Comparison of the efficacy and tolerability of pitavastatin and atorvastatin: An 8-week, multicenter, randomized, open-label, dose-titration study in korean patients with hypercholesterolemia

2007 ◽  
Vol 29 (11) ◽  
pp. 2365-2373 ◽  
Author(s):  
Sang Hak Lee ◽  
Namsik Chung ◽  
Jun Kwan ◽  
Doo-Il Kim ◽  
Won Ho Kim ◽  
...  
Keyword(s):  
Dose Titration ◽  
Open Label ◽  
Korean Patients ◽  
Label Dose ◽  
Titration Study

scholarly journals Pan-European, open-label dose titration study of fentanyl buccal tablet in patients with breakthrough cancer pain

2014 ◽  
Vol 19 (4) ◽  
pp. 528-537 ◽  
Author(s):  
U.R. Kleeberg ◽  
A. Davies ◽  
J. Jarosz ◽  
S. Mercadante ◽  
P. Poulain ◽  
...  
Keyword(s):  
Cancer Pain ◽  
Dose Titration ◽  
Open Label ◽  
Breakthrough Cancer Pain ◽  
Fentanyl Buccal Tablet ◽  
Buccal Tablet ◽  
Label Dose ◽  
Titration Study

scholarly journals Safety and Efficacy of Oral Octreotide in Acromegaly: Results of a Multicenter Phase III Trial

2015 ◽  
Vol 100 (4) ◽  
pp. 1699-1708 ◽  
Author(s):  
Shlomo Melmed ◽  
Vera Popovic ◽  
Martin Bidlingmaier ◽  
Moises Mercado ◽  
Aart Jan van der Lely ◽  
...  
Keyword(s):  
Somatostatin Receptor ◽  
Phase Iii ◽  
Dose Titration ◽  
Controlled Study ◽  
Open Label ◽  
The Core ◽  
End Of Treatment ◽  
Label Dose ◽  
Somatostatin Receptor Ligand ◽  
Oral Therapeutic

Background: A novel oral octreotide formulation was tested for efficacy and safety in a phase III, multicenter, open-label, dose-titration, baseline-controlled study in patients with acromegaly. Methods: We enrolled 155 complete or partially controlled patients (IGF-1 <1.3 × upper limit of normal [ULN], and 2-h integrated GH <2.5 ng/mL) receiving injectable somatostatin receptor ligand (SRL) for ≥3 months. Subjects were switched to 40 mg/d oral octreotide capsules (OOCs), and the dose escalated to 60 and then up to 80 mg/d to control IGF-1. Subsequent fixed doses were maintained for a 7-month core treatment, followed by a voluntary 6-month extension. Results: Of 151 evaluable subjects initiating OOCs, 65% maintained response and achieved the primary endpoint of IGF-1 <1.3 × ULN and mean integrated GH <2.5 ng/mL at the end of the core treatment period and 62% at the end of treatment (up to 13 mo). The effect was durable, and 85 % of subjects initially controlled on OOCs maintained this response up to 13 months. When controlled on OOCs, GH levels were reduced compared to baseline, and acromegaly-related symptoms improved. Of 102 subjects completing the core treatment, 86% elected to enroll in the 6-month extension. Twenty-six subjects who were considered treatment failures (IGF-1 ≥1.3 × ULN) terminated early, and 23 withdrew for adverse events, consistent with those known for octreotide or disease related. Conclusions: OOC, an oral therapeutic peptide, achieves efficacy in controlling IGF-1 and GH after switching from injectable SRLs for up to 13 months, with a safety profile consistent with approved SRLs. OOC appears to be effective and safe as an acromegaly monotherapy.

Sign in / Sign up

Export Citation Format

Share Document