334 – Long-term safety/tolerability of paliperidone extended-release tablets: 52-week, open-label extension study

ABSTRACTIntroduction: This 52-week open-label extension (OLE) to a double-blind placebo-controlled recurrence prevention study examined the long-term safety and efficacy of flexibly-dosed paliperidone extended-release (ER) tablets in patients with schizophrenia.Methods: Patients entering the OLE either entered from the double-blind phase (placebo or paliperidone ER treatment) or entered directly from the run-in or stabilization phase (paliperidone ER) of the earlier study. During the OLE, patients were treated with flexibly-dosed paliperidone ER (3–15 mg/day; 9 mg starting dose). Safety and tolerability assessments included incidence of adverse events and extrapyramidal symptoms. Efficacy was also assessed.Results: The study population (n=235) was predominantly men (66%), 18–58 years of age. Twelve patients (5%) experienced an adverse event requiring treatment discontinuation. One or more serious treatment-emergent adverse events were reported in 13 patients (6%). There was one death. The mean Positive and Negative Syndrome Scale total score decreased from open-label baseline to endpoint for all groups, regardless of previous double-blind treatment (placebo or paliperidone ER).Conclusion: This year-long OLE provides information on the long-term safety and tolerability of paliperidone ER in patients with schizophrenia. The resulting safety and tolerability profile was similar to that seen in earlier short-term studies.

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EFFICACY OF LONG-TERM TREATMENT WITH VILOXAZINE EXTENDED-RELEASE CAPSULES (QELBREE™) IN CHILDREN AND ADOLESCENTS WITH ADHD: AN OPEN-LABEL EXTENSION STUDY

Journal of the American Academy of Child & Adolescent Psychiatry ◽

10.1016/j.jaac.2021.09.414 ◽

2021 ◽

Vol 60 (10) ◽

pp. S258

Author(s):

Azmi Nasser ◽

Joseph Hull ◽

Soumya Chaturvedi ◽

Zulane Maldonado-Cruz ◽

Tesfaye Liranso ◽

...

Keyword(s):

Children And Adolescents ◽

Extended Release ◽

Term Treatment ◽

Extension Study ◽

Open Label ◽

Long Term Treatment ◽

Open Label Extension

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Efficacy of Lanadelumab in Hereditary Angioedema Patients With and Without Prior Use of Long-Term Prophylaxis: Final Results From the HELP Open-Label Extension Study

Journal of Allergy and Clinical Immunology ◽

10.1016/j.jaci.2020.12.524 ◽

2021 ◽

Vol 147 (2) ◽

pp. AB145

Author(s):

Kim Paes ◽

Jonathan Bernstein ◽

Hilary Longhurst ◽

Emel Aygoren-Pursun ◽

Hong Ren ◽

...

Keyword(s):

Hereditary Angioedema ◽

Extension Study ◽

Open Label ◽

Prior Use ◽

Open Label Extension

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P.570 Effectiveness of lurasidone 40-80mg/d in the long-term treatment of schizophrenia: a post hoc analysis of 6-month, open-label extension study

European Neuropsychopharmacology ◽

10.1016/j.euroneuro.2020.09.416 ◽

2020 ◽

Vol 40 ◽

pp. S323-S324

Author(s):

S. Liang ◽

A. Pikalov ◽

J. Zhao

Keyword(s):

Term Treatment ◽

Extension Study ◽

Open Label ◽

Post Hoc Analysis ◽

Long Term Treatment ◽

Open Label Extension ◽

Post Hoc

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Long-term safety of lumacaftor–ivacaftor in children aged 2–5 years with cystic fibrosis homozygous for the F508del-CFTR mutation: a multicentre, phase 3, open-label, extension study

The Lancet Respiratory Medicine ◽

10.1016/s2213-2600(21)00069-2 ◽

2021 ◽

Author(s):

Jordana E Hoppe ◽

Mark Chilvers ◽

Felix Ratjen ◽

John J McNamara ◽

Caroline A Owen ◽

...

Keyword(s):

Cystic Fibrosis ◽

Extension Study ◽

Open Label ◽

Phase 3 ◽

Multicentre Phase ◽

Open Label Extension

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

CNS Spectrums ◽

10.1017/s1092852900014115 ◽

2005 ◽

Vol 10 (S15) ◽

pp. 22-30 ◽

Cited By ~ 15

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.

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Sustained response and long-term safety of eculizumab in paroxysmal nocturnal hemoglobinuria

Blood ◽

10.1182/blood-2005-02-0564 ◽

2005 ◽

Vol 106 (7) ◽

pp. 2559-2565 ◽

Cited By ~ 146

Author(s):

Anita Hill ◽

Peter Hillmen ◽

Stephen J. Richards ◽

Dupe Elebute ◽

Judith C. Marsh ◽

...

Keyword(s):

Paroxysmal Nocturnal Hemoglobinuria ◽

Extension Study ◽

Transfusion Rate ◽

Complement Protein ◽

Open Label ◽

Hematologic Disorder ◽

Humanized Monoclonal Antibody ◽

Close Relationship ◽

Open Label Extension

AbstractParoxysmal nocturnal hemoglobinuria (PNH) is a hematologic disorder characterized by clonal expansion of red blood cells (RBCs) lacking the ability to inhibit complement-mediated hemolysis. Eculizumab, a humanized monoclonal antibody that binds the C5 complement protein, blocks serum hemolytic activity. This study evaluated the long-term safety and efficacy of eculizumab in 11 patients with PNH during an open-label extension trial. After completion of an initial 12-week study, all patients chose to participate in the 52-week extension study. Eculizumab, administered at 900 mg every 12 to 14 days, was sufficient to completely and consistently block complement activity in all patients. A dramatic reduction in hemolysis was maintained throughout the study, with a decrease in lactate dehydrogenase (LDH) levels from 3110.7 IU/L before treatment to 622.4 IU/L (P = .002). The proportion of PNH type III RBCs increased from 36.7% at baseline to 58.4% (P = .005). The paroxysm rate of days with gross evidence of hemoglobinuria per patient each month decreased from 3.0 during screening to 0.2 (P < .001) during treatment. The median transfusion rate decreased from 1.8 U per patient each month before eculizumab treatment to 0.3 U per patient each month (P = .001) during treatment. Statistically significant improvements in quality-of-life measures were also maintained during the extension study. Eculizumab continued to be safe and well tolerated, and all patients completed the study. The close relationship between sustained terminal complement inhibition, hemolysis, and symptoms was demonstrated. (Blood. 2005; 106:2559-2565)

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