Safety, tolerability, and feasibility of high-dose naltrexone in alcohol dependence: an open-label study

2011 ◽  
Vol 26 (2) ◽  
pp. 125-132 ◽  
Author(s):  
Gihyun Yoon ◽  
Suck Won Kim ◽  
Paul Thuras ◽  
Joseph Westermeyer
Keyword(s):  
Alcohol Dependence ◽  
High Dose ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

Safety of AT-1015, a novel 5-HT2A antagonist, in combination with high-dose aspirin: an open-label study

2004 ◽  
Vol 42 (02) ◽  
pp. 98-102 ◽  
Author(s):  
D. Anderson ◽  
N. Kato ◽  
K. Onomichi ◽  
H. Uchida ◽  
S. Shelley ◽  
...  
Keyword(s):  
High Dose ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Dose Aspirin ◽  
High Dose Aspirin

Effect of Bosentan on Systemic Sclerosis-associated Interstitial Lung Disease Ineligible for Cyclophosphamide Therapy: A Prospective Open-label Study

2011 ◽  
Vol 38 (10) ◽  
pp. 2186-2192 ◽  
Author(s):  
YOSHIAKI FURUYA ◽  
MASATAKA KUWANA
Keyword(s):  
Systemic Sclerosis ◽  
Interstitial Lung Disease ◽  
Pulmonary Function ◽  
Lung Disease ◽  
Pulmonary Function Tests ◽  
High Dose ◽  
Open Label ◽  
High Resolution Computed Tomography ◽  
Open Label Study ◽  
Label Study

Objective.To evaluate the clinical benefits of the endothelin receptor antagonist bosentan on interstitial lung disease (ILD) in patients with systemic sclerosis (SSc) who are ineligible for cyclophosphamide (CYC) therapy.Methods.In this prospective open-label study, 9 patients with SSc and ILD received bosentan for 24 months. The main reasons for avoiding CYC included severely impaired lung function, long disease duration, and relapse after CYC treatment. Pulmonary function tests and Doppler echocardiograms were evaluated every 6 months, and high-resolution computed tomography (HRCT) was performed every 12 months. For an extended survival analysis, 17 historical controls who met the inclusion criteria at referral and had not used any immunosuppressive or antifibrotic agents thereafter were selected from the SSc database.Results.Two patients did not finish the study; one developed vasculitis requiring high-dose corticosteroids and another died of bacterial pneumonia. The remaining 7 patients tolerated bosentan and completed the study period. There were trends toward mildly reduced forced vital capacity, total lung capacity, and diffusing capacity for carbon monoxide over time. Two patients developed pulmonary hypertension during the 24-month period. HRCT scores for ground-glass opacity, pulmonary fibrosis, and honeycomb cysts gradually increased. In the extended study, there was no difference in cumulative survival rate between the bosentan-treated and historical control groups.Conclusion.The gradual worsening of pulmonary function and HRCT findings in patients treated with bosentan was consistent with the natural course of SSc-associated ILD. This study does not support the use of bosentan for SSc-associated ILD even when CYC treatment is inadvisable.

Open-label Study with Nalmefene as Needed Use in Alcohol-Dependent Patients with Evidence of Elevated Liver Stiffness and/or Hepatic Steatosis

2019 ◽  
Author(s):  
Sebastian Mueller ◽  
Mathias Luderer ◽  
Doris Zhang ◽  
Didier Meulien ◽  
Björn Steiniger Brach ◽  
...  
Keyword(s):  
Alcohol Consumption ◽  
Alcohol Dependence ◽  
Hepatic Steatosis ◽  
Transient Elastography ◽  
Heavy Drinking ◽  
Liver Stiffness ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Liver Parameters

Abstract Aims This open-label study in patients with alcohol dependence and evidence of elevated liver stiffness and/or hepatic steatosis was designed to explore the efficacy of nalmefene (18 mg) in reducing alcohol consumption and its subsequent effects on a variety of clinically relevant liver parameters. Methods Adult patients with a diagnosis of alcohol dependence and evidence of elevated liver stiffness and/or hepatic steatosis (liver stiffness >6 kPa or controlled attenuation parameter (CAP) >215 dB/m as measured by transient elastography) were recruited at two study sites in Germany. During the 12-week treatment period, patients were instructed to take nalmefene each day they perceived a risk of drinking alcohol. Results All 45 enrolled patients took at least one dose of nalmefene and 39 completed the study. After 12 weeks of study treatment with nalmefene patients showed a reduction in alcohol consumption of −13.5 days/month heavy drinking days and −45.8 g/day total alcohol consumption. Most liver parameters showed modest changes at Week 12; there was a 13% decrease in liver stiffness and 10% reduction in CAP values. Results indicated non-significant negative associations between alcohol consumption and liver stiffness and/or CAP over this 12-week study. Nalmefene was generally well tolerated, and most adverse events were mild or moderate, the most frequent being dizziness. Conclusions Patients treated with nalmefene for 12 weeks had reductions in alcohol consumption by ~50% relative to baseline and showed trends to improvement in liver stiffness and CAP.

An Open-Label Study of the Therapeutic Efficacy of High-Dose Famotidine Adjuvant Pharmacotherapy in Schizophrenia: Preliminary Evidence for Treatment Efficacy

1996 ◽  
Vol 19 (4) ◽  
pp. 341-348 ◽  
Author(s):  
Richard B. Rosse ◽  
Kathie Kendrick ◽  
Maureen Fay-McCarthy ◽  
George D. Prell ◽  
Paul Rosenberg ◽  
...  
Keyword(s):  
Treatment Efficacy ◽  
Therapeutic Efficacy ◽  
Preliminary Evidence ◽  
High Dose ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

scholarly journals Nalmefene, Given as Needed, in the Routine Treatment of Patients with Alcohol Dependence: An Interventional, Open-Label Study in Primary Care

2018 ◽  
Vol 24 (6) ◽  
pp. 293-303 ◽  
Author(s):  
Philippe Castera ◽  
Edmund Stewart ◽  
Josef Großkopf ◽  
Carlos Brotons ◽  
Maiken Brix Schou ◽  
...  
Keyword(s):  
Primary Care ◽  
Alcohol Dependence ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Routine Treatment
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