RARITAN, N.J., March 14, 2016 – After-effects of a new assay of abstracts from real-world analytic convenance appearance that, in adults with blazon 2 diabetes, use of the once-daily articulate medication INVOKANA (canagliflozin) is associated with decidedly greater improvements in claret glucose ascendancy compared to dipeptidyl peptidase-4 (DPP-4) inhibitors, a accepted chic of medicines for blazon 2 diabetes that includes Januvia (sitagliptin). The new real-world findings, the aboriginal to analyze the capability of a sodium glucose co‐transporter 2 (SGLT2) inhibitor with DPP-4 inhibitors, were appear in Accepted Medical Analysis & Opinion.
The analysis, based on abstracts from U.S. bloom plans, evaluated the glycemic ascendancy of bodies with blazon 2 diabetes advised with INVOKANA against DPP-4 inhibitors over a aeon of nine months. Of the 1,439 bodies with blazon 2 diabetes and accessible A1C ethics included in the analysis, those advised with INVOKANA had a beggarly abridgement in A1C of 0.92 percent compared to baseline, against a beggarly abridgement of 0.63 percent amid those advised with a DPP-4 inhibitor (p
‘This absolute apple assay complements allegation from the cardinal trials that a the approval of INVOKANA, as it provides insights to physicians on how these medicines are assuming post-approval for bodies active with blazon 2 diabetes,’ said abstraction co-author Richard Aguilar, M.D.*, Medical Director of Diabetes Nation. ‘These new allegation are important in ablaze of the charge to analyze ameliorative options with the best abeyant for accomplishing assay goals, abnormally aback they are estimated to abide unmet for up to one-half of bodies with blazon 2 diabetes.’
In Phase 3 analytic trials, compared to the DPP-4 inhibitor sitagliptin, INVOKANA 300 mg resulted in decidedly greater reductions in A1C, and additionally greater reductions in anatomy weight and systolic claret pressure.
The American Diabetes Association recommends best adults with blazon 2 diabetes advance A1C levels of 7 percent or less. Medicare and abounding bloom affairs use an A1C akin of beneath than 8 percent as a assay goal.
Abstraction DetailsThis attendant matched-control accomplice analysis, advised and conducted accordingly by Janssen Pharmaceuticals and Optum, drew from the Optum Analysis Database. The database included 131,474 adults with blazon 2 diabetes who had one or added pharmacy claims for INVOKANA or a DPP-4 inhibitor amid April 1, 2013 and December 31, 2013. Through adeptness account analogous for agnate accommodating and assay characteristics, advisers akin 2,766 patients assigned INVOKANA (100 mg or 300 mg daily) with an according cardinal of patients assigned DPP-4 inhibitors. The empiric assay was based on patients in the two cohorts who had six months of baseline abstracts and nine months of aftereffect abstracts afterwards starting assay on INVOKANA or a DPP-4 inhibitor. Of the patients advised with DPP-4 inhibitors, added than bisected (53.2 percent) were advised with sitagliptin.
‘INVOKANA is the number-one assigned SGLT2 inhibitor with added than 7 actor prescriptions and growing, and our analysis continues exploring the achievement of this anesthetic beyond assorted patients with blazon 2 diabetes to admonition physicians and patients accomplish a assay decisions,’ said Paul Burton, MD, PhD, Vice President, Medical Affairs, Janssen. ‘Coupled with after-effects from randomized analytic trials of INVOKANA, real-world affirmation is important to providers and payers because it demonstrates the affection outcomes that can be accomplished in accustomed analytic practice.’
INVOKANA is acclimated forth with diet and exercise to lower claret glucose in adults with blazon 2 diabetes.
INVOKANA works with the kidneys to lower A1C. It is not adumbrated for weight accident or as antihypertensive treatment.
About Blazon 2 DiabetesOf the about 29 actor bodies who accept diabetes in the United States, 90 to 95 percent of them accept blazon 2 diabetes, which is abiding and affects the body’s adeptness to metaize amoroso (glucose), and is characterized by the disability of pancreatic beta corpuscle action to accumulate up with the body’s appeal for insulin.
WHAT IS INVOKANA?
INVOKANA is a decree anesthetic acclimated forth with diet and exercise to lower claret amoroso in adults with blazon 2 diabetes. INVOKANA is not for bodies with blazon 1 diabetes or with diabetic ketoacidosis (increased ketones in claret or urine). It is not accepted if INVOKANA is safe and able in accouchement beneath 18 years of age.
IMPORTANT SAFETY INFORMATION
INVOKANA can account important ancillary effects, including:
Talk to your doctor about what to do if you get affection of a aggrandize infection of the or penis.
Do not booty INVOKANA if you:
Before you booty INVOKANA, acquaint your doctor if you accept branch problems; alarmist problems; pancreas problems; are on a low sodium (salt) diet; are activity to accept surgery; are bistro beneath due to illness, surgery, or a absolute low calorie diet; anytime had an allergic acknowledgment to INVOKANA; booze booze absolute generally (or booze a lot of booze in short-term); or accept added medical conditions.
Acquaint your doctor if you are or plan to become pregnant, are feeding, or plan to feed. It is not accepted if INVOKANA will abuse your approaching baby. It is additionally not accepted if INVOKANA passes into your milk.
Acquaint your doctor about all the medicines you take, including decree and non-prescription medicines, vitamins, and herbal supplements. Abnormally acquaint your doctor if you booty diuretics (water pills), rifampin (used to amusement or anticipate tuberculosis), phenytoin or phenobarbital (used to ascendancy seizures), ritonavir (Norvir, Kaletra- acclimated to amusement HIV infection), or digoxin (Lanoxin- acclimated to amusement affection problems).
Possible Ancillary Furnishings of INVOKANA
INVOKANA may account austere ancillary effects, including:
Signs and affection of low claret amoroso may include: headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, shaking, or activity jittery.
Austere allergic reaction. If you accept any affection of a austere allergic reaction, stop demography INVOKANA and alarm your doctor appropriate abroad or go to the aing hospital emergency room.
Broken Bones (fractures): Cartilage fractures accept been apparent in patients demography INVOKANA. Talk to your doctor about factors that may access your accident of cartilage fracture.
The best accepted ancillary furnishings of INVOKANA include: l aggrandize infections and aggrandize infections of the penis; urinary amplitude infection; or changes in urination, including burning charge to defecate added often, in beyond amounts, or at night.
Acquaint your doctor if you accept any ancillary aftereffect that bothers you or that does not go away. Alarm your doctor for medical admonition about ancillary effects. You may address ancillary furnishings to FDA at 1-800-FDA-1088. You may additionally address ancillary furnishings to Janssen Scientific Affairs, LLC at 1-800-526-7736.
Please see abounding Artefact Advice and Medication Guide.
Canagliflozin is accountant from Mitsubishi Tanabe Pharma Corporation.
Trademarks are those of their corresponding owners.
About Janssen Pharmaceuticals, Inc.At Janssen, we are committed to acclamation and analytic some of the best important unmet medical needs of our time in oncology, immunology, neuroscience, communicable diseases and vaccines, and cardiovascular and metaic diseases. Driven by our charge to patients, we advance avant-garde products, casework and healthcare solutions to admonition bodies throughout the world. Janssen Pharmaceuticals, Inc. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please appointment JanssenPharmaceuticalsInc.com for added information.
This columnist absolution contains ‘forward-looking statements’ as authentic in the Private Securities Litigation Reform Act of 1995 apropos artefact development and use. The clairvoyant is cautioned not to await on these advanced statements. These statements are based on accepted expectations of approaching events. If basal assumptions prove inaccurate or accepted or alien risks or uncertainties materialize, absolute after-effects could alter materially from the expectations and projections of Janssen Pharmaceuticals, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not bound to: challenges and uncertainties inherent in artefact research, development and commercialization, including the ambiguity of analytic success and of accepting authoritative approvals; competition, including abstruse advances, new articles and patents accomplished by competitors; challenges to patents; changes to applicative laws and regulations, including all-around bloom affliction reforms; and trends against bloom affliction amount containment. A added account and description of these risks, uncertainties and added factors can be begin in Johnson & Johnson’s Annual Address on Form 10-K for the budgetary year concluded January 3, 2016, including in Exhibit 99 thereto, and the company’s consecutive filings with the Securities and Exchange Commission. Copies of these filings are accessible online at www.sec.gov,www.jnj.com or on appeal from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to amend any advanced account as a aftereffect of new advice or approaching contest or developments.
*Dr. Aguilar was not associated with the INVOKANA analytic trials and was not compensated for any media work. He has been a paid adviser to Janssen Pharmaceuticals, Inc.
Thayer S, Chow W, Korrer S, Aguilar R. Real-world appraisal of glycemic ascendancy amid patients with blazon 2 diabetes mellitus advised with canagliflozin against dipeptidyl peptidase-4 inhibitors. Curr Med Res Opin. 2016 Mar 3:1-38. [Epub advanced of print].
Ali MK, Bullard KM, Saaddine JB, et al. Achievement of goals in U.S. diabetes care, 1999-2010. N Engl J Med 2013;368:1613-24.
Lavalle-González F, Januszewicz A, Davidson J, et al. Efficacy and assurance of canagliflozin compared with placebo and sitagliptin in patients with blazon 2 diabetes on accomplishments metformin monotherapy: a randomised trial. Diabetologia 2013;56:2582-92.
Schernthaner G, Gross JL, Rosenstock J, et al. Canagliflozin compared with sitagliptin for patients with blazon 2 diabetes who do not accept able glycemic ascendancy with metformin additional sulfonylurea. Diabetes Affliction 2013;36:2508-15.
INVOKANA (canagliflozin) tablets, for articulate use. Prescribing information, adapted 12/2015. Janssen Pharmaceuticals, Inc., Titusville, NJ, 08560.
National Committee for Affection Assurance. http://www.ncqa.org/HEDISQualityMeasurement/HEDISMeasures.aspx. Accessed 2015 May 7.
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