Therapeutic Uses Of Empagliflozin - EP2981255

The patent EP2981255 was granted to Boehringer Ingelheim on Sep 14, 2022. The application was originally filed on Apr 3, 2014 under application number EP14715274A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP2981255

BOEHRINGER INGELHEIM
Application Number
EP14715274A
Filing Date
Apr 3, 2014
Status
Granted And Under Opposition
Aug 12, 2022
Grant Date
Sep 14, 2022
External Links
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Patent Summary

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Patent Family

Patent Oppositions (10)

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GENERICS UKJun 14, 2023ADMISSIBLE
HGFJun 14, 2023ADMISSIBLE
ADALVOJun 13, 2023ADMISSIBLE
AERAJun 13, 2023ADMISSIBLE
SANOVEL IIAC SAN VE TICJun 13, 2023ADMISSIBLE
STADA ARZNEIMITTELJun 13, 2023ADMISSIBLE
ZENTIVA KSJun 13, 2023ADMISSIBLE
POLPHARMAJun 8, 2023ADMISSIBLE
SANDOZJun 8, 2023ADMISSIBLE
TEVA PHARMACEUTICALSApr 20, 2023ADMISSIBLE

Patent Citations (16) New

Patent citations refer to prior patents cited during different phases such as opposition or international search.

Citation PhasePublication NumberPublication Link
INTERNATIONAL-SEARCH-REPORTWO2011039337
INTERNATIONAL-SEARCH-REPORTWO2012062698
INTERNATIONAL-SEARCH-REPORTWO2012107476
OPPOSITIONWO2010092123
OPPOSITIONWO2010092124
OPPOSITIONWO2010092125
OPPOSITIONWO2010092126
OPPOSITIONWO2011039337
OPPOSITIONWO2012062698
OPPOSITIONWO2012107476
OPPOSITIONWO2012120040
OPPOSITIONWO2013139777
OPPOSITIONWO2014161918
OPPOSITIONWO2017157816
OTHEREP147152748
OTHEREP2981255

Non-Patent Literature (NPL) Citations (72) New

NPL citations refer to non-patent references such as research papers, articles, or other publications cited during examination or opposition phases.

Citation PhaseReference TextLink
EXAMINATION- "Annex 1 - Summary of product Characteristics - Jardiance", (2019), pages 1 - 47, European Medicines Agency, URL: https://www.ema.europa.eu/en/documents/product-information/jardiance-epar-product-information_en.pdf-
EXAMINATION- FITCHETT DAVID ET AL, "Heart failure outcomes with empagliflozin in patients with type 2 diabetes at high cardiovascular risk: results of the EMPA-REG OUTCOME (R) trial", EUROPEAN HEART JOURNAL,, (20160126), vol. 37, no. 19, doi:10.1093/EURHEARTJ/EHV728, pages 1526 - 1534, XP002769965
OPPOSITION- Anonymous, "12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus", ClinicalTrials.gov; NCT01370005, (20121212), ClinicalTrials.gov; NCT01370005, URL: https://classic.clinicaltrials.gov/ct2/history/NCT01370005?V_22=View#StudyPageTop, (20240130), XP093125511-
OPPOSITION- Anonymous, "BI 10773 Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients", ClinicalTrials.gov; NCT01131676, (20130403), ClinicalTrials.gov; NCT01131676, URL: https://classic.clinicaltrials.gov/ct2/history/NCT01131676?V_39=View#StudyPageTop, (20240129), XP093124819-
OPPOSITION- Anonymous, "BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME).", ClinicalTrials.gov ID NCT01131676, (20121219), ClinicalTrials.gov ID NCT01131676, URL: https://clinicaltrials.gov/study/NCT01131676, (20240205), XP093127162-
OPPOSITION- Anonymous, "BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) | NCT01131676", ClinicalTrials.gov, NLM, (20130403), pages 1 - 120, ClinicalTrials.gov, URL: https://clinicaltrials.gov/study/NCT01131676?tab=history&a=39#StudyPageTop, (20240208), XP093128923-
OPPOSITION- Anonymous, "Boehringer Ingelheim and Eli Lilly and Company announce positive top-line pivotal Phase III data results for empagliflozin ", Eli Lilly and Company; Boehringer Ingelheim, (20130107), Eli Lilly and Company; Boehringer Ingelheim, URL: https://www.prnewswire.com/news-releases/boehringer-ingelheim-and-eli-lilly-and-company-announce-positive-top-line-pivotal-phase-iii-data-results-for-empagliflozin-185862972.html, (20240129), XP093124824-
OPPOSITION- Anonymous, "Dapagliflozin Tablets, 5 and 10 mg", FDA Briefing Document, NDA 202293, (20110719), XP093150372-
OPPOSITION- Anonymous, "Guidance for Industry Diabetes Mellitus — Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes", (20081201), pages 1 - 8, XP093121420-
OPPOSITION- Anonymous, "Guidance for Industry Diabetes Mellitus — Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes", U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), (20081201), pages 1 - 8, XP093121420-
OPPOSITION- Anonymous, "Guidance for Industry Diabetes Mellitus — Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes", U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), (20081201), U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) , (20240129), XP093124831-
OPPOSITION- Anonymous, "Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus ", European medicine agency science medicines health, (20120514), pages 1 - 28, XP093121266-
OPPOSITION- Anonymous, "History of Changes for Study: NCT01131676 BI 10773 Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients", ClinicalTrials.gov, (20130710), ClinicalTrials.gov, URL: https://clinicaltrials.gov/ct2/history/NCT01131676?V_46=View#StudyPageTop, (20220104), XP055876128-
OPPOSITION- Anonymous, "History of Changes for Study: NCT01131676 Bl 10773 Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients", Clinical Trials, (20130320), pages 1 - 90, XP093123308-
OPPOSITION- Anonymous, "History of Changes for Study: NCT01370005 12 Week Efficacy and Safety Study of Empagliflozin (Bl 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus", Clinical Trials, (20121212), pages 1 - 21, XP093123316-
OPPOSITION- Anonymous, "Hypertension Facts and Figures", Government of Canada - Gouvernement du Canada, (20100722), Government of Canada - Gouvernement du Canada, (20240411), XP093150678-
OPPOSITION- Anonymous, "PART 312—INVESTIGATIONAL NEW DRUG APPLICATION ", Code of Federal Regulations (Annual Edition), Office of the Federal Register Publications, (20130401), pages 49 - 92, Code of Federal Regulations (Annual Edition), URL: https://www.govinfo.gov/content/pkg/CFR-2013-title21-vol5/pdf/CFR-2013-title21-vol5-part312.pdf, (20240208), XP093128925-
OPPOSITION- Anonymous, "Prix Galien - Auszeichnung 2019 für Jardiance", (20190830), URL: https://medical-tribune.ch/news/prix-galien/10047368/auszeichnung-2019-fuer-jardiance/, XP093150373-
OPPOSITION- "BI 10773 Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients", ClinicalTrials.gov; NCT01131676, (20130403), URL: https://classic.clinicaltrials.gov/ct2/history/NCT01131676?V_39=View#StudyPageTop, XP093124819-
OPPOSITION- "Boehringer Ingelheim and Eli Lilly and Company announce positive top-line pivotal Phase III data results for empagliflozin ", Eli Lilly and Company; Boehringer Ingelheim, (20130107), URL: https://www.prnewswire.com/news-releases/boehringer-ingelheim-and-eli-lilly-and-company-announce-positive-top-line-pivotal-phase-iii-data-results-for-empagliflozin-185862972.html, XP093124824-
OPPOSITION- Einhart Natascha, " Empagliflozin bei Herzinsuffizienz: neue Erkenntnisse?", Arzneiverordnung in der Praxis, (20220913), vol. 43, no. 3, pages 124 - 127, XP093224567-
OPPOSITION- European medicine agency, "Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus ", (20120514), pages 1 - 28, XP093121266-
OPPOSITION- F. M. Turnbull ; C. Abraira ; R. J. Anderson ; R. P. Byington ; J. P. Chalmers ; W. C. Duckworth ; G. W. Evans ; H. C. Gerstein ; R. R. Holman ; T. E. Moritz ; B. C. Neal ; T. Ninomiya ; A. A. Patel ; S. K. Paul ; F. Travert ; M. Woodward, "Intensive glucose control and macrovascular outcomes in type 2 diabetes", Diabetologia, Springer, Berlin, DE, Berlin, DE , (20090805), vol. 52, no. 11, ISSN 1432-0428, pages 2288 - 2298, XP019797039-
OPPOSITION- Forsyth Jennifer, "Boehringer Ingelheim and Eli Lilly and Company announce positive top-line pivotal Phase III data results for empagliflozin", Boehringer Ingelheim - Press release, Boehringer Ingelheim International GmbH, US, US, (20130107), pages 1 - 8, Boehringer Ingelheim - Press release, URL: https://www.boehringer-ingelheim.com/us/press-release/boehringer-ingelheim-and-eli-lilly-and-company-announce-positive-top-line-pivotal, (20240208), XP093128928-
OPPOSITION- Ganguli Pial, "US, EU and Japanese filings in 2013 for BI /Lilly's empagliflozin in type 2 diabetes", Scrip Pharma Intelligence, (20130108), Scrip Pharma Intelligence , URL: https://scrip.citeline.com/SC019981/US-EU-and-Japanese-filings-in-2013-for-BI-Lillys-empagliflozin-in-type-2-diabetes, (20240411), XP093150675-
OPPOSITION- Hach T., H.J. Lambers Heerspink, E. Pfarr, S. Lund, L. Ley, U.C. Broedl, H.J. Woerle, "770. The sodium glucose cotransporter-2 (SGLT-2) inhibitor empagliflozin lowers blood pressure independent of weight or HbA1c changes ", Diabetologia, (20120101), vol. 55, no. Suppl. 1, page S317, XP093128899-
OPPOSITION- Hach T., H.J. Lambers Heerspink, E. Pfarr, S. Lund, L. Ley, U.C. Broedl, H.J. Woerle, "Abstract 770: The sodium glucose cotransporter-2 (SGLT-2) inhibitor empagliflozin lowers blood pressure independent of weight or HbA1c changes", Diabetologia, (20120824), vol. 55, no. 1, pages S317 - S317, XP093150673-
OPPOSITION- Hach Thomas, Lambers Heerspink Hiddo J., Pfarr Egon, Lund Sören, Ley Ludwin, Broedl Uli C, Woerle Hans J. , "The Sodium Glucose Cotransporter-2 (SGLT-2) Inhibitor Empagliflozin Lowers Blood Pressure Independent of Weight or HbAic Changes", Poster: 770,48th Annual Meeting of the European Association for the Study of Diabetes (EASD). 15 October 2012, Berlin, Germany, (20120101), Poster: 770,48th Annual Meeting of the European Association for the Study of Diabetes (EASD). 15 October 2012, Berlin, Germany, (20240130), XP093125530-
OPPOSITION- Jelsing1 J, E. Mayoux, T. Klein, R. Grempler, M. Mark, "Empagliflozin, a novel sodium glucose cotransporter-2 inhibitor, improves glucose homeostasis and preserves pancreatic beta cell mass in db/db mice", Diabetologia, (20120101), vol. 55, no. Suppl 1, pages S317 - S317, XP093121224-
OPPOSITION- Jelsing Jacob, Niels Vrang , Michael Mark . Eric Mayoux , Thomas Klein , "1018-P The Sodium Glucose Cotransporter-2 (SGLT-2) Inhibitor Empagliflozin has a Durable Effect on the Restoration of Glucose Homeostasis by Preserving Beta-Cell Mass in Zucker Diabetic Fatty Rats", Diabetes, (20120101), vol. 61, no. Suppl 1, pages A261 - A261, XP093121418-
OPPOSITION- Jelsing Jacob, Niels Vrang , Michael Mark . Eric Mayoux , Thomas Klein, "The sodium glucose contransporter-2 (SGLT-2) inhibitor empagliflozin has a durable effect on the restoration of glucose homeostasis by preserving beta-cell mass in Zucker diabetic fatty rats", Diabetes, (20120101), vol. 61, no. Suppl 1, doi:10.1124/jpet.114.213454, pages A261 - A261, XP093121418-
OPPOSITION- Jelsing J, E. Mayoux, T. Klein, R. Grempler, M. Mark, "Empagliflozin, a novel sodium glucose cotransporter-2 inhibitor, improves glucose homeostasis and preserves pancreatic beta cell mass in db/db mice", Diabetologia, (20120101), vol. 55, no. Suppl 1, pages S317 - S317, XP093121224-
OPPOSITION- Lilly Eli, Ingelheim Boehringer, "Boehringer Ingelheim and Eli Lilly and Company announce positive top-line pivotal Phase III data results for empagliflozin", (20230107), pages 1 - 6, PR Newswire, URL: https://www.prnewswire.com/news-releases/boehringer-ingelheim-and-eli-lilly-and-company-announce-positive-top-line-pivotal-phase-iii-data-results-for-empagliflozin-185862972.html, (20240118), XP093121242-
OPPOSITION- Pial Ganguli, "US, EU and Japanese filings in 2013 for BI /Lilly's empagliflozin in type 2 diabetes", SCRIP Citeline Commercial, page 1, SCRIP Citeline Commercial, URL: https://scrip.citeline.com/SC019981/US-EU-and-Japanese-filings-in-2013-for-BI-Lillys-empagliflozin-in-type-2-diabetes?vid=, XP009551694-
OPPOSITION- Yu, P.C. ; Bosnyak, Z. ; Ceriello, A., "The importance of glycated haemoglobin (HbA"1"c) and postprandial glucose (PPG) control on cardiovascular outcomes in patients with type 2 diabetes", DIABETES RESEARCH AND CLINICAL PRACTICE, AMSTERDAM, NL, NL , (20100701), vol. 89, no. 1, ISSN 0168-8227, pages 1 - 9, XP027087355-
OPPOSITION- Zinman Bernard, Silvio E. Inzucchi, John Lachin, Christoph Wanner, Roberto Ferrari, Erich Bluhmki, Stefan Hantel, Odd Eirk Johansen, Hans-Juergen Woerle, Uli C. Broedl, "Design of the Empagliflozin Cardiovascular (CV) Outcome Event Trial in Type 2 Diabetes (T2D)", Can J Diabetes, (20130101), vol. 37, pages S29 - S30, XP093125526-
OPPOSITION- Gerstein Hertzel C., Swedberg Karl, Carlsson Jonas, Mcmurray John J V, Michelson Eric L, Olofsson Bertil, Pfeffer Marc A, Yusuf Salim, Dphil, "The Hemoglobin A1c Level as a Progressive Risk Factor for Cardiovascular Death, Hospitalization for Heart Failure, or Death in Patients With Chronic Heart Failure : An Analysis of the Candesartan in Heart Failure: Assessment of Reduction in Mortality and Morbidity (CHARM) Program", ARCHIVES OF INTERNAL MEDICINE., American Medical Association, US, US , (20080811), vol. 168, no. 15, doi:10.1001/archinte.168.15.1699, ISSN 0003-9926, pages 1699 - 1704, XP093121415
OPPOSITION- Gerstein Hertzel C., Swedberg Karl, Carlsson Jonas, Mcmurray John J V, Michelson Eric L, Olofsson Bertil, Pfeffer Marc A, Yusuf Salim, Dphil, "The Hemoglobin A1c Level as a Progressive Risk Factor for Cardiovascular Death, Hospitalization for Heart Failure, or Death in Patients With Chronic Heart Failure : An Analysis of the Candesartan in Heart Failure: Assessment of Reduction in Mortality and Morbidity (CHARM) Program", Archives of Internal Medicine, US , (20080811), vol. 168, no. 15, doi:10.1001/archinte.168.15.1699, ISSN 0003-9926, pages 1699 - 1704, XP093121415
OPPOSITION- Leo Seman; Sreeraj Macha; Gerhard Nehmiz; Gudrun Simons; Bailuo Ren; Sabine Pinnetti; Hans J. Woerle; Klaus Dugi, "Empagliflozin (BI 10773), a Potent and Selective SGLT2 Inhibitor, Induces Dose‐Dependent Glucosuria in Healthy Subjects", Clinical Pharmacology in Drug Development, Wiley-Blackwell Publishing Ltd., GB, GB , (20130327), vol. 2, no. 2, doi:10.1002/cpdd.16, ISSN 2160-763X, pages 152 - 161, XP072464938
OPPOSITION- Proschan Michael, Ford Charles E., Cutler Jeffrey A., Graumlich James F., Pavlik Valory, Cushman William C., Davis Barry R., Alderman Michael H., Gordon David, Furberg Curt D., Franklin Stanley S., Blumenthal Samuel S., Castaldo Richard S., Preston Richard A., "How much effect of different antihypertensive medications on cardiovascular outcomes is attributable to their effects on blood pressure?", STATISTICS IN MEDICINE, WILEY, NEW YORK, NY, US, US , (20130228), vol. 32, no. 5, doi:10.1002/sim.5580, ISSN 0277-6715, pages 884 - 897, XP093146824
OPPOSITION- Hafkamp Frederique J., Tio Rene A., Otterspoor Luuk C., De Greef Tineke, Van Steenbergen Gijs J., Van De Ven Arjen R. T., Smits Geert, Post Hans, Van Veghel Dennis, "Optimal effectiveness of heart failure management — an umbrella review of meta-analyses examining the effectiveness of interventions to reduce (re)hospitalizations in heart failure", Heart failure reviews, NL , (20220101), vol. 27, no. 5, doi:10.1007/s10741-021-10212-8, ISSN 1382-4147, pages 1683 - 1748, XP093123320
OPPOSITION- Redon, Josep, "The Importance of 24-Hour Ambulatory Blood Pressure Monitoring in Patients at Risk of Cardiovascular Events", HIGH BLOOD PRESSURE AND CARDIOVASCULAR PREVENTION, EDITRICE KURTIS, MILAN, IT, IT , (20130327), vol. 20, no. 1, doi:10.1007/s40292-013-0006-3, ISSN 1120-9879, pages 13 - 18, XP009554208
OPPOSITION- Basile Jan N., "The potential of sodium glucose cotransporter 2 (SGLT2) inhibitors to reduce cardiovascular risk in patients with type 2 diabetes (T2DM)", JOURNAL OF DIABETES AND ITS COMPLICATIONS, ELSEVIER SCIENCE, NEW YORK, NY, US, US , (20130501), vol. 27, no. 3, doi:10.1016/j.jdiacomp.2012.12.004, ISSN 1056-8727, pages 280 - 286, XP055876126
OPPOSITION- Basile Jan N., "The potential of sodium glucose cotransporter 2 (SGLT2) inhibitors to reduce cardiovascular risk in patients with type 2 diabetes (T2DM)", Journal of diabetes and its complications, US , (20130501), vol. 27, no. 3, doi:10.1016/j.jdiacomp.2012.12.004, ISSN 1056-8727, pages 280 - 286, XP055876126
OPPOSITION- Scotti Lorenza; Baio Gianluca; Merlino Luca; Cesana Giancarlo; Mancia Giuseppe; Corrao Giovanni, "Cost-Effectiveness of Enhancing Adherence to Therapy with Blood Pressure-Lowering Drugs in the Setting of Primary Cardiovascular Preven", Value in Health, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (20130325), vol. 16, no. 2, doi:10.1016/j.jval.2012.11.008, ISSN 1098-3015, pages 318 - 324, XP028525572
OPPOSITION- Marks Jennifer B, Raskin Philip, "Cardiovascular risk in diabetes: A brief review", JOURNAL OF DIABETES AND ITS COMPLICATIONS, ELSEVIER SCIENCE, NEW YORK, NY, US, US , (20000301), vol. 14, no. 2, doi:10.1016/S1056-8727(00)00065-9, ISSN 1056-8727, pages 108 - 115, XP093128893
OPPOSITION- Maas Renke, Böger Rainer H., "Old and new cardiovascular risk factors: from unresolved issues to new opportunities", Atherosclerosis Supplements, Elsevier, AMSTERDAM, NL, AMSTERDAM, NL , (20031201), vol. 4, no. 4, doi:10.1016/S1567-5688(03)00028-X, ISSN 1567-5688, pages 5 - 17, XP093128895
OPPOSITION- Bernard Zinman , Christoph Wanner, John M Lachin, David Fitchett, Erich Bluhmki, Stefan Hantel, Michaela Mattheus, Theresa Devins, Odd Erik Johansen, Hans J Woerle, Uli C Broedl, Silvio E Inzucchi, "Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes", New England Journal of Medicine, (20151101), vol. 373, no. 22, doi:10.1056/NEJMoa1504720, pages 2117 - 2128, XP002769966
OPPOSITION- D. Fitchett et al., "Empagliflozin, Cardiovascular Outcomes and Mortality in Type 2 Diabetes", New England Journal of Medicine, (2015), vol. 373, doi:10.1056/NEJMoa1504720, XP002769966
OPPOSITION- Wood David, "Established and emerging cardiovascular risk factors", American Heart Journal, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (20010201), vol. 141, no. 2, doi:10.1067/mhj.2001.109951, ISSN 0002-8703, pages S49 - S57, XP093128894
OPPOSITION- Zannad Faiez, Stough Wendy Gattis, Pitt Bertram, Cleland John G.F., Adams Kirkwood F., Geller Nancy L., Torp-Pedersen Christian, Kirwan Bridget-Anne, Follath Ferenc, "Heart failure as an endpoint in heart failure and non-heart failure cardiovascular clinical trials: the need for a consensus definition", European Heart Journal, Oxford University Press, GB, GB , (20080201), vol. 29, no. 3, doi:10.1093/eurheartj/ehm603, ISSN 0195-668X, pages 413 - 421, XP093127163
OPPOSITION- Zannad F., Stough W. G., Pocock S. J., Sleight P., Cushman W. C., Cleland J. G. F., Mcmurray J. J. V., Lonn E., Geller N. L., Wedel H., Abadie E., Alonso-Garcia A., Pitt B., "Diabetes clinical trials: helped or hindered by the current shift in regulatory requirements?", European Heart Journal, Oxford University Press, GB, GB , (20120501), vol. 33, no. 9, doi:10.1093/eurheartj/ehr437, ISSN 0195-668X, pages 1049 - 1057, XP093125518
OPPOSITION- Zannad Faiez, Garcia Angeles Alonso, Anker Stefan D., Armstrong Paul W., Calvo Gonzalo, Cleland John G.F., Cohn Jay N., Dickstein Kenneth, Domanski Michael J., Ekman Inger, Filippatos Gerasimos S., Gheorghiade Mihai, Hernandez Adrian F., Jaarsma Tiny, Koglin Joerg, Konstam Marvin, Kupfer Stuart, Maggioni Aldo P., Mebazaa Alexandre, Metra Marco, Nowack Christina, Pieske Burkert, Piña Ileana L., Pocock Stuart J., Ponikowski Piotr, Rosano Giuseppe, Ruilope Luis M., Ruschitzka Frank, Severin Thomas, Solomon Scott, Stein Kenneth, Stockbridge Norman L., Stough Wendy Gattis, Swedberg Karl, Tavazzi Luigi, Voors Adriaan A., Wasserman Scott M., Woehrle Holger, Zalewski Andrew, Mcmurray John J.V., "Clinical outcome endpoints in heart failure trials: a European Society of Cardiology Heart Failure Association consensus document", EUROPEAN JOURNAL OF HEART FAILURE, ELSEVIER, AMSTERDAM, NL, NL , (20131001), vol. 15, no. 10, doi:10.1093/eurjhf/hft095, ISSN 1388-9842, pages 1082 - 1094, XP093127164
OPPOSITION- Krentz A J, "EMPA-REG OUTCOME: Cardiovascular outcome trials in diabetes come of age", Cardiovascular Endocrinology, (20151001), vol. 4, no. 4, doi:10.1097/XCE.0000000000000069, pages 115 - 116, XP009194325
OPPOSITION- Vepsäläinen T., Laakso M., Kantola I., Lehto S., Juutilainen A., Rönnemaa T., "Proteinuria modifies the effect of systolic blood pressure on total and cardiovascular disease mortality in patients with type 2 diabetes", JOURNAL OF INTERNAL MEDICINE, Blackwell Publishing Ltd, GB, GB , (20121201), vol. 272, no. 6, doi:10.1111/j.1365-2796.2012.02581.x, ISSN 0954-6820, pages 611 - 619, XP093150687
OPPOSITION- R Grempler, L Thomas, M Eckhardt, F Himmelsbach, A Sauer, D E Sharp, R A Bakker, M Mark, T Klein, & P Eickelmann, "Empagliflozin, a novel selective sodium glucose cotransporter-2 (SGLT-2) inhibitor: characterisation and comparison with other SGLT-2 inhibitors Introduction", Diabetes Obesity and Metabolism, (20120101), vol. 14, doi:10.1111/j.1463-1326.2011.01517.x, pages 83 - 90, XP055228524
OPPOSITION- G. Luippold; T. Klein; M. Mark; R. Grempler, "Empagliflozin, a novel potent and selective SGLT‐2 inhibitor, improves glycaemic control alone and in combination with insulin in streptozotocin‐induced diabetic rats, a model of type 1 diabetes mellitus", Diabetes, Obesity and Metabolism, Blackwell Science, GB, GB , (20120223), vol. 14, no. 7, doi:10.1111/j.1463-1326.2012.01569.x, ISSN 1462-8902, pages 601 - 607, XP072206908
OPPOSITION- Hicks Karen A., Tcheng James E., Bozkurt Biykem, Chaitman Bernard R., Cutlip Donald E., Farb Andrew, Fonarow Gregg C., Jacobs Jeffrey P., Jaff Michael R., Lichtman Judith H., Limacher Marian C., Mahaffey Kenneth W., Mehran Roxana, Nissen Steven E., Smith Eric E., Targum Shari L., "2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials : A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Cardiovascular Endpoints Data Standards)", Circulation, American Heart Association, US, US , (20150728), vol. 132, no. 4, doi:10.1161/CIR.0000000000000156, ISSN 0009-7322, pages 302 - 361, XP093150375
OPPOSITION- Solomon Scott D., Dobson Joanna, Pocock Stuart, Skali Hicham, Mcmurray John J.V., Granger Christopher B., Yusuf Salim, Swedberg Karl, Young James B., Michelson Eric L., Pfeffer Marc A., "Influence of Nonfatal Hospitalization for Heart Failure on Subsequent Mortality in Patients With Chronic Heart Failure", Circulation, American Heart Association, US, US , (20070925), vol. 116, no. 13, doi:10.1161/CIRCULATIONAHA.107.696906, ISSN 0009-7322, pages 1482 - 1487, XP093125523
OPPOSITION- Foote Celine, Perkovic Vlado, Neal Bruce, "Effects of SGLT2 inhibitors on cardiovascular outcomes", Diabetes and Vascular Disease Research, GB , (20120401), vol. 9, no. 2, doi:10.1177/1479164112441190, ISSN 1479-1641, pages 117 - 123, XP093121254
OPPOSITION- Foote Celine, Perkovic Vlado, Neal Bruce, "Effects of SGLT2 inhibitors on cardiovascular outcomes", DIABETES AND VASCULAR DISEASE RESEARCH, MEDINEWS, BIRMINGHAM, GB, GB , (20120401), vol. 9, no. 2, doi:10.1177/1479164112441190, ISSN 1479-1641, pages 117 - 123, XP093121254
OPPOSITION- David ZI Cherney;Bruce A Perkins;Nima Soleymanlou;Ronnie Har;Nora Fagan;Odd Erik Johansen;Hans-Juergen Woerle;Maximilian von Eynatten;Uli C Broedl, "The effect of empagliflozin on arterial stiffness and heart rate variability in subjects with uncomplicated type 1 diabetes mellitus", Cardiovasc Diabetology, BIOMED CENTRAL, LONDON, GB, GB , (20140129), vol. 13, no. 1, doi:10.1186/1475-2840-13-28, ISSN 1475-2840, page 28, XP021175864
OPPOSITION- American Diabetes Association, "Standards of Medical Care in Diabetes—2009", DIABETES CARE, AMERICAN DIABETES ASSOCIATION, ALEXANDRIA, VA, US, US , (20090101), vol. 32, no. Supplement_1, doi:10.2337/dc09-S013, ISSN 0149-5992, pages S13 - S61, XP093121256
OPPOSITION- American Diabetes Association, "Standards of Medical Care in Diabetes—2009", Diabetes Care, US , (20090101), vol. 32, no. Supplement_1, doi:10.2337/dc09-S013, ISSN 0149-5992, pages S13 - S61, XP093121256
OPPOSITION- S. Cernea, R. Buzzetti, P. Pozzilli, "B -Cell Protection and Therapy for Latent Autoimmune Diabetes in Adults", Diabetes care, (20091101), vol. 32, no. suppl_2, doi:10.2337/dc09-S317, ISSN 01495992, pages S246 - S252, XP055128102
OPPOSITION- S. Cernea, R. Buzzetti, P. Pozzilli, "Beta-Cell Protection and Therapy for Latent Autoimmune Diabetes in Adults", Diabetes care, American Diabetes Association, (20091101), vol. 32, no. suppl_2, doi:10.2337/dc09-S317, ISSN 01495992, pages S246 - S252, XP055128102
OPPOSITION- M. J Fowler, "Microvascular and Macrovascular Complications of Diabetes", Clinical diabetes, American Diabetes Association, Alexandria, Alexandria , doi:10.2337/diaclin.26.2.77, (20080401), pages 77 - 82, Clinical diabetes, XP055745756
OPPOSITION- Röhrig Bernd, Prel Jean-Baptist Du, Wachtlin Daniel, Kwiecien Robert, Blettner Maria, "Sample Size Calculation in Clinical Trials", DEUTSCHES ARZTEBLATT INTERNATIONAL FEB 2013, (20100101), vol. 107, no. 31-32, doi:10.3238/arztebl.2010.0552, ISSN 1866-0452, pages 552 - 556, XP093125528
OPPOSITION- Maria Angela Sortino, Tiziana Sinagra, Pier Luigi Canonico, "Linagliptin: A thorough Characterization beyond Its Clinical Efficacy", Frontiers in Endocrinology, CH , (20130216), vol. 4, doi:10.3389/fendo.2013.00016, ISSN 1664-2392, pages 1 - 9, XP055116550
OPPOSITION- Maria Angela Sortino, Tiziana Sinagra, Pier Luigi Canonico, "Linagliptin: A thorough Characterization beyond Its Clinical Efficacy", Frontiers in Endocrinology, CH , vol. 4, doi:10.3389/fendo.2013.00016, ISSN 1664-2392, pages 16 - 16-9, XP055116550
OPPOSITION- Maria Angela Sortino, Tiziana Sinagra, Pier Luigi Canonico, "Linagliptin: A thorough Characterization beyond Its Clinical Efficacy", FRONTIERS IN ENDOCRINOLOGY, Frontiers Research Foundation, CH, CH , vol. 4, doi:10.3389/fendo.2013.00016, ISSN 1664-2392, pages 16 - 16-9, XP055116550
OPPOSITION- Aronow Wilbert S., "What Should the Blood Pressure Goal Be in Patients with Hypertension Who Are at High Risk for Cardiovascular Disease?", Hospital Practice, Taylor & Francis Inc., US, US , (20121001), vol. 40, no. 4, doi:10.3810/hp.2012.10.1000, ISSN 2154-8331, pages 28 - 32, XP093146826

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