Efficacy and safety of telotristat ethyl in patients with carcinoid syndrome inadequately controlled by somatostatin analogs: Analysis of the completed TELESTAR extension period

2017 ◽  
Author(s):  
D Horsch ◽  
MH Kulke ◽  
M Caplin ◽  
L Anthony ◽  
E Bergsland ◽  
...  
Keyword(s):  
Carcinoid Syndrome ◽  
Somatostatin Analogs ◽  
Efficacy And Safety ◽  
Extension Period

scholarly journals Durable Effects of iGlarLixi Up to 52 Weeks in Type 2 Diabetes: The LixiLan-G Extension Study

2021 ◽  
Author(s):  
Lawrence Blonde ◽  
Julio Rosenstock ◽  
Juan Frias ◽  
Andreas L. Birkenfeld ◽  
Elisabeth Niemoeller ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Fixed Ratio ◽  
Efficacy And Safety ◽  
Open Label ◽  
Once Daily ◽  
Glucagon Like Peptide ◽  
Glucagon Like Peptide 1 ◽  
Design And Methods ◽  
Extension Period

<b>Objective</b> <p><a>In the LixiLan-G trial, switching to iGlarLixi, a once-daily titratable fixed-ratio combination of insulin glargine </a>100 units/mL and the glucagon-like peptide-1 receptor agonist (GLP-1 RA) lixisenatide, improved glucose control in type 2 diabetes (T2D) uncontrolled with GLP-1 RAs over 26 weeks versus continuing prior GLP-1 RA. A prespecified, 26-week, single-arm extension of LixiLan-G aimed to determine the durability of iGlarLixi efficacy and safety over 52 weeks. </p> <p><b>Research Design and Methods</b></p> <p>Participants with T2D uncontrolled by GLP-1 RAs (HbA<sub>1c</sub> 7–9 % [53–75 mmol/mol]) were initially randomized to switch to iGlarLixi or continue prior GLP-1 RA. Those randomized to iGlarLixi who completed the 26-week primary endpoint period could continue iGlarLixi open-label treatment over a 26-week extension to assess durability of efficacy and safety.</p> <p><b>Results</b></p> <p>Glycemic control achieved with iGlarLixi at week 26 (mean HbA<sub>1c</sub> 6.7 % [50 mmol/mol]) was maintained at week 52 (mean HbA<sub>1c</sub> 6.7 % [50 mmol/mol]; mean ± standard deviation change from baseline at week 52: −1.0 ± 0.9 % [11 ± 10 mmol/mol]). Proportions of participants reaching HbA<sub>1c</sub> <7 % (53 mmol/mol) with iGlarLixi were similar at week 26 (62%) and 52 (64%), as were those reaching this target without documented symptomatic (<3.0 mmol/L) hypoglycemia (57% and 58%). Safety of iGlarLixi was similar at weeks 26 and 52, with low rates of documented symptomatic hypoglycemia and gastrointestinal events.</p> <p><b>Conclusions</b></p> The efficacy and safety of iGlarLixi at the end of the 26-week randomized treatment period was maintained over the 26-week extension period in the LixiLan-G trial.

Long-Term Efficacy and Safety of Pegvisomant in Combination With Long-Acting Somatostatin Analogs in Acromegaly

2014 ◽  
Vol 99 (10) ◽  
pp. 3644-3652 ◽  
Author(s):  
S. J. C. M. M. Neggers ◽  
S. E. Franck ◽  
F. W. M. de Rooij ◽  
A. H. G. Dallenga ◽  
R. M. L. Poublon ◽  
...  
Keyword(s):  
Somatostatin Analogs ◽  
Efficacy And Safety ◽  
Term Efficacy ◽  
Long Acting

scholarly journals Long-Term Efficacy and Safety of Combined Treatment of Somatostatin Analogs and Pegvisomant in Acromegaly

2007 ◽  
Vol 92 (12) ◽  
pp. 4598-4601 ◽  
Author(s):  
Sebastian J. C. M. M. Neggers ◽  
Maarten O. van Aken ◽  
Joop A. M. J. L. Janssen ◽  
Richard A. Feelders ◽  
Wouter W. de Herder ◽  
...  
Keyword(s):  
Combined Treatment ◽  
Somatostatin Analogs ◽  
Efficacy And Safety ◽  
Term Efficacy

scholarly journals Efficacy and safety of switching from rituximab to biosimilar CT-P10 in rheumatoid arthritis: 72-week data from a randomized Phase 3 trial

Rheumatology ◽  
2019 ◽  
Vol 58 (12) ◽  
pp. 2193-2202 ◽  
Author(s):  
Seung Cheol Shim ◽  
Ljubinka Božić-Majstorović ◽  
Alfredo Berrocal Kasay ◽  
Elias Chalouhi El-Khouri ◽  
Fedra Irazoque-Palazuelos ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Disease Activity ◽  
Study Drug ◽  
Efficacy And Safety ◽  
Drug Infusion ◽  
Phase 3 ◽  
Double Blind ◽  
American College Of Rheumatology ◽  
Extension Period

Abstract Objective To evaluate the efficacy and safety of CT-P10, a rituximab biosimilar after a single switch, during a multinational, randomized, double-blind Phase 3 trial involving patients with RA. Methods Patients received 48 weeks’ treatment with CT-P10 or United States- or European Union-sourced reference rituximab (US-RTX and EU-RTX, respectively). Patients entering the extension period (weeks 48–72) remained on CT-P10 (CT-P10/CT-P10; n = 122) or US-RTX (US-RTX/US-RTX; n = 64), or switched to CT-P10 from US-RTX (US-RTX/CT-P10; n = 62) or EU-RTX (EU-RTX/CT-P10; n = 47) for an additional course. Efficacy endpoints included Disease Activity Score using 28 joints (DAS28), American College of Rheumatology (ACR) response rates, and quality of life-related parameters. Pharmacodynamics, immunogenicity and safety were also assessed. Results At week 72, similar improvements were observed by disease activity parameters including DAS28 and ACR response rate in the four extension period treatment groups. Quality of life improvements at week 72 vs baseline were similarly shown during the extension period in all groups. Newly developed anti-drug antibodies were detected in two patients following study drug infusion in the extension period. Similar pharmacodynamic and safety profiles were observed across groups. Conclusion Long-term use of CT-P10 up to 72 weeks was effective and well tolerated. Furthermore, switching from reference rituximab to CT-P10 in RA was well tolerated and did not result in any clinically meaningful differences in terms of efficacy, pharmacodynamics, immunogenicity and safety. Trail registration ClinicalTrials.gov, http://clinicaltrials.gov, NCT02149121.

Sign in / Sign up

Export Citation Format

Share Document