Long-term safety and tolerability of iloperidone: results from a 25-week, open-label extension trial

CNS Spectrums ◽  
2013 ◽  
Vol 18 (1) ◽  
pp. 43-54 ◽  
Author(s):  
Andrew J. Cutler ◽  
Amir H. Kalali ◽  
Greg W. Mattingly ◽  
Jelena Kunovac ◽  
Xiangyi Meng
Keyword(s):  
Serum Glucose ◽  
Favorable Effect ◽  
Controlled Clinical Trial ◽  
Open Label ◽  
Once Daily ◽  
Syndrome Scale ◽  
Open Label Extension ◽  
Negative Syndrome ◽  
Extension Trial

Introduction/ObjectiveLong-term use of the atypical antipsychotic iloperidone has not been investigated at doses above 16 mg/d. This article describes safety and tolerability results from the 25-week open-label extension of a 4-week placebo- and ziprasidone-controlled clinical trial of iloperidone.MethodsPatients received a dose of 24 mg/d (given as 12 mg twice daily; mean dose = 21.6 mg) that could be reduced to 12 mg/d (given once daily at bedtime) any time after day 35 at the investigator's discretion.ResultsA total of 72/173 patients (41.6%) completed the open-label extension. Treatment-emergent adverse events (TEAEs), most mild to moderate in severity, included headache (13.9%), weight increase (9.2%), dizziness (6.9%), nausea (6.4%), sedation (6.4%), and insomnia (5.2%). The only notable dose-related TEAEs were increased weight and headache. Levels of serum glucose, lipids, and prolactin were essentially unchanged or decreased during treatment. In general, akathisia and extrapyramidal symptoms (EPS) improved or were unchanged during treatment. There was no signal of worsening of efficacy based on changes from baseline in the Positive and Negative Syndrome Scale-Total.Discussion/ConclusionThis study further supports the long-term safety and tolerability of iloperidone for the treatment of schizophrenia, including iloperidone's favorable effect on metabolic laboratory parameters and low propensity to cause akathisia or EPS.

scholarly journals Long‐term safety and efficacy of add‐on cannabidiol in patients with Lennox–Gastaut syndrome: Results of a long‐term open‐label extension trial

Epilepsia ◽  
2021 ◽  
Author(s):  
Anup D. Patel ◽  
Maria Mazurkiewicz‐Bełdzińska ◽  
Richard F. Chin ◽  
Antonio Gil‐Nagel ◽  
Boudewijn Gunning ◽  
...  
Keyword(s):  
Open Label ◽  
Safety And Efficacy ◽  
Open Label Extension ◽  
Extension Trial

Short- and Long-Term Cardiovascular Effects of Mixed Amphetamine Salts Extended-Release in Adolescents With ADHD

CNS Spectrums ◽  
2005 ◽  
Vol 10 (S15) ◽  
pp. 22-30 ◽  
Author(s):  
Timothy E. Wilens ◽  
Thomas J. Spencer ◽  
Joseph Biederman
Keyword(s):  
Extended Release ◽  
Cardiovascular Effects ◽  
Dose Titration ◽  
Open Label ◽  
Double Blind ◽  
Once Daily ◽  
Open Label Extension ◽  
Short And Long Term ◽  
Clinically Significant

AbstractObjectiveAssess cardiovascular effects of once-daily mixed amphetamine salts extended release (MAS XR) in adolescents (13–17 years of age) with attention-deficit/hyperactivity disorder (ADHD).MethodsBlood pressure (BP), pulse, and electrocardiograms were assessed in 327 healthy subjects during a 4-week, randomized, double-blind, placebo-controlled, forced dose-titration study. Placebo (n=69) or once-daily MAS XR(10, 20, 30, or 40 mg) was administered to subjects ≤75 kg (n=233); 50- and 60-mg MAS XR was administered to subjects >75 kg (n=25). One hundred thirty-eight subjects participated in a 6-month, open-label extension study.FindingsChanges in BP and QTcB (Bazett's formula) intervals at 4 weeks with MAS XR were not significantly different from the placebo group. Pulse increased by 5.0 and 8.5 bpm after 3 weeks with MAS XR 20 and 50 mg/day, respectively (P≤.002). After 6 months of open-label MAS XR treatment, mean increases in systolic BP (1.7 mm Hg; P=.0252) and pulse (4.4 bpm; P<.0001) were statistically, but not clinically, significant diastolic BP was not significantly changed (0.6 mm Hg) A decrease in QTcB interval (-4.6±19.9 msec) was statistically (P=.009), but not clinically, significant. There were no serious cardiovascular adverse events.ConclusionCardiovascular effects of short- and long-term MAS XR treatment (≤60 mg/day) were minimal in otherwise healthy adolescents with ADHD.

scholarly journals Safety and effectiveness of lurasidone in adolescents with schizophrenia: results of a 2-year, open-label extension study

CNS Spectrums ◽  
2020 ◽  
pp. 1-11
Author(s):  
Christoph U. Correll ◽  
Robert L. Findling ◽  
Michael Tocco ◽  
Andrei Pikalov ◽  
Ling Deng ◽  
...  
Keyword(s):  
Body Weight ◽  
Adverse Events ◽  
Rating Scales ◽  
Extension Study ◽  
Open Label ◽  
Double Blind ◽  
Syndrome Scale ◽  
Open Label Extension ◽  
Glycemic Indices

Abstract Background Minimal long-term benefit: Risk data are available regarding antipsychotic treatments for schizophrenia in pediatric populations. This study evaluated the long-term safety, tolerability, and effectiveness of lurasidone in adolescents with schizophrenia. Methods Patients aged from 13 to 17 who completed 6 weeks of double-blind (DB), placebo-controlled treatment with lurasidone were enrolled in a 2-year, open-label (OL), flexible dose (20-80 mg/day) lurasidone treatment study. Safety was assessed via spontaneous reporting, rating scales, body weight measurement, metabolic, and prolactin testing. Effectiveness measures included the Positive and Negative Syndrome Scale (PANSS) total score. Results About 271 patients completed 6 weeks of DB treatment and entered the 2-year OL extension study. Altogether, 42.4% discontinued prematurely, 10.7% due to adverse events. During OL treatment, the most common adverse events were headache (24.0%); anxiety (12.9%), schizophrenia, and nausea (12.5%); sedation/somnolence (12.2%); and nasopharyngitis (8.9%). Minimal changes were observed on metabolic parameters and prolactin. Mean change from DB baseline in weight at week 52 and week 104 was +3.3 kg and + 4.9 kg, respectively, compared to an expected weight gain of +3.4 kg and + 5.7 kg, respectively, based on the sex- and age-matched US Center for Disease Control normative data. Continued improvement was observed in PANSS total score, with mean change from OL baseline of −15.6 at week 52 and −18.4 at week 104. Conclusion In adolescents with schizophrenia, long-term lurasidone treatment was associated with minimal effects on body weight, lipids, glycemic indices, and prolactin. Continued improvement in symptoms of schizophrenia was observed over 2 years of lurasidone treatment.

scholarly journals 0641 Effects of Weight Loss During Long-Term Solriamfetol Treatment on Cardiometabolic Indices

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A245-A245
Author(s):  
A Malhotra ◽  
P Strollo ◽  
J Pepin ◽  
P Schweitzer ◽  
G Lammers ◽  
...  
Keyword(s):  
Weight Loss ◽  
High Glucose ◽  
Cardiometabolic Risk ◽  
Clinical Laboratory ◽  
Serum Glucose ◽  
Long Term Effects ◽  
Open Label ◽  
Obstructive Sleep ◽  
Open Label Extension

Abstract Introduction Increased prevalence of obesity has been reported in patients with narcolepsy and obstructive sleep apnea (OSA). Results from a 1-year open-label extension (OLE) study showed ≥5% weight loss in 4.5%, 17.3%, and 32.4% of participants with narcolepsy or OSA receiving solriamfetol 75, 150, or 300mg/d. We examined whether clinically significant weight loss (≥5%) in this population had favorable effects on biomarkers of cardiometabolic risk compared to no such weight loss. Methods We evaluated changes in weight and BP (parent study baseline to OLE week 40) and clinical laboratory assessments (OLE baseline to week 40) in participants with narcolepsy (n=124) or OSA (n=250) from the OLE study. Results Of 374 participants, 96 (25.7%) had ≥5% weight loss and 34 (9.1%) had ≥5% weight gain. Demographics were similar in those with and without (n=278) ≥5% weight loss. From baseline to week 40, among participants with weight loss, there were decreases in percentage with high (ie, &gt;ULN) serum glucose (36.6% to 28.1%) or triglycerides (26.6% to 21.9%), whereas among participants without weight loss, there was an increase in percentage with high glucose (43.3% to 50%) and no change in percentage with high triglycerides (37.1% to 37.2%). The percentage of participants with high total cholesterol was stable among participants with weight loss (22.3% to 22.9%) and increased (32.7% to 37.2%) in participants without weight loss. Participants with weight loss had mean±SD reductions in SBP (-2.6±11.4mmHg) and DBP (-1.0±9.0mmHg), whereas participants without weight loss had increases of +0.65±12.5mmHg and +1.2±8.7mmHg, respectively. Conclusion Among solriamfetol-treated participants with ≥5% weight loss, there were decreases in BP and percentage of participants with high glucose and triglycerides. Further research is required to examine prospective long-term effects of solriamfetol on specific biomarkers of cardiometabolic risk. Support Jazz Pharmaceuticals

Long-Term Improvement in Efficacy and Safety After Switching to Ziprasidone in Stable Outpatients with Schizophrenia

CNS Spectrums ◽  
2008 ◽  
Vol 13 (10) ◽  
pp. 898-905 ◽  
Author(s):  
George M. Simpson ◽  
Cedric J. O'Gorman ◽  
Antony Loebel ◽  
Ruoyong Yang
Keyword(s):  
Clinical Global Impression ◽  
Open Label ◽  
Conventional Antipsychotics ◽  
Syndrome Scale ◽  
Number Of Patients ◽  
Severity Scores ◽  
Intent To Treat ◽  
Study Designs ◽  
Negative Syndrome

ABSTRACTIntroduction:The long-term efficacy and tolerability of treatment with ziprasidone following a switch from prior antipsychotics was evaluated in outpatients with schizophrenia or schizoaffective disorder in three open-label, flexible-dose, 1-year extension studies.Methods:These studies enrolled completers of 6-week trials in which subjects were switched to ziprasidone from conventional antipsychotics, olanzapine, or risperidone. Identical study designs and the small number of patients entering the extensions supported pooling of the data.Results:Of 185 pooled subjects entering the extension studies, 72 completed 58 weeks of treatment. Median treatment duration was 34.6 weeks; median dose was 120 mg/day at endpoint. The intent-to-treat population showed significant improvement in Positive and Negative Syndrome Scale (PANSS) total scores (−4.3 [P≤.01]), PANSS negative scores (−2.4 [P≤.0001]), and Clinical Global Impression of severity score (−0.3 [P≤.001]). Completers showed significant improvement in mean PANSS total scores (−10.2 [P<.0001]), PANSS positive scores (−2.7 [P<.0001]), PANSS negative scores (−2.7 [P<.001]), and Clinical Global Impression of severity scores (−0.6 [P<.0001]).Conclusion:Ziprasidone was well tolerated, and patients demonstrated significant improvement in metabolic parameters and in all movement disorder assessments. Insomnia and somnolence were the only adverse events with an incidence >10% in pooled subjects. No subject had a corrected QT interval ≥500 msec.

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