Dapagliflozin is a medication used to treat type 2 diabetes. It is also used to treat adults with heart failure and chronic kidney disease.
RS -32.00 FOR Dapagliflozine 10mg tab (for 10 tab)
RS - 25 FOR Dapagliflozin 5 mg tab. (for 10 tab)
AVAILABLE AT JAN AUSHADHI KOTTIYAM, JAN AUSHADHI
KALLUMTHAZHAM, JAN AUSHADHI KANNANALLOOR,
JAN AUSHADHI MAYYANADU
Dapagliflozin is used along with diet, exercise and usually with other glucose lowering medications, to improve glycaemic control in adults with type 2 diabetes and to reduce the risk of hospitalisation for heart failure among adults with type 2 diabetes and known cardiovascular disease or other cardiovascular risk factors (including high blood pressure, high cholesterol and smokers). Dapagliflozin was also shown to reduce the rate of decline in kidney function and kidney failure in adults with type 2 diabetes, a finding that has recently been confirmed in both diabetic and non-diabetic populations. Dapagliflozin is also an important treatment option in patients with comorbid type 2 diabetes and heart failure with a reduced ejection fraction (on top of standard medical and/or device therapy), and lowers the risk of hospitalisation for heart failure and cardiovascular deaths in this group (as well as non-diabetic patients with HFrEF). All SGLT-2 inhibitors are useful to reduce the risk of hospitalisation for heart failure in people with atherosclerotic cardiovascular disease, however a small number of meta-analyses and cohort studies have shown that dapagliflozin is superior to others such as empagliflozin.
In addition,
dapagliflozin is indicated for the treatment of adults with heart failure with
reduced ejection fraction to reduce the risk of cardiovascular death and
hospitalization for heart failure. It is also indicated to reduce the risk of
kidney function decline, kidney failure, cardiovascular death and hospitalization
for heart failure in adults with chronic kidney disease who are at risk of
disease progression.
Mechanism
of action
Dapagliflozin
inhibits subtype 2 of the sodium-glucose transport proteins which are responsible for at least 90% of the
glucose reabsorption in the kidney. Blocking this transporter mechanism causes
blood glucose to be eliminated through the urine. In combination with
metformin, dapagliflozin at standard treatment dose of 10 mg daily lowered
HbA1c by 0.54-0.84 percentage points when compared to metformin monotherapy in
patients with inadequately controlled type 2 diabetes and normal renal
function.
Regarding
its protective effects in heart failure, this is attributed primarily to
haemodynamic effects, where SGLT2 inhibitors potently reduce intravascular
volume through osmotic diuresis and natriuresis. This consequently may lead to
a reduction in preload and afterload, thereby alleviating cardiac workload and
improving left ventricular function.
History
In 2012, the
Committee for Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) issued a positive opinion on the drug.
In two
studies involving 840 participants with type 2 diabetes, dapagliflozin when
used alone decreased HbA1c levels by 0.66 percentage points more than placebo
(a dummy treatment) after 24 weeks. In four other studies involving 2,370
participants, adding dapagliflozin to other diabetes medicines decreased HbA1c
levels by 0.54–0.68 percentage points more than adding placebo after 24 weeks.
In a study
involving 814 participants with type 2 diabetes, dapagliflozin used in
combination with metformin was at least as effective as a sulphonylurea
(another type of diabetes medicines) used with metformin. Both combinations
reduced HbA1c levels by 0.52 percentage points after 52 weeks.
A long-term
study, involving over 17,000 participants with type 2 diabetes, looked at the
effects of dapagliflozin on cardiovascular (heart and circulation) disease. The
study indicated that dapagliflozin's effects were in line with those of other
diabetes medicines that also work by blocking SGLT2
In two
studies involving 1,648 participants with type 1 diabetes whose blood sugar was
not controlled well enough on insulin alone, adding dapagliflozin 5 mg
decreased HbA1c levels after 24 hours by 0.37% and by 0.42% more than adding
placebo.
Dapagliflozin
was approved for medical use in the European Union in November 2012. It is
marketed in a number of European countries.
Adverse
effects
Since
dapagliflozin leads to heavy glycosuria (sometimes up to about 70 grams per
day) it can lead to rapid weight loss and tiredness. The glucose acts as an
osmotic diuretic (this effect is the cause of polyuria in diabetes) which can
lead to dehydration. The increased amount of glucose in the urine can also
worsen the infections already associated with diabetes, particularly urinary
tract infections and thrush (candidiasis). Rarely, use of an SGLT2 drug,
including dapagliflozin, is associated with necrotizing fasciitis of the
perineum, also called Fournier gangrene.
Absorption
Oral
dapagliflozin reaches a maximum concentration within 1 hour of administration
when patients have been fasting.
DRUG
INTERACTIONS
Abacavir - Dapagliflozin
may increase the excretion rate of Abacavir which could result in a lower serum
level and potentially a reduction in efficacy.
Abametapir - The
serum concentration of Dapagliflozin can be increased when it is combined with
Abametapir.
Abatacept - The
metabolism of Dapagliflozin can be increased when combined with Abatacept.
Abiraterone The
serum concentration of Dapagliflozin can be increased when it is combined with
Abiraterone.
Abrocitinib The
metabolism of Abrocitinib can be decreased when combined with Dapagliflozin.
Acarbose Dapagliflozin
may increase the hypoglycemic activities of Acarbose.
Acebutolol The
therapeutic efficacy of Dapagliflozin can be increased when used in combination
with Acebutolol.
Aceclofenac Dapagliflozin
may increase the excretion rate of Aceclofenac which could result in a lower
serum level and potentially a reduction in efficacy.
Acemetacin The
therapeutic efficacy of Dapagliflozin can be decreased when used in combination
with Acemetacin.
Acenocoumarol The
metabolism of Acenocoumarol can be decreased when combined with Dapagliflozin.
Food
Interactions
Avoid
excessive or chronic alcohol consumption. Binge drinking or drinking alcohol
often may predispose patients to ketoacidosis.
Take with or
without food.
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