Long-Term (120-Week) antiviral efficacy and tolerability of fosamprenavir/ritonavir once daily in therapy-naive patients with HIV-1 infection: An uncontrolled, open-label, single-arm follow-on study

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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ABPM Comparison of the Anti-Hypertensive Profiles of Telmisartan and Enalapril in Patients with Mild-to-Moderate Essential Hypertension

Journal of International Medical Research ◽

10.1177/147323000203000601 ◽

2002 ◽

Vol 30 (6) ◽

pp. 543-552 ◽

Cited By ~ 17

Author(s):

J Amerena ◽

S Pappas ◽

J-P Ouellet ◽

L Williams ◽

D O'Shaughnessy

Keyword(s):

Blood Pressure ◽

Essential Hypertension ◽

Blood Pressure Monitoring ◽

Study Drug ◽

Pressure Control ◽

Moderate Essential Hypertension ◽

Open Label ◽

Night Time ◽

Once Daily

In this multicentre, prospective, randomized, open-label, blinded-endpoint (PROBE) study, the efficacy of 12 weeks' treatment with once-daily telmisartan 40–80 mg and enalapril 10–20 mg was evaluated using ambulatory blood pressure monitoring (ABPM) in 522 patients with mild-to-moderate essential hypertension. Patients were titrated to the higher dose of study drug at week 6 if mean seated diastolic blood pressure (DBP) was ≥ 90 mmHg. The primary endpoint was the change from baseline in ambulatory DBP in the last 6 h of the 24-h dosing interval after 12 weeks' treatment. Telmisartan and enalapril produced similar reductions from baseline in DBP and systolic blood pressure (SBP) over all ABPM periods evaluated (last 6 h, 24-h, daytime and night-time). Telmisartan produced a significantly greater reduction in mean seated trough DBP, measured unblinded with an automated ABPM device in the clinic, amounting to a difference of −2.02 mmHg ( P < 0.01). A significantly greater proportion of patients achieved a seated diastolic response with telmisartan than enalapril (59% versus 50%; P < 0.05), also measured with the same ABPM device. Both treatments were well tolerated. Compared with telmisartan, enalapril was associated with a higher incidence of cough (8.9% versus 0.8%) and hypotension (3.9% versus 1.1%). Therefore, telmisartan may provide better long-term compliance and, consequently, better blood pressure control than enalapril.

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

CNS Spectrums ◽

10.1017/s1092852912000764 ◽

2013 ◽

Vol 18 (1) ◽

pp. 43-54 ◽

Cited By ~ 15

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.

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Long-Term Safety and Efficacy of a Once-Daily Formulation of Alfuzosin 10 mg in Patients with Symptomatic Benign Prostatic Hyperplasia: Open-Label Extension Study

European Urology ◽

10.1016/s0302-2838(01)00016-1 ◽

2002 ◽

Vol 41 (1) ◽

pp. 54-61 ◽

Cited By ~ 43

Author(s):

P van Kerrebroeck ◽

A Jardin ◽

P van Cangh ◽

K.U Laval

Keyword(s):

Benign Prostatic Hyperplasia ◽

Prostatic Hyperplasia ◽

Extension Study ◽

Open Label ◽

Symptomatic Benign Prostatic Hyperplasia ◽

Once Daily ◽

Safety And Efficacy ◽

Open Label Extension

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Carteolol Treatment of Essential Hypertension: A Long-Term Study of Safety and Efficacy

Journal of International Medical Research ◽

10.1177/030006058601400402 ◽

1986 ◽

Vol 14 (4) ◽

pp. 175-184 ◽

Cited By ~ 4

Author(s):

Robert R Luther ◽

Clemeth J Maurath ◽

Michael J Klepper ◽

Robert O Peckinpaugh ◽

Gary L Ringham ◽

...

Keyword(s):

Blood Pressure ◽

Multicenter Trial ◽

Open Label ◽

Once Daily ◽

Long Term Study ◽

Daily Dose ◽

Baseline Values ◽

The Mean ◽

Oral Doses

The long-term safety and antihypertensive efficacy of carteolol were evaluated in an open-label, multicenter trial of 245 hypertensive patients. For those patients maintained on carteolol monotherapy, three months of treatment with once-daily oral doses of carteolol ranging from 2.5 to 60 mg reduced the mean recumbent blood pressure by 12/14 mm Hg from baseline values of 151/100. Blood pressure reductions observed at three months were maintained throughout the study. The final daily dose of carteolol for most patients was 10 mg or less. Carteolol was shown to be safe and well tolerated by most patients.

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Faculty Opinions recommendation of Once-daily dolutegravir versus darunavir plus ritonavir in antiretroviral-naive adults with HIV-1 infection (FLAMINGO): 48 week results from the randomised open-label phase 3b study.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.718338285.793498092 ◽

2014 ◽

Author(s):

Anthony Harries

Keyword(s):

Open Label ◽

Once Daily ◽

Open Label Phase ◽

Hiv 1

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Long-Term Safety and Efficacy Data on Childhood Venous Thrombosis Treated with Enoxaparin: An Open Label Survey of Once-Daily Versus Twice-Daily Administration.

Blood ◽

10.1182/blood.v106.11.549.549 ◽

2005 ◽

Vol 106 (11) ◽

pp. 549-549

Author(s):

Ulrike Nowak-Gottl ◽

Christine During ◽

Christoph Bidlingmaier ◽

Nick Merkel ◽

Rosemarie Schobess

Keyword(s):

Efficacy And Safety ◽

Open Label ◽

Once Daily ◽

Randomised Study ◽

Catchment Areas ◽

Prothrombotic Risk Factors ◽

The Individual ◽

A Minor

Abstract Low molecular weight heparin is as effective as unfractionated heparin for treatment of venous thromboembolism (VT) in adults, and it has been recently demonstrated that once-daily (q24h) or twice-daily (q12h) enoxaparin (E) administration had no impact on safety (bleeding rate) of efficacy (re-thrombosis rate) in the treatment of acute VT. However, in this setting it is still unclear for children, if enoxaparin should be administered q24h or q12h. In this open label pilot safety study 75 children > the neonatal period, enrolled from two different catchment areas of Germany were treated with E with a target 2–4 h anti Xa activity between 0.4 – 0.8 IU/ml. After the acute thrombotic onset during which E was administered q12h for a median (range) period of 7 (1–14) days, based on the individual decision of the study centres stratification into the study arms once-daily versus twice daily was performed. Enoxaparin was administered in both study centres regardless of age at DVT-onset, thrombus burden, underlying basic diseases or presence of prothrombotic risk factors. No difference was observed between the stratifications performed in the study centres (p=0.5). Median (range) dose administered q24h (n=50) or q12h (n=25) in children with DVT was 1.2 mg/kg (0.5–3.0) respectively. Median (range) treatment duration was 5 months (1–13). Prospectively defined study endpoints were adverse effects, e.g. re-thrombosis, bleeding, and therapy-related death. Median follow-up time was 24 months. No significant differences were found between the two patient groups treated with respect to anti Xa activities, efficacy and safety. Further statistical analysis performed to evaluate the overall differences between q24h and q12h E administration again revealed no significant differences for the study endpoints: Re-thrombosis occurred in two patients each (p=0.6), and a minor subdural bleeding was diagnosed in one patient treated q12h (p=0.4). During the follow-up no major bleeding or therapy-related death was observed. In conclusion, data presented here give evidence that long-term enoxaparin administration within the reported target anti Xa activity for treatment of childhood VT has a good efficacy and safety profile when administered q24h. These data have to be confirmed in a multicentre randomised study.

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