scholarly journals Long-term oral blonanserin treatment for schizophrenia: a review of Japanese long-term studies

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Mitsukuni Murasaki ◽  
Yoshifumi Inoue ◽  
Hiroshi Nakamura ◽  
Toshihiko Kinoshita
Keyword(s):  
Antipsychotic Medication ◽  
Negative Symptoms ◽  
Clinical Symptoms ◽  
Open Label ◽  
Eligibility Criteria ◽  
Long Term Treatment ◽  
Negative Score ◽  
Positive Score ◽  
Long Term Studies

AbstractIn general, the course of schizophrenia is chronic accompanied not only by positive and negative symptoms but also by cognitive dysfunction associated with psychosocial disability, and thus treatment combining antipsychotics and psychological therapy is considered promising. This review focused on two prospective, open-label, multicenter, phase 3 long-term studies for approval of oral blonanserin for the treatment of schizophrenia. These two studies included both inpatients and outpatients with variable disease duration or symptom prominence according to the Positive and Negative Syndrome Scale (PANSS). The selected two studies consisted of almost the same study schedule and eligibility criteria but different protocols regarding prior medications and concomitant antipsychotics. The proportion of patients who had a baseline PANSS negative score higher than the positive score was 82.2 and 67.2% in the two studies. In both studies, patients with an illness duration of ≥ 10 years were the most common. Based on the clinical symptoms at baseline, the physician determined the treatment: blonanserin monotherapy, blonanserin in combination with the existing antipsychotic medication, or therapy simplified to haloperidol together with blonanserin. The 28-week completion rate for long-term blonanserin treatment was high in both studies (82.2 and 78.7%). The types of adverse events in both studies were similar to those in the preceding 8-week randomized, active-controlled studies in Japan, which were included in the application package for the approval of oral blonanserin for patients with schizophrenia. Long-term blonanserin use did not increase the risk of extrapyramidal symptoms but reduced the dose of antiparkinsonian drugs, minimally affecting functioning. In both studies, the PANSS total score, positive score, and negative score were improved at the last observation carried forward compared with those at baseline. In conclusion, blonanserin is useful for long-term treatment of chronic schizophrenic patients when the appropriate management of clinical symptoms and adverse drug reactions are applied. Blonanserin might represent a promising treatment option that partially or completely relieves patients with chronic schizophrenia of polypharmacy. Blonanserin may possibly fit both the current real-world clinical setting and the currently recommended approach to antipsychotic medication.

scholarly journals Long-term treatment of patients with idiopathic pulmonary fibrosis with nintedanib: results from the TOMORROW trial and its open-label extension

Thorax ◽  
2017 ◽  
Vol 73 (6) ◽  
pp. 581-583 ◽  
Author(s):  
Luca Richeldi ◽  
Michael Kreuter ◽  
Moisés Selman ◽  
Bruno Crestani ◽  
Anne-Marie Kirsten ◽  
...  
Keyword(s):  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Term Treatment ◽  
Adverse Event Profile ◽  
Open Label ◽  
Comparator Group ◽  
Long Term Treatment ◽  
Open Label Extension ◽  
Rate Of Decline

The TOMORROW trial of nintedanib comprised a randomised, placebo-controlled, 52-week period followed by a further blinded treatment period and an open-label extension. We assessed outcomes across these periods in patients randomised to nintedanib 150 mg twice daily or placebo at the start of TOMORROW. The annual rate of decline in FVC was −125.4 mL/year (95% CI −168.1 to −82.7) in the nintedanib group and −189.7 mL/year (95% CI −229.8 to −149.6) in the comparator group. The adverse event profile of nintedanib remained consistent throughout the studies. These results support a benefit of nintedanib on slowing progression of idiopathic pulmonary fibrosis beyond 52 weeks.

Long-term outcomes in patients with schizophrenia treated with risperidone long-acting injection or oral antipsychotics in Spain: Results from the electronic Schizophrenia Treatment Adherence Registry (e-STAR)

2009 ◽  
Vol 24 (5) ◽  
pp. 287-296 ◽  
Author(s):  
J.M. Olivares ◽  
A. Rodriguez-Morales ◽  
J. Diels ◽  
M. Povey ◽  
A. Jacobs ◽  
...  
Keyword(s):  
Observational Study ◽  
Treatment Adherence ◽  
Prospective Observational Study ◽  
Clinical Symptoms ◽  
Retrospective Chart Review ◽  
Treatment Retention ◽  
Severity Scores ◽  
Long Term Treatment ◽  
Long Acting

AbstractBackgroundThe electronic Schizophrenia Treatment Adherence Registry (e-STAR) is a prospective, observational study of patients with schizophrenia designed to evaluate long-term treatment outcomes in routine clinical practice.MethodsParameters were assessed at baseline and at 3 month intervals for 2 years in patients initiated on risperidone long-acting injection (RLAI) (n = 1345) or a new oral antipsychotic (AP) (n = 277; 35.7% and 36.5% on risperidone and olanzapine, respectively) in Spain. Hospitalization prior to therapy was assessed by a retrospective chart review.ResultsAt 24 months, treatment retention (81.8% for RLAI versus 63.4% for oral APs, p < 0.0001) and reduction in Clinical Global Impression Severity scores (−1.14 for RLAI versus −0.94 for APs, p = 0.0165) were significantly higher with RLAI. Compared to the pre-switch period, RLAI patients had greater reductions in the number (reduction of 0.37 stays per patient versus 0.2, p < 0.05) and days (18.74 versus 13.02, p < 0.01) of hospitalizations at 24 months than oral AP patients.ConclusionsThis 2 year, prospective, observational study showed that, compared to oral antipsychotics, RLAI was associated with better treatment retention, greater improvement in clinical symptoms and functioning, and greater reduction in hospital stays and days in hospital in patients with schizophrenia. Improved treatment adherence, increased efficacy and reduced hospitalization with RLAI offer the opportunity of substantial therapeutic improvement in schizophrenia.

621 PL02.05 LONG-TERM TREATMENT OF PATIENTS WITH EOSINOPHILIC GASTRITIS AND/OR EOSINOPHILIC DUODENITIS WITH LIRENTELIMAB, A MONOCLONAL ANTIBODY AGAINST SIGLEC-8

2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
Kathryn Peterson ◽  
Mirna Chehade ◽  
Joseph Murray ◽  
Gary Falk ◽  
Nirmala Gonsalves ◽  
...  
Keyword(s):  
Mast Cells ◽  
Common Adverse Event ◽  
Symptom Improvement ◽  
Duration Of Treatment ◽  
Open Label ◽  
Double Blind ◽  
Long Term Treatment ◽  
Patient Reported ◽  
Symptom Scores

Abstract   Eosinophilic esophagitis (EoE), gastritis (EG), and/or duodenitis (EoD) are associated with accumulation and activation of eosinophils and mast cells in the esophagus, stomach, and/or duodenum, respectively. Lirentelimab (AK002), an antibody against siglec-8, depletes eosinophils and inhibits mast cells. We performed an open-label extension (OLE) study of subjects who completed ENIGMA (a randomized, double-blind, placebo-controlled phase 2 study of lirentelimab in adults with symptomatic, biopsy-confirmed EG and/or EoD, with or without EoE) to evaluate long-term responses. Methods Subjects who received 4 monthly infusions of lirentelimab or placebo during ENIGMA (n = 59) were eligible for the OLE; they received monthly, escalating doses of lirentelimab (0.3 or 1 mg/kg escalating to 3 mg/kg). Symptoms were assessed weekly using an electronic daily patient-reported outcome questionnaire and total symptom scores (TSS) were calculated. Patients underwent upper endoscopy with biopsy at screening and at the end of ENIGMA (day 99, week 16, blinded); in the OLE, endoscopies were performed on day 323 (30 weeks after the first dose in the OLE). Histopathology was assessed by a single pathologist. Results Fifty-eight subjects entered the OLE; 45 completed ≥52 weeks lirentelimab (including exposure during ENIGMA) and 29 completed 70 weeks. Mean TSS improved through week 70 (Figure 1). Subjects receiving 70 weeks lirentelimab (ENIGMA+OLE) had further improvements in TSS from baseline (mean reductions: 68% at weeks 29–30, 70% at weeks 51–52, 75% at weeks 69–70). Symptom scores (abdominal pain, nausea, vomiting, early satiety, appetite loss, abdominal cramping, bloating, diarrhea) decreased significantly from baseline. Treatment response was not associated with concomitant EoE. The most common adverse event was mild to moderate infusion-related reactions, usually with the first infusion. Conclusion In the OLE of the ENIGMA study, patients with EG and or EoD (with or without concomitant EoE) who received lirentelimab had sustained tissue eosinophil depletion and significant long-term symptom improvement. Symptoms continued to improve with duration of treatment. Lirentelimab appears to be a promising targeted treatment for EG and/or EoD.

Fluvoxamine in the Treatment of Trichotillomania: An 8-Week, Open-Label Study

CNS Spectrums ◽  
1998 ◽  
Vol 3 (9) ◽  
pp. 64-71 ◽  
Author(s):  
Gary A. Christenson ◽  
Scott J. Crow ◽  
James E. Mitchell ◽  
Thomas B. Mackenzie ◽  
Ross D. Crosby ◽  
...  
Keyword(s):  
Treatment Response ◽  
Term Treatment ◽  
Hair Pulling ◽  
Short Term ◽  
Open Label ◽  
Short Term Treatment ◽  
Open Label Study ◽  
Label Study ◽  
Long Term Treatment

AbstractThis short-term, open-label study investigates short- and long-term effects of the selective serotonin reuptake inhibitor (SSRI) fluvoxamine for the treatment of trichotillomania (TTM). Additionally, this study aimed to test the hypothesis that the presence of hair pulling compulsiveness is predictive of SSRI response. Nineteen subjects meeting the Diagnostic and Statistical Manual of Mental Disorders, Third Edition Revised, (DSM-III-R) criteria for TTM were treated with fluvoxamine at doses up to 300 mg/day. Random regression analysis of change across time for patients who completed the study (n=14) and those who dropped out (n=5) revealed statistically significant improvements in Physician Rating Scale, hair-pulling episodes, Trichotillomania Impairment Scale, and Trichotillomania Symptom Severity Scale, but not in estimated amount of hair pulled. In addition, the percentage of patients' focused or compulsive hair-pulling symptoms was predictive of treatment response. Unfortunately, all three subjects who entered long-term treatment displayed substantial movement back toward baseline by the end of 6 months. We concluded that fluvoxamine produces moderate reductions in symptoms during the short-term treatment of TTM and that the presence of focused or compulsive hair pulling may be predictive of treatment response. However, responses may be short lived when treatment is extended.

scholarly journals T214. ANTIPSYCHOTIC TREATMENT PATTERNS AND EFFECTS DURING THE EARLY YEARS AMONG 316 NEWLY DIAGNOSED PATIENTS WITH SCHIZOPHRENIA FROM THE OPUS TRIAL

2020 ◽  
Vol 46 (Supplement_1) ◽  
pp. S314-S314
Author(s):  
Nikolai Albert ◽  
Karl Ole Köhler-Forsberg ◽  
Carsten Hjorthøj ◽  
Merete Nordentoft
Keyword(s):  
Early Intervention ◽  
Medical Treatment ◽  
Relapse Rate ◽  
Antipsychotic Medication ◽  
Negative Symptoms ◽  
Psychotic Symptoms ◽  
Follow Up Studies ◽  
Long Term Follow Up

Abstract Background In studies investigating the relapse rate of psychotic symptoms in patients diagnosed with schizophrenia there is a discrepancy between discontinuation studies finding a relapse rate up to 90% after discontinuation of antipsychotic medication and long-term follow-up studies finding approx. 30% of patients living without antipsychotic medication and psychotic symptoms. Long-term follow-up studies often have multiple follow-up assessments, but little is known about the use of medication in the intervals between the follow-up points. While register studies can follow large cohorts of patients, they are unable to investigate psychopathology and level of functioning in patients who discontinue their medication. In this study we use data from a clinical cohort with information on participants symptoms and functioning and combine them with register data on the individual participants prescriptions and hospitalizations. Methods The present study represents a combination of a clinical study from early intervention settings and register-based information on antipsychotic drug use and hospital contacts. For the present study, patients were included 18 months into their 24 months early intervention treatment and followed up 3 ½ year later. At baseline and follow-up we performed clinical assessments with all patients and via the Danish National Hospital Register and the Danish National Prescription Register, we had complete nationwide information for all patients identifying all redeemed prescriptions for antipsychotic drugs from 6 to 42 months after inclusion into the study. Based on medication information from the Danish National Prescription Register, we divided participants in the following four groups: 1) Non-users, 2) compliant on medication, 3) stopped but resumed later with medication, and 4) stopped with medication. Results Of the 316 participants included in this study 94.3% had I diagnosis of schizophrenia. In the 3 years preceding the 5 years follow-up 28.2% did not redeem any prescriptions for antipsychotics drugs while 21.2% discontinued their treatment during the follow-up, 20.9% discontinued their treatment but resumed later and 29.7% remained in stable treatment. At the 5 years follow-up the 30.3% of the Never-users where in competitive employment, the mean psychotic symptom score were 1.4 SD (1.4) and negative symptoms 1.1 SD (0.9). Whiles these results were worse for patients Compliant on medication (17%, 1.9 SD (1.3), 1.8 SD (1.0)), Stopped but resumed medication (10.6%, 22.4 SD (1.4), 1.5 SD (1.0)) and Stopped medication (17%, 1.6 SD (1.3), 1.3 SD (1.0)), respectively. Of the Never-user 23.6% were in remission of both positive and negative symptoms, while this was only the case for 12.8% of those compliant on medication. Discussion This study is a naturalistic cohort study and we are unable to draw any conclusion regarding the causality between symptoms remission and use of antipsychotic medication. The study shows that a substantial proportion of patients, for several years, can discontinue their medical treatment without being re-hospitalized and with lower symptoms burden then patients who continue their medical treatment. Some patients discontinue their treatment but resume it later. These patients have approximately the same functional level and psychotypological scores as those who are compliant with their medical treatment and are treated with equivalent doses of antipsychotic at the time of the follow-up.

The health economic implications of treatment with quetiapine: an audit of long-term treatment for patients with chronic schizophrenia

2001 ◽  
Vol 16 (5) ◽  
pp. 307-312 ◽  
Author(s):  
J. Lynch ◽  
J. Morrison ◽  
N. Graves ◽  
D. Meddis ◽  
M.F. Drummond ◽  
...  
Keyword(s):  
Health Economic ◽  
Case Series ◽  
Chronic Schizophrenia ◽  
Term Treatment ◽  
Revolving Door ◽  
Psychotic Symptoms ◽  
Open Label ◽  
Economic Implications ◽  
Long Term Treatment

SummaryThis retrospective, case series audit assessed the clinical and health-economic impact of long-term treatment with quetiapine (‘Seroquel’), a new atypical antipsychotic, in patients with chronic schizophrenia.The study design was of a case series format, comprising patients entered from one centre into the open-label extension of a multicentre 6-week efficacy study. Twenty-one patients (15 male, six female; mean age 39 years) were studied, of whom 17 (81%) had been rated as ‘partially responsive’ to previous antipsychotics. Data on hospitalisations and information on symptoms were collected retrospectively for the 12 months before quetiapine treatment was initiated and for the 12 months after.Quetiapine was effective in reducing psychotic symptoms with mean BPRS scores reducing significantly, from 38 to 21 (P < 0.005). Motor function was also significantly improved with mean Simpson scale scores reducing from 15 to 12 (P < 0.005). Average inpatient days were reduced by 11% in year two (97 compared with 109 days) while the overall costs of treatment, including drug costs, fell by 5% (I£20,843 to I£19,827).Four patients had been hospitalised for longer than 5 years before starting quetiapine; these chronically institutionalised patients remained in hospital, despite improved clinical outcomes (mean BPRS scores after treatment of 34, compared with 43 before), for the full 12 months of quetiapine treatment. Were the data from this audit to be re-analysed excluding these four patients then average inpatient days would have been reduced by 33% (45 to 30 days) and overall cost of treatment by 19% (I£8617 to I£7011).This audit suggests that treatment with quetiapine over this 1-year period was associated with both clinical improvements and a decreased usage of inpatient services. The reduction in hospitalisation costs would appear to compensate for the increased cost of drug treatment. Significantly, potential savings appear to be greatest for those patients with a ‘revolving door’ pattern of repeated readmission.

scholarly journals Long-term treatment of Cushing’s disease with pasireotide: 5-year results from an open-label extension study of a Phase III trial

Endocrine ◽  
2017 ◽  
Vol 57 (1) ◽  
pp. 156-165 ◽  
Author(s):  
S. Petersenn ◽  
L. R. Salgado ◽  
J. Schopohl ◽  
L. Portocarrero-Ortiz ◽  
G. Arnaldi ◽  
...  
Keyword(s):  
Cushing’S Disease ◽  
Term Treatment ◽  
Phase Iii ◽  
Cushing's Disease ◽  
Extension Study ◽  
Open Label ◽  
Phase Iii Trial ◽  
Long Term Treatment ◽  
Open Label Extension
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