TITUSVILLE, N.J. and
ORLANDO, Fla., June 23, 2018 /PRNewswire/ -- The Janssen
Pharmaceutical Companies of Johnson & Johnson today announced
new findings from two real-world studies comparing sodium glucose
co-transporter-2 inhibitor (SGLT2i) INVOKANA®
(canagliflozin) and glucagon-like peptide-1 receptor agonists
(GLP-1s) in treating adults with type 2 diabetes. One study showed
INVOKANA® treatment resulted in similar blood glucose
control while achieving greater treatment adherence, less therapy
discontinuation and lower treatment cost, while a second study
showed INVOKANA® resulted in greater and longer-lasting
weight loss. These findings were revealed in two poster
presentations at the American Diabetes Association's (ADA)
78th Scientific Sessions in Orlando, FL.
One of the two real-world studies, which was based on data from
the HealthCore Integrated Research Database, showed that
INVOKANA® treatment resulted in similar levels of
glucose control based on A1C levels at three-month intervals,
compared to treatment with GLP-1s, while demonstrating better
outcomes on multiple endpoints:
- Over 12 months, about ten percent more patients maintained
treatment adherence with INVOKANA®: 47.5 percent vs 37.5
percent (p<0.001). Adherence was defined as a patient taking the
medication for 80 percent or more of the days during the 12-month
period.
- Over 12 months, patients were 22 percent less likely to
discontinue treatment with INVOKANA® – 49.6 percent vs
57.4 percent (HR 0.78, 95 percent CI 0.70, 0.88; p<0.001) – or
to initiate insulin (4.1 percent vs. 7.8 percent, p=0.001).
- Approximately 31 percent lower initial anti-hyperglycemic agent
annual medication cost: $1,421 less
with INVOKANA® than with GLP-1 therapy.
The second study, which was based on the U.S. Optum database,
also assessed patient data at three-month intervals, and showed
that, over nine months, treatment with INVOKANA® nearly
doubled the likelihood of achieving clinically significant weight
loss (defined as five percent or more of body weight) compared to
GLP-1s (HR: 1.93, CI: 1.40, 2.66; p<0.0001).
"The real-world outcomes that we're seeing in these studies show
that INVOKANA® performs better on these measures than
GLP-1s," said Paul Burton, MD, PhD,
FACC, Vice President, Medical Affairs, Janssen Scientific Affairs,
LLC. "The findings of similar blood glucose control, greater
adherence and lower treatment costs with INVOKANA® are
especially relevant for physicians and payers to consider for the
treatment of type 2 diabetes."
Studies and Findings
Abstract No.
1287-P
Based on medical claims data from the HealthCore Integrated
Research Database (HIRD), this real-world study evaluated adults
with type 2 diabetes who initiated therapy with
INVOKANA® (750 patients) or a GLP-1 (2,417 patients).
Patient data were collected at three-month intervals, beginning 12
months before initiating INVOKANA® or a GLP-1, and
ending 12 months afterwards. In the 12 months following therapy
initiation, the propensity-adjusted analysis showed that treatment
with INVOKANA® also resulted in similar reductions in
A1C at each three-month measurement after treatment initiation, and
at 12 months.
Abstract No. 1291-P
A second real-world study was based on health records data from the
U.S. Optum database. It evaluated adults with type 2 diabetes who
had one or more prescription claim for INVOKANA® (213
patients) or a GLP-1 (235 patients), and at least two body weight
measurements, including one at baseline and at least one at 31 days
or more after starting treatment. The analysis showed that in the
nine months following therapy initiation, the results of
INVOKANA® treatment and GLP-1 treatment were as
follows:
- With INVOKANA® treatment, significantly lower body
weight levels over six months (104.4 kg vs. 108.4 kg) and nine
months (101.1 kg vs. 110.2); p<0.05 for both six-month and
nine-month comparisons.
- With INVOKANA® treatment, a significantly longer
duration of clinically significant weight loss: 133 vs. 103 days,
p=0.01.
Real-World Study Limitations
Real-world data have the potential to supplement randomized
controlled trial data by providing additional information about how
a medicine performs in routine medical practice. However, they have
limitations and cannot be used as stand-alone evidence to validate
the efficacy and/or safety of a treatment.
In retrospective analyses, diagnosis coding errors are possible
based on administrative claims data. For these two ADA analyses,
the results apply to the patients in the databases and may not be
generalizable to the overall U.S. managed care population. Further,
a prescription claim does not ensure that the medication was taken
as prescribed nor does it reflect the use of medication samples,
which is what likely resulted in an underestimate of adherence to
INVOKANA® versus GLP-1s in the HIRD study.
Although the recommended starting dose of INVOKANA®
is 100 mg, the HIRD study examined results for patients initiated
on the 300 mg dose, which is associated with broad utilization in
the real world. Additionally, not all risk factors, including
length of diabetes history and body mass index, could be determined
and balanced. In the U.S. Optum database analysis, there were
standardized differences in baseline variables in the balanced
cohorts. However, the remaining differences in the subset of
patients with weight data were driven by low event numbers, small
sample sizes, or were already identified in the results.
WHAT IS INVOKANA®?
INVOKANA® (canagliflozin) 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. The recommended
starting dose is 100 mg once daily, taken before the first
meal of the day. The dose can be increased to 300 mg once
daily in patients tolerating INVOKANA® 100 mg once
daily who have an eGFR of 60 mL/min/1.73 m2 or greater and
require additional glycemic control.
IMPORTANT SAFETY INFORMATION
INVOKANA® (canagliflozin) can cause important side
effects, including:
- Amputations. INVOKANA® may increase your risk of
lower-limb amputations. Amputations mainly involve removal of the
toe or part of the foot; however, amputations involving 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 of lower-limb amputation if you: have a history of
amputation, have heart disease or are at risk for heart disease,
have had blocked or narrowed blood vessels (usually in leg), have
damage to the nerves (neuropathy) in the leg, or have had diabetic
foot ulcers or sores. Call your doctor right away if you have
new pain or tenderness, any sores, 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 (the loss of too much body water), 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 a history of amputation; heart disease or are at risk
for heart disease; blocked or narrowed blood vessels (usually in
leg); damage to the nerves (neuropathy) of your leg; diabetic foot
ulcers or sores; kidney problems; liver problems; history of
urinary tract infections or problems with urination; are on a low
sodium (salt) diet; are going to have surgery; are eating less due
to illness, surgery, or change in diet; pancreas problems; drink
alcohol very often (or drink a lot of alcohol in short-term); 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. INVOKANA® may
harm your unborn baby. If you become pregnant while taking
INVOKANA®, tell your doctor right away.
INVOKANA® may pass into your breast milk and may harm
your baby. Do not breastfeed while taking INVOKANA®.
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:
- Ketoacidosis (increased ketones in your blood or urine).
Ketoacidosis has happened in people who have type 1 or type 2
diabetes, during treatment with INVOKANA®.
Ketoacidosis is a serious condition, which may need to be treated
in a hospital. Ketoacidosis may lead to death. Ketoacidosis can
happen with INVOKANA® even if your blood sugar is less
than 250 mg/dL. Stop taking INVOKANA® and call your
doctor right away if you get any of the following symptoms: nausea,
vomiting, stomach-area pain, tiredness, or trouble
breathing
- Kidney problems. Sudden kidney injury has happened to
people taking INVOKANA®. Talk to your doctor right away
if you: 1) reduce the amount of food or liquid you drink, if you
are sick, or cannot eat or 2) you start to lose liquids from your
body from vomiting, diarrhea, or being in the sun too long
- A high amount of potassium in your blood
(hyperkalemia)
- Serious Urinary Tract Infections may lead to
hospitalization and have happened in people taking
INVOKANA®. Tell your doctor if you have signs or
symptoms of a urinary tract infection such as: burning feeling
while urinating, need to urinate often or right away, pain in the
lower part of your stomach (pelvis), or blood in the urine. Some
people may also have high fever, back pain, nausea, or
vomiting
- 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; 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 full Product Information, including
Boxed Warning, and Medication Guide for
INVOKANA®.
Janssen Pharmaceuticals, Inc. and its affiliates have rights to
canagliflozin through a license agreement with Mitsubishi Tanabe
Pharma Corporation, including in the
United States. Trademarks are those of their respective
owners.
About the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of Johnson & Johnson,
we are working to create a world without disease. Transforming
lives by finding new and better ways to prevent, intercept, treat
and cure disease inspires us. We bring together the best minds and
pursue the most promising science. We are Janssen. We collaborate
with the world for the health of everyone in it. Learn more
at www.janssen.com. Follow us on Twitter at @JanssenUS.
Janssen Pharmaceuticals, Inc. and Janssen Scientific Affairs, LLC
are part of the Janssen Pharmaceutical Companies of Johnson &
Johnson.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995
regarding the potential benefits and further 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
underlying assumptions prove inaccurate or known or unknown risks
or uncertainties materialize, actual results could vary materially
from the expectations and projections of Janssen Scientific
Affairs, LLC, any of the other Janssen Pharmaceutical Companies
and/or Johnson & Johnson. Risks and uncertainties include, but
are not limited to: challenges and uncertainties inherent in
product research and development, including the uncertainty of
clinical success and of obtaining regulatory approvals; uncertainty
of commercial success; manufacturing difficulties and delays;
competition, including technological advances, new products and
patents attained by competitors; challenges to patents; product
efficacy or safety concerns resulting in product recalls or
regulatory action; changes in behavior and spending patterns of
purchasers of health care products and services; changes to
applicable laws and regulations, including global health care
reforms; and trends toward health care cost containment. A further
list and descriptions of these risks, uncertainties and other
factors can be found in Johnson & Johnson's Annual Report on
Form 10-K for the fiscal year ended December
31, 2017, including in the sections captioned
"Cautionary Note Regarding Forward-Looking Statements" and "Item
1A. Risk Factors," and in the company's subsequent Quarterly
Reports on Form 10-Q, and other filings with the Securities and
Exchange Commission. Copies of these filings are available online
at www.sec.gov, www.jnj.com or
on request from Johnson & Johnson. None of the Janssen
Pharmaceutical Companies or Johnson & Johnson undertakes to
update any forward-looking statement as a result of new information
or future events or developments.
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SOURCE Janssen Pharmaceutical Companies