AstraZeneca PLC, Diabetes Hands Foundation Partner To Help Adults With Type 2 Diabetes Walk Their Way To Better Health

WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca and the Diabetes Hands Foundation today announced the launch of Everyday Steps, a new campaign designed to help the nearly 28 million Americans with type 2 diabetes¹ develop and maintain a walking routine – one step at a time.

“When I work with patients, I emphasize the importance of lifestyle modifications, but many people find incorporating exercise into their treatment plan challenging. Walking is a great example of an accessible exercise that can lead to benefits, along with diet and medication.”

Serge Jabbour, M.D., FACP, FACE, endocrinologist, Thomas Jefferson University Hospital, Philadelphia said: “When I work with patients, I emphasize the importance of lifestyle modifications, but many people find incorporating exercise into their treatment plan challenging. Walking is a great example of an accessible exercise that can lead to benefits, along with diet and medication.”

The Everyday Steps walking guide, at www.everydaystepsguide.com, features tips to help participants create a walking routine. Tips in the walking guide include:

• Setting goals and tracking your progress
• Inviting a friend to walk with you
• Making a song list on your smartphone or MP3 player
• Rewarding yourself with something healthy after each walk
• Exploring different types of walking (e.g. power walking, lunges)

Cynthia Rogers, community manager for TuDiabetes.org said: "Exercise is recognized by TuDiabetes members as an important part of healthful living with diabetes. How exercise helps improve diabetes management is a popular topic in our online forum, especially among adults living with type 2. But many find it difficult to know how to start and keep the exercise habit going. The Everyday Steps guide provides a lot of useful information about how to individualize a walking routine so that it fits a person's preferences and lifestyle. And that's key for long-term success."

Before beginning a fitness program like Everyday Steps, people should consult a healthcare professional.

Topher Brooke, Vice President, Diabetes, AstraZeneca said: “A successful type 2 diabetes treatment plan not only includes medication, but lifestyle and behavior modifications like diet and exercise. Our aim is to offer people the tools and resources that will help empower them to manage their disease in a variety of ways.”

Everyday Steps was codeveloped by AstraZeneca, maker of FARXIGA^® (dapagliflozin), and the Diabetes Hands Foundation. FARXIGA is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. FARXIGA should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased ketones in your blood or urine).

Important Safety Information
Who should not take FARXIGA?

Do not take FARXIGA if you:

• are allergic to dapagliflozin or any of the ingredients in FARXIGA. Symptoms of a serious allergic reaction to FARXIGA may include skin rash, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. If you have any of these symptoms, stop taking FARXIGA and contact your healthcare provider or go to the nearest hospital emergency room right away.
• have severe kidney problems or are on dialysis. Your healthcare provider should do blood tests to check how well your kidneys are working before and during your treatment with FARXIGA.

What are the possible side effects of FARXIGA?

FARXIGA may cause serious side effects including:

• Dehydration (the loss of body water and salt), which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at a higher risk of dehydration if you have low blood pressure, take medicines to lower your blood pressure, including water pills (diuretics), are 65 years of age or older, are on a low salt diet, or have kidney problems.
• Ketoacidosis, a condition where the body produces high levels of acids called ketones, which can be life threatening and require hospitalization, has happened in people with type 1 diabetes or type 2 diabetes during treatment with FARXIGA. Symptoms of ketoacidosis may include nausea, tiredness, vomiting, trouble breathing, and stomach area (abdominal) pain. If you get any of these symptoms, stop taking FARXIGA and call your healthcare provider right away. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL.
• Serious urinary tract infections (UTI), some that lead to hospitalization, have happened in people taking FARXIGA. Tell your doctor if you have any signs or symptoms of UTI including a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine with or without fever, back pain, nausea or vomiting.
• Low blood sugar (hypoglycemia) can occur if you take FARXIGA with another medicine that can cause low blood sugar, such as sulfonylureas or insulin. Symptoms of low blood sugar include shaking, sweating, fast heartbeat, dizziness, hunger, headache and irritability. Follow your healthcare provider's instructions for treating low blood sugar.
• Vaginal yeast infections in women who take FARXIGA. Talk to your healthcare provider if you experience vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), or vaginal itching.
• Yeast infection of skin around the penis (balanitis) in men who take FARXIGA. Talk to your healthcare provider if you experience redness, itching, or swelling of the penis; rash of the penis; foul smelling discharge from the penis; or pain in the skin around penis. Certain uncircumcised men may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis.
• Increase in bad cholesterol (LDL-C). Your healthcare provider should check your LDL-C during treatment with FARXIGA.
• Bladder cancer. In studies of FARXIGA in people with diabetes, bladder cancer occurred in a few more people who were taking FARXIGA than in people who were taking other diabetes medications. There were too few cases of bladder cancer to know if bladder cancer was related to FARXIGA. Tell your healthcare provider right away if you have blood or a red color in your urine or pain while you urinate.
• Kidney problems

The most common side effects of FARXIGA include yeast infections of the vagina or penis, and changes in urination, including urgent need to urinate more often, in larger amounts, or at night.

What should I tell my healthcare provider before taking FARXIGA?

Before you take FARXIGA, tell your healthcare provider:

• all of your medical conditions, including problems with your kidneys, bladder, or pancreas.
• if you have had, or have risk factors for, ketoacidosis (including type 1 diabetes, are eating less due to illness, surgery, or a change in your diet, are going to have surgery, or binge drink).
• if you are pregnant. FARXIGA may harm your unborn baby.
• if you are breastfeeding, or plan to breastfeed. It is unknown if FARXIGA passes into your breast milk.
• about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

What is FARXIGA?

FARXIGA is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

FARXIGA should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased ketones in your blood or urine).

Please see full Prescribing Information and Medication Guide for FARXIGA.

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.

NOTES TO EDITORS

About Type 2 Diabetes

Diabetes is estimated to affect 29.1 million people in the United States¹ and more than 382 million people worldwide.² The prevalence of diabetes is projected to reach more than 471 million people worldwide by 2035.² Type 2 diabetes accounts for approximately 90-95 percent of all cases of diagnosed diabetes in the United States.¹ Type 2 diabetes is a chronic disease characterized by pathophysiologic defects leading to elevated glucose levels.^2,3 Significant unmet needs still exist, as many patients remain inadequately controlled on their current glucose-lowering regimen.⁴ It is estimated that more than half of people living with type 2 diabetes are not achieving recommended HbA1c goals based on guidelines established by professional societies and advocacy organizations for diabetes management.⁵

About AstraZeneca in Diabetes

AstraZeneca is pushing the boundaries of science with the goal of developing life-changing medicines that aim to reduce the global burden and complications of diabetes. Our commitment to diabetes is exemplified by the depth and breadth of our global clinical research program. AstraZeneca is committed to advancing understanding of the treatment effects of our diabetes medicines in broad patient populations, as well as exploring combination treatment approaches to help more patients achieve treatment success earlier in their disease progression. Our ambition is to reduce the long-term impact of diabetes. As a core strategic area for the company, we are focusing our research and development efforts in diverse populations and patients with significant co-morbidities, such as cardiovascular disease, heart failure, obesity, non-alcoholic steatohepatitis (NASH), and chronic kidney disease.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as in infection and neuroscience. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit www.astrazeneca-us.com.

¹ Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2014. http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf. Accessed August 12, 2014.
² International Diabetes Federation. IDF Diabetes Atlas, 6th ed. Brussels, Belgium: International Diabetes Federation; 2013. http://www.idf.org/diabetesatlas. Accessed November 26, 2013.
³ Kahn SE. The relative contributions of insulin resistance and beta-cell dysfunction to the pathophysiology of type 2 diabetes. Diabetologia. 2003;46:3-19.
⁴ Cheung B, Lond E, Ong KL, et al. Diabetes prevalence and therapeutic target achievement in the United States, 1999-2006. Am J Med. 2009;122:443-453.
⁵ Cook M.N., et al. Initial monotherapy with either metformin or sulphonylureas often fails to achieve or maintain current glycaemic goals in patients with type 2 diabetes in UK primary care. Diabetic Med 2007:24;350-358.

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