Takeda to Present Sub-Analyses Data at American Heart Association
Scientific Sessions 2014
Zurich, November 17, 2014 – Takeda Pharmaceuticals International GmbH (“Takeda”), today announced the presentation of two data subsets regarding alogliptin in patients with Type 2 diabetes mellitus (DM) from the EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) study, at the American Heart Association (AHA) Scientific Sessions 2014. EXAMINE was a randomized, double-blind, placebo-controlled, multinational trial conducted with 5,380 Type 2 diabetes patients, with recent acute coronary syndrome (ACS) and high underlying cardiovascular (CV) risk. The study evaluated the CV safety of alogliptin in addition to standard of care, versus placebo in addition to standard of care. The primary endpoint of the EXAMINE study was major adverse CV events (MACE) defined as CV death (CVD), myocardial infarction, or stroke.[i]
Sub-analyses data to be presented at the AHA Scientific Sessions include:
• “N-Terminal-pro-Brain Natriuretic Peptide Decreases Following Treatment with Alogliptin in Patients with Type 2 Diabetes and Recent Acute Coronary Syndromes: Results from EXAMINE” (Zannad et al.), poster #15319
o Presented on Monday, November 17 (3:00 – 4:30 p.m. CT)
o N-Terminal-pro-B-type natriuretic peptide (NT-pro-BNP), a heart failure biomarker, was measured in a total of 5,380 patients in the EXAMINE study, at baseline and at six months post-randomization and included patients with a history of heart failure (28% of subjects) as well as patients without a history of heart failure prior to randomization.[ii]
o The post-hoc analysis found that NT-pro-BNP decreased equally with alogliptin and placebo in a post-ACS Type 2 diabetes population. Subgroup analyses showed that NT-pro-BNP decreased to the same extent with alogliptin and placebo even in the highest risk groups – i.e. those patients with a history of heart failure and those with the highest baseline NT-pro-BNP.
• “Cardiovascular Biomarkers and Long-term Outcomes in Patients with Type 2 Diabetes Mellitus Treated with Alogliptin vs. Placebo in the EXAMINE Trial” (Morrow et al.), poster #17295
o Presented on Tuesday, November 18 (9:30 – 11:00 a.m. CT)
o The post-hoc analysis measured B-type natriuretic peptide (BNP) and high sensitivity troponin I (hsTnI) at baseline. Among patients with DM who were stable after a recent ACS, BNP & hsTnI identified patients at a high risk of poor CV outcomes.[iii]
? A total of 5,230 patients with baseline markers were followed for 18 months (median). Baseline BNP
(categorized by quartiles) and hsTnl (categorized using pre-specified cut-points) showed a significant graded relationship with CV outcomes at 18 months. BNP & hsTnI were found to be independently related to CV outcomes after adjusting for age, sex, type of qualifying ACS, eGFR and history of HF. The rates of MACE were similar with alogliptin vs. placebo in the highest risk patients identified by BNP (19.9 vs. 22.2%) or hsTnI (18.3 vs. 20.6%). Similar results with alogliptin vs. placebo were also observed for the composite of CV death and heart failure in the highest risk patient subgroups identified by BNP (17.5 vs. 19.4%) or hsTnl (14.3 vs. 14.9%).
Worldwide, more than 382 million people suffer from diabetes.[iv] Takeda’s strong, diverse diabetes portfolio and available medications mark important milestones in the company’s ongoing commitment to patient care and helping to meet the individual needs of this growing patient population.
Indication Alogliptin is indicated in adults aged 18 years and older with Type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.[v]
Important Safety Information
• ALOGLIPTIN is contraindicated in patients with a history of serious hypersensitivity reaction to alogliptin-containing products such as anaphylaxis, angioedema, or severe cutaneous adverse reactions.
• Acute pancreatitis: There have been post marketing reports of acute pancreatitis. If pancreatitis is suspected, promptly discontinue ALOGLIPTIN.
• Hypersensitivity: Hypersensitivity reactions, including anaphylactic reactions, angioedema and exfoliative skin conditions including Stevens-Johnson syndrome have been observed for DPP-4 inhibitors. In clinical studies of alogliptin, anaphylactic reactions were reported with a low incidence.
• Hepatic effects: Post marketing reports of hepatic failure, sometimes fatal. Causality cannot be excluded. Baseline liver test panel is recommended. If liver injury is detected, promptly interrupt ALOGLIPTIN and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart ALOGLIPTIN if liver injury is confirmed and no alternative etiology can be found.
• Cardiac failure: Experience of ALOGLIPTIN use in clinical trials in patients with congestive heart failure of New York Heart Association (NYHA) functional class III and IV is limited and caution is warranted in these patients.
• Hypoglycemia: Insulin and insulin secretagogues are known to cause hypoglycemia. A lower dose of the insulin or insulin secretagogue may be required to minimize the risk when used in combination with ALOGLIPTIN.
• Most common adverse reactions: pooled phase 3 controlled studies (=1/10 frequency) with ALOGLIPTIN: Upper respiratory infection, nasopharyngitis, headache, abdominal pain, gastroesophageal reflux disease, pruritis, and rash.
Please see local prescribing information for ALOGLIPTIN.
For more information please contact Elissa Johnsen at +1 224-554-3185
About Takeda Pharmaceuticals International GmbH
Headquartered in Zurich as a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Osaka, Japan, the Company has a commercial presence covering more than 70 countries, with particular strength in Asia, North America, Europe and fast-growing emerging markets including Latin America, Russia-CIS and China. Areas of focus are central nervous system, cardiovascular and metabolic, gastroenterology, oncology, and vaccines.
Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Through the integration of Millennium Pharmaceuticals and Nycomed, Takeda has been transforming itself, broadening its therapeutic expertise and geographic outreach.
About Takeda’s Diabetes Business
Takeda’s heritage in diabetes globally includes significant contributions towards scientific discovery and exchange, starting with the discovery of the thiazolidinedione (TZD) pioglitazone, and developments of other fixed-dose combinations. The company’s strong, diverse diabetes portfolio and available medications mark important milestones in Takeda’s ongoing commitment to advancing patient care and helping to meet the individual needs of this growing patient population.
Additional information about Takeda is available through its corporate website, www.takeda.com.
# # #
Carrie M. Rose
Managing Account Supervisor, Media Specialist
+1 646 935 3938
+1 201 362 7883 (M)
Help employers find you! Check out all the jobs and post your resume.
Zurich, November 17, 2014 – Takeda Pharmaceuticals International GmbH (“Takeda”), today announced the presentation of two data subsets regarding alogliptin in patients with Type 2 diabetes mellitus (DM) from the EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) study, at the American Heart Association (AHA) Scientific Sessions 2014. EXAMINE was a randomized, double-blind, placebo-controlled, multinational trial conducted with 5,380 Type 2 diabetes patients, with recent acute coronary syndrome (ACS) and high underlying cardiovascular (CV) risk. The study evaluated the CV safety of alogliptin in addition to standard of care, versus placebo in addition to standard of care. The primary endpoint of the EXAMINE study was major adverse CV events (MACE) defined as CV death (CVD), myocardial infarction, or stroke.[i]
Sub-analyses data to be presented at the AHA Scientific Sessions include:
• “N-Terminal-pro-Brain Natriuretic Peptide Decreases Following Treatment with Alogliptin in Patients with Type 2 Diabetes and Recent Acute Coronary Syndromes: Results from EXAMINE” (Zannad et al.), poster #15319
o Presented on Monday, November 17 (3:00 – 4:30 p.m. CT)
o N-Terminal-pro-B-type natriuretic peptide (NT-pro-BNP), a heart failure biomarker, was measured in a total of 5,380 patients in the EXAMINE study, at baseline and at six months post-randomization and included patients with a history of heart failure (28% of subjects) as well as patients without a history of heart failure prior to randomization.[ii]
o The post-hoc analysis found that NT-pro-BNP decreased equally with alogliptin and placebo in a post-ACS Type 2 diabetes population. Subgroup analyses showed that NT-pro-BNP decreased to the same extent with alogliptin and placebo even in the highest risk groups – i.e. those patients with a history of heart failure and those with the highest baseline NT-pro-BNP.
• “Cardiovascular Biomarkers and Long-term Outcomes in Patients with Type 2 Diabetes Mellitus Treated with Alogliptin vs. Placebo in the EXAMINE Trial” (Morrow et al.), poster #17295
o Presented on Tuesday, November 18 (9:30 – 11:00 a.m. CT)
o The post-hoc analysis measured B-type natriuretic peptide (BNP) and high sensitivity troponin I (hsTnI) at baseline. Among patients with DM who were stable after a recent ACS, BNP & hsTnI identified patients at a high risk of poor CV outcomes.[iii]
? A total of 5,230 patients with baseline markers were followed for 18 months (median). Baseline BNP
(categorized by quartiles) and hsTnl (categorized using pre-specified cut-points) showed a significant graded relationship with CV outcomes at 18 months. BNP & hsTnI were found to be independently related to CV outcomes after adjusting for age, sex, type of qualifying ACS, eGFR and history of HF. The rates of MACE were similar with alogliptin vs. placebo in the highest risk patients identified by BNP (19.9 vs. 22.2%) or hsTnI (18.3 vs. 20.6%). Similar results with alogliptin vs. placebo were also observed for the composite of CV death and heart failure in the highest risk patient subgroups identified by BNP (17.5 vs. 19.4%) or hsTnl (14.3 vs. 14.9%).
Worldwide, more than 382 million people suffer from diabetes.[iv] Takeda’s strong, diverse diabetes portfolio and available medications mark important milestones in the company’s ongoing commitment to patient care and helping to meet the individual needs of this growing patient population.
Indication Alogliptin is indicated in adults aged 18 years and older with Type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.[v]
Important Safety Information
• ALOGLIPTIN is contraindicated in patients with a history of serious hypersensitivity reaction to alogliptin-containing products such as anaphylaxis, angioedema, or severe cutaneous adverse reactions.
• Acute pancreatitis: There have been post marketing reports of acute pancreatitis. If pancreatitis is suspected, promptly discontinue ALOGLIPTIN.
• Hypersensitivity: Hypersensitivity reactions, including anaphylactic reactions, angioedema and exfoliative skin conditions including Stevens-Johnson syndrome have been observed for DPP-4 inhibitors. In clinical studies of alogliptin, anaphylactic reactions were reported with a low incidence.
• Hepatic effects: Post marketing reports of hepatic failure, sometimes fatal. Causality cannot be excluded. Baseline liver test panel is recommended. If liver injury is detected, promptly interrupt ALOGLIPTIN and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart ALOGLIPTIN if liver injury is confirmed and no alternative etiology can be found.
• Cardiac failure: Experience of ALOGLIPTIN use in clinical trials in patients with congestive heart failure of New York Heart Association (NYHA) functional class III and IV is limited and caution is warranted in these patients.
• Hypoglycemia: Insulin and insulin secretagogues are known to cause hypoglycemia. A lower dose of the insulin or insulin secretagogue may be required to minimize the risk when used in combination with ALOGLIPTIN.
• Most common adverse reactions: pooled phase 3 controlled studies (=1/10 frequency) with ALOGLIPTIN: Upper respiratory infection, nasopharyngitis, headache, abdominal pain, gastroesophageal reflux disease, pruritis, and rash.
Please see local prescribing information for ALOGLIPTIN.
For more information please contact Elissa Johnsen at +1 224-554-3185
About Takeda Pharmaceuticals International GmbH
Headquartered in Zurich as a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Osaka, Japan, the Company has a commercial presence covering more than 70 countries, with particular strength in Asia, North America, Europe and fast-growing emerging markets including Latin America, Russia-CIS and China. Areas of focus are central nervous system, cardiovascular and metabolic, gastroenterology, oncology, and vaccines.
Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Through the integration of Millennium Pharmaceuticals and Nycomed, Takeda has been transforming itself, broadening its therapeutic expertise and geographic outreach.
About Takeda’s Diabetes Business
Takeda’s heritage in diabetes globally includes significant contributions towards scientific discovery and exchange, starting with the discovery of the thiazolidinedione (TZD) pioglitazone, and developments of other fixed-dose combinations. The company’s strong, diverse diabetes portfolio and available medications mark important milestones in Takeda’s ongoing commitment to advancing patient care and helping to meet the individual needs of this growing patient population.
Additional information about Takeda is available through its corporate website, www.takeda.com.
# # #
Carrie M. Rose
Managing Account Supervisor, Media Specialist
+1 646 935 3938
+1 201 362 7883 (M)
Help employers find you! Check out all the jobs and post your resume.
