Metabolic Syndrome in German Patients with Schizophrenia - Baseline-data from Treatment-naive Patients and Patients Previously Treated with Antipsychotics

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1
Author(s):  
S. Kraemer ◽  
A. Minarzyk ◽  
C. Beal ◽  
H.P. Hundemer ◽  
T. Forst ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
Atypical Antipsychotics ◽  
American Heart ◽  
Previous Treatment ◽  
Antipsychotic Treatment ◽  
Lower Prevalence ◽  
Antipsychotic Therapy ◽  
Treatment Naïve ◽  
Previously Treated Patients ◽  
Previously Treated

Introduction:Several studies have already reported increased prevalence of metabolic and cardiovascular risk factors in patients on antipsychotics. This observational aimed to assess the prevalence of metabolic syndrome (MetS) in differently treated patients with schizophrenia.Methods:Patients with schizophrenia (age >=18 years) from 162 psychiatric practices throughout Germany were enrolled if they were either treatment-naive and initiated on antipsychotic therapy, or had received previous antipsychotic treatment and were switched to a new medication. Baseline physical and laboratory parameters were evaluated to assess the prevalence of MetS (American Heart Association's definition). Clopper-Pearson 95%CIs were calculated. Patients were assigned to evaluation cohorts by previous treatment: olanzapine (Olz, N=62), risperidone (Risp, N=67), quetiapine (Quet, N=49), other atypical monotherapy (Atyp, N=103), typical therapy (Typ, N=90), atypical combination (Comb, N=109), treatment-naive (TN, N=162).Results:The sample included 642 patients, mean age 45.2 ±13.3 years, 325 (50.6%) women. Characteristics for the TN-cohort were: mean BMI 25.3 ±4.5, mean blood triglycerides 157.3 ±122.4 mg/DL, rates of concomitant diseases (28.4%), and prevalence of MetS (24.7%, CI18.3;32.1). in comparison, previously treated patients had a mean BMI: 27.0 ±4.9 (Quet) to 29.3 ±5.4 (Comb), mean triglycerides: 182.4 ±116.9mg/DL (Risp) to 232.3 ±164.3mg/DL (Comb), concomitant diseases: 29.9% (Risp) to 41.7% (Comb), MetS: 42.4% (Risp, CI30.3-55.2) to 57.0% (Comb, CI47.1-66.5).Conclusion:TN-patients (see above) had a significantly lower prevalence of MetS than the overall sample (42.8 CI 38.9;46.7). Comb-patients showed the highest prevalence of MetS. Typ-patients had a similar prevalence of MetS (43.3, CI32.9;54.2) than patients treated with atypical antipsychotics.

Abstract 95: Nonvalvular Atrial Fibrillation Emergency Department Encounters where Dabigatran Etexilate was Administered are Associated with Lower Admission Rate Compared to Encounters where Warfarin was Administered

2013 ◽  
Vol 6 (suppl_1) ◽  
Author(s):  
Eileen Fonseca ◽  
David R Walker ◽  
Gregory P Hess
Keyword(s):  
Atrial Fibrillation ◽  
Emergency Department ◽  
Sensitivity Analysis ◽  
Propensity Score ◽  
Dabigatran Etexilate ◽  
Admission Rate ◽  
Nonvalvular Atrial Fibrillation ◽  
Treatment Naïve ◽  
Previously Treated Patients ◽  
Previously Treated

Background: Warfarin and dabigatran etexilate (DE) are oral anticoagulants (OAC) that reduce stroke risk among patients with nonvalvular atrial fibrillation (AF). However, DE does not require titration and INR monitoring. This study examined whether emergency department (ED) rate of admissions differed between the two therapies. Methods: Admission rate was evaluated for hospital encounters initiated in the ED, with a primary or secondary discharge diagnosis of AF between 1/1/2011-3/31/2012, with DE or warfarin administered during the encounter, and excluding encounters of valvular AF patients. Encounters were identified from a hospital Charge Detail Masters database containing 387 eligible hospitals. Samples were propensity score matched using nearest neighbor within a caliper of 0.20 standard deviations of the logit, without replacement, and a 2:1 match. Admission rates were estimated for encounters representing previously-treated patients and those representing treatment-naive patients using binominal generalized linear models, fitted by generalized estimating equations (clustered by hospital). Covariates estimating the propensity score and admission rate included age, payer type, use of bridging agents, AF as primary or secondary diagnosis, CHADS 2 and HAS-BLED scores, comorbid conditions, and hospital attributes. As a sensitivity analysis, admission rate was also estimated from the unmatched sample. Results: Matched samples included 2,688 warfarin and 1,344 DE ED encounters of previously-treated patients out of 15,053 and 1,367 ED encounters, respectively; and 2,578 warfarin and 1,289 DE ED encounters of OAC-treatment-naive patients out of 8,361 and 1,406 ED encounters, respectively. There were too few (n<5) matched encounters where the patient had prior OAC use but were new to the drug administered during the encounter, so these were excluded. No covariates used in matching had standardized mean differences > 10% after matching. Among the previously-treated sample, the estimated admission rate was 3.2% lower for DE compared to warfarin (88.3% vs. 91.5%, p=0.010) with sensitivity analysis confirming a lower admission rate for DE (91.1% vs. 93.8%, delta=2.7%, p=0.001). Among the treatment-naive sample, DE had a 1.2% lower admission rate compared to warfarin (95.2% vs. 96.3%, p=0.048). Sensitivity analysis confirmed a lower admission rate for DE (95.5% vs. 97.0%, delta=1.5%, p=0.001). Conclusions: While the vast majority of AF encounters initiated in the ED result in admission, encounters where patients were treated with DE as continuing or new therapy were less likely to be admitted compared to similar encounters where warfarin was administered.

The efficacy and safety of sunitinib in patients with advanced well-differentiated pancreatic neuroendocrine tumors.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 380-380 ◽  
Author(s):  
Eric Raymond ◽  
Matthew H. Kulke ◽  
Shukui Qin ◽  
Michael Schenker ◽  
Antonio Cubillo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Neuroendocrine Tumors ◽  
Phase Iii ◽  
Pancreatic Neuroendocrine Tumors ◽  
Pivotal Phase ◽  
Treatment Naïve ◽  
Phase Iii Study ◽  
Previously Treated Patients ◽  
Previously Treated ◽  
Well Differentiated

380 Background: Sunitinib was approved by the FDA in 2011 for treatment of progressive, well-differentiated, advanced pancreatic neuroendocrine tumors (pNETs) based on a pivotal phase III study (NCT00428597) that showed a significant increase in progression-free survival (PFS) over placebo following early study termination. Subsequently, the FDA requested a post-approval study to support these findings. Methods: In this open-label, phase IV clinical trial (NCT01525550), patients with progressive, well-differentiated, unresectable advanced/metastatic pNETs received continuous sunitinib 37.5 mg once daily. Eligibility criteria were similar to the phase III study. Primary endpoint was investigator-assessed PFS per RECIST 1.0. This study is ongoing. Results: Sixty one treatment-naïve and 45 previously treated patients with progressive pNETs were treated with sunitinib: mean age, 54.6 years; males, 59.4%; white, 63.2%; ECOG PS 0, 65.1% or PS 1, 34.0%; and prior somatostatin analog, 48.1% (treatment-naïve, 39.3%; previously treated, 60.0%). At the data cutoff date, 82 (77%) patients discontinued treatment, mainly due to disease progression (46%). Median duration of treatment was ~11.9 months. Investigator-assessed median PFS (mPFS) was 13.2 months (95% CI, 10.9–16.7) in the overall population, with comparable mPFS in treatment-naïve and previously treated patients (13.2 vs 13.0 months). mPFS per independent radiologic review was 11.1 months (95% CI, 7.4–16.6). Objective response rate (ORR) per RECIST was 24.5%: 21.3% in treatment-naïve and 28.9% in previously treated patients. Median overall survival, although not yet mature, was 37.8 months. Treatment-emergent, all-causality adverse events (AEs) reported by ≥ 20% of all patients included neutropenia, diarrhea, leukopenia, fatigue, hand–foot syndrome, hypertension, abdominal pain, dysgeusia, and nausea. Most common grade 3/4 AEs were neutropenia (22%) and diarrhea (9%). Conclusions: The mPFS of 13.2 months and ORR of 24.5% observed in this study support the outcomes of the pivotal phase III study of sunitinib in pNETs and confirm its activity in this setting. AEs were consistent with known safety profile of sunitinib. Clinical trial information: NCT01525550.

Overall survival results for durvalumab and savolitinib in metastatic papillary renal cancer.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 619-619 ◽  
Author(s):  
Cristina Suarez Rodriguez ◽  
James M. G. Larkin ◽  
Poulam Patel ◽  
Begona Pérez Valderrama ◽  
Alejo Rodriguez-Vida ◽  
...  
Keyword(s):  
Overall Survival ◽  
Renal Cancer ◽  
Progression Free Survival ◽  
Clinical Activity ◽  
Treatment Naïve ◽  
Previously Treated Patients ◽  
Previously Treated ◽  
Grade 3 ◽  
Treatment Safety

619 Background: There is a strong rationale for investigating MET and PD-L1 inhibition in metastatic papillary renal cancer (PRC). We previously reported response rates (RR) and progression free survival (PFS) for savolitinib (MET inhibitor) and durvalumab (PD-L1 inhibitor) together. Here we report overall survival (OS) data available 12 months after the last patient was enrolled. Methods: This single arm phase I/II trial explores durvalumab (1500mg Q4W) and savolitinib (600mg OD) together in PRC, with a 4wk savolitinib run in. Treatment naïve or previously treated patients with metastatic PRC were included. Confirmed RR (RECIST v1.1), PFS, tolerability (CTCAE v4.03) and overall survival (OS) were analysed. MET and PD-L1 biomarkers were explored (NCT02819596). Results: 42 patients were enrolled with 41 receiving at least one dose of study treatment. Safety and efficacy analyses were performed on these 41 patients. The median follow up was 14.3 months. IMDC good, intermediate and poor risk disease occurred in 29%, 63%, and 7% of patients respectively. Overall confirmed RR was 27% while median PFS was 4.9 months (95% CI: 2.5 – 12.0 months). Median OS was 12.3 months (95% CI: 5.8 – 21.3 months). Confirmed RR and median OS in the previously untreated cohort (N=27) were 33% and 12.3 months (95% CI: 4.7 – not reached (NR) months) respectively. Treatment related Grade 3/4 toxicity occurred in 34% of patients. No new safety signals were seen. PD-L1 and MET expression were not associated with higher RR (25% and 40% respectively) or longer OS. Conclusions: The combination of savolitinib and durvalumab has clinical activity in PRC and outcomes were not enhanced in biomarker positive cancers. Clinical trial information: NCT02819596.

Ipilimumab in Treatment-naive and Previously Treated Patients with Metastatic Melanoma

2012 ◽  
Vol 35 (1) ◽  
pp. 73-77 ◽  
Author(s):  
John A. Thompson ◽  
Omid Hamid ◽  
David Minor ◽  
Asim Amin ◽  
Ilan G. Ron ◽  
...  
Keyword(s):  
Metastatic Melanoma ◽  
Treatment Naïve ◽  
Previously Treated Patients ◽  
Previously Treated

scholarly journals Monocyte-mediated inhibition of lymphocyte blastogenesis in Hodgkin disease

Blood ◽  
1978 ◽  
Vol 52 (2) ◽  
pp. 261-271
Author(s):  
GP Schechter ◽  
F Soehnlen
Keyword(s):  
Previous Treatment ◽  
Hodgkin Disease ◽  
Mononuclear Leukocytes ◽  
Cell Mediated Immunity ◽  
Lymphocyte Blastogenesis ◽  
Previously Treated Patients ◽  
Previously Treated ◽  
High Concentrations ◽  
Disseminated Disease

Mononuclear leukocytes isloated from the blood of previously treated patients with advanced active Hodgkin disease contained high concentrations of monocytes and showed poor lymphocyte blastogenesis to mitogens. In five of eight patients with disseminated disease, blastogenesis became normal or improved markedly when the leukocyte suspensions were depleted of monocytes before culture. Addition of autologous macrophages to the monocyte-depleted lymphocytes resulted in a reappearance of the inhibition of blastogenesis. Monocyte inhibition was associated with the presence of active disease, lymphocytopenia, and low lymphocyte/monocyte ratios in the peripheral blood. The role of previous treatment is uncertain, since inhibition tended to disappear when the patients were retreated. Inhibitory monocyte-lymphocyte interactions may be one of the causes of impaired cell-mediated immunity in Hodgkin disease.

scholarly journals Ocrelizumab initiation in patients with MS

2020 ◽  
Vol 7 (4) ◽  
pp. e719 ◽  
Author(s):  
Erik Ellwardt ◽  
Leoni Rolfes ◽  
Julia Klein ◽  
Katrin Pape ◽  
Tobias Ruck ◽  
...  
Keyword(s):  
Side Effects ◽  
Disease Course ◽  
Relapsing Remitting ◽  
Immune Therapies ◽  
Treatment Naïve ◽  
Previously Treated Patients ◽  
Pretreated Patients ◽  
Previously Treated ◽  
Class Iv

ObjectiveTo provide first real-world experience on patients with MS treated with the B cell–depleting antibody ocrelizumab.MethodsWe retrospectively collected data of patients who had received at least 1 treatment cycle (2 infusions) of ocrelizumab at 3 large neurology centers. Patients' characteristics including premedication, clinical disease course, and documented side effects were analyzed.ResultsWe could identify 210 patients (125 women, mean age ± SD, 42.1 ± 11.4 years) who had received ocrelizumab with a mean disease duration of 7.3 years and a median Expanded Disability Status Scale score of 3.75 (interquartile range 2.5–5.5; range 0–8). Twenty-six percent of these patients had a primary progressive MS (PPMS), whereas 74% had a relapsing-remitting (RRMS) or active secondary progressive (aSPMS) disease course. Twenty-four percent of all patients were treatment naive, whereas 76% had received immune therapies before. After ocrelizumab initiation (median follow-up was 200 days, range 30–1,674 days), 13% of patients with RRMS/aSPMS experienced a relapse (accounting for an annualized relapse rate of 0.17, 95% CI 0.10–0.24), and 5% of all patients with MS experienced a 12-week confirmed disability progression. Treatment was generally well tolerated, albeit only short-term side effects were recorded, including direct infusion-related reactions and mild infections.ConclusionsWe provide class IV evidence that treatment with ocrelizumab can stabilize naive and pretreated patients, indicating that ocrelizumab is an option following potent MS drugs such as natalizumab and fingolimod. Further studies are warranted to confirm these findings and to reveal safety concerns in the longer-term follow-up.Classification of evidenceThis study provides Class IV evidence that for patients with MS, ocrelizumab can stabilize both treatment-naive and previously treated patients.

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