scholarly journals Lurasidone in the long-term treatment of Japanese patients with bipolar I disorder: a 52 week open label study

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Teruhiko Higuchi ◽  
Tadafumi Kato ◽  
Mari Miyajima ◽  
Kei Watabe ◽  
Takahiro Masuda ◽  
...  
Keyword(s):  
Adverse Events ◽  
Rating Scale ◽  
Japanese Patients ◽  
Term Treatment ◽  
Open Label ◽  
Mixed Episode ◽  
Depressed Group ◽  
Long Term Treatment ◽  
Symptom Measures

Abstract Background The current study evaluated the long-term (52 week) safety and impact on symptom measures of lurasidone (with or without lithium or valproate) for the treatment of bipolar I disorder in Japanese patients. Methods Bipolar patients for this open-label flexibly dosed lurasidone (20–120 mg/day) study were recruited from those with a recent/current depressive episode who completed an initial 6 week, double-blind, placebo-controlled, lurasidone study (depressed group), and those with a recent/current manic, hypomanic, or mixed episode (non-depressed group) who agreed to enroll directly into the long-term study. Measures of adverse events and safety included treatment-emergent adverse events, vital signs, body weight, ECG, laboratory tests, and measures of suicidality and extrapyramidal symptoms. Symptom measures included Montgomery Åsberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS). Results The most common adverse events associated with lurasidone were akathisia (30.7%), nasopharyngitis (26.6%), nausea (12.1%), and somnolence (12.1%). Minimal changes in lipids and measures of glycemic control occurred. Mean change in body weight was + 1.0 kg in the non-depressed group and − 0.8 kg in the depressed group. MADRS total scores declined by a mean (SD) of 2.0 (14.7) points from long-term baseline to endpoint in the depressed group who had received placebo in the prior 6 week trial. The depressed group that had received lurasidone during the prior 6 week study maintained their depressive symptom improvements. For the non-depressed group, YMRS total scores decreased over time. Limitations No control group was included, treatment was open-label, and 49.7% of patients completed the 52 week study. Conclusions Long-term treatment with lurasidone 20–120 mg/day for Japanese patients with bipolar disorder maintained improvements in depressive symptoms for depressed patients who were treated in a prior 6 week trial and led to improvements in manic symptoms among a newly recruited subgroup of patients with a recent/current manic, hypomanic, or mixed episode. Few changes in weight or metabolic parameters were evident. Clinical trial registration: JapicCTI-132319, clinicaltrials.gov—NCT01986114.

Long-Term, Open-Label Extension Study of Guanfacine Extended Release in Children and Adolescents with ADHD

CNS Spectrums ◽  
2008 ◽  
Vol 13 (12) ◽  
pp. 1047-1055 ◽  
Author(s):  
Joseph Biederman ◽  
Raun D. Melmed ◽  
Anil Patel ◽  
Keith McBurnett ◽  
Jessica Donahue ◽  
...  
Keyword(s):  
Adverse Events ◽  
Extended Release ◽  
Rating Scale ◽  
Multicenter Trial ◽  
Term Treatment ◽  
Open Label ◽  
Double Blind ◽  
Long Term Treatment ◽  
Open Label Extension

ABSTRACTIntroduction:Guanfacine is a noradrenergic agonist that is believed to improve symptoms of attention-deficit/hyperactivity disorder (ADHD) through selective actions at α2A-adrenoceptors in the prefrontal cortex. A recent double-blind, multicenter trial supports the efficacy and safety of guanfacine extended release (GXR) for pediatric ADHD. This long-term, open-label extension was conducted to study the safety profile and effectiveness of GXR for up to 2 years.Methods:Subjects were 240 children 6–17 years of age with a diagnosis of ADHD who participated in the preceding randomized trial. GXR was initiated at 2 mg/day and titrated as needed in 1-mg increments to a maximum of 4 mg/day to achieve optimal clinical response.Results:The most common adverse events were somnolence (30.4%), headache (26.3%), fatigue (14.2%), and sedation (13.3%). Somnolence, sedation, and fatigue were usually transient. Cardiovascular-related adverse events were uncommon, although small reductions in mean blood pressure and pulse rate were evident at monthly visits. ADHD Rating Scale, Version IV, total and subscale scores improved significantly from baseline to endpoint for all dose groups (P<.001 for all comparisons, intent-to-treat population).Conclusion:Long-term treatment with GXR was generally safe for up to 24 months of treatment, and effectiveness was maintained over this treatment period.

scholarly journals Long-Term Treatment With Evolocumab Among Japanese Patients　― Final Report of the OSLER Open-Label Extension Studies ―

2019 ◽  
Vol 83 (5) ◽  
pp. 971-977
Author(s):  
Atsushi Hirayama ◽  
Shizuya Yamashita ◽  
Andrea Ruzza ◽  
Hyoe Inomata ◽  
Marcoli Cyrille ◽  
...  
Keyword(s):  
Japanese Patients ◽  
Term Treatment ◽  
Final Report ◽  
Open Label ◽  
Long Term Treatment ◽  
Open Label Extension

scholarly journals 0764 Pitolisant In The Treatment Of Patients With Narcolepsy: A 2-year, Prospective, Observational, Single-center Study

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A290-A290
Author(s):  
A Triller ◽  
A Hof zum Berge ◽  
B Finger ◽  
U Kallweit
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Short Form ◽  
Term Treatment ◽  
Real World Data ◽  
Open Label ◽  
Long Term Treatment ◽  
Nighttime Sleep

Abstract Introduction Pitolisant, a selective histamine H3 receptor antagonist/inverse agonist, increases histamine release in the brain. The efficacy of pitolisant in adults with narcolepsy was demonstrated in randomized, placebo-controlled trials. This study evaluated long-term use of pitolisant in clinical practice. Methods This prospective, open-label, 2-year, observational study was conducted at a major narcolepsy center in Germany and enrolled adults with a diagnosis of narcolepsy who had no prior treatment with pitolisant. Assessments included excessive daytime sleepiness (Epworth Sleepiness Scale [ESS]), weekly rate of cataplexy (WRC), and health-related quality of life (Short-Form Veterans RAND [VR-36]). Results The study enrolled 147 patients: mean age, 29.9 years; 57.1% female, 65.3% with cataplexy, and 66.7% with disrupted nighttime sleep. In patients who were tested, CSF hypocretin-1 was &lt;110 pg/mL in 70.8% (51/72), and 79.4 % (77/97) were HLA-DQB1*0602 positive. The pitolisant dose was 35.6 mg/d in 38.1% of patients at Month 3, and 73.5% at Month 24. Most patients received concomitant narcolepsy medications (63.3% at baseline; 79.6% at month 24). Mean ESS score decreased from 16.2 at baseline to 12.4 at Month 12 and 12.6 at Month 24. Mean WRC was reduced by 31% at Month 24. Significant improvement in quality of life was noted at Months 12 and 24 on VR-36 subscales that assess general health perception, vitality, and social function. In all, 38 patients (25.8%) discontinued from the study before Month 24: 15.0% for lack of efficacy and 10.8% due to adverse events. The most common adverse events were disrupted nighttime sleep (29.3% of patients), headache (15.5%), and nausea (12.2%). Conclusion These real-world data show that long-term treatment with pitolisant (usually with 35.6 mg/d) was efficacious for reducing EDS and cataplexy and improving quality of life in patients with narcolepsy. Treatment was generally well tolerated. Support Writing support funded by Harmony Biosciences, LLC.

Tolerability and Efficacy of Naratriptan Tablets with Long-Term Treatment (6 Months)

Cephalalgia ◽  
1998 ◽  
Vol 18 (1) ◽  
pp. 33-37 ◽  
Author(s):  
MAM Bomhof ◽  
J Heywood ◽  
A Pradalier ◽  
H Enahoro ◽  
P Winter ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Median Number ◽  
Term Treatment ◽  
Open Label ◽  
Long Term Treatment ◽  
Term Tolerability ◽  
Treat All ◽  
Headache Recurrence

This open-label study was conducted to examine the long-term tolerability and efficacy of the novel 5HT1 agonist naratriptan tablets 2.5 mg used to treat all migraine attacks for 6 months. Patients could reduce the dose to 1 mg in the event of intolerable adverse events. The results demonstrate that the majority (median 83%) of attacks treated with naratriptan tablets 2.5 mg were not associated with an adverse event. Among attacks treated with naratriptan tablets 2.5 mg (+optional 2.5 mg for headache recurrence), the most frequently reported adverse event was nausea (4% of attacks after a single naratriptan dose). Both the overall incidence of adverse events and the incidences of specific adverse events were no higher during months 4-6 of treatment compared with months 1-3. Only 5 of 414 patients elected to reduce their naratriptan dose to 1 mg. Headache relief 4 h postdose was reported in a mean of 68% of 6770 moderate or severe migraine attacks treated with naratriptan tablets 2.5 mg. The median number of naratriptan tablets used per attack was 1.0 (mean 1.25); patients treated only a median 7% of attacks (mean 13%) with a 2nd naratriptan tablet for headache recurrence. Patients rated naratriptan tablets as good or excellent in 61% of 7566 treated attacks. In summary, the data from this study demonstrate that naratriptan tablets 2.5 mg were very well tolerated and effective for the acute treatment of migraine for 6 months in a situation closely resembling actual clinical use.

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.

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.

Effects of Long-term Treatment of Linagliptin on Glycemic Control in Japanese Patients with Type 2 Diabetes

2018 ◽  
Vol 14 (8) ◽  
pp. 1153-1159
Author(s):  
Masataka Kusunoki ◽  
Yukie Natsume ◽  
Hideyo Tsutsui ◽  
Tetsuro Miyata ◽  
Kazuhiko Tsutsumi ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Glycemic Control ◽  
Japanese Patients ◽  
Term Treatment ◽  
Long Term Treatment
Sign in / Sign up

Export Citation Format

Share Document