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1.
Pharmacoecon Open ; 3(2): 255-264, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30377992

RESUMO

BACKGROUND: With progress being made in the treatment of psoriasis, a variety of clinical research and treatment options are being pursued. This study used a discrete choice experiment (DCE) to estimate treatment characteristic preferences for both patients and physicians in Japan. Subgroup analysis was also applied in order to examine differences within the range of patients and within the range of physicians. METHODS: The DCE was developed with the input of clinical experts in the treatment of psoriasis to ensure inclusion of the most relevant attributes at appropriate levels in a way that is understandable to both physicians and patients. The study was conducted on parallel samples of Japanese physicians (n = 161) and Japanese psoriasis patients (n = 306) through an online panel. For each sample, a conditional logit statistical model and subgroup analysis were then performed to estimate respondent preferences for treatment attributes. RESULTS: The overall findings are that better treatment efficacy as measured by proportion of patients achieving 90% reduction in the Psoriasis Area and Severity Index score (PASI 90), lower risk of adverse events and the availability of a bio-holiday are important decision factors for both patients and physicians. Low injection frequency is less of a priority for both samples. Also, while both groups demonstrate a preference to receive the treatment injections at a clinic by a healthcare professional rather than self-injection at home, this is more pronounced for the patient sample. The physician sample shows considerably more emphasis on the type of injection, though both samples prefer subcutaneous injections to intravenous injections. IMPLICATIONS: This study reveals the importance of addressing both clinical effectiveness and process factors in systemic, non-topical psoriasis treatments to gain acceptance by both physicians and patients. As well as efficacy (as measured by PASI 90), which remains a consistent priority in treatment, administration and development of new treatments should also consider process factors such as the mode of administration and possibility for a bio-holiday.

2.
J Glob Oncol ; 4: 1-9, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-30241183

RESUMO

This article adds the Japanese perspective to our knowledge of shared decision-making (SDM) preferences by surveying patients with prostate cancer (PCA) and physicians in Japan. In 2015, 103 Japanese patients with PCA were asked about their SDM preferences by using an Internet-based 5-point-scale questionnaire. Concurrently, 127 Japanese physicians were surveyed regarding their perceptions of patient preferences on SDM. Drivers of preferences and perceptions were analyzed using univariable ordinal logistic regression and graphing the fitted response probabilities. Although 41% of both patients and physicians expressed and expected a desire for active involvement in treatment decisions (a higher rate than in a similar study for the United States in 2001), almost half the Japanese patients preferred SDM, but only 33% of physicians assumed this was their choice. That is, 29% of Japanese physicians underestimated patients' preference for involvement in making treatment decisions. Patients with lower health-related quality of life (as measured by the Functional Assessment of Cancer Therapy-Prostate [FACT-P]) expressed a stronger preference for SDM. The study shows that the worse the medical situation, the more patients with PCA prefer to be involved in the treatment decision, yet physicians tend to underestimate the preferences of their patients. Perhaps in contrast to common assumptions, Japanese patients are as interested in being involved in decision making as are patients in the United States.


Assuntos
Tomada de Decisões , Relações Médico-Paciente , Neoplasias da Próstata/terapia , Idoso , Idoso de 80 Anos ou mais , Atitude do Pessoal de Saúde , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Participação do Paciente , Preferência do Paciente , Médicos , Qualidade de Vida , Inquéritos e Questionários
3.
Am J Mens Health ; 12(4): 1094-1101, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29774804

RESUMO

The purpose of the present study is to investigate the concordance of treatment preferences between patients and physicians in prostate cancer (PCa) in Japan. An internet-based discrete choice experiment was conducted. Patients and physicians were asked to select their preferred treatment from a pair of hypothetical treatments consisting of four attributes: quality of life (QOL), treatment effectiveness, side effects, and accessibility of treatment. The data were analyzed using a conditional logistic regression model to calculate coefficients and the relative importance (RI) of each attribute. A total of 103 PCa patients and 127 physicians responded. The study looked at 37 patients considered as advanced PCa and 66 who were non-advanced PCa. All of the physicians were urologists. Advanced PCa patients ranked the attributes as follows: treatment effectiveness (RI: 32%), accessibility of treatment (RI: 26%), QOL (RI: 23%), and side effects (RI: 19%). For physicians, the RI ranking was the same as for advanced PCa patients; treatment effectiveness (RI: 29%), accessibility of treatment (RI: 27%), QOL (RI: 26%), and side effects (RI: 18%). For non-advanced PCa patients, accessibility of treatment ranked the highest RI (27%) and treatment effectiveness ranked as the lowest RI (14%). Our study suggests that the ranking of the attributes was consistent between advanced PCa patients and physicians. The most influential attribute was treatment effectiveness. Treatment preferences also vary by disease stage.


Assuntos
Preferência do Paciente , Neoplasias da Próstata/terapia , Qualidade de Vida , Idoso , Tomada de Decisão Clínica , Humanos , Japão , Julgamento , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Invasividade Neoplásica/patologia , Estadiamento de Neoplasias , Neoplasias da Próstata/diagnóstico , Inquéritos e Questionários , Resultado do Tratamento , Urologistas
4.
Rheumatol Ther ; 5(1): 135-148, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29500791

RESUMO

INTRODUCTION: Golimumab has been proven as an effective treatment for rheumatoid arthritis in clinical trials. However, there is a scarcity of data regarding its use in elderly patients in a real-world setting. This study aims to evaluate the safety, effectiveness, and treatment persistence of golimumab in elderly Japanese patients (≥ 75 years) with rheumatoid arthritis. METHODS: This study was a post hoc analysis of post-marketing surveillance data on 5137 Japanese patients with active rheumatoid arthritis who received golimumab for 24 weeks. The study population was divided into two age groups (younger: < 75 years and elderly: ≥ 75 years), and the safety, effectiveness, and treatment persistence of golimumab were assessed. Also, the reasons for discontinuing golimumab treatment were analyzed by multi-logistic regression. RESULTS: During golimumab treatment over 24 weeks, younger and elderly groups exhibited comparable improvement of disease activity as measured by EULAR response criteria with similar overall rates of adverse events. However, the survival curve of golimumab for elderly patients was significantly different from that for younger patients due largely to the discontinuation at 4 weeks. The most common reason for discontinuation in elderly patients was patient choice, while it was disease progression in younger patients. Analysis of elderly patients who discontinued treatment by their own decision identified EULAR good response as a factor associated with continuation of golimumab treatment whereas no predictive factor associated with discontinuation was identified. CONCLUSIONS: The safety and effectiveness of golimumab treatment in elderly Japanese patients aged 75 years or older were comparable to those in younger patients in real-world clinical practice. Analysis of the survival curves suggested that continuous use of golimumab might further improve clinical benefit of golimumab in elderly patients, underpinning the importance of effective communication between physicians and elderly patients based on the treat-to-target strategy. FUNDING: Janssen Pharmaceutical K.K. and Mitsubishi Tanabe Pharma Corporation.

5.
Rheumatol Ther ; 5(1): 185-201, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29470832

RESUMO

INTRODUCTION: The aim of this study was to investigate real-world treatment patterns for use of golimumab and concomitant medications in Japanese patients with rheumatoid arthritis. METHODS: This study was a post hoc retrospective analysis from post-marketing surveillance data on 2350 Japanese patients with moderate/severe rheumatoid arthritis who received golimumab for 24 weeks. The study population was divided based on initiation treatment or dose adjustment patterns with golimumab, methotrexate, or oral glucocorticoids. RESULTS: Logistic regression analysis revealed that the baseline factors associated with administration of golimumab (100 mg) were higher body weight, failure of prior biological therapy (bio-failure), no previous methotrexate use, and respiratory disease, while previous methotrexate use and absence of renal impairment or respiratory disease were associated with concomitant methotrexate therapy, and previous glucocorticoid use was associated with concomitant glucocorticoid therapy. The following associations were identified with regard to dose adjustment during treatment: bio-failure, no previous methotrexate use, previous csDMARDs use, presence of respiratory disease, allergy history, and higher CRP for golimumab dose escalation; shorter disease duration, previous GC, and no previous methotrexate use for methotrexate dose escalation; no prior biological therapy and renal impairment for methotrexate dose reduction; no previous GC use for glucocorticoid dose escalation; and absence of Steinbrocker's stage II/III/IV, absence of Steinbrocker's class II, no bio-failure, and no previous csDMARDs use for glucocorticoid dose reduction. CONCLUSIONS: This study revealed that various baseline factors were associated with initiation of treatment and dose adjustment of golimumab, methotrexate, or oral glucocorticoids, reflecting both the treatment strategies of physicians for improving RA symptoms and/or reducing adverse events. FUNDING: Janssen Pharmaceutical K.K. and Mitsubishi Tanabe Pharma Corporation.

6.
Neuropsychiatr Dis Treat ; 13: 1115-1124, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28458553

RESUMO

BACKGROUND: Long-term maintenance of cognitive function is an important goal of treatment for Alzheimer's disease (AD), but evidence about the long-term efficacy of cholinesterase inhibitors is sparse. To evaluate the long-term efficacy and safety of galantamine for AD in routine clinical practice, we conducted a 72-week post-marketing surveillance study. The effect of galantamine on cognitive function was estimated in comparison with a simulated disease trajectory. PATIENTS AND METHODS: Patients with mild-to-moderate AD received flexible dosing of galantamine (16-24 mg/day) during this study. Cognitive function was assessed by the mini mental state examination (MMSE) and the clinical status was determined by the Clinical Global Impression-Improvement (CGI-I). Changes of the MMSE score without treatment were estimated in each patient using Mendiondo's model. Generalized linear mixed model analysis was performed to compare the simulated MMSE scores with the actual scores. RESULTS: Of the 661 patients who were enrolled, 642 were evaluable for safety and 554 were assessed for efficacy. The discontinuation rate was 46.73%. Cognitive decline indicated by the mean change of actual MMSE scores was significantly smaller than the simulated decline. Individual analysis demonstrated that >70% of patients had better actual MMSE scores than their simulated scores. Significant improvement of CGI-I was also observed during the observation period. Adverse events occurred in 28.5% of patients and were serious in 8.41%. The reported events generally corresponded with the safety profile of galantamine in previous studies. CONCLUSION: These findings support the long-term efficacy of galantamine for maintaining cognitive function and the clinical state in AD patients. Treatment with galantamine was generally safe. Importantly, this study revealed that galantamine improved cognitive function above the predicted level in >70% of the patients.

7.
Pain Pract ; 17(2): 239-248, 2017 02.
Artigo em Inglês | MEDLINE | ID: mdl-27080988

RESUMO

OBJECTIVE: The purpose of this study was to discuss the safety, treatment profile, and clinical effectiveness of 12-month treatment with fentanyl patch (FP), a strong opioid, in medical practice in Japan under the risk minimization action plan (RMAP). METHODS: Patients with moderate-to-severe chronic noncancer pain who had switched to FP from another opioid were registered to take this survey to assess adverse drug reactions (ADRs), therapeutic effect, and pain intensity for up to 12 months. RESULTS: A total of 517 patients were enrolled, and 499 patients (male, 50.9%; mean [SD] age, 63.0 [15.4] years) were included in the safety population. During the 12-month observation period, an ADR occurred in 262 patients (52.5%); most frequent ADRs included nausea (24.2%), somnolence (22.4%), constipation (18.2%), vomiting (9%), and dizziness (4.6%). The prespecified priority survey items, including respiratory depression, drug dependence, and drug withdrawal syndrome, occurred in 2 (both nonserious), 3 (all serious), and 9 (all serious) patients, respectively. In 418 patients from the efficacy population, the response rate was 77.3%, the rate of achievement of the therapeutic goal was 64.5%, and the visual analog scale (VAS) scores for pain severity decreased by 22.3 (26.9) mm. CONCLUSION: Our results identified a reasonable risk-benefit profile for the management of moderate-to-severe chronic noncancer pain in patients previously treated with opioids under long-term treatment with FP under the RMAP. Respiratory depression, drug dependency, and drug withdrawal were rarely observed even under the RMAP in Japan.


Assuntos
Analgésicos Opioides/administração & dosagem , Analgésicos Opioides/uso terapêutico , Dor Crônica/tratamento farmacológico , Fentanila/administração & dosagem , Fentanila/uso terapêutico , Adulto , Idoso , Analgésicos Opioides/efeitos adversos , Feminino , Fentanila/efeitos adversos , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Medição da Dor , Padrões de Prática Médica , Vigilância de Produtos Comercializados , Comportamento de Redução do Risco , Adesivo Transdérmico , Resultado do Tratamento
8.
J Health Psychol ; 22(8): 993-1003, 2017 07.
Artigo em Inglês | MEDLINE | ID: mdl-26786174

RESUMO

This study examined self-efficacy (confidence to exercise), pros (exercise's advantages), and cons (exercise's disadvantages) as variables associated across the transtheoretical model's six stages of change in 403 Japanese college students. A series of logistic regression analyses were conducted. Results showed that higher pros and lower cons were associated with being in contemplation compared to precontemplation. Lower cons were associated with being in preparation compared to contemplation. Higher self-efficacy was associated with being in action compared to preparation as well as being in maintenance compared to action. Lower cons were associated with being in termination compared to maintenance.


Assuntos
Exercício , Comportamentos Relacionados com a Saúde , Autoeficácia , Estudantes , Adulto , Exercício/fisiologia , Exercício/psicologia , Feminino , Comportamentos Relacionados com a Saúde/fisiologia , Humanos , Japão , Masculino , Modelos Psicológicos , Estudantes/psicologia , Universidades , Adulto Jovem
9.
Gynecol Oncol ; 143(2): 246-251, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-27612976

RESUMO

BACKGROUND: In clinical practice, 40mg/m2 of pegylated liposomal doxorubicin (PLD40) has been used as an initial dosage for treating recurrent epithelial ovarian cancer (OC) instead of the recommended dose of 50mg/m2 (PLD50). However, no robust evidence is available to support the use of PLD40. This post-hoc study aimed to compare the efficacy and safety of initial PLD dosages in propensity score (P-score)-matched dataset. METHODS: The data source was a PLD postmarketing surveillance dataset (n=2189) conducted in Japan. Eligibility criteria for the present study were as follows: recurrent OC, history of chemotherapy, and treatment with PLD monotherapy at a dosage between 35.5 and 54.4mg/m2. Overall survival (OS) was compared between PLD50- and PLD40-treated groups using the log-rank test. Incidences of palmar-plantar erythrodysesthesia (PPE) and stomatitis were also compared between the groups. RESULTS: Overall, 503 matched pairs were generated using P-score analysis. The median survival time with PLD50 and PLD40 was 383 and 350days, respectively, with a hazard ratio of 1.10 (95% confidence interval, 0.98-1.26; p=0.211), although the difference was not statistically significant in the P-score-matched dataset. However, the incidence and severity of PPE and stomatitis were significantly lower with PLD40. CONCLUSIONS: Our study showed that the efficacy of PLD did not differ based on initial dosages, but the risk of adverse events was reduced with PLD40. Considering the balance between patient benefits and risks, our results support the use of PLD40 in clinical practice.


Assuntos
Antibióticos Antineoplásicos/uso terapêutico , Doxorrubicina/análogos & derivados , Recidiva Local de Neoplasia/tratamento farmacológico , Neoplasias Epiteliais e Glandulares/tratamento farmacológico , Neoplasias Ovarianas/tratamento farmacológico , Pontuação de Propensão , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Antibióticos Antineoplásicos/administração & dosagem , Carcinoma Epitelial do Ovário , Doxorrubicina/administração & dosagem , Doxorrubicina/uso terapêutico , Feminino , Humanos , Pessoa de Meia-Idade , Neoplasias Epiteliais e Glandulares/mortalidade , Neoplasias Ovarianas/mortalidade , Polietilenoglicóis/administração & dosagem , Polietilenoglicóis/uso terapêutico
10.
BMC Urol ; 16(1): 27, 2016 Jun 08.
Artigo em Inglês | MEDLINE | ID: mdl-27278777

RESUMO

BACKGROUND: Previous studies have demonstrated an association between prostate-specific antigen (PSA) kinetics and predictive value for treatment outcomes. Abiraterone acetate (AA) is a newly approved cytochrome-P450C17 inhibitor for treatment of metastatic castration-resistant prostate cancer (mCRPC), and few studies have evaluated PSA kinetics using AA so far. Results of a study evaluating PSA kinetics in the beginning of AA and enzalutamide responded chemotherapy-treated patients suggested different trends between the drugs. PSA kinetics of AA-treated patients has been reported using large datasets; however, no studies which have fully evaluated PSA kinetics in the beginning treatment. The present study aimed to assess the PSA kinetics and relationship between the PSA kinetics and PSA progression in chemotherapy-naïve and chemotherapy-treated mCRPC patients receiving AA. METHODS: We used two Japanese phase II trial datasets: JPN-201, chemotherapy-naïve mCRPC (n = 48) and JPN-202, chemotherapy-treated mCRPC (n = 46). PSA kinetic parameters were calculated using actual PSA values measured every 4 weeks, and a subgroup analysis was performed to evaluate the influence of early PSA response on time to PSA progression (TTPP). In addition, we used a Cox proportional hazard model to investigate the influence of variables on TTPP. RESULTS: PSA declined from week 4 but took more time to achieve nadir. PSA kinetic parameters were different between the datasets, mean time to PSA nadir was 5.3 ± 5.6 and 2.0 ± 3.4 months, and TTPP was 9.5 ± 7.4 and 3.8 ± 4.8 months in JPN-201 and JPN-202, respectively. In the subgroup analysis of week 4 PSA decline status, Kaplan-Meier curves for TTPP were similar between early responders and non-progression patients in JPN-201 (median, 9.2 vs. 6.5 months, respectively) but separated in JPN-202 (median, 3.7 vs. 1.9 months, respectively). According to univariate Cox regression analysis, achievement of PSA response (≥50 %) at week 12 was associated with TTPP in the both trials, but the hazard ratio of PSA decline (≥30 %) at week 4 was not significant in JPN-201. CONCLUSIONS: Our results suggest that PSA kinetics were not comparable and early PSA response showed different association to TTPP according to prior history of chemotherapy. TRIAL REGISTRATION: The original trials are registered at ClinicalTrials.gov. The identifiers are; JNJ-212082-JPN-201 , registered 20 December 2012 and JNJ-212082-JPN-202 , registered 30January 2013.


Assuntos
Acetato de Abiraterona/uso terapêutico , Antígeno Prostático Específico/sangue , Neoplasias de Próstata Resistentes à Castração/irrigação sanguínea , Neoplasias de Próstata Resistentes à Castração/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos/uso terapêutico , Biomarcadores Tumorais/sangue , Progressão da Doença , Humanos , Japão/epidemiologia , Masculino , Pessoa de Meia-Idade , Prevalência , Neoplasias de Próstata Resistentes à Castração/epidemiologia , Reprodutibilidade dos Testes , Estudos Retrospectivos , Fatores de Risco , Sensibilidade e Especificidade , Resultado do Tratamento
11.
Health Qual Life Outcomes ; 14: 35, 2016 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-26931101

RESUMO

BACKGROUND: Quality of life (QoL) is routinely assessed and evaluated in medical research. However, in Japan, there is a lack of solid cutoff criteria for evaluating QoL improvement in chronic noncancer pain management. The present study was conducted to identify the minimal clinically important change (MCIC) of the Japanese version of EuroQol-5D 3L(EQ-5D) utility score and numeric rating scale (NRS) with an emphasis on chronic noncancer pain. METHODS: The data source for this post hoc research was the post-marketing surveillance (PMS) data for a tramadol/acetaminophen combination tablet, which was previously conducted in real-world settings. The parameters extracted from the PMS data were sociodemographic characteristics, NRS, EQ-5D, and dichotomous physician's global impression of treatment effectiveness (PGI). The optimal cutoff points of MCIC for EQ-5D utility and NRS scores were evaluated using receiver operating characteristics (ROC) analysis. An anchor-based approach using PGI was applied. RESULTS: Data of 710 patients with chronic noncancer pain were extracted from the PMS database. The NRS score decreased by 2.7 (standard deviation, 2.3) points, whereas the EQ-5D score increased by 0.16 (0.20) points at 4 weeks from baseline. The changes from baseline in NRS and EQ-5D were significantly correlated (r = 0.53, p < 0.001). The estimated optimal cutoff points of MCIC for EQ-5D and NRS were 0.10 and -2.0 points, respectively. The area under the curve of ROC was > 0.80 in both analyses. CONCLUSION: These results demonstrated novel cutoff criteria for the Japanese version of EQ-5D, focusing on patients with chronic noncancer pain. The obtained criteria were fairly consistent and can be confidently utilized as an evaluation tool in medical research on chronic noncancer pain in Japan, with additional functionality and usability for QoL assessment in pain management practice. TRIAL REGISTRATION: The data source of this post hoc research was a PMS study with the identifier number UMIN000015901 at umin.ac.jp, UMIN clinical trial registry (UMIN-CTR).


Assuntos
Analgésicos Opioides/administração & dosagem , Dor Crônica/tratamento farmacológico , Dor Crônica/psicologia , Pacientes/psicologia , Pacientes/estatística & dados numéricos , Qualidade de Vida/psicologia , Tramadol/administração & dosagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Análise de Regressão , Estudos Retrospectivos , Resultado do Tratamento
12.
Int J Geriatr Psychiatry ; 31(8): 892-904, 2016 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-26680338

RESUMO

BACKGROUND: Comparative evidence for efficacy and safety of second-generation cholinesterase inhibitors (ChEIs) is still sparse. OBJECTIVES: The purpose of this research is to compare three ChEIs, donepezil, galantamine and rivastigmine, in patients with mild-to-moderate Alzheimer's disease (AD). METHODS: We conducted a systematic review for published articles and included randomised, double-blind, placebo-controlled trials and head-to-head randomised trials evaluating the efficacy and safety of ChEIs in patients with AD. We examined Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-Cog), Neuropsychiatric Inventory (NPI), Clinician's Interview-Based Impression of Change plus caregiver's input (CIBIC+) and Clinical Global Impression of Change (CGIC) as efficacy endpoints. Withdrawals due to adverse events and number of patients experiencing nausea, vomiting, diarrhoea and dizziness were examined as safety profiles. Network meta-analyses were sequentially performed for efficacy and safety outcomes based on drug/dose treatment conditions. RESULTS: Among the 21 trials included, network meta-analysis showed that all treatments were significantly more efficacious than placebo in cognition measured by ADAS-Cog. All treatments except galantamine were significantly more efficacious than placebo in global change in CIBIC+ or CGIC. Across all conditions, no significant efficacy was observed in neuropsychiatric symptoms measured by NPI. Derived hierarchies in the efficacy of treatment conditions were variables across efficacy and safety. CONCLUSIONS: Our analysis is the first attempt to incorporate available direct and indirect evidence. The results suggest that ChEIs should have significant efficacy for cognition and global change assessment, but the efficacy on neuropsychiatric symptoms is questionable in patients with mild-to-moderate AD.


Assuntos
Doença de Alzheimer/tratamento farmacológico , Inibidores da Colinesterase/uso terapêutico , Cognição/efeitos dos fármacos , Idoso , Teorema de Bayes , Inibidores da Colinesterase/efeitos adversos , Donepezila , Feminino , Galantamina/efeitos adversos , Galantamina/uso terapêutico , Humanos , Indanos/efeitos adversos , Indanos/uso terapêutico , Masculino , Pessoa de Meia-Idade , Meta-Análise em Rede , Piperidinas/efeitos adversos , Piperidinas/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Rivastigmina/efeitos adversos , Rivastigmina/uso terapêutico
13.
Hepatol Int ; 10(1): 158-68, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26264253

RESUMO

BACKGROUND: Simeprevir with peginterferon and ribavirin has been used for the treatment of chronic hepatitis caused by genotype 1 hepatitis C virus (HCV). We explored the predictive factors for sustained virological response (SVR) and viral relapse using datasets from four Japanese phase 3 studies (CONCERTO). METHODS: We used a multiple logistic regression model. First, an integrated dataset comprising 357 patients was analyzed. Subsequently, prior treatment-naïve and relapser (223 patients) and nonresponder (134 patients) of interferon-based treatment subsets were analyzed to identify predictors of SVR. A subset of nonresponders (106 patients) who were treated ≥24 weeks was also analyzed to identify predictors for viral relapse. RESULTS: In the integrated dataset, prior treatment response was significantly associated with SVR. In subset analyses, interleukin-28B (IL28B) TT genotype and undetectable plasma HCV RNA level at week 4 were associated in treatment-naïve patients and relapsers [odds ratio (OR); 4.106 and 3.701, respectively]. In the nonresponders, the IL28B TT genotype population was very small, and inosine triphosphatase (ITPA) and undetectable plasma HCV RNA at week 4 were associated (OR; 2.506 and 3.333, respectively). Furthermore, ribavirin dose intensity (RBV-DI) and detectable plasma HCV RNA at week 4 were significantly associated with viral relapse (OR; 0.327 and 2.922, respectively). CONCLUSION: IL28B and plasma HCV RNA level at week 4 were clinically relevant predictive factors for SVR in treatment-naïve patients and relapsers. Moreover, RBV-DI and plasma HCV level at week 4 were identified as relevant predictive factors for viral relapse in nonresponders.


Assuntos
Antivirais/administração & dosagem , Hepacivirus/efeitos dos fármacos , Hepatite C Crônica/tratamento farmacológico , Hepatite C Crônica/virologia , Interferons/administração & dosagem , Ribavirina/administração & dosagem , Simeprevir/administração & dosagem , Adulto , Idoso , Antivirais/farmacologia , Quimioterapia Combinada , Feminino , Hepatite C Crônica/genética , Hepatite C Crônica/imunologia , Humanos , Interleucinas/genética , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , RNA Viral/sangue , Resultado do Tratamento , Carga Viral/efeitos dos fármacos , Adulto Jovem
14.
Neuropsychiatr Dis Treat ; 11: 1511-21, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26150722

RESUMO

BACKGROUND: Social functioning is an important outcome for patients with schizophrenia. To evaluate the effects of paliperidone extended-release (PAL-ER) on social function, symptomatology, and safety in the routine clinical practice, we conducted a 1-year post-marketing surveillance study of PAL-ER. We also explored relationships between symptomatic improvement and socially functional outcome in patients with schizophrenia. PATIENTS AND METHODS: Patients with an established diagnosis of schizophrenia were allowed flexible 3-12 mg/day dosing during the surveillance. Patients were assessed on social functioning using the Social and Occupational Functioning Assessment Scale (SOFAS) and on symptomatology using the Clinical Global Impression-Schizophrenia scale. All adverse events (AEs) were also collected. RESULTS: A total of 1,429 patients were enrolled in the surveillance study, of whom 1,405 were evaluable for safety and 1,142 were evaluable for efficacy. The treatment discontinuation rate for any reason during the observation period was 34.66%. Significant improvements were observed on both Social and Occupational Functioning Assessment Scale and Clinical Global Impression-Schizophrenia scale during the observation period. The percentage of patients with socially functional remission (SOFAS ≥61) also increased significantly. A significant association between early improvements in positive symptoms, sex, severity of negative symptoms at baseline, and socially functional remission was observed. A total of 33.52% of patients had AEs and 8.75% of patients had serious AEs. Despite the recommendation of monotherapy with PAL-ER, 65.84% of patients were given additional antipsychotics (polypharmacy). Post hoc comparisons of monotherapy versus polypharmacy revealed that the monotherapy group had better outcomes and fewer AEs than the polypharmacy treated group. The improvement in social functioning and the rate of socially functional remission did not differ between groups. CONCLUSION: PAL-ER treatment showed effective symptom control and improvement in social functioning. The data suggest that early response to antipsychotic treatment should be important for functional outcomes.

15.
Int J Environ Health Res ; 25(3): 241-53, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-25089023

RESUMO

Single occupancy vehicle (SOV) transportation is a key contributor to climate change and air pollution. Sustainable transportation (ST), commuting by any means other than SOV, could both slow climate change and enhance public health. The transtheoretical model (TTM) provides a useful framework for examining how people progress towards adopting ST. Short valid and reliable measures for ST decisional balance, self-efficacy, and climate change doubt were developed and their relationship with stages of change was examined. Two large university-based volunteer samples participated in measurement studies. Using multiple procedures, three brief internally consistent measures were developed: decisional balance, self-efficacy, and climate change doubt. The stages of change correctly discriminated both decisional balance and self-efficacy, as well as replicated hypothesized relationships. Climate change doubt did not vary by stages; however, it may prove useful in future studies. Results support the validation of these measures and the application of the TTM to ST.


Assuntos
Conservação dos Recursos Naturais , Modelos Teóricos , Veículos Automotores , Adulto , Atitude , Mudança Climática , Feminino , Humanos , Masculino , New England , Análise de Componente Principal , Reprodutibilidade dos Testes , Autoeficácia , Universidades , Adulto Jovem
16.
Health Educ Res ; 30(1): 162-78, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-24794584

RESUMO

Smoking and sexual risk behaviors in urban adolescent females are prevalent and problematic. Family planning clinics reach those who are at most risk. This randomized effectiveness trial evaluated a transtheoretical model (TTM)-tailored intervention to increase condom use and decrease smoking. At baseline, a total of 828 14- to 17-year-old females were recruited and randomized within four urban family planning clinics. Participants received TTM or standard care (SC) computerized feedback and stage-targeted or SC counseling at baseline, 3, 6 and 9 months. Blinded follow-up telephone surveys were conducted at 12 and 18 months. Analyses revealed significantly more consistent condom use in the TTM compared with the SC group at 6 and 12, but not at 18 months. In baseline consistent condom users (40%), significantly less relapse was found in the TTM compared with the SC group at 6 and 12, but not at 18 months. No significant effects for smoking prevention or cessation were found, although cessation rates matched those found previously. This TTM-tailored intervention demonstrated effectiveness for increasing consistent condom use at 6 and 12 months, but not at 18 months, in urban adolescent females. This intervention, if replicated, could be disseminated to promote consistent condom use and additional health behaviors in youth at risk.


Assuntos
Preservativos/estatística & dados numéricos , Comportamentos Relacionados com a Saúde , Promoção da Saúde/organização & administração , Abandono do Hábito de Fumar/métodos , Prevenção do Hábito de Fumar , Adolescente , Comportamento do Adolescente , Afro-Americanos , Aconselhamento , Feminino , Humanos , Modelos Psicológicos , Assunção de Riscos , Comportamento Sexual , Doenças Sexualmente Transmissíveis/etnologia , Doenças Sexualmente Transmissíveis/prevenção & controle , Método Simples-Cego , Fumar/etnologia , Fatores Socioeconômicos
17.
J Nutr Educ Behav ; 46(5): 324-33, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24613445

RESUMO

OBJECTIVE: To develop and validate an instrument to assess environmentally conscious eating (Green Eating [GE]) behavior (BEH) and GE Transtheoretical Model constructs including Stage of Change (SOC), Decisional Balance (DB), and Self-efficacy (SE). DESIGN: Cross-sectional instrument development survey. SETTING/PARTICIPANTS: Convenience sample (n = 954) of 18- to 24-year-old college students from a northeastern university. ANALYSIS: The sample was randomly split: (N1) and (N2). N1 was used for exploratory factor analyses using principal components analyses; N2 was used for confirmatory analyses (structural modeling) and reliability analyses (coefficient α). The full sample was used for measurement invariance (multi-group confirmatory analyses) and convergent validity (BEH) and known group validation (DB and SE) by SOC using analysis of variance. RESULTS: Reliable (α > .7), psychometrically sound, and stable measures included 2 correlated 5-item DB subscales (Pros and Cons), 2 correlated SE subscales (school [5 items] and home [3 items]), and a single 6-item BEH scale. Most students (66%) were in Precontemplation and Contemplation SOC. Behavior, DB, and SE scales differed significantly by SOC (P < .001) with moderate to large effect sizes, as predicted by the Transtheoretical Model, which supported the validity of these measures. CONCLUSIONS AND IMPLICATIONS: Successful development and preliminary validation of this 25-item GE instrument provides a basis for assessment as well as development of tailored interventions for college students.


Assuntos
Conservação dos Recursos Naturais/métodos , Tomada de Decisões , Comportamento Alimentar , Autoeficácia , Estudantes/estatística & dados numéricos , Inquéritos e Questionários/normas , Adolescente , Adulto , Estudos Transversais , Análise Fatorial , Feminino , Comportamentos Relacionados com a Saúde , Humanos , Masculino , Modelos Psicológicos , Análise de Componente Principal , Psicometria , Reprodutibilidade dos Testes , Universidades , Adulto Jovem
18.
Glob J Health Sci ; 7(4): 40-4, 2014 Dec 17.
Artigo em Inglês | MEDLINE | ID: mdl-25946916

RESUMO

The aim of this 2-week study was to examine the effects of self-administered acupressure intervention onlevels of mood of 54 students (34 males and 20 females) majoring in acupuncture and moxibustion medicineat a college located in Fukuoka, Japan. Eligibility criteria were the ability to complete the intervention accurately and no history of psychiatric diseases. The students were randomly assigned to one of the two groups: an intervention group (IG, n = 28) and a control group (CG, n = 26). The IG participants completed fiveacupressure sessions three times a day (morning, noon, and night), involving the application of pressure to six acupuncture points (GB12, SI17, and LI18 according to 2008 World Health OrganizationRegional Office in the Western Pacific standard), three on the left and three on the right side of the neck for 5 s each. The CG participants were requested to spend their time as usual. Self-reported levels of tension-anxiety, depression-dejection, anger-hostility, vigor, fatigue, and confusion over the past week were measured before and after the study as the main outcomes. Side effects were not predicted and not assessed. The retention rate of this trial was 100%. Improvements in mood, defined as a change from baseline to 2 weeks later, were significantly greater in IG. Our results showed that self-administered intervention had the ability to alter mood levels in college students.


Assuntos
Acupressão/métodos , Afeto , Autocuidado/métodos , Estudantes/psicologia , Adulto , Análise de Variância , Ansiedade/psicologia , Ansiedade/terapia , Depressão/psicologia , Depressão/terapia , Fadiga/psicologia , Fadiga/terapia , Feminino , Humanos , Japão , Masculino , Resultado do Tratamento
19.
Transl Behav Med ; 3(1): 62-71, 2013 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-23630546

RESUMO

The dominant paradigm of changing multiple health behaviors (MHBs) is based on treating, assessing, and studying each behavior separately. This study focused on individuals with co-occurring baseline health-risk behavior pairs and described whether they changed over time on both or only one of the behaviors within each pair. Data from five randomized trials of computer-tailored interventions (CTIs) that simultaneously treated MHBs were analyzed. The differences between treatment and control proportions that achieved paired action and singular action at 24 months follow-up, and the proportional contribution of paired action to overall change on each behavior, were assessed across 12 behavior pairs (including energy balance, addictive, and appearance-related behaviors). CTIs consistently produced more paired action across behavior pairs. Paired action contributed substantially more to the treatment-related outcomes than singular action. Studying concurrent changes on MHBs as demonstrated allows the effect of simultaneously treating MHBs to be assessed.

20.
Risk Anal ; 32(12): 2182-97, 2012 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-22642774

RESUMO

Drinking water supplies are at risk of contamination from a variety of physical, chemical, and biological sources. Ranked among these threats are hazardous material releases from leaking or improperly managed underground storage tanks located at municipal, commercial, and industrial facilities. To reduce human health and environmental risks associated with the subsurface storage of hazardous materials, government agencies have taken a variety of legislative and regulatory actions--which date back more than 25 years and include the establishment of rigorous equipment/technology/operational requirements and facility-by-facility inspection and enforcement programs. Given a history of more than 470,000 underground storage tank releases nationwide, the U.S. Environmental Protection Agency continues to report that 7,300 new leaks were found in federal fiscal year 2008, while nearly 103,000 old leaks remain to be cleaned up. In this article, we report on an alternate evidence-based intervention approach for reducing potential releases from the storage of petroleum products (gasoline, diesel, kerosene, heating/fuel oil, and waste oil) in underground tanks at commercial facilities located in Rhode Island. The objective of this study was to evaluate whether a new regulatory model can be used as a cost-effective alternative to traditional facility-by-facility inspection and enforcement programs for underground storage tanks. We conclude that the alternative model, using an emphasis on technical assistance tools, can produce measurable improvements in compliance performance, is a cost-effective adjunct to traditional facility-by-facility inspection and enforcement programs, and has the potential to allow regulatory agencies to decrease their frequency of inspections among low risk facilities without sacrificing compliance performance or increasing public health risks.


Assuntos
Água Potável , Poluentes Químicos da Água/análise , Abastecimento de Água , Humanos , Rhode Island , Estados Unidos , United States Environmental Protection Agency
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