Evidence from the field shows that oral INVOKANA® (canagliflozin) leads to more weight loss and treatment adherence in patients with type 2 diabetes than injectable GLP-1 receptor agonists - press release

Evidence from practice shows that oral INVOKANA® (canagliflozin) leads to greater weight loss and better treatment adherence than injectable GLP-1 receptor agonists in type 2 diabetes patients

Janssen pharmaceutical company
Published: 24 Jun 18

TITUSVILLE, NJ and ORLANDO, Fla., June 23, 2018 / PRNewswire / – Johnson & Johnson's Janssen Pharmaceutical Companies today announced new findings from two recent studies comparing SUCT2i (SGLT2i) INVOKANA® ( Canagliflozin) and glucagon-like peptide-1 receptor agonists (GLP-1) in the treatment of adults with type 2 diabetes. One study showed that treatment with INVOKANA® resulted in similar glycemic control, while at the same time achieving greater adherence to therapy, less treatment discontinuation, and lower treatment costs. A second study showed that INVOKANA® resulted in greater and longer lasting weight loss. These findings were revealed in two poster presentations at the 78th Scientific Sessions of the American Diabetes Association (ADA) in Orlando, FL.

One of the two real-world studies, based on data from the HealthCore Integrated Research Database, showed that INVOKANA® treatment resulted in similar glucose control levels based on A1C levels compared to GLP-1 at three-month intervals, whereas better ones Results are shown at several endpoints:

For about 12 months, about 10 percent more patients were on therapy adherence with INVOKANA®: 47.5 percent versus 37.5 percent (p <0.001). Adherence was defined as one patient taking the drug for 80 percent or more of the days during the 12-month period.

For 12 months, patients were 22 percent less likely to receive INVOKANA® treatment – 49.6 percent versus 57.4 percent (HR 0.78, 95 percent CI 0.70, 0.88, p <0.001) quit or insulin (4.1 percent vs. 7.8 percent, p = 0.001).

About 31 percent lower initial anti-hyperglycemic agents require annual medication costs: $ 1,421 less with INVOKANA® than with GLP-1 therapy.

The second study, based on the US Optum database, also reviewed patient data at three-month intervals and showed that treatment with INVOKANA® for nine months nearly doubled or increased the likelihood of clinically significant weight loss (defined as five percent) Body weight) compared to GLP-1 (HR: 1.93, CI: 1.40, 2.66, p <0.0001).

"The actual results we see in these studies show that INVOKANA® outperforms GLP-1 in these measures," said Paul Burton, MD, PhD, FACC, vice president, medical affairs, Janssen Scientific Affairs, LLC. "Findings from similar glycemic control, greater adherence, and lower treatment costs with INVOKANA® are particularly relevant to physicians and payers to consider when treating type 2 diabetes."

Studies and results
Abstract No. 1287-P
Based on medical data from the HealthCore Integrated Research Database (HIRD), this real-life study examined adults with type 2 diabetes who had started on INVOKANA® (750 patients) or a GLP-1 (2,417 patients). Patient data was collected every three months, starting 12 months before the start of INVOKANA® or a GLP-1, and ending 12 months later. In the 12 months after initiation of therapy, the slope-proportional analysis showed that treatment with INVOKANA® also resulted in a similar reduction in A1C at each 3-month measurement after initiation of treatment and at 12 months.

Abstract No. 1291-P
A second real study was based on health data from the US Optum database. She examined adults with type 2 diabetes who had one or more prescriptions for INVOKANA® (213 patients) or a GLP-1 (235 patients) and at least two body weight measurements, one at baseline and at least one after 31 days more after the start of treatment. The analysis showed that in the nine months after initiation of therapy, the results of INVOKANA® treatment and GLP-1 treatment were as follows:

With INVOKANA® treatment significantly lower body weight values ​​over six months (104.4 kg vs. 108.4 kg) and nine months (101.1 kg vs. 110.2); p <0.05 both for the six-month comparison and for the nine-month comparison.

With INVOKANA® treatment, a significantly longer duration of clinically significant weight loss: 133 vs. 103 days, p = 0.01.

Limitations of the real world
Data from the field has the potential to complement randomized controlled trial data by providing additional information about how a drug behaves in routine medical work. However, they have limitations and can not be used as standalone evidence to validate the efficacy and / or safety of a treatment.

In retrospective analyzes, diagnostic coding errors based on administrative claim data are possible. For these two ADA analyzes, the results for the patients in the databases apply and may not be generalized to the entire US managed care population. A prescription application neither assures that the drug was prescribed nor does it reflect the use of drug samples, which is likely to underestimate the compliance of INVOKANA® with GLP-1 in the HIRD study.

Although the recommended starting dose of INVOKANA® is 100 mg, the HIRD study examined the outcomes for patients who started at the 300 mg dose, which is associated with widespread use in the real world. In addition, not all risk factors, including length of diabetes history and body mass index, could be determined and compensated. In the US Optum database analysis, there were standardized differences in baseline variables in the matched cohorts. However, the remaining differences in the subset of patients with weight data were identified by low event counts, small sample sizes or already in the results.

WHAT IS INVOKANA®?

INVOKANA® (Canagliflozin) is a prescription medication used with diet and exercise to lower blood sugar levels in adults with type 2 diabetes. INVOKANA® is not for people with type 1 diabetes or diabetic ketoacidosis (elevated ketones in blood or urine). It is not known if INVOKANA® is safe and effective in children under 18 years of age. The recommended starting dose is 100 mg once daily before the first meal of the day. For patients taking INVOKANA® 100 mg once daily with an eGFR value of 60 ml / min / 1.73 m2 or more and needing additional glycemic control, the dose may be increased to 300 mg once daily.

IMPORTANT SAFETY INSTRUCTIONS

INVOKANA® (Canagliflozin) can cause important side effects, including:

Amputations. INVOKANA® can increase the risk of leg amputations. Amputations mainly involve the removal of the toe or part of the foot; However, amputations on the leg, below and above the knee have also occurred. Some people had more than one amputation, some on both sides of the body. You may be at a higher risk for a leg amputation if you: have a history of amputation, heart disease or a risk of heart disease, blocked or narrowed blood vessels (usually in the leg), have nerve damage (neuropathy) in the leg, or had diabetic foot ulcers or ulcers. Call your doctor immediately if you have new pain or tenderness, ulcers, ulcers or infections in your leg or foot. Your doctor may decide to stop your INVOKANA® for a while if you have any of these signs or symptoms. Talk to your doctor about proper foot care

Dehydration. INVOKANA® can cause some people to become dehydrated (loss of too much body water), which can make you feel dizzy, weak, dizzy or weak, especially when you get up (orthostatic hypotension). If you have low blood pressure, you may be at a higher risk of dehydration. Take medications to lower your blood pressure (including diuretics) [water pills]), are on a low sodium (salt) diet, have kidney problems or are 65 years old or older

Vaginal yeast infection. Women taking INVOKANA® may get vaginal yeast infections. Symptoms include: vaginal odor, white or yellowish 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® can get a fungal infection of the skin around the penis. The 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 the penis

Talk to your doctor about what to do if you get symptoms of yeast infection of the vagina or penis.

Do not take INVOKANA® if you:

are allergic to canagliflozin or one of the ingredients of INVOKANA®. Symptoms of an allergic reaction can be: rash; raised red patches on the skin (hives); or swelling of the face, lips, tongue, and throat, which may cause difficulty in breathing or swallowing

have severe kidney problems or are on dialysis

Before taking INVOKANA®, tell your doctor if you have an amputation in the past. Heart disease or are at risk for heart disease; blocked or narrowed blood vessels (usually in the leg); Nerve damage (neuropathy) of your leg; diabetic foot ulcers or ulcers; Kidney problems; Liver problems; History of urinary tract infections or urinary problems; are on a low sodium (salt) diet; will be operated on; eat less because of illness, surgery or diet change; Pancreas problems; drink alcohol very often (or drink a lot of alcohol in the short term); ever had an allergic reaction to INVOKANA®; or have other medical conditions.

Tell your doctor if you are pregnant or planning to conceive, breastfeed or intend to breastfeed. INVOKANA® can harm your unborn baby. If you become pregnant while taking INVOKANA®, tell your doctor immediately. INVOKANA® can pass into your breast milk and harm your baby. Do not breast-feed while taking INVOKANA®.

Tell your doctor about all the medicines you are taking, including prescription and non-prescription medicines, vitamins and herbal supplements. Talk to your doctor if you are taking diuretics (water pills), rifampicin (used to treat or prevent tuberculosis), phenytoin or phenobarbital (used to control seizures), ritonavir (Norvir®, Kaletra® used to treat HIV infection) or digoxin (Lanoxin® – for the treatment of heart problems).

Possible side effects of INVOKANA®
INVOKANA® can cause serious side effects, including:

Ketoacidosis (elevated ketones in your blood or urine). In patients with type 1 or type 2 diabetes, ketoacidosis has occurred during treatment with INVOKANA®. Ketoacidosis is a serious condition that may need to be treated in a hospital. Ketoacidosis can lead to death. Ketoacidosis can occur with INVOKANA®, even if your blood sugar is less than 250 mg / dL. Stop taking INVOKANA® and call your doctor immediately if any of the following symptoms occur: nausea, vomiting, abdominal pain, tiredness or difficulty breathing

Kidney problems. People taking INVOKANA® have experienced sudden kidney damage. Talk to your doctor immediately if you: 1) reduce the amount of food or liquid you drink, if you are ill or can not eat, or 2) you start to vomit fluids, or diarrhea, in the sun to lose too long

A high amount of potassium in your blood (hyperkalemia)

Severe urinary tract infections can lead to hospitalization and have occurred in patients taking INVOKANA®. Tell your doctor if you have signs or symptoms of urinary tract infection, such as: burning sensation when urinating, urinating frequently or immediately, pain in the lower part of the stomach (pelvis), or blood in the urine. Some people may also experience high fever, back pain, nausea or vomiting

Low blood sugar (hypoglycemia). If you take INVOKANA® with another medicine that may cause low blood sugar levels, such as: As sulfonylurea or insulin, the risk of low blood sugar levels is higher. The dose of your sulphonylurea drug or insulin may need to be reduced while you are taking INVOKANA®

Signs and symptoms of low blood sugar levels may include: headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, rapid heartbeat, sweating, shaking or trembling.

Severe allergic reaction. If you have symptoms of a severe allergic reaction, stop taking INVOKANA® and call your doctor or nearest hospital emergency room immediately.

Broken bones (fractures). In patients taking INVOKANA®, fractures were observed. Talk to your doctor about factors that may increase the risk of fractures.

The most common side effects with INVOKANA® are: vaginal fungal infections and fungal infections of the penis; Changes in urination, including an urgent need to urinate more often, in larger quantities or at night.

Tell your doctor if you have any side effects that bother you or that do not disappear. Tell your doctor about side effects. You can report side effects to the FDA at 1-800-FDA-1088. You can also report side effects to Janssen Scientific Affairs, LLC at 1-800-526-7736.

Please read the full product information, including Boxed Warning and Medication Guide for INVOKANA®.

Janssen Pharmaceuticals, Inc. and its affiliates have rights to canagliflozin through a licensing agreement with Mitsubishi Tanabe Pharma Corporation, including in the United States. Trademarks are those of their respective owners.

About the Janssen Pharmaceutical Companies
At Johnson & Johnson's Janssen Pharmaceutical Companies, we work to create a world without disease. Transforming life by finding new and better ways to prevent, catch, treat and heal diseases inspires us. We bring the best minds together and pursue the most promising science. We are Janssen. We work with the world for the health of all in it. Find out more at www.janssen.com. Follow us on Twitter @JanssenUS. Janssen Pharmaceuticals, Inc. and Janssen Scientific Affairs, LLC are part of Johnson & Johnson's Janssen Pharmaceutical Companies.

Beware of forward-looking statements

This press release contains "forward-looking statements" as defined in the 1995 Private Securities Litigation Reform Act regarding the potential benefits and development of INVOKANA® (canagliflozin). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If the underlying assumptions prove inaccurate or there are known or unknown risks or uncertainties, the actual results may differ materially from the expectations and forecasts of Janssen Scientific Affairs, LLC, any of the other Janssen Pharmaceutical Companies and / or Johnson & Johnson. Risks and uncertainties include, among others, the challenges and uncertainties inherent in research and development of products, including the uncertainty of clinical success and obtaining regulatory approvals; Uncertainty of commercial success; Manufacturing difficulties and delays; Competition, including technological advances, new products and patents of competitors; Challenges for patents; Product efficacy or safety concerns leading to product recalls or regulatory action; Behavioral changes and spending patterns of purchasers of health products and services; Changes to applicable laws and regulations, including global health care reforms; and trends to reduce health care costs. For a further list and descriptions of these risks, uncertainties and other factors, see Johnson & Johnson's Annual Report on Form 10-K for the year ended December 31, 2017, including the sections entitled "Forward-Looking Statements Cautionary Statement" and "Item 1A. Risk Factors "and subsequent Company Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission Copies of these materials are available online at www.sec.gov, www.jnj.com or upon request from Johnson & Johnson None of the Janssen Pharmaceutical Companies or Johnson & Johnson agrees to update any forward-looking statements, whether as a result of new information or future events or developments.

Details of the publisher

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 24/06/2018

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