 3 study, 678 schizophrenia patients were randomized to either pomaglumetad methionil ( ) or aripiprazole ( ). Treatment groups were also compared on efficacy and various safety measures, including serious adverse events (SAEs), discontinuation due to adverse events (AEs), treatment-emergent adverse events (TEAEs), extrapyramidal symptoms (EPS), and suicide-related thoughts and behaviors. The pomaglumetad methionil group showed significantly greater weight loss at Week 24 (Visit 12) compared with the aripiprazole group (?2.8?±?0.4 versus 0.4?±?0.6; ). However, change in Positive and Negative Syndrome Scale (PANSS) total scores for aripiprazole was significantly greater than for pomaglumetad methionil (?15.58?±?1.58 versus ?12.03?±?0.99; ). The incidences of SAEs (8.2% versus 3.1%; ) and discontinuation due to AEs (16.2% versus 8.7%; ) were significantly higher for pomaglumetad methionil compared with aripiprazole. No statistically significant differences in the incidence of TEAEs, EPS, or suicidal ideation or behavior were noted between treatment groups. In conclusion, long-term treatment with pomaglumetad methionil resulted in significantly less weight gain than aripiprazole. This trial is registered with ClinicalTrials.gov NCT01328093. 1. Introduction All of the current antipsychotics target dopamine receptors as their common mechanism of action [1, 2]. Due to differences in the affinities to the dopamine receptors and interactions with other biogenic monoamine receptors, therapeutic profiles and limitations of individual drugs vary [1]. The conventional/typical antipsychotic drugs are effective in treating positive symptoms of schizophrenia [3, 4]. However, they are associated with extrapyramidal symptoms (EPS) and hyperprolactinemia [3, 4]. The newer generation atypical antipsychotics not only improve positive and, to some extent, negative symptoms of schizophrenia [5, 6] but also have a lower propensity to cause EPS [3, 4, 7, 8] and hyperprolactinemia [3, 4]. However, these agents may still be associated with other adverse events (AEs), such as body weight gain, lipid abnormalities [9, 10], and glucose dysregulation [3, 4] in some patients. Furthermore, drug-induced weight gain may affect long-term compliance, which directly influences the likelihood of successfully managing the course of disease [11, 12]. Hence, a
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