Media Statement: FortiHFy Global Clinical Program for Entresto®
May 19, 2016
Novartis has established FortiHFy, the largest global clinical program in the heart failure disease area, comprising over 40 active or planned clinical studies designed to generate an array of additional data on symptom reduction, efficacy, safety, quality of life benefits and real world evidence with its novel heart failure medicine Entresto® (sacubitril/valsartan) tablets, and extend understanding of heart failure. FortiHFy (Fortifying Heart Failure clinical evidence and patient qualitY of life) will enroll patients from over 50 countries, including the US, to participate over 5 years.1 The FortiHFy program reinforces Novartis’ long-term commitment to improving heart failure treatment for as many patients as possible. Major trials in FortiHFy include PARAGON-HF2, PARADISE-MI1, TRANSITION-HF3 and PIONEER-HF4.
Heart failure is a life-threatening disease that impacts nearly 6 million Americans and is the leading cause of hospitalization among people over the age of 65.5,6 About half of US patients with chronic heart failure have the reduced ejection fraction form of the condition (HFrEF), and the other half have preserved ejection fraction (HFpEF).5,7
We believe that Entresto represents a major medical advance and has the potential to significantly improve the way heart failure is treated in this country. Entresto is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic HFrEF (NYHA Class II-IV).8 It’s the first and only medicine for HFrEF to demonstrate a significant reduction in the rate of cardiovascular death or heart failure hospitalization over a guideline-recommended therapy (ACE inhibitor enalapril).9 The outcomes of the trials in FortiHFy will increase our understanding of heart failure and additional patient populations who may benefit from Entresto, and could potentially support future regulatory applications for additional indications.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ENTRESTO?
ENTRESTO can harm or cause death to your unborn baby. Talk to your doctor about other ways to treat heart failure if you plan to become pregnant. If you get pregnant while taking ENTRESTO, tell your doctor right away.
What is ENTRESTO?
ENTRESTO is a prescription medicine used to reduce the risk of death and hospitalization in people with certain types of long-lasting (chronic) heart failure. ENTRESTO is usually used with other heart failure therapies, in place of an ACE inhibitor or other ARB therapy.
Who should not take ENTRESTO?
Do not take ENTRESTO if you:
are allergic to sacubitril or valsartan or any of the ingredients in ENTRESTO
have had an allergic reaction including swelling of your face, lips, tongue, throat (angioedema) or trouble breathing while taking a type of medicine called an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB)
take an ACE inhibitor medicine. Do not take ENTRESTO for at least 36 hours before or after you take an ACE inhibitor medicine. Talk with your doctor or pharmacist before taking ENTRESTO if you are not sure if you take an ACE inhibitor medicine
have diabetes and take a medicine that contains aliskiren
What should I tell my doctor before taking ENTRESTO?
Before you take ENTRESTO, tell your doctor about all of your medical conditions, including if you have kidney or liver problems; are pregnant or plan to become pregnant; are breastfeeding or plan to breastfeed. You should either take ENTRESTO or breastfeed. You should not do both.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take potassium supplements or a salt substitute; nonsteroidal anti-inflammatory drugs (NSAIDs); lithium; or other medicines for high blood pressure or heart problems such as an ACE inhibitor, ARB, or aliskiren.
What are the possible side effects of ENTRESTO?
ENTRESTO may cause serious side effects including:
angioedema that may cause trouble breathing and death. Get emergency medical help right away if you have symptoms of angioedema or trouble breathing. Do not take ENTRESTO again if you have had angioedema while taking ENTRESTO. People who are Black or who have had angioedema and take ENTRESTO may have a higher risk of having angioedema
low blood pressure (hypotension). Call your doctor if you become dizzy or lightheaded, or you develop extreme fatigue
increased amount of potassium in your blood
The most common side effects were low blood pressure, high potassium, cough, dizziness, and kidney problems.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
References 1. Novartis Data on File. 2. ClinicalTrials.gov. Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction (PARAGON-HF). https://clinicaltrials.gov/ct2/show/NCT01920711?term=PARAGON-HF&rank=1. Published August 8, 2013. Accessed May 12, 2016. 3. ClinicalTrials.gov. Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event (TRANSITION). https://clinicaltrials.gov/ct2/show/NCT02661217?term=TRANSITION&cond=%22Heart+Failure%22&rank=7. Published January 19, 2016. Accessed May 12, 2016. 4. ClinicalTrials.gov. Comparison of Sacubitril/valsartan Versus Enalapril on Effect on ntpRo-bnp in Patients Stabilized From an Acute Heart Failure Episode (PIONEER-HF). https://clinicaltrials.gov/ct2/show/NCT02554890?term=pioneer+lcz696&rank=1. Published September 17, 2015. Accessed May 12, 2016. 5. Mozaffarian D, Benjamin EJ, Go AS, et al. Heart Disease and Stroke Statistics—2016 Update: A report from the American Heart Association. Circulation. 2015; 2015;133:e38-e360. 6. Wier LM, Pfuntner A, Maeda J, et al. HCUP facts and figures: statistics on hospital-based care in the United States, 2009. Rockville, MD: Agency for Healthcare Research and Quality, 2011. 7. Owan TE, Hodge DO, Herges RM, et al. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006;355:251–9. 8. Entresto Prescribing Information. 9. McMurray JJV, Packer M, Desai AS, et al. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014;371:993-1004. doi: 10.1056/NEJMoa1409077.
Novartis Media Relations
Eric Althoff Novartis Global Media Relations +1 212 830 2408 (direct) + 41 79 593 4202 (mobile) [email protected]