Long-Term Safety of Paliperidone Extended Release in Adolescents with Schizophrenia: An Open-Label, Flexible Dose 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 solifenacin in patients previously treated with tolterodine extended release 4 mg: Results of a 12-week, multicenter, open-label, flexible-dose study

Clinical Therapeutics ◽

10.1016/j.clinthera.2008.10.011 ◽

2008 ◽

Vol 30 (10) ◽

pp. 1766-1781 ◽

Cited By ~ 39

Author(s):

Michael B. Chancellor ◽

Norman Zinner ◽

Kristene Whitmore ◽

Kathleen Kobashi ◽

Jeffrey A. Snyder ◽

...

Keyword(s):

Extended Release ◽

Open Label ◽

Dose Study ◽

Previously Treated ◽

Flexible Dose

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Effects of paliperidone extended release on functioning level and symptoms of patients with recent onset schizophrenia: An open-label, single-arm, flexible-dose, 12-months follow-up study

Nordic Journal of Psychiatry ◽

10.3109/08039488.2014.996252 ◽

2014 ◽

Vol 69 (6) ◽

pp. 1708-1714 ◽

Cited By ~ 9

Author(s):

Alp Üçok ◽

Meram Can Saka ◽

Mustafa Bilici

Keyword(s):

Extended Release ◽

Open Label ◽

Recent Onset ◽

Follow Up Study ◽

Functioning Level ◽

Flexible Dose ◽

Paliperidone Extended Release

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Open-label, Flexible-dose Study of Vortioxetine in Patients With Depression in India

Case Medical Research ◽

10.31525/ct1-nct04288895 ◽

2020 ◽

Author(s):

Keyword(s):

Open Label ◽

Dose Study ◽

Flexible Dose

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Long-term efficacy and safety of oral semaglutide and the effect of switching from sitagliptin to oral semaglutide in patients with type 2 diabetes: a 52-week, randomized, open-label extension of the PIONEER 7 trial

BMJ Open Diabetes Research & Care ◽

10.1136/bmjdrc-2020-001649 ◽

2020 ◽

Vol 8 (2) ◽

pp. e001649

Author(s):

John B Buse ◽

Bruce W Bode ◽

Ann Mertens ◽

Young Min Cho ◽

Erik Christiansen ◽

...

Keyword(s):

Type 2 Diabetes ◽

Body Weight ◽

Dose Adjustment ◽

Main Phase ◽

Open Label ◽

Open Label Extension ◽

Registration Number ◽

Flexible Dose

IntroductionThe PIONEER 7 trial demonstrated superior glycemic control and weight loss with once-daily oral semaglutide with flexible dose adjustment versus sitagliptin 100 mg in type 2 diabetes. This 52-week extension evaluated long-term oral semaglutide treatment and switching from sitagliptin to oral semaglutide.Research design and methodsA 52-week, open-label extension commenced after the 52-week main phase. Patients on oral semaglutide in the main phase continued treatment (n=184; durability part); those on sitagliptin were rerandomized to continued sitagliptin (n=98) or oral semaglutide (n=100; initiated at 3 mg) (switch part). Oral semaglutide was dose-adjusted (3, 7, or 14 mg) every 8 weeks based on glycated hemoglobin (HbA1c) (target <7.0% (<53 mmol/mol)) and tolerability. Secondary endpoints (no primary) included changes in HbA1c and body weight.ResultsIn the durability part, mean (SD) changes in HbA1c and body weight from week 0 were –1.5% (0.8) and –1.3% (1.0) and –2.8 kg (3.8) and –3.7 kg (5.2) at weeks 52 and 104, respectively. In the switch part, mean changes in HbA1c from week 52 to week 104 were –0.2% for oral semaglutide and 0.1% for sitagliptin (difference –0.3% (95% CI –0.6 to 0.0); p=0.0791 (superiority not confirmed)). More patients achieved HbA1c <7.0% with oral semaglutide (52.6%) than sitagliptin (28.6%; p=0.0011) and fewer received rescue medication (9% vs 23.5%). Respective mean changes in body weight were –2.4 kg and –0.9 kg (difference –1.5 kg (95% CI –2.8 to –0.1); p=0.0321). Gastrointestinal adverse events were the most commonly reported with oral semaglutide.ConclusionsLong-term oral semaglutide with flexible dose adjustment maintained HbA1c reductions, with additional body weight reductions, and was well tolerated. Switching from sitagliptin to flexibly dosed oral semaglutide maintained HbA1c reductions, helped more patients achieve HbA1c targets with less use of additional glucose-lowering medication, and offers the potential for additional reductions in body weight.Trial registration numberNCT02849080.

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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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