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E-mail: stschwar@gmail.com
www.schwartzdiabetesdoc.com
Diabetes, Cardio-Metabolic Newsletter
Farxiga (dapagliflozin)
1/13/2014
A new study in older men, has shown that those with testosterone levels in the mid-range had the lowest rates of death from any cause.This
FDA NEWS RELEASE Jan. 8, 2014
The U.S. Food and Drug Administration today approved Farxiga (dapagliflozin) tablets to improve glycemic control, [second
SGLT-2 inhibitor on US market], along with diet and exercise, in adults with type 2 diabetes. Type 2 diabetes affects about
24 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high
blood sugar levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney
damage.
Farxiga is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that blocks the reabsorption of glucose by the kidney,
increases glucose excretion, and lowers blood glucose levels. The drug’s safety and effectiveness were evaluated in 16
clinical trials involving more than 9,400 patients with type 2 diabetes.
The trials showed improvement in HbA1c (similar to cangliflozin). Farxiga has been studied as a stand-alone therapy and in
combination with other type 2 diabetes therapies including metformin, pioglitazone, glimepiride, sitagliptin, and insulin.
Farxiga should not be used to treat people with type 1 diabetes; those who have increased ketones in their blood or urine
(diabetic ketoacidosis); or those with moderate or severe renal impairment, end stage renal disease, or patients on dialysis.
[Similar to canagliflozin]
[Dapagliflozin=Cannot use if eGFR<60, just not effective; whereas canagliflozin can be efficatious down to eGFR= 45]
An increased number of bladder cancers were diagnosed among Farxiga users in clinical trials so Farxiga is not
recommended for patients with active bladder cancer. Patients with a history of bladder cancer should talk to their physician
before using Farxiga. [ not an issue with canagliflozin ]
Farxiga can cause dehydration, leading to a drop in blood pressure (hypotension) that can result in dizziness and/or fainting
and a decline in renal function. The elderly, patients with impaired renal function, and patients on diuretics to treat other
conditions appeared to be more susceptible to this risk. [just like cana- Recommend advising patients to drink ‘enough
fluids’ to keep urine dilute to obviate symptoms. Also, if initial BP low, can cut back on diuretic, ACE/ARB
proactively]
The FDA is requiring six post-marketing studies for Farxiga:
 a cardiovascular outcomes trial (CVOT) to evaluate the cardiovascular risk of Farxiga in patients with high baseline
risk of cardiovascular disease;
 a double-blind, randomized, controlled assessment of bladder cancer risk in patients enrolled in the CVOT;
 an animal study evaluating the role of Farxiga-induced urinary flow/rate and composition changes on bladder tumor
promotion in rodents;
 two clinical trials to assess the pharmacokinetics, efficacy, and safety in pediatric patients; and
 an enhanced pharmacovigilance program to monitor reports of liver abnormalities and pregnancy outcomes.
In clinical trials the most common side effects observed in patients treated with Farxiga were genital mycotic (fungal)
infections and urinary tract infections. [Obviate but pushing PO intake, fastitious bathroom habits- men= get head of
penis dry after urination; woman- wipe front-to back- get dry and urinate after intercourse before sleep]
[We have patients return in 2-4 weeks with K=, Cr, U/A and to make sure their BP fine, tolerating well.]