Long-term safety, tolerability and efficacy of flexible-dose fesoterodine in elderly patients with overactive bladder: Open-label extension of the SOFIA trial

2013 ◽  
Vol 33 (1) ◽  
pp. 106-114 ◽  
Author(s):  
Adrian Wagg ◽  
Vik Khullar ◽  
Martin C. Michel ◽  
Matthias Oelke ◽  
Amanda Darekar ◽  
...  
Keyword(s):  
Overactive Bladder ◽  
Elderly Patients ◽  
Open Label ◽  
Open Label Extension ◽  
Flexible Dose

scholarly journals 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

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.

Long-term darifenacin treatment for overactive bladder in patients aged 65 years and older: analysis of results from a 2-year, open-label extension study

2007 ◽  
Vol 23 (11) ◽  
pp. 2697-2704 ◽  
Author(s):  
Simon Hill ◽  
Mostafa Elhilali ◽  
Richard J Millard ◽  
Peter L Dwyer ◽  
Karine Lheritier ◽  
...  
Keyword(s):  
Overactive Bladder ◽  
Extension Study ◽  
Open Label ◽  
Open Label Extension ◽  
Analysis Of Results

Long-term treatment with darifenacin for overactive bladder: results of a 2-year, open-label extension study

2006 ◽  
Vol 98 (5) ◽  
pp. 1025-1032 ◽  
Author(s):  
François Haab ◽  
Jacques Corcos ◽  
Paul Siami ◽  
Karin Glavind ◽  
Peter Dwyer ◽  
...  
Keyword(s):  
Overactive Bladder ◽  
Term Treatment ◽  
Extension Study ◽  
Open Label ◽  
Long Term Treatment ◽  
Open Label Extension
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