Survey of Safety and Efficacy of Long-acting Injectable Risperidone in Daily Practice: An Open-label, Non-interventional Prospective Study

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1 ◽  
Author(s):  
E. Parellada ◽  
F. Kouniakis ◽  
A. Siurkute ◽  
A. Schreiner ◽  
L. Don
Keyword(s):  
Clinical Practice ◽  
Paranoid Schizophrenia ◽  
Daily Practice ◽  
Routine Clinical Practice ◽  
Open Label ◽  
Antipsychotic Therapy ◽  
Patient Functioning ◽  
Insufficient Response ◽  
Long Acting

Objective:This post-authorization safety survey evaluated the long-term safety, tolerability, and efficacy of risperidone long-acting injectable (RLAI) in routine clinical practice.Methods:In this 6-month, multicenter, European, naturalistic survey, patients were included if, during routine clinical practice, long-term antipsychotic therapy with RLAI was deemed necessary by the treating physician. Efficacy measures (at baseline and after 1, 3, 6 months) included Clinical Global Impression-Severity (CGI-S) and Global Assessment of Functioning (GAF). Safety was evaluated by recording treatment-emergent adverse events (TEAEs) at every visit.Results:RLAI was initiated in 5,134 predominantly male (58.6%) patients (aged 14-94 years) with a diagnosis of paranoid schizophrenia (69.8%). RLAI initial doses were 25 mg every-two-weeks in 37.0%, or 50 mg in 44.4% of patients. at endpoint, RLAI dosages were 50 mg in 49.3% of patients, 25 mg in 27.0%, and 37.5 mg in 22.1%. Six-month treatment with RLAI was completed by 4,314 patients (84.0%). RLAI was discontinued due to loss to follow-up (n=346;6.7%), insufficient response (n=116;2.3%), and AEs (n=106;2.1%). CGI-S significantly improved from baseline to endpoint (p< 0.001). Patient functioning in the GAF scale also significantly improved from baseline to endpoint (45.4±16.0 versus 62.4±17.7, respectively, p< 0.001). TEAEs were recorded by 20% of patients. AEs occurring in ≥5% of patients were akathisia, extrapyramidal disorders, depression, psychotic disorder, anxiety, and weight gain. Serious AEs were reported by 384 (8%) patients.Conclusions:This large prospective survey confirms the good safety, tolerability, and efficacy of RLAI as reported in previous controlled clinical trials when used in routine clinical practice.

scholarly journals Personalized management of differentiated thyroid cancer in real life – practical guidance from a multidisciplinary panel of experts

Endocrine ◽  
2020 ◽  
Vol 70 (2) ◽  
pp. 280-291
Author(s):  
Alfredo Campennì ◽  
Daniele Barbaro ◽  
Marco Guzzo ◽  
Francesca Capoccetti ◽  
Luca Giovanella
Keyword(s):  
Nuclear Medicine ◽  
Thyroid Cancer ◽  
Clinical Practice ◽  
Molecular Imaging ◽  
Routine Clinical Practice ◽  
Whole Body ◽  
Neck Ultrasound ◽  
Long Term Follow Up

Abstract Purpose The standard of care for differentiated thyroid carcinoma (DTC) includes surgery, risk-adapted postoperative radioiodine therapy (RaIT), individualized thyroid hormone therapy, and follow-up for detection of patients with persistent or recurrent disease. In 2019, the nine Martinique Principles for managing thyroid cancer were developed by the American Thyroid Association, European Association of Nuclear Medicine, Society of Nuclear Medicine and Molecular Imaging, and European Thyroid Association. In this review, we present our clinical practice recommendations with regard to implementing these principles in the diagnosis, treatment, and long-term follow-up of patients with DTC. Methods A multidisciplinary panel of five thyroid cancer experts addressed the implementation of the Martinique Principles in routine clinical practice based on clinical experience and evidence from the literature. Results We provide a suggested approach for the assessment and diagnosis of DTC in routine clinical practice, including the use of neck ultrasound, measurement of serum thyroid-stimulating hormone and calcitonin, fine-needle aspiration, cytology, and molecular imaging. Recommendations for the use of surgery (lobectomy vs. total thyroidectomy) and postoperative RaIT are also provided. Long-term follow-up with neck ultrasound and measurement of serum anti-thyroglobulin antibody and basal/stimulated thyroglobulin is standard, with 123/131I radioiodine diagnostic whole-body scans and 18F-fluoro-2-deoxyglucose positron emission tomography/computed tomography suggested in selected patients. Management of metastatic DTC should involve a multidisciplinary team. Conclusions In routine clinical practice, the Martinique Principles should be implemented in order to optimize clinical management/outcomes of patients with DTC.

scholarly journals Lipodystrophy syndrome in HIV-infected children on HAART

2009 ◽  
Vol 10 (4) ◽  
pp. 76 ◽  
Author(s):  
Steve Innes ◽  
Leon Levin ◽  
Mark Cotton
Keyword(s):  
Clinical Practice ◽  
Early Detection ◽  
Nucleoside Reverse Transcriptase Inhibitor ◽  
Fat Distribution ◽  
Transcriptase Inhibitor ◽  
Routine Clinical Practice ◽  
Lipodystrophy Syndrome ◽  
Practical Guidelines ◽  
Reverse Transcriptase Inhibitor

Lipodystrophy Syndrome (LD) is common in HIV-infected children, particularly in those taking Didanosine, Stavudine, or Zidovudine. Lipoatrophy in particular causes major stigmatization and interferes with adherence. In addition, LD may have significant long-term health consequences, particularly cardiovascular. Since the stigmatizing fat distribution changes of LD are largely permanent, the focus of management remains on early detection and arresting progression. Practical guidelines for surveillance and avoidance of LD in routine clinical practice are presented. Diagnosis of LD is described and therapeutic options are reviewed. The most important therapeutic intervention is to switch the most likely offending antiretroviral to a non-LD-inducing agent as soon as LD is recognised. Typically, where lipoatrophy or lipohypertrophy is diagnosed, the thymidine nucleoside reverse transcriptase inhibitor (NRTI) is switched to a non-thymidine agent such as Abacavir (or Tenofovir in adults). Where dyslipidaemia is predominant, a dietician review is helpful, and the clinician may consider switching to a protease inhibitor (PI)-sparing regimen or to Atazanavir.

scholarly journals Olanzapine long-acting injection: a review of first experiences of post-injection delirium/sedation syndrome in routine clinical practice

2015 ◽  
Vol 15 (1) ◽  
Author(s):  
Chris J Bushe ◽  
Deborah Falk ◽  
Ernie Anand ◽  
Marta Casillas ◽  
Elena Perrin ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Routine Clinical Practice ◽  
Post Injection ◽  
Long Acting

scholarly journals The Effect of Smartphone-Based Cognitive Training on the Functional/Cognitive Markers of Schizophrenia: A One-Year Randomized Study

2020 ◽  
Vol 9 (11) ◽  
pp. 3681
Author(s):  
Marek Krzystanek ◽  
Krzysztof Krysta ◽  
Mariusz Borkowski ◽  
Katarzyna Skałacka ◽  
Jacek Przybyło ◽  
...  
Keyword(s):  
Cognitive Function ◽  
Cognitive Training ◽  
Cognitive Rehabilitation ◽  
Reference Group ◽  
Paranoid Schizophrenia ◽  
Randomized Study ◽  
Functional Markers ◽  
Open Label ◽  
Antipsychotic Therapy ◽  
The Impact

Background: Cognitive impairment is associated with long-term disability that results in the deterioration of both the social and professional status of individuals with schizophrenia. The impact of antipsychotic therapy on cognitive function is insufficient. Cognitive training is therefore proposed as a tool for cognitive rehabilitation in schizophrenia. In this study we investigated the effect of self-administered cognitive training using a smartphone-based application on the cognitive function of paranoid schizophrenia patients focusing on response time, correct answer rate, incorrect answer rate, and fatigability to check, if these functions can be functional markers of successful cognitive-smartphone rehabilitation. Methods: 1-year multicenter, open-label randomized study was conducted on 290 patients in a state of symptomatic remission. 191 patients were equipped with the full version of the application and conducted cognitive training twice a week. Reference group (n = 99) was provided with a version of the application having only limited functionality, testing the cognitive performance of patients every 6 months. Results: Statistically significant improvement was observed in both the rate of correct answers (by 4.8%, p = 0.0001), and cognitive fatigability (by 2.9%, p = 0.0001) in the study group, along with a slight improvement in the rate of incorrect answers (by 0.9%, p = 0.15). In contrast, the reference group, who performed cognitive training every 6 months, demonstrated no significant changes in any cognitive activities. Conclusions: Cognitive trainings facilitated by a smartphone-based application, performed regularly for a longer period of time are feasible and may have the potential to improve the cognitive functioning of individuals with schizophrenia. Correct answers and cognitive fatigability have potential to be functional markers of successful smartphone-based psychiatric rehabilitations in schizophrenia patients.

scholarly journals Long-Term Durability of Tenofovir-Based Antiretroviral Therapy in Relation to the Co-Administration of Other Drug Classes in Routine Clinical Practice

PLoS ONE ◽  
2016 ◽  
Vol 11 (10) ◽  
pp. e0160761 ◽  
Author(s):  
Silvia Costarelli ◽  
Alessandro Cozzi-Lepri ◽  
Giuseppe Lapadula ◽  
Stefano Bonora ◽  
Giordano Madeddu ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Antiretroviral Therapy ◽  
Routine Clinical Practice ◽  
Drug Classes

LONG-TERM REDUCTION IN AORTIC STIFFNESS IN ROUTINE CLINICAL PRACTICE.

2011 ◽  
Vol 29 ◽  
pp. e347
Author(s):  
I. Orlova ◽  
I. Patrusheva ◽  
I. Barinova ◽  
Z. Blankova ◽  
F. Ageev
Keyword(s):  
Clinical Practice ◽  
Aortic Stiffness ◽  
Routine Clinical Practice

Patient (pt) characteristics and treatment patterns in the radium (Ra)-223 REASSURE observational study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 5042-5042 ◽  
Author(s):  
Celestia S. Higano ◽  
Shawn H. Zimberg ◽  
Sabina Dizdarevic ◽  
Lauren Christine Harshman ◽  
John Logue ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Observational Study ◽  
Interim Analysis ◽  
Routine Clinical Practice ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Observation Methods ◽  
Short And Long Term ◽  
Grade 3

5042 Background: Ra-223, a targeted alpha therapy, prolonged survival with good safety in metastatic castration-resistant prostate cancer (mCRPC) in the phase 3 ALSYMPCA trial. REASSURE will evaluate Ra-223 short- and long-term safety in routine clinical practice settings. This is the first planned interim analysis (median 7 mo observation). Methods: This global, prospective, single-arm, observational study enrolled pts with mCRPC with bone metastases (mets) for whom Ra-223 therapy was planned. Follow-up will continue up to 7 years after last Ra-223 dose. Results: 1106 pts (437 N. America, 665 Europe, 4 not recorded) enrolled from 2 Sep 2014 to 22 Sep 2016. Baseline data are available from 583 pts receiving 1st- (1L), 2nd- (2L), or ≥3rd-line (≥3L) Ra-223 for mCRPC(Table). The majority of pts (n=369, 63%) completed 5–6 doses (1L, 70%; 2L, 64%; ≥3L, 49%); median 6 doses (1L,6; 2L, 6; ≥3L, 4). Treatment-emergent drug-related AEs occurred in 215 pts (37%). Post-treatment grade 3/4 thrombocytopenia occurred in 14 pts (2.4%) and anemia in 45 (7.7%). Conclusions: In routine clinical practice, Ra-223 was associated with no short-term safety concerns and appeared to be used in pts with less advanced mCRPC than in ALSYMPCA. The majority of pts on 1L/2L Ra-223 therapy received 5–6 doses. Ra-223 was often used with abiraterone or enzalutamide, but not chemotherapy. The next interim analysis in 2019 will report long-term safety and outcomes on all pts. Clinical trial information: NCT02141438. [Table: see text]

Clinical outcomes and patient (pt) profiles in REASSURE: An observational study of radium-223 (Ra-223) in metastatic castration-resistant prostate cancer (mCRPC).

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 32-32
Author(s):  
Celestia S. Higano ◽  
Fred Saad ◽  
A. Oliver Sartor ◽  
Kurt Miller ◽  
Peter Conti ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Clinical Practice ◽  
Observational Study ◽  
Clinical Outcomes ◽  
Bone Fractures ◽  
Bone Marrow Suppression ◽  
Routine Clinical Practice ◽  
Metastatic Sites

32 Background: Ra-223 is a targeted alpha therapy that showed a survival advantage and favorable safety profile in the phase 3 ALSYMPCA trial in pts with mCRPC. REASSURE (NCT02141438) is evaluating the long-term safety of Ra-223 in routine clinical practice in pts with mCRPC over a 7-year follow-up period. Methods: In this global, prospective, single-arm, observational study, the second prespecified interim analysis (data cut-off March 2019) evaluated safety and clinical outcomes of Ra-223 in pts with mCRPC. Primary outcome measures were incidence of second primary malignancies (SPM), bone marrow suppression and short- and long-term safety in pts who had ≥1 Ra-223 dose. Secondary outcomes included overall survival (OS). Results: For 1465 pts in the safety analysis, median follow up was 11.5 months. Median PSA (n=1053), ALP (n=1048), and LDH (n=555) levels at baseline were 59 ng/mL, 135 U/L, and 269 U/L, respectively. 81% of pts had bone metastases only at baseline; 19% of pts had other metastatic sites, mostly in the lymph nodes. 19% of pts had <6 metastatic sites, 47% had 6–20 sites, 20% had >20 lesions but not a superscan, and 6% had a superscan. 45%, 38%, 37%, 9%, and 8% of pts received prior abiraterone, docetaxel, enzalutamide, cabazitaxel, or sipuleucel-T as prior therapies, respectively. Median number of Ra-223 doses received was 6; 67% of pts had ≥5 doses. SPM occurred in 1% of pts. The most common treatment-emergent drug-related adverse event (AE) of any grade was diarrhea (11%). 10% of pts had a bone-associated event, 5% had fractures, and 15% had a hematological AE. Median OS was 15.6 months (95% CI 14.6–16.5). Conclusions: In REASSURE, there was a low incidence of SPM, bone fractures, and bone marrow suppression after Ra-223 treatment, with no new AEs identified. This study confirms that in routine clinical practice, Ra-223 AE rates were low, and pts generally received ≥5 doses. Clinical trial information: NCT02141438. [Table: see text]

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