Matching articles for "Forxiga"
In Brief: Empagliflozin (Jardiance) for Chronic Kidney Disease
The Medical Letter on Drugs and Therapeutics • November 13, 2023; (Issue 1689)
The sodium-glucose cotransporter 2 (SGLT2) inhibitor
empagliflozin (Jardiance – Boehringer Ingelheim/Lilly) is now FDA-approved to reduce the risk of
sustained eGFR decline, end-stage kidney...
The sodium-glucose cotransporter 2 (SGLT2) inhibitor
empagliflozin (Jardiance – Boehringer Ingelheim/Lilly) is now FDA-approved to reduce the risk of
sustained eGFR decline, end-stage kidney disease,
cardiovascular death, and hospitalization in adults with
chronic kidney disease (CKD) at risk of progression.
It is also approved to improve glycemic control in
patients ≥10 years old with type 2 diabetes, to reduce
the risk of cardiovascular death and hospitalization
for heart failure (HF) in adults with HF, and to reduce
the risk of cardiovascular death in adults with type 2
diabetes and established cardiovascular disease.
Bexagliflozin (Brenzavvy) — A Fifth SGLT2 Inhibitor for Type 2 Diabetes
The Medical Letter on Drugs and Therapeutics • August 21, 2023; (Issue 1683)
Bexagliflozin (Brenzavvy – TheracosBio), a sodium-glucose
cotransporter 2 (SGLT2) inhibitor, has been
approved by the FDA to improve glycemic control
in adults with type 2 diabetes. It is the fifth...
Bexagliflozin (Brenzavvy – TheracosBio), a sodium-glucose
cotransporter 2 (SGLT2) inhibitor, has been
approved by the FDA to improve glycemic control
in adults with type 2 diabetes. It is the fifth SGLT2
inhibitor to be approved in the US for this indication
(see Table 4).
Sotagliflozin (Inpefa) for Heart Failure
The Medical Letter on Drugs and Therapeutics • July 24, 2023; (Issue 1681)
The FDA has approved sotagliflozin (Inpefa –
Lexicon), an oral sodium-glucose cotransporter
1 and 2 (SGLT1/2) inhibitor, to reduce the risk of
hospitalization for heart failure (HF), urgent HF visits,
and...
The FDA has approved sotagliflozin (Inpefa –
Lexicon), an oral sodium-glucose cotransporter
1 and 2 (SGLT1/2) inhibitor, to reduce the risk of
hospitalization for heart failure (HF), urgent HF visits,
and cardiovascular death in adults with either HF
(with any left ventricular ejection fraction [LVEF]) or
type 2 diabetes, chronic kidney disease (CKD), and
other cardiovascular risk factors. Sotagliflozin is
the first dual SGLT1/2 inhibitor to be approved in the
US. Unlike SGLT2 inhibitors, it is not FDA-approved
to improve glycemic control in adults with type 2
diabetes. Sotagliflozin is approved in the European
Union as Zynquista for adjunctive treatment of type
1 diabetes.
In Brief: Expanded Heart Failure Indication for Dapagliflozin (Farxiga)
The Medical Letter on Drugs and Therapeutics • June 26, 2023; (Issue 1679)
The sodium-glucose cotransporter 2 (SGLT2)
inhibitor dapagliflozin (Farxiga – AstraZeneca) was
approved by the FDA in 2020 to reduce the risk of
cardiovascular death and hospitalization for heart
failure...
The sodium-glucose cotransporter 2 (SGLT2)
inhibitor dapagliflozin (Farxiga – AstraZeneca) was
approved by the FDA in 2020 to reduce the risk of
cardiovascular death and hospitalization for heart
failure (HF) in adults with heart failure with reduced
ejection fraction (HFrEF). The indication has now
been expanded to include a reduction in the risk
of urgent HF visits and use in adults with any left
ventricular ejection fraction (LVEF).
Drugs for Type 2 Diabetes
The Medical Letter on Drugs and Therapeutics • November 14, 2022; (Issue 1663)
Diet, exercise, and weight loss can improve glycemic
control, but almost all patients with type 2 diabetes
require antihyperglycemic drug therapy. Treating to
a target A1C of...
Diet, exercise, and weight loss can improve glycemic
control, but almost all patients with type 2 diabetes
require antihyperglycemic drug therapy. Treating to
a target A1C of <7% while minimizing hypoglycemia
is recommended to prevent microvascular complications
of diabetes (retinopathy, nephropathy, and
neuropathy). An A1C target of <8% may be appropriate
for some older patients.
In Brief: Expanded Heart Failure Indication for Empagliflozin (Jardiance)
The Medical Letter on Drugs and Therapeutics • April 18, 2022; (Issue 1648)
The sodium-glucose cotransporter 2 (SGLT2) inhibitor
empagliflozin (Jardiance – Boehringer Ingelheim)
was approved by the FDA in 2021 to reduce the
risk of hospitalization for heart failure (HF)...
The sodium-glucose cotransporter 2 (SGLT2) inhibitor
empagliflozin (Jardiance – Boehringer Ingelheim)
was approved by the FDA in 2021 to reduce the
risk of hospitalization for heart failure (HF) and
cardiovascular death in patients with heart failure
with reduced ejection fraction (HFrEF; LVEF ≤40%),
regardless of whether or not they have type 2
diabetes. The indication has now been expanded to
include patients with HF with any ejection fraction.
Empagliflozin is the first SGLT2 inhibitor to be
approved in the US for this indication.
Rivaroxaban (Xarelto) - A New Peripheral Artery Disease Indication
The Medical Letter on Drugs and Therapeutics • November 1, 2021; (Issue 1636)
The FDA has approved an expansion of the
peripheral artery disease (PAD) indication for the
oral direct factor Xa inhibitor rivaroxaban (Xarelto – Janssen) to include patients who have recently
undergone a...
The FDA has approved an expansion of the
peripheral artery disease (PAD) indication for the
oral direct factor Xa inhibitor rivaroxaban (Xarelto – Janssen) to include patients who have recently
undergone a lower extremity revascularization
procedure for symptomatic PAD (see Table 1).
Rivaroxaban is the first direct oral anticoagulant
(DOAC) to be approved for use in patients with PAD.
In Brief: Dapagliflozin (Farxiga) for Chronic Kidney Disease
The Medical Letter on Drugs and Therapeutics • July 26, 2021; (Issue 1629)
The sodium-glucose cotransporter 2 (SGLT2) inhibitor
dapagliflozin (Farxiga – AstraZeneca) has been
approved by the FDA for treatment of adults with
chronic kidney disease (CKD) at risk of...
The sodium-glucose cotransporter 2 (SGLT2) inhibitor
dapagliflozin (Farxiga – AstraZeneca) has been
approved by the FDA for treatment of adults with
chronic kidney disease (CKD) at risk of progression
(not defined in the label). Dapagliflozin is the first
SGLT2 inhibitor to be approved in the US for treatment
of CKD.
Drugs for Chronic Heart Failure
The Medical Letter on Drugs and Therapeutics • June 14, 2021; (Issue 1626)
Among patients with chronic heart failure, those with
a left ventricular ejection fraction (LVEF) ≤40% are
considered to have heart failure with reduced ejection
fraction (HFrEF). Patients with a LVEF...
Among patients with chronic heart failure, those with
a left ventricular ejection fraction (LVEF) ≤40% are
considered to have heart failure with reduced ejection
fraction (HFrEF). Patients with a LVEF ≥50% are
considered to have heart failure with preserved ejection
fraction (HFpEF). Those with a LVEF of 41-49% are an
intermediate group more similar to patients with HFpEF.
Empagliflozin (Jardiance) for Heart Failure
The Medical Letter on Drugs and Therapeutics • November 16, 2020; (Issue 1611)
In a randomized, placebo-controlled trial, the
sodium-glucose cotransporter 2 (SGLT2) inhibitor
empagliflozin (Jardiance – Boehringer Ingelheim/Lilly)
reduced the composite risk of cardiovascular death
or...
In a randomized, placebo-controlled trial, the
sodium-glucose cotransporter 2 (SGLT2) inhibitor
empagliflozin (Jardiance – Boehringer Ingelheim/Lilly)
reduced the composite risk of cardiovascular death
or hospitalization for worsening heart failure (HF)
in patients with heart failure with reduced ejection
fraction (HFrEF), whether or not they had type 2
diabetes. To date, empagliflozin has not been
approved by the FDA for such use. The SGLT2 inhibitor
dapagliflozin (Farxiga) was approved by the FDA for
this indication earlier this year.
Comparison Chart: SGLT2 Inhibitors (online only)
The Medical Letter on Drugs and Therapeutics • November 16, 2020; (Issue 1611)
...
View the Comparison Chart: SGLT2 Inhibitors
In Brief: Canagliflozin and Lower Limb Amputations
The Medical Letter on Drugs and Therapeutics • September 21, 2020; (Issue 1607)
The FDA has removed a boxed warning from the labeling
of products containing the sodium-glucose co-transporter
2 (SGLT2) inhibitor canagliflozin (Invokana, Invokamet,
Invokamet XR) that described an...
The FDA has removed a boxed warning from the labeling
of products containing the sodium-glucose co-transporter
2 (SGLT2) inhibitor canagliflozin (Invokana, Invokamet,
Invokamet XR) that described an increased risk of lower
limb amputation associated with use of the drug. Package
inserts for canagliflozin products still contain a standard
warning about a risk of lower limb amputation.
Dapagliflozin (Farxiga) - A New Indication for Heart Failure
The Medical Letter on Drugs and Therapeutics • June 29, 2020; (Issue 1601)
The sodium-glucose cotransporter 2 (SGLT2)
inhibitor dapagliflozin (Farxiga), which was
initially approved by the FDA for treatment of
type 2 diabetes and then to reduce the risk of hospitalization for HF in...
The sodium-glucose cotransporter 2 (SGLT2)
inhibitor dapagliflozin (Farxiga), which was
initially approved by the FDA for treatment of
type 2 diabetes and then to reduce the risk of hospitalization for HF in adults who have type 2 diabetes and established cardiovascular disease
(CVD) or multiple cardiovascular risk factors, has
now been approved for a third indication: to reduce
the risk of cardiovascular death and hospitalization
for heart failure (HF) in patients with heart failure
with reduced ejection fraction (with or without
type 2 diabetes). It is the first SGLT2 inhibitor to be
approved in the US for this indication.
Drugs for Type 2 Diabetes
The Medical Letter on Drugs and Therapeutics • November 4, 2019; (Issue 1584)
Diet, exercise, and weight loss can improve glycemic
control, but almost all patients with type 2 diabetes
eventually require drug therapy. Treating to a glycated
hemoglobin (A1C) concentration of...
Diet, exercise, and weight loss can improve glycemic
control, but almost all patients with type 2 diabetes
eventually require drug therapy. Treating to a glycated
hemoglobin (A1C) concentration of <7% can prevent
microvascular complications (retinopathy, nephropathy,
and neuropathy), but whether it prevents macrovascular
complications and death is unclear. An A1C target of
<8% may be appropriate for older patients and those
with underlying cardiovascular disease (CVD), a history
of severe hypoglycemia, diabetes-related complications,
a limited life expectancy, or a long duration of disease.
Cardiovascular Benefits of SGLT2 Inhibitors and GLP-1 Receptor Agonists in Type 2 Diabetes
The Medical Letter on Drugs and Therapeutics • February 25, 2019; (Issue 1566)
Since 2008, because of safety concerns, the FDA has
mandated that long-term cardiovascular outcomes trials
be conducted for all new drugs for type 2 diabetes.
Reductions in the incidence of macrovascular...
Since 2008, because of safety concerns, the FDA has
mandated that long-term cardiovascular outcomes trials
be conducted for all new drugs for type 2 diabetes.
Reductions in the incidence of macrovascular complications
in these trials with some sodium-glucose
co-transporter 2 (SGLT2) inhibitors and glucagon-like
peptide 1 (GLP-1) receptor agonists in patients at risk
for cardiovascular disease (see Table 1) have led to
new recommendations.
Ertugliflozin for Type 2 Diabetes
The Medical Letter on Drugs and Therapeutics • April 23, 2018; (Issue 1545)
The FDA has approved the sodium-glucose co-transporter
2 (SGLT2) inhibitor ertugliflozin (Merck)
for treatment of adults with type 2 diabetes, both
alone (Steglatro) and in fixed-dose combinations
with...
The FDA has approved the sodium-glucose co-transporter
2 (SGLT2) inhibitor ertugliflozin (Merck)
for treatment of adults with type 2 diabetes, both
alone (Steglatro) and in fixed-dose combinations
with metformin (Segluromet) and sitagliptin
(Steglujan). Ertugliflozin is the fourth SGLT2 inhibitor
to be approved in the US. All four are available in
combination with metformin and three are available
in combination with a dipeptidyl peptidase-4 (DPP-4)
inhibitor (see Table 3).
Dapagliflozin/Saxagliptin (Qtern) for Type 2 Diabetes
The Medical Letter on Drugs and Therapeutics • March 26, 2018; (Issue 1543)
The FDA has approved Qtern (AstraZeneca), a
fixed-dose combination of the sodium-glucose
co-transporter 2 (SGLT2) inhibitor dapagliflozin
(Farxiga) and the dipeptidyl peptidase-4 (DPP-4)
inhibitor...
The FDA has approved Qtern (AstraZeneca), a
fixed-dose combination of the sodium-glucose
co-transporter 2 (SGLT2) inhibitor dapagliflozin
(Farxiga) and the dipeptidyl peptidase-4 (DPP-4)
inhibitor saxagliptin (Onglyza), for oral treatment
of adults with type 2 diabetes. Dapagliflozin and
saxagliptin have each been available for years alone
and in combination with extended-release metformin
(Xigduo XR; Kombiglyze XR). Three SGLT2/DPP-4
inhibitor combinations are now available in the US
(see Table 2).
Cardiovascular Effects of Some Antidiabetic Drugs
The Medical Letter on Drugs and Therapeutics • August 14, 2017; (Issue 1527)
For many years, the goal of drug therapy for most
patients with type 2 diabetes has been to achieve
and maintain an A1C of...
For many years, the goal of drug therapy for most
patients with type 2 diabetes has been to achieve
and maintain an A1C of <7%. Achieving that goal
can prevent microvascular complications (diabetic
retinopathy, nephropathy, neuropathy), but whether it
prevents macrovascular complications (myocardial
infarction [MI], stroke) has been less clear. The FDA
now requires that cardiovascular safety studies be
performed for all new drugs for type 2 diabetes.1
Recent findings that some of the newer second-line
drugs for type 2 diabetes have cardiovascular benefits
have led to new interest in the cardiovascular efficacy
and safety of all antidiabetic drugs.
Drugs for Type 2 Diabetes
The Medical Letter on Drugs and Therapeutics • January 16, 2017; (Issue 1512)
The goal of drug therapy for type 2 diabetes is
to achieve and maintain a near-normal glycated
hemoglobin (A1C) concentration without inducing
hypoglycemia; the target is generally an A1C of
≤7%. Treating...
The goal of drug therapy for type 2 diabetes is
to achieve and maintain a near-normal glycated
hemoglobin (A1C) concentration without inducing
hypoglycemia; the target is generally an A1C of
≤7%. Treating to this target has been shown to
prevent microvascular complications (retinopathy,
nephropathy, and neuropathy), but whether it prevents
macrovascular outcomes is unclear. An A1C target of
<8% may be appropriate for older patients and those
with underlying cardiovascular disease, a history of
severe hypoglycemia, diabetes-related complications
or comorbidities, or a long duration of disease.
SGLT2 Inhibitors and Renal Function
The Medical Letter on Drugs and Therapeutics • July 18, 2016; (Issue 1499)
At the same time that the FDA announced it was
strengthening existing warnings about the risk of acute
kidney injury in patients with type 2 diabetes treated with
the sodium-glucose co-transporter 2 (SGLT2)...
At the same time that the FDA announced it was
strengthening existing warnings about the risk of acute
kidney injury in patients with type 2 diabetes treated with
the sodium-glucose co-transporter 2 (SGLT2) inhibitors
canagliflozin (Invokana, and others) and dapagliflozin
(Farxiga, and others), a study was published showing
that the third SGLT2 inhibitor, empagliflozin (Jardiance,
and others), slowed the progression of renal dysfunction
in patients with type 2 diabetes.
Empagliflozin/Metformin (Synjardy) for Type 2 Diabetes
The Medical Letter on Drugs and Therapeutics • December 21, 2015; (Issue 1484)
The FDA has approved Synjardy (Boehringer Ingelheim/Lilly), a fixed-dose combination of the sodium-glucose
co-transporter 2 (SGLT2) inhibitor empagliflozin
(Jardiance) and metformin (Glucophage, and...
The FDA has approved Synjardy (Boehringer Ingelheim/Lilly), a fixed-dose combination of the sodium-glucose
co-transporter 2 (SGLT2) inhibitor empagliflozin
(Jardiance) and metformin (Glucophage, and others),
for treatment of patients with type 2 diabetes not
adequately controlled on either of these drugs alone
or already being treated with both empagliflozin and
metformin. It is the third SGLT2 inhibitor/metformin
combination to be approved in the US.
SGLT2 Inhibitors: New Reports
The Medical Letter on Drugs and Therapeutics • October 12, 2015; (Issue 1479)
The recent report of a reduction in cardiovascular
mortality in patients with type 2 diabetes treated with
the SGLT2 inhibitor empagliflozin (Jardiance) was
published soon after the FDA issued new...
The recent report of a reduction in cardiovascular
mortality in patients with type 2 diabetes treated with
the SGLT2 inhibitor empagliflozin (Jardiance) was
published soon after the FDA issued new warnings
about an increased risk of fractures with canagliflozin
(Invokana).
In Brief: Ketoacidosis with SGLT2 Inhibitors
The Medical Letter on Drugs and Therapeutics • June 22, 2015; (Issue 1471)
The FDA has warned that use of an SGLT2 (sodium-glucose co-transporter 2) inhibitor for treatment of type 2 diabetes may lead to ketoacidosis.1 Three SGLT2 inhibitors, canagliflozin (Invokana, Invokamet),...
The FDA has warned that use of an SGLT2 (sodium-glucose co-transporter 2) inhibitor for treatment of type 2 diabetes may lead to ketoacidosis.1 Three SGLT2 inhibitors, canagliflozin (Invokana, Invokamet), dapagliflozin (Farxiga, Xigduo XR), and empagliflozin (Jardiance, Glyxambi), are approved for treatment of type 2 diabetes in the US. Between March 2013 and June 2014, 20 cases of ketoacidosis requiring emergency room visits or hospitalization were reported in patients who had recently started taking an SGLT2 inhibitor; the median time to onset of symptoms after initiation of therapy was 2 weeks (range 1-175 days). SGLT2 inhibitors decrease renal glucose reabsorption and increase urinary glucose excretion, resulting in a reduction in blood glucose levels. The mechanism by which these drugs could cause ketoacidosis has not been established.
Diabetic ketoacidosis (DKA) occurs primarily in patients with type 1 diabetes; it is characterized by elevated blood glucose levels (usually ≥250 mg/dL), a high anion gap, glucosuria, and ketonuria.2 Unlike typical cases of DKA, most ketoacidosis cases associated with SGLT2 inhibitors have occurred in patients with type 2 diabetes, and in some patients glucose levels were <200 mg/dL. Only half of the 20 cases were associated with a recognizable DKA-precipitating factor, such as infection, reduced caloric intake, or reduced insulin dose. Other factors that may contribute to the development of high anion gap metabolic acidosis, such as hypovolemia, hypoxemia, reduced oral intake, acute renal impairment, and a history of alcohol use, were identified in some patients.1
Download complete U.S. English article
Diabetic ketoacidosis (DKA) occurs primarily in patients with type 1 diabetes; it is characterized by elevated blood glucose levels (usually ≥250 mg/dL), a high anion gap, glucosuria, and ketonuria.2 Unlike typical cases of DKA, most ketoacidosis cases associated with SGLT2 inhibitors have occurred in patients with type 2 diabetes, and in some patients glucose levels were <200 mg/dL. Only half of the 20 cases were associated with a recognizable DKA-precipitating factor, such as infection, reduced caloric intake, or reduced insulin dose. Other factors that may contribute to the development of high anion gap metabolic acidosis, such as hypovolemia, hypoxemia, reduced oral intake, acute renal impairment, and a history of alcohol use, were identified in some patients.1
- FDA drug safety communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood. Available at: www.fda.gov. Accessed June 11, 2015.
- AE Kitabchi et al. Hyperglycemic crises in adult patients with diabetes. Diabetes Care 2009; 32:1335.
Download complete U.S. English article
Diet, Drugs, and Surgery for Weight Loss
The Medical Letter on Drugs and Therapeutics • February 16, 2015; (Issue 1462)
Adults with a body mass index (BMI) between
25 and 29.9 kg/m2 are considered overweight. Those
with a BMI ≥30 are considered obese. Losing even
a small amount of weight and increasing physical
activity...
Adults with a body mass index (BMI) between
25 and 29.9 kg/m2 are considered overweight. Those
with a BMI ≥30 are considered obese. Losing even
a small amount of weight and increasing physical
activity can prevent some of the complications
of obesity, particularly type 2 diabetes. Diet and
exercise are the preferred methods for losing weight,
but long-term failure rates are high. Several drugs
have been approved by the FDA for weight reduction,
but adherence is poor, adverse effects are common,
and patients usually regain the lost weight when
the drug is stopped. Bariatric surgery can produce
substantial weight loss and significantly reduce
obesity-related comorbidities; long-term data on its
safety are encouraging, but still limited. Guidelines
for the management of overweight or obese adults
have recently been published.
Canagliflozin (Invokana) for Type 2 Diabetes
The Medical Letter on Drugs and Therapeutics • May 13, 2013; (Issue 1416)
Canagliflozin (kan" a gli floe' zin; Invokana – Janssen),
a sodium-glucose co-transporter 2 (SGLT2) inhibitor,
has been approved by the FDA for oral treatment of
type 2...
Canagliflozin (kan" a gli floe' zin; Invokana – Janssen),
a sodium-glucose co-transporter 2 (SGLT2) inhibitor,
has been approved by the FDA for oral treatment of
type 2 diabetes.