This randomized clinical study, which investigated the efficacy and safety of INVOKANA® on systolic blood pressure (SBP) after a short treatment duration of six weeks, found that treatment with INVOKANA® 300 mg led to a statistically significant reduction in average 24-hour SBP compared with placebo in patients with type 2 diabetes. Additionally, reductions in average 24-hour SBP and diastolic blood pressure (DBP) were observed as early as day 2 after the first treatment with INVOKANA® 100 mg and 300 mg. Both doses of INVOKANA® reduced average daytime and nighttime SBP and DBP compared with placebo. Treatment with INVOKANA® 300 mg also improved blood glucose control and reduced body weight. In the study, 24-hour BP was monitored by a portable device that measured BP every 20–30 minutes over a 24-hour period while patients did their normal daily activities, including sleep.
These data provide important information about the early effects of treatment (i.e., less than 12 weeks) with INVOKANA®. Prior to this study, early treatment with SGLT2 inhibitors had not been well evaluated.
"High blood pressure is common among people with type 2 diabetes, so having a treatment that can positively affect both blood glucose control and blood pressure is of great value," said lead investigator Raymond R. Townsend, MD, Director, Hypertension Program, Hospital of the University of Pennsylvania. "Ongoing studies will help further characterize the impact of SGLT2 inhibition on cardiovascular outcomes in patients with type 2 diabetes, and this study builds on the growing portfolio of the value of SGLT2 inhibition in diabetes."
Hypertension (high blood pressure) is reported in more than two-thirds of patients with type 2 diabetes, a condition affecting approximately 27 million Americans. Lowering blood pressure can significantly reduce the risk of cardiovascular events in people with diabetes. INVOKANA® is not indicated as an antihypertensive treatment.
INVOKANA® is the number-one prescribed SGLT2 inhibitor for the treatment of type 2 diabetes, with more than 6 million prescriptions written since launch.
In this study, INVOKANA® demonstrated an overall safety profile consistent with previous clinical studies that show treatment is generally well tolerated. A greater percentage of patients receiving INVOKANA® 300 mg had significant orthostasis, volume depletion, and osmotic diuresis adverse events compared with the INVOKANA® 100 mg and placebo groups.
WHAT IS INVOKANA®?
INVOKANA® is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. INVOKANA® is not for people with type 1 diabetes or with diabetic ketoacidosis (increased ketones in blood or urine). It is not known if INVOKANA® is safe and effective in children under 18 years of age.
IMPORTANT SAFETY INFORMATION
INVOKANA® can cause important 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 higher risk of dehydration if you have low blood pressure, take medicines to lower your blood pressure (including diuretics [water pills]), are on a low sodium (salt) diet, have kidney problems, or are 65 years of age or older
· Vaginal yeast infection. Women who take INVOKANA® may get vaginal yeast infections. Symptoms include: vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), or vaginal itching
· Yeast infection of the penis (balanitis or balanoposthitis). Men who take INVOKANA® may get a yeast infection of the skin around the penis. Symptoms include: redness, itching, or swelling of the penis; rash of the penis; foul-smelling discharge from the penis; or pain in the skin around penis
Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis.
Do not take INVOKANA® if you:
· are allergic to canagliflozin or any of the ingredients in INVOKANA®. Symptoms of allergic reaction may include: rash; raised red patches on your skin (hives); or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing
· have severe kidney problems or are on dialysis
Before you take INVOKANA®, tell your doctor if you have kidney problems, liver problems, are on a low sodium (salt) diet, ever had an allergic reaction to INVOKANA®, or have other medical conditions.
Tell your doctor if you are or plan to become pregnant, are breastfeeding, or plan to breastfeed. It is not known if INVOKANA® will harm your unborn baby. It is also not known if INVOKANA® passes into your breast milk.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take diuretics (water pills), rifampin (used to treat or prevent tuberculosis), phenytoin or phenobarbital (used to control seizures), ritonavir (Norvir®, Kaletra® – used to treat HIV infection), or digoxin (Lanoxin®– used to treat heart problems).
Possible Side Effects of INVOKANA®
INVOKANA® may cause serious side effects, including: kidney problems, a high amount of potassium in your blood (hyperkalemia), or low blood sugar (hypoglycemia). If you take INVOKANA® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take INVOKANA®.
Signs and symptoms of low blood sugar may include: headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, shaking, or feeling jittery.
Serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking INVOKANA® and call your doctor right away or go to the nearest hospital emergency room.
Broken Bones (fractures): Bone fractures have been seen in patients taking INVOKANA®. Talk to your doctor about factors that may increase your risk of bone fracture.
The most common side effects of INVOKANA® include: vaginal yeast infections and yeast infections of the penis; urinary tract infection; or changes in urination, including urgent need to urinate more often, in larger amounts, or at night.
Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Janssen Scientific Affairs, LLC at 1-800-526-7736.
Please see the full Product Information and Medication Guide.
Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation.
Trademarks are those of their respective owners.