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|New Post-Hoc Analysis Supports YOSPRALA™ Efficacy And Safety In Previous Heart Attack Patients Who Need Daily Aspirin Therapy To Prevent A Second Cardiovascular Event|
-Shows Significant Reduction in Gastrointestinal Side Effects with Use of Fixed-Dose Combination of Aspirin and Proton Pump Inhibitor-
The study, titled "Efficacy and Safety of PA32540 (Enteric-Coated Aspirin 325 mg and Immediate-Release Omeprazole 40 mg) in Patients With a History of Myocardial Infarction: Analyses From Two Phase 3 Clinical Trials," found that YOSPRALA 325 mg / 40 mg was associated with significantly lower rates of gastric ulceration compared to 325 mg of enteric-coated aspirin (2.3% vs 7.5%; p=0.020) in these patients. Treatment with YOSPRALA was also associated with lower rates of duodenal ulcers (2.3% vs 9.5%; p=0.002) compared to enteric-coated aspirin in this population. Safety results in this population were comparable with the entire study population.
"Treatment guidelines continue to support daily aspirin therapy as a critically important agent in the prevention of secondary cardiovascular events, but gastrointestinal symptoms prompt many patients to discontinue their treatment, which may leave them open to significant risk," said
In the study overall, participants were adults with established cardiovascular disease who had been taking 325 mg of aspirin daily for at least three months for the secondary prevention of cardiovascular events and were expected to continue daily aspirin therapy for at least six months. All patients were at risk for aspirin-associated gastric ulceration, defined as either being at least 55 years of age or 18 to 54 years old with a documented history of gastric or duodenal ulcer within five years before study enrollment. Endoscopy was performed at baseline, and after one, three and six months of treatment.
"The evidence for daily aspirin therapy in secondary prevention is well supported in the literature, as is the risk patients may face if they discontinue aspirin treatment," said
Aspirin: A "Gold Standard" for Secondary Prevention
Recent guidelines from the
The aspirin component of YOSPRALA is indicated for reducing the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli; reducing the combined risk of death and nonfatal myocardial infarction (MI) in patients with a previous MI or unstable angina pectoris; and reducing the combined risk of MI and sudden death in patients with chronic stable angina pectoris. It is also indicated for use in patients who have undergone revascularization procedures − coronary artery bypass graft or percutaneous transluminal coronary angioplasty − when there is a pre-existing condition for which aspirin is already indicated.
The omeprazole component of YOSPRALA is indicated for decreasing the risk of developing aspirin associated gastric ulcers in patients at risk for developing aspirin-associated gastric ulcers due to age (≥ 55) or documented history of gastric ulcers.
YOSPRALA is not for use as the initial dose of aspirin therapy during onset of acute coronary syndrome, acute MI or before percutaneous coronary intervention. YOSPRALA was evaluated in clinical studies for the reduction of gastric ulcers. It was not evaluated for the reduction of GI bleeding and therefore has not been shown to reduce the risk of gastrointestinal bleeding due to aspirin. YOSPRALA is not interchangeable with the individual components of aspirin and omeprazole.
Important Safety Information
Do not take YOSPRALA if you are allergic to aspirin, omeprazole, or any of the ingredients in YOSPRALA. Do not take YOSPRALA if have a medical condition with severe shortness of breath, chest tightness or pain, coughing or wheezing (asthma), sneezing, runny nose or itchy nose (rhinitis), and growths inside of your nose or sinuses (nasal polyps). Do not take YOSPRALA if you are allergic to any non-steroidal anti-inflammatory drug.
Do not take YOSPRALA if you are taking a medicine that contains rilpivirine such as EDURANT®, COMPLERA®, or ODEFSEY®. YOSPRALA should not be used in children.
Tell your doctor if you have unexpected bleeding, if you bleed more than usual, or if your bleeding lasts longer than is normal for you, such as increased bruising or more frequent nose bleeds after taking YOSPRALA.
Tell your doctor if you have stomach problems while taking or after you stop taking YOSPRALA. Stop taking YOSPRALA and call your doctor right away if you have any of the following signs or symptoms: black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds, or severe nausea, vomiting, or stomach pain.
Avoid heavy alcohol use (3 or more drinks daily) during treatment with YOSPRALA.
YOSPRALA contains aspirin and omeprazole. Before taking YOSPRALA, tell your doctor if you take:
Kidney problems may happen at any time during treatment with YOSPRALA. Call your doctor if you have a decrease in the amount that you urinate, have blood in your urine, changes in urination, swelling, skin rash or itching, or your breath smells like ammonia.
YOSPRALA can cause diarrhea caused by an infection (Clostridium difficile) in your intestines. Call your doctor if you have watery stools or stomach pain that does not go away. You may or may not have a fever.
Bone fractures (hip, wrist, or spine) in people who take multiple daily doses of proton pump inhibitor (PPI)-containing medicines like YOSPRALA for a long period of time (a year or longer) may occur.
Certain types of lupus erythematosus may happen or get worse in people who already have lupus and who take PPI medicines, including YOSPRALA. Call your doctor right away if you have joint pain or a rash on your cheeks or arms that gets worse in the sun.
Liver problems may happen during treatment with YOSPRALA. Tell your doctor if you have signs or symptoms of liver problems, including: yellowing of your skin or your eyes, stomach-area (abdominal) pain and swelling, itchy skin, and dark (tea-colored) urine.
Low vitamin B12 levels in your body can happen in people who have taken a PPI medicine, such as omeprazole, for a long time (more than 3 years). Tell your doctor if you have symptoms of low vitamin B12 levels, including: shortness of breath, lightheadedness, irregular heartbeat, muscle weakness, pale skin, feeling tired, mood changes, and tingling or numbness. Low magnesium levels in your body can happen in people who have taken YOSPRALA for at least 3 months. Tell your doctor if you have symptoms of low magnesium levels, including: seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, and spasms of hands, feet or voice.
If you are pregnant, planning to become pregnant, or nursing, talk to your doctor before taking YOSPRALA. Breastfeeding is not recommended during treatment with YOSPRALA.
Tell your doctor about all the medicines you take, including prescription and non-prescription drugs, anti-cancer drugs, vitamins, and herbal supplements. YOSPRALA may affect how other medicines work, and other medicines may affect how YOSPRALA works. This can cause serious side effects.
Especially tell your doctor if you are taking:
YOSPRALA is not interchangeable with the individual components of aspirin and omeprazole.
The most common side effects of YOSPRALA include: indigestion or heartburn and stomach-area pain, nausea, diarrhea, growths (polyps) in your stomach, and chest pain behind the breastbone, for example, with eating.
For full prescribing information and additional important safety information, please visit: www.YOSPRALA.com.
Cautionary Language Concerning Forward-Looking Statements
You should be aware that the forward-looking statements included herein represent management's current judgment and expectations, and are based on current estimates and assumptions made by management in light of its experience and perception of historical trends, current conditions and expected future developments, as well as other factors that it believes are appropriate and reasonable under the circumstances, but there can be no assurance that such estimates and assumptions will prove to be correct and, as a result, the forward-looking statements based on those assumptions could prove to be incorrect. Accordingly, actual results, level of activity, performance or achievements or future events or developments could differ materially from those expressed or implied in the forward-looking statements. Our operations involve risks and uncertainties, many of which are outside of our control, and any one or any combination of these risks and uncertainties could also affect whether the forward-looking statements ultimately prove to be correct and could cause our actual results, level of activity, performance or achievements or future events or developments to differ materially from those expressed or implied by the forward-looking statements. These risks and uncertainties include, without limitation, our inability to build, acquire or contract with a sales force of sufficient scale for the commercialization of our products in a timely and cost-effective manner; our failure to successfully commercialize our products and product candidates; competition, including increased generic competition; costs and delays in the development and/or approval of our product candidates, including as a result of the need to conduct additional studies or due to issues with third-party API or finished product manufacturers, or the failure to obtain such approval of our product candidates for all expected indications, including as a result of changes in regulatory standards or the regulatory environment during the development period of any of our product candidates; with respect to certain products, dependence on reimbursement from third-party payors and the possibility of a failure to obtain coverage or reduction in the extent of reimbursement; the inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products, including our dependence on
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