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Labadzhyan A, Nachtigall LB, Fleseriu M, et al. Oral Octreotide Capsules for the Treatment of Acromegaly: Comparison of 2 Phase 3 Trial Results. Pituitary. 2021. https://doi.org/10.1007/s11102-021-01163-2.

June 25, 2021

Gordon MB, Fleseriu M, Bondar I, et al. Injection Site Reactions and Their Impact in Patients with Acromegaly Receiving Injectable Somatostatin Receptor Ligands in the Phase 3 MPOWERED Trial. Endocr Pract. 2021; 27(6): S112-S113. https://doi.org/10.1016/j.eprac.2021.04.708

June 1, 2021

Gordon MB, Fleseriu M, Biermasz N, et al. Effects of Prior Injectable Somatostatin Receptor Ligand Type and Dose in Patients with Acromegaly Receiving Oral Octreotide Capsules in the Phase 3 MPOWERED Trial. Endocr Pract. 2021; 27(6): S131. https://doi.org/10.1016/j.eprac.2021.04.745

June 1, 2021

Biermasz N, Fleseriu M, Gordon MB, et al. Improved Quality of Life and Work Productivity in Patients With Acromegaly Receiving Oral Octreotide Capsules in the Phase 3 MPOWERED Trial. Endocr Pract. 2021; 27(6): S132. https://doi.org/10.1016/j.eprac.2021.04.747.

June 1, 2021

Gordon MB, Fleseriu M, Dreval AV, et al. Improved Acromegaly Patient Satisfaction With Oral Octreotide Capsules Compared With Injectable Somatostatin Receptor Ligands In The MPOWERED Trail. Endocrine Abs. 2021; 73: PEP13.6. https://doi.org/10.1530/endoabs.73.PEP13.6

May 22, 2021

Fleseriu M, Dreval AV, Pokramovich Y, et al. A Phase 3 Large International Noninferiority Trial (MPOWERED): Assessing Maintenance of Response to Oral Octreotide Capsules in Comparison to Injectable Somatostatin Receptor Ligands. Endocrine Abs. 2021; 73: OC13.6. https://doi.org/10.1530/endoabs.73.OC13.6.

May 22, 2021

Biermasz N, Fleseriu M, Dreval AV, et al. Oral Octreotide Capsules Lowered Incidence And Improved Severity of Acromegaly Symptoms Compared To Injectable Somatostatin Receptor Ligands—Results From The MPOWERED Trial. Endocrine Abs. 2021; 73: PEP8.1. https://doi.org/10.1530/endoabs.73.PEP8.1

May 22, 2021

Freda P, Fleseriu M, Dreval AV, et al. Safety Results From MPOWERED, A Phase 3 Trial Of Oral Octreotide Capsules In Adults With Acromegaly. Endocrine Abs. 2021; 73: PEP3.2. https://doi.org/10.1530/endoabs.73.PEP3.2

May 22, 2021

Fleseriu M, Dreval AV, Pokramovich Y, et al. Addition Of Cabergoline To Oral Octreotide Capsules May Improve Biochemical Control In Patients With Acromegaly Who Are Inadequately Controlled With Monotherapy. Endocrine Abs. 2021; 73: PEP8.3. https://doi.org/10.1530/endoabs.73.PEP8.3

May 22, 2021

Samson SL, Nachtigall LB, Fleseriu M, et al. One-Year Outcomes of the Open-Label Extension of CHIASMA OPTIMAL, a Phase 3 Study of Oral Octreotide Capsules in Acromegaly. J Endocr Soc. 2021;5(suppl 1): A515-A516. https://doi.org/10.1210/jendso/bvab048.1054

March 22, 2021

Fleseriu M, Dreval AV, Pokramovich Y, et al. Addition Of Cabergoline To Oral Octreotide Capsules May Improve Biochemical Control In Patients With Acromegaly Who Are Inadequately Controlled With Monotherapy. J Endocr Soc. 2021;5(suppl 1): A518-A519. https://doi.org/10.1210/jendso/bvab048.1058

March 20, 2021

Gordon MB, Fleseriu M, Dreval AV, et al. Improved Acromegaly Patient Satisfaction With Oral Octreotide Capsules Compared With Injectable Somatostatin Receptor Ligands In The MPOWERED Trail. J Endocr Soc. 2021;4(suppl 1): A520-A521. https://doi.org/10.1210/jendso/bvab048.1062

March 20, 2021

Biermasz N, Fleseriu M, Dreval AV, et al. Oral Octreotide Capsules Lowered Incidence And Improved Severity of Acromegaly Symptoms Compared To Injectable Somatostatin Receptor Ligands—Results From The MPOWERED Trial. J Endocr Soc. 2021;5(suppl 1): A522-A523. https://doi.org/10.1210/jendso/bvab048.1065

March 20, 2021

Freda P, Fleseriu M, Dreval AV, et al. Safety Results From MPOWERED, A Phase 3 Trial Of Oral Octreotide Capsules In Adults With Acromegaly. J Endocr Soc. 2021;5(suppl 1): A527-A528. https://doi.org/10.1210/jendso/bvab048.1074

March 20, 2021

Fleseriu M, Dreval AV, Pokramovich Y, et al. A Phase 3 Large International Noninferiority Trial (MPOWERED): Assessing Maintenance Of Response To Oral Octreotide Capsules In Comparison To Injectable Somatostatin Receptor Ligands. J Endocr Soc. 2021;5(suppl 1): A517. https://doi.org/10.1210/jendso/bvab048.1056

March 20, 2021

Fleseriu M, Molitch M, Dreval A, et al. Disease and Treatment-Related Burden in Patients With Acromegaly Who Are Biochemically Controlled on Injectable Somatostatin Receptor Ligands. Front Endocrinol (Lausanne). 2021. https://doi.org/10.3389/fendo.2021.627711

March 15, 2021

Labadzhyan A, Samson S, Nachtigall LB, et al. Gastrointestinal Adverse Events With Oral Octreotide Capsules: Safety Results From the Phase 3 CHIASMA OPTIMAL Study. Presented at: 19th Congress of the European NeuroEndocrine Association (ENEA); November 27–29, 2020; Virtual. [ENEA 2020 abstract OP-05]

November 1, 2020

Samson SL, Nachtigall LB, Fleseriu M, et al. Results from the phase 3, randomized, double-blind, placebo-controlled OPTIMAL study of oral octreotide capsules in adult patients with acromegaly. Endocrine Abstracts. 2020; 70: 0C4.6. https://doi.org/10.1530/endoabs.70.OC4.6.

September 8, 2020

Samson SL, Nachtigall LB, Fleseriu M, et al. Impact of Imputation Method on Efficacy Results From the Phase 3 OPTIMAL Study Of Oral Octreotide Capsules in Adult Patients With Acromegaly. Endocrine Abstracts. 2020; 70: AEP669. http://doi.org/10.1530/endoabs.70.AEP669

September 5, 2020

Samson SL, Nachtigall LB, Fleseriu M, et al. Sustained response to treatment with oral octreotide capsules: Results from the phase 3, randomized, double blind, placebo-controlled OPTIMAL study. Endocrine Abstracts. 2020; 70: AEP576. https://doi.org/10.1530/endoabs.70.AEP576

September 5, 2020

Labadzhyan A, Samson SL, Nachtigall LB, et al. Analysis of adverse events in adult patients with acromegaly receiving oral octreotide capsules: results from the phase 3, randomized, double-blind, placebo-controlled CHIASMA OPTIMAL study. Endocrine Abstracts. 2020; 70: AEP613. https://doi.org/10.1530/endoabs.70.AEP613

September 5, 2020

Fleseriu M, Samson SL, Nachtigall LB, et al. Biochemical Control of Most Patients Reverting to Injectable Long-Acting Somatostatin Receptor Ligands is Achieved After One Dose: Results From the Phase 3, Randomized, Double Blind, Placebo-Controlled OPTIMAL study. Endocrine Abstracts. 2020; 70: AEP577. https://doi.org/10.1530/endoabs.70.AEP577

September 5, 2020

Nachtigall LB, Samson SL, Fleseriu M, et al. Patients receiving a range of doses of prior injectable somatostatin receptor ligands respond to oral octreotide in the treatment of acromegaly: Results From The Phase 3 OPTIMAL Study. Endocrine Abstracts. 2020; 70: AEP756. https://doi.org/10.1530/endoabs.70.AEP756

September 5, 2020

Samson SL, Nachtigall LB, Fleseriu M, et al. IGF-I variability and its association with demographic and clinical characteristics in patients with acromegaly treated with injectable somatostatin receptor ligands (SRLs): results from an international prospective phase 3 study. Endocrine Abstracts. 2020; 70: AEP612. https://doi.org/10.1530/endoabs.70.AEP612

September 5, 2020

Nachtigall LB, Samson SL, Fleseriu M, et al. Withdrawal from long-acting somatostatin receptor ligand injections in adult patients with acromegaly: results from the phase 3, randomized, double-blind, placebo-controlled CHIASMA OPTIMAL study. Endocrine Abstracts. 2020; 70: AEP668. https://doi.org/10.1530/endoabs.70.AEP668

September 5, 2020

Samson S, Nachtigall L, Fleseriu M, et al. Maintenance of Acromegaly Control in Patients Switching From Injectable Somatostatin Receptor Ligands to Oral Octreotide. J Clin Endocrinol Metab.2020;105(10): dgaa526.

August 16, 2020

Geer EB, Sisco J, Adelman DT, et al. Patient reported outcome data from acromegaly patients treated with injectable somatostatin receptor ligands (SRLs) in routine clinical practice. BMC Endocr Disord. 2020;20(1):117.

July 31, 2020

Samson SL, Nachtigall LB, Fleseriu M, et al. Treatment with oral octreotide capsules may not adversely affect glycemic control in patients with acromegaly: results from the phase 3 CHIASMA OPTIMAL study. Endocrine Practice. 2020; 26 (suppl 2):236. https://doi.org/10.1016/S1530-891X(20)39880-3

June 5, 2020

Fleseriu M, Samson SL, Nachtigall LB, et al. Biochemical Control of Most Patients Reverting to Injectable Long-Acting Somatostatin Receptor Ligands is Achieved After One Dose: Results From the Phase 3, Randomized, Double Blind, Placebo-Controlled OPTIMAL study. J Endocr Soc. 2020;4(suppl 1): MON-LB55. https://doi.org/10.1210/jendso/bvaa046.2123.

May 8, 2020

Labadzhyan A, Samson SL, Nachtigall LB, et al. Analysis of adverse events in adult patients with acromegaly receiving oral octreotide capsules: results from the phase 3, randomized, double-blind, placebo-controlled CHIASMA OPTIMAL study. J Endocr Soc. 2020;4(suppl 1): MON-314. https://doi.org/10.1210/jendso/bvaa046.1870.

May 8, 2020

Nachtigall LB, Samson SL, Fleseriu M, et al. Prior Injectable Somatostatin Receptor Ligand Dose Does Not Predict Oral Octreotide Response In The Treatment Of Acromegaly: Results From The Phase 3 OPTIMAL Study. J Endocr Soc. 2020;4(suppl 1): MON-LB53. https://doi.org/10.1210/jendso/bvaa046.2121.

May 8, 2020

Nachtigall LB, Samson SL, Fleseriu M, et al. Withdrawal from long-acting somatostatin receptor ligand injections in adult patients with acromegaly: results from the phase 3, randomized, double-blind, placebo-controlled CHIASMA OPTIMAL study. J Endocr Soc. 2020;4(suppl 1): MON-297. https://doi.org/10.1210/jendso/bvaa046.1833.

May 8, 2020

Samson SL, Nachtigall LB, Fleseriu M, et al. Impact of Imputation Method and Response Cutoffs on Results From the Phase 3 OPTIMAL Study Of Oral Octreotide Capsules in Adult Patients With Acromegaly. J Endocr Soc. 2020;4(suppl 1): MON-LB57. https://doi.org/10.1210/jendso/bvaa046.2120.

May 8, 2020

Samson SL, Nachtigall LB, Fleseriu M, et al. IGF-I variability and its association with demographic and clinical characteristics in patients with acromegaly treated with injectable somatostatin receptor ligands (SRLs): results from an international prospective phase III study. J Endocr Soc. 2020;4(suppl 1): MON-323. https://doi.org/10.1210/jendso/bvaa046.1907.

May 8, 2020

Samson SL, Nachtigall LB, Fleseriu M, et al. Results from the phase 3, randomized, double-blind, placebo-controlled CHIASMA OPTIMAL study of oral octreotide capsules in adult patients with acromegaly. J Endocr Soc. 2020;4(suppl 1): OR23-07. https://doi.org/10.1210/jendso/bvaa046.211.

May 8, 2020

Fleseriu M, Fogelfeld L, Gordon MB, et al. An evaluation of the Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ) in adult patients with acromegaly, including correlations with other patient-reported outcome measures: data from two large multicenter international studies. Pituitary (2020).

March 27, 2020

Fleseriu M, Fogelfeld L, Gordon MB, et al. Development of a novel patient-reported measure for acromegaly: the Acro-TSQ. Pituitary. 2019;22(6):581-593.

December 22, 2019

Geer EB, Sisco J, Adelman DT, et al. Observed discordance between outcomes reported by acromegaly patients and their treating endocrinology medical provider. Pituitary. 2020;23(2):140‐148.

December 5, 2019

Pulaski-Liebert KJ, Yedinak C. Transitional care model for patients with acromegaly. Int J Nur Health. 2019;2(1):82-89.

May 20, 2019

Geer E, Sisco J, Adelman D, et al. Biochemically controlled acromegaly patients on a stable dose of injectable somatostatin analogues in routine clinical practice still remain symptomatic: preliminary results from endocrinology health care professionals. [ENDO 2019 abstract SUN-LB078]. J Endocr Soc. 2019;3(suppl 1): SUN-LB078. doi: 10.1210/js.2019-SUN-LB078.

April 30, 2019

Geer E, Sisco J, Adelman D, et al. Relationship between responses from acromegaly patients treated with a stable dose of injectable somatostatin analogues in routine clinical practice and their endocrinology health care professional regarding treatment outcomes: preliminary findings [ENDO 2019 abstract SUN-LB077]. J Endocr Soc. 2019;3(suppl 1): SUN-LB077. doi: 10.1210/js.2019-SUN-LB077.

April 30, 2019

Geer E, Sisco J, Adelman D, et al. Patient reported outcome data from acromegaly patients treated with injectable somatostatin analogues in routine clinical practice: preliminary results [ENDO 2019 abstract SAT-434]. J Endocr Soc. 2019;3(suppl 1):SAT-434. doi: 10.1210/js.2019-SAT-434.

April 30, 2019

Fleseriu M, Molitch M, Dreval A, et al. Symptom burden and impact of treatment in patients with acromegaly treated with injectable somatostatin receptor ligands. Presented at: 18th Congress of the European NeuroEndocrine Association (ENEA); October 17-20, 2018; Warsaw, Poland. [ENEA 2018 abstract OP01-07]

October 18, 2018

Biermasz NR, Dreval A, Fleseriu M, et al. Symptom burden in patients with acromegaly treated with injectable somatostatin receptor ligands. Presented at: 9th International Congress of the Growth Hormone Research Society (GRS) and the International Society for IGF Research (IGF Society); September 14-17, 2018; Seattle, WA.

September 14, 2018

Yedinak C, Pulaski-Liebert KJ, Adelman DT, Williams J. Acromegaly: current therapies benefits and burdens. Clin Pract. 2018;15(2):499-511.

May 13, 2018

Samson SL, Fleseriu M, Giustina A, et al. CHIASMA OPTIMAL: Study design of a phase 3 double blind trial evaluating oral octreotide capsules versus placebo in patients with acromegaly [ENDO 2018 abstract SUN-552]. Endocr Rev. 2018;39(2)(suppl 1):i1-i1417. doi: 10.1093/edrv/39.supp.1.

March 18, 2018

Fleseriu M, Melmed S, Mangal B, et al. Longitudinal assessment of response to treatment with oral octreotide capsules in patients with acromegaly: post-hoc analysis of a phase 3 trial [ECE 2016 abstract GP151]. Endocr Abs. 2016;41:GP151. doi: 10.1530/endoabs.41.GP151.

May 31, 2016

Fleseriu M, Fogelfeld L, Gordon MB, et al. A study to develop a novel patient-reported (PRO) instrument to assess satisfaction with acromegaly treatment: the ACRO-TSQ; [AACE 2016 abstract 1304]. Endocr Pract. 2016;22(suppl 2):193-226. doi: 10.4158/1530-891X-22.s2.193.

May 1, 2016

Fleseriu M, Popovic V, Biermasz NR, et al. Novel approach to dose optimization of oral octreotide in patients with acromegaly transitioned from injectable somatostatin analogs [ENDO 2016 abstract LB-Sun34]. Endocr Rev. 2016;37(2)(suppl 1):i1-i1699. doi: 10.1093/edrv/37.supp.1.

April 3, 2016

Strasburger CJ, Katznelson L, Melmed S, et al. Oral octreotide capsules improve acromegaly-related symptoms in patients transitioned from injectable octreotide or lanreotide [ENDO 2016 abstract OR18-2]. Endocr Rev. 2016;37(2)(suppl 1):i1-i1699. doi: 10.1093/edrv/37.supp.1.

April 2, 2016

Fleseriu M, Katznelson L, Clemmons D, et al. Mpowered: study design of a phase 3 head-to-head trial evaluating oral octreotide capsules versus injectable somatostatin analogs in patients with acromegaly [AACE 2016 abstract 938]. Endocr Pract. 2016;22(suppl 2):193-226. doi: 10.4158/1530-891X-22.s2.193.

February 1, 2016

Strasburger CJ, Karavitaki N, Störmann S, et al. Patient-reported outcomes of parenteral somatostatin analogue injections in 195 patients with acromegaly. Eur J Endocrinol. 2016;174(3):355-362.

December 18, 2015

Haviv A, Patou G, Mathias S. Patient reported outcomes comparing octreotide capsules to somatostatin analogues injections: results from a multicentre, baseline controlled, phase 3 study in acromegaly [ECE 2015 abstract EP710]. Endocr Abs. 2015;37:EP710. doi: 10.1530/endoabs.37.EP710.

May 16, 2015

Haviv A, Kramer W, Patou G, Tillotson G. Parenteral somatostatin analogues: a focus on injection site adverse reactions [ECE 2015 abstract EP711]. Endocr Abs. 2015;37:EP711. doi: 10.1530/endoabs.37.EP711.

May 16, 2015

Strasburger CJ, Karavitaki N, Stoermann S, et al. Patient reported outcomes survey in acromegaly patients treated with parenteral somatostatin analogues [ENDO 2015 abstract PP09-4]. Endocr Rev. 2015;36(2)(suppl 1):i1-i1599. doi: 10.1093/edrv/36.supp.1.

April 1, 2015

Melmed S, Biermasz NR, Trainer PJ, et al. Determinants of oral octreotide capsules efficacy in acromegaly [ENDO 2015 abstract OR 09-03]. Endocr Rev. 2015;36(2)(suppl 1):i1-i1599. doi: 10.1093/edrv/36.supp.1.

March 5, 2015

Melmed S, Popovic V, Bidlingmaier M, et al. Safety and efficacy of oral octreotide in acromegaly: results of a multicenter phase III trial. J Clin Endocrinol Metab. 2015;100(4):1699-1708.

February 9, 2015

Melmed S, Popovic-Brkic V, Bidlingmaier M, et al. Efficacy and safety of oral octreotide in acromegaly: results of a multicenter phase III trial in 155 patients. Presented at: 16th International Congress of Endocrinology and the Endocrine Society’s 96th Annual Meeting and Expo; June 21-24, 2014; Chicago, IL. [ICE/ENDO 2014 abstract OR17-5]

June 22, 2014

Tuvia S, Pelled D, Marom K, et al. A novel suspension formulation enhances intestinal absorption of macromolecules via transient and reversible transport mechanisms. Pharm Res. 2014; 31(8):2010-2021.

February 14, 2014

Tuvia S, Teichman SL, Pelled D, et al. Oral octreotide absorption in human subjects: comparable pharmacokinetics to parenteral octreotide and effective growth hormone suppression [GRF-IGS Congress 2012 abstract P02-44]. Growth Horm IGF Res. 2012;22(suppl 1):S66. doi: 10.1016/S1096-6374(12)60173-7.

October 19, 2012

Teichman S, Tuvia S, Atsmon J, et al. Octreolin™ is an oral octreotide formulation to treat acromegaly and other indications. Presented at: 15th Congress of the European NeuroEndocrine Association (ENEA); September 12-15, 2012; Vienna, Austria. [ENEA 2012 abstract OC19]

September 12, 2012

Teichman S, Tuvia S, Atsmon J, et al. Octreolin™ pharmacodynamics: an oral octreotide formulation to treat acromegaly suppresses growth hormone in healthy volunteers [ENDO 2012 abstract OR49-4]. Endocr Rev. 2012;33(3)(suppl 1):i1-i1057. doi: 10.1093/edrv/33.supp.1.

June 1, 2012

Tuvia S, Pelled D, Kischitzky A, et al. A novel formulation of octreotide enables its enteral absorption and growth hormone inhibition in animals [ENDO 2012 abstract Mon-688]. Endocr Rev. 2012;33(3)(suppl 1):i1-i1057. doi: 10.1093/edrv/33.supp.1

June 1, 2012

Tuvia S, Kramer WG, Teichman S, et al. Pharmacokinetic modeling of oral octreotide (Octreolin) in healthy volunteers and dosing regimen optimization for acromegaly patients [ENDO 2012 abstract OR29-6]. Endocr Rev. 2012;33(3)(suppl 1):i1-i1057. doi: 10.1093/edrv/33.supp.1.

June 1, 2012

Tuvia S, Atsmon J, Teichman S, et al. Oral octreotide absorption in human subjects: comparable pharmacokinetics to parenteral octreotide and effective growth hormone suppression. J Clin Endocrinol Metab. 2012;97(7):2362-2369.

April 26, 2012

Tuvia S, Salama P, Weinstein I, et al. Octreolin™, a safe oral alternative for parenteral octreotide treatment [GRS-IGF Congress 2010 abstract OR14-80]. Growth Horm IGF Res. 2010;20(suppl 1):S35-S36. doi: 10.1016/S1096-6374(10)70096-4.

October 7, 2010

Atsmon J, Katz S, Salama P, et al. Octreolin™, a safe oral alternative for parenteral octreotide treatment; phase 1 study results. Presented at: 14th Congress of the European NeuroEndocrine Association (ENEA); September 22-25, 2010; Liége, Belgium.

January 1, 2010