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Cui Y.-M.,Peking University | Wang Z.-N.,Peking University | Chen X.-W.,Lilly Suzhou Pharmaceutical Co | Zhang H.-L.,Peking University | And 2 more authors.
Acta Pharmacologica Sinica | Year: 2012

Aim: To characterize the pharmacokinetics (PKs), pharmacodynamics (PDs), and tolerability of different dose regimens of prasugrel in healthy Chinese subjects. Methods: This was a single-centered, open-label, parallel-design study. Subjects received a single loading dose (LD) of prasugrel followed by once-daily maintenance dose (MD) for 10 d. They were enrolled into 3 groups: 60 mg LD/10 mg MD; 30 mg LD/7.5 mg MD; 30 mg LD/5 mg MD. Blood samples were collected after the first and last dose. The serum concentration of the active metabolite of prasugrel was determined using a LC/MS/MS method. Platelet aggregation was assessed using the VerifyNow-P2Y 12 assay. Results: Thirty-six healthy native Chinese subjects (19 males) aged 18-45 were enrolled; mean age and body weight were similar across the treatment groups (n=12 for each). The metabolite AUC 0-4 and C max increased dose-proportionally across the dose range of 5 mg to 60 mg. The median T max was 0.5 h in all groups. The PD parameters, indicated by the inhibition of ADP-induced platelet aggregation, were met more rapidly in the 60 mg group than the 30 mg group after the LD (94%-98%). This high degree of inhibition of platelet aggregation was maintained following the 10 mg MD (87%-90%) and was lower in the 7.5 mg and 5 mg MD groups (79%-83% and 64%-67%, respectively). Prasugrel was well tolerated in healthy Chinese subjects for single doses up to 60 mg and a MD of 10 mg for 10 d. Conclusion: The PKs and PDs of the active metabolite of prasugrel were similar to those in Chinese subjects reported by a previous bridging study, which demonstrated that the exposure to the active metabolite in Chinese subjects was higher than in Caucasians. © 2012 CPS and SIMM All rights reserved.


PubMed | Nanjing Drum Tower Hospital, Lilly Suzhou Pharmaceutical Co., Peking University and Peking Union Medical College
Type: Journal Article | Journal: Asian journal of andrology | Year: 2016

The impact of erectile dysfunction is distressing to both males and their female partners, but less attention has been paid to identify female partners preferred treatment and sexual quality of life outcomes. The present analysis explores female partners treatment preference for erectile dysfunction in Chinese Men. This was a phase 4, randomized, open-label, multicenter, crossover study in Chinese men with erectile dysfunction who were nave to phosphodiesterase type 5 inhibitor treatments. Eligible patients were randomized to sequential 20-mg tadalafil/100-mg sildenafil or 100-mg sildenafil/20-mg tadalafil for 8 weeks each. Of 418 patients, female partners of 64 patients agreed to enter the study; of 64 patients who entered the study with female partners, 63 were randomized, and 62 completed the study. Baseline demographics and disease characteristics were comparable between treatment groups. Significantly more couples preferred tadalafil compared with sildenafil overall (75.4% vs 24.6%; P < 0.001), and irrespective of erectile dysfunction severity at baseline (P 0.005). Significant improvements in sexual quality of life scores were reported at endpoint (Visit 8) in male patients and female partners in both tadalafil and sildenafil treatment groups (P < 0.001). Significantly higher mean changes from baseline were observed for male patients in the tadalafil group compared with the sildenafil group for the erectile function (P = 0.013) and overall satisfaction (P = 0.019) International Index for Erectile Function domains and the spontaneity domain (P < 0.001) of the Psychological and Interpersonal Relationship Scale. No major safety concerns were reported during the study. Though both treatments were effective, safe, and tolerable, more couples preferred tadalafil compared with sildenafil.


PubMed | Adverse Drug Reaction Reporting Center, REAL WORLD, University of Cincinnati and Lilly Suzhou Pharmaceutical Co.
Type: | Journal: Value in health regional issues | Year: 2016

Acute coronary syndrome (ACS) is a leading cause of morbidity and mortality worldwide.To describe patient profile, treatment patterns, and disease burden for patients with ACS.A retrospective descriptive cohort study was conducted. Data were obtained from electronic medical records from seven Shanghai medical centers. Patients with at least one primary diagnosis of ACS from 2006 to 2012 were included. Patient ACS-related antithrombotic medication use, laboratory tests, key comorbidities, health care utilization, and direct medical costs were examined. Log-linear regression was conducted to explore factors associated with total direct medical costs.The mean age for the 6601 patients included was 69.7 12.5 years, and most of the patients (73%) were men. Comorbidities included diabetes (18.2%), hypertension (21.2%), and hyperlipidemia (8.6%). Out of these, 6466 (98%) patients had been hospitalized for ACS with an average length of stay of 14.0 16.4 days per hospitalization. A total of 914 (13.8%) patients had emergency room visits. Of these, 93.5% received any antithrombotic therapy, including antiplatelet agents (92.7%) and anticoagulants (20.8%). ACS-related direct medical costs (in yuan renminbi []) were 18,421 24,741 per hospitalization, including costs for medications (6,776) and laboratory tests (1,355), and 2,894 7,060 per outpatient visit, including costs for medications (620) and laboratory tests (464). The higher direct medical cost was associated significantly (P < 0.05) with age, being male, antiplatelet and anticoagulant use, and several comorbid disease states (diabetes, hyperlipidemia, hypertension, and chronic kidney disease).Antithrombotic therapeutic treatments were commonly used among patients with ACS in Shanghai, China. Higher treatment costs for patients with ACS in Shanghai, China, involved their antithrombotic medication use and key comorbidities.


Montgomery W.,Eli Lilly and Company | Liu L.,Lilly Suzhou Pharmaceutical Company | Stensland M.D.,Agile Outcomes Research Inc | Xue H.B.,Lilly Suzhou Pharmaceutical Company | And 2 more authors.
ClinicoEconomics and Outcomes Research | Year: 2013

Background: This article describes the personal, societal, and economic burden attributable to schizophrenia in the People's Republic of China and highlights the potential for effective outpatient treatment to reduce this burden given recent changes in the Chinese health care system. The importance of effective antipsychotic therapy in reducing the burden of schizophrenia is also examined. Methods: Published research on the burden, disability, management, and economic costs of schizophrenia in the People's Republic of China was examined in the context of the larger body of global research. Research written in English or Chinese and published before June 2012 was identified using PubMed, CNKI, and Wanfang Med database searches. The contribution of effective antipsychotic therapy in reducing the risk for relapse and hospitalization and improving patients' functioning is described. Results: Schizophrenia imposes a substantial burden on Chinese society, with indirect costs accounting for the majority of the total cost. Functional impairment is high, leading to lost wages and work impairment. In the People's Republic of China, schizophrenia is the most common diagnosis among hospitalized psychiatric patients. Ongoing changes in the Chinese health care system may reduce some barriers to effective relapse prevention in schizophrenia and potentially reduce hospitalizations. The use of antipsychotics for acute episodes and maintenance treatment has been shown to decrease symptom severity and reduce the risk for relapse and hospitalization. However, discontinuing antipsychotic medication appears common and is a strong predictor of relapse. Cost-effectiveness research in the People's Republic of China is needed to examine the potential gains from improved outpatient antipsychotic treatment. Conclusion: Schizophrenia is a very costly mental illness in terms of personal, economic, and societal burden, both in the People's Republic of China and globally. When treated effectively, patients tend to persist longer with antipsychotic treatment, have fewer costly relapses, and have improved functioning. Further research examining the long-term effects of reducing barriers to effective treatments on the societal burden of schizophrenia in the People's Republic of China is needed. © 2013 Montgomery et al.


Ye W.,Eli Lilly and Company | Montgomery W.,Eli Lilly and Company | Kadziola Z.,Eli Lilly and Company | Liu L.,Lilly Suzhou Pharmaceutical Co Ltd | And 3 more authors.
Neuropsychiatric Disease and Treatment | Year: 2014

Background: The aims of this analysis were to identify factors associated with early response (at 4 weeks) to olanzapine treatment and to assess whether early response is associated with better longer-term outcomes for patients with schizophrenia in the People's Republic of China. Methods: A post hoc analysis of a multi-country, 6-month, prospective, observational study of outpatients with schizophrenia or bipolar mania who initiated or switched to treatment with oral olanzapine was conducted using data from the Chinese schizophrenia subgroup (n=330). Factors associated with early response were identified using a stepwise logistic regression with baseline clinical characteristics, baseline participation in a weight control program, and adherence with antipsychotics during the first 4 weeks of treatment. Mixed models for repeated measures with baseline covariates were used to compare outcomes over time between early responders and early nonresponders to olanzapine. Results: One hundred and thirty patients (40%) achieved an early response. Early response was independently predicted by higher baseline Clinical Global Impressions-Severity score (odds ratio [OR] 1.51, 95% confidence interval [CI] 1.15-1.97), fewer years since first diagnosis (OR 0.94, CI 0.90-0.98), a greater number of social activities (OR 1.22, CI 1.05-1.40), participation in a weight control program (OR 1.81, CI 1.04-3.15), and high adherence with antipsychotics during the first 4 weeks of treatment (OR 2.98, CI 1.59-5.58). Relative to early nonresponders, early responders were significantly more likely to meet treatment response criteria at endpoint, had significantly greater symptom improvement (Clinical Global Impressions-Severity), and had significantly greater improvement in functional outcomes (all P<0.05). Conclusion: High levels of adherence to prescribed antipsychotics and participation in a weight control program were associated with early response to olanzapine in Chinese patients with schizophrenia. Early response was associated with greater improvement in symptomatic, functional, and quality of life outcomes at 6 months compared with early nonresponse. Current findings are consistent with previous research outside of the People's Republic of China. © 2014 Ye et al.


Xue H.B.H.,Lilly Suzhou Pharmaceutical Co Ltd | Liu L.,Lilly Suzhou Pharmaceutical Co Ltd | Zhang H.,China Pharmaceutical University | Montgomery W.,Eli Lilly and Company | Treuer T.,Eli Lilly and Company
Neuropsychiatric Disease and Treatment | Year: 2014

Background: Despite the burden of schizophrenia and bipolar disorder in the Chinese population, country-specific data to guide practitioners regarding antipsychotic therapy are lacking. The primary aim of this systematic review was to examine evidence of the efficacy, effectiveness, and safety of olanzapine in Chinese populations. Methods: A systematic literature search was conducted using databases covering international and Chinese core journals using search terms related to schizophrenia and bipolar disorder, specified countries (People's Republic of China, Hong Kong, Taiwan), and olanzapine treatment. Following initial screening, inclusion and exclusion criteria were applied to the search results to identify relevant studies from which data were extracted. Results: A total of 489 publications were retrieved and 61 studies were identified for inclusion. Most studies were related to schizophrenia (n=54), with six studies related to bipolar disorder and one study related to both conditions. The quality of study methods and reporting in international journals was noticeably better than in Chinese language journals. Most studies included relatively small patient populations and were of short duration. The efficacy of olanzapine in Chinese populations was confirmed by multiple comparative and noncomparative studies that found statistically significant reductions in symptom measures in studies conducted for ≥6 weeks (schizophrenia) or ≥3 weeks (bipolar disorder). Findings related to effectiveness (treatment discontinuation, quality of life, and neurocognitive improvements) were generally consistent with those observed in non-Chinese populations. No new safety signals specific for Chinese populations were raised for olanzapine. Conclusion: Chinese and non-Chinese populations with schizophrenia or bipolar disorder treated with olanzapine display broadly similar responses. Differences between these populations, especially in relation to the relative efficacy of olanzapine versus other antipsychotics, may warrant further investigation via studies incorporating both populations. Use of local data to provide evidence for practice guidelines should be encouraged, and may promote ongoing improvements in the quality of research and study reporting. © 2014 Xue et al.


Kimball A.B.,Harvard University | Jemec G.B.E.,Copenhagen University | Yang M.,Analysis Group Inc. | Kageleiry A.,Analysis Group Inc. | And 6 more authors.
British Journal of Dermatology | Year: 2014

Background Quantification of disease severity supports the development of evidence-based treatments. Assessments to capture clinical improvement in hidradenitis suppurativa (HS) can be improved. Objectives This study aimed to validate the Hidradenitis Suppurativa Clinical Response (HiSCR), which is defined as a ≥ 50% reduction in inflammatory lesion count (sum of abscesses and inflammatory nodules, AN), and no increase in abscesses or draining fistulas in HS when compared with baseline as a meaningful clinical endpoint for HS treatment. Methods Patients with ≥ 3 ANs at baseline in a Phase II adalimumab trial for HS were included for analysis. HiSCR achievers vs. nonachievers were assessed at week 16 and week 52. Criteria measures included physician-rated assessments [Hurley stage, modified Sartorius score (MSS), and HS Physician's Global Assessment] and patient-reported outcomes (PROs: visual analogue pain scale, Dermatology Life Quality Index, and Work Productivity and Activity Impairment questionnaire). Test-retest reliability, convergent validity, responsiveness and predictive validity of HiSCR, and its meaningfulness to patients were assessed. Results Among 138 eligible study participants, the majority were female (69·6%) with a mean age of 36·7 years. The mean (median) MSS was 125·2 (85·5) at baseline. Test-retest reliability of the AN count was 0·91. HiSCR was significantly correlated with improvements in all physician-rated and PRO measures (Spearman's rho between -0·61 and -0·27, all P < 0·001). Improvements of all PROs in HiSCR achievers exceeded the respective meaningful improvement thresholds. Conclusions In patients with HS with ≥ 3 ANs, HiSCR achievers had significant improvements in physician-rated and patient-reported HS disease severity and impact. HiSCR is a valid and meaningful endpoint for assessing HS treatment effectiveness in controlling inflammatory manifestations in this population. What's already known about this topic? Hurley stage, modified Sartorius score and Physician's Global Assessment have been used in clinical studies to assess severity of hidradenitis suppurativa. However, these clinical measures assessing treatment effectiveness may not have optimal sensitivity, measurement consistency and ease of use. What does this study add? The Hidradenitis Suppurativa Clinical Response (HiSCR) is a valid, responsive and meaningful clinical endpoint of the inflammatory manifestations of HS that can be adapted to clinical research and daily practice. © 2014 British Association of Dermatologists.


PubMed | Lilly Suzhou Pharmaceutical Co., Juntendo University, Shanghai JiaoTong University, China Japan Friendship Hospital and Eli Lilly and Company
Type: Journal Article | Journal: Diabetes/metabolism research and reviews | Year: 2016

Lispro Mix 25% insulin lispro/75% insulin lispro protamine (LM25) and Lispro Mix 50% insulin lispro/50% insulin lispro protamine (LM50) were compared as starter insulins in East Asian patients with type 2 diabetes.Phase 4, open-label, randomized trial conducted in China, Japan, Korea, and Turkey. Subjects received twice-daily LM25 (n=207) or LM50 (n=196) for 26weeks. The primary outcome was the HbAThe least squares mean changes from baseline in HbALM25 and LM50 were noninferior to each other in improving glycemic control in Asian patients with type 2 diabetes. In addition, LM50 was more efficacious than LM25 with respect to the percentage of subjects reaching target HbA


PubMed | Eli Lilly and Company, Peoples Hospital of Beijing University, China Pharma and Lilly Suzhou Pharmaceutical Company
Type: | Journal: Neuropsychiatric disease and treatment | Year: 2016

The objective of the study was to investigate medication usage patterns, health care resource utilization, and direct medical costs of patients with major depressive disorder (MDD) in Beijing, Peoples Republic of China.Data were extracted from a random sample of the Beijing Urban Employee Basic Medical Insurance database. Patients aged 18 years, with 1 primary diagnosis of MDD and 12-month continuous enrollment after their first observed MDD diagnosis between 2012 and 2013 were identified. Those with a diagnosis of schizophrenia, bipolar disorder, or cancer during the analysis period were excluded.In total 8,484 patients, with a mean age of 57.2 years, were included and 63% were female. The top three commonly observed comorbidities were hypertension (70.9%), anxiety disorder (68.6%), and coronary heart disease (65.1%). Furthermore, 71.4% of patients were treated with antidepressant medications, including 60.5% of patients treated with selective serotonin reuptake inhibitors, followed by noradrenergic and specific serotonergic antidepressants (9.0%) and serotonin-norepinephrine reuptake inhibitors (8.3%). The proportions of patients who discontinued their initial antidepressant within the first and second months after the index date were 45.4% and 77.0%, respectively. Concomitant medications were prescribed for 76.8% of patients. Only 0.42% of patients experienced 1 MDD-related hospitalization(s) during the 1-year follow-up, and the average annual number of hospitalization was 1.2 for those hospitalized. The mean length of stay was 33.4 days per hospitalization. All patients had 1 MDD-related outpatient visit(s). The mean annual number of outpatient visits per patient was 3.1. The mean annual direct medical costs per patient with MDD was RMB 1,694.1 (48.5% for antidepressant medications), and that for hospitalized patients was RMB 21,291.0 (15.0% for antidepressant medications).In Beijing, the majority of patients with MDD were treated in the outpatient setting only and they received antidepressants. Selective serotonin reuptake inhibitors were the most commonly used antidepressants. However, the duration to antidepressant medication was short, and persistence was low. The economic burden of MDD-related hospitalization was considerable.


PubMed | Eli Lilly and Company, University of South Florida, Lilly Suzhou Pharmaceutical Company Ltd and Lilly Emerging Markets
Type: Comparative Study | Journal: Human psychopharmacology | Year: 2016

We compared functional impairment outcomes assessed with Sheehan Disability Scale (SDS) after treatment with duloxetine versus selective serotonin reuptake inhibitors (SSRIs) in patients with major depressive disorder.Data were pooled from four randomized studies comparing treatment with duloxetine and SSRIs (three double blind and one open label). Analysis of covariance, with last-observation-carried-forward approach for missing data, explored treatment differences between duloxetine and SSRIs on SDS changes during 8 to 12 weeks of acute treatment for the intent-to-treat population. Logistic regression analysis examined the predictive capacity of baseline patient characteristics for remission in functional impairment (SDS total score 6 and SDS item scores 2) at endpoint.Included were 2193 patients (duloxetine n = 1029; SSRIs n = 835; placebo n = 329). Treatment with duloxetine and SSRIs resulted in significantly (p < 0.01) greater improvements in the SDS total score versus treatment with placebo. Higher SDS (p < 0.0001) or 17-item Hamilton Depression Rating Scale baseline scores (p < 0.01) predicted lower probability of functional improvement after treatment with duloxetine or SSRIs. Female gender (p 0.05) predicted higher probability of functional improvement after treatment with duloxetine or SSRIs.Treatment with SSRIs and duloxetine improved functional impairment in patients with major depressive disorder. Higher SDS or 17-item Hamilton Depression Rating Scale baseline scores predicted less probability of SDS improvement; female gender predicted better improvement in functional impairment at endpoint.

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