FORXIGA® is a highly selective SGLT2 inhibitor for type 2 diabetes mellitus, with 4-year safety and efficacy data, that removes glucose and its associated calories via the kidney.1
FORXIGA®: Safety and tolerability
Results from an extensive clinical trial programme1
Overview of safety and tolerability
Adverse reactions in placebo-controlled clinical studiesa and postmarketing experience
Pre-specified pooled analysis of 13 placebo-controlled studies with 2,360 patients on FORXIGA® 10 mg and 2,295 patients on placebo.1
‡Reactions related to volume depletion (including, reports of dehydration, hypovolaemia or hypotension) were reported in 1.1% and 0.7% of subjects who received FORXIGA® 10 mg and placebo, respectively; serious reactions occurred in <0.2% of subjects balanced between FORXIGA® 10 mg and placebo.1
a) The table shows up to 24-week (short-term) data regardless of glycaemic rescue.
b) See corresponding subsection below for additional information.
c) Vulvovaginitis, balanitis and related genital infections includes. e.g., the predefined preferred terms: vulvovaginal mycotic infection, vaginal infection, balanitis, genital infection fungal, vulvovaginal, candidiasis, vulvogainitis, balanitis, candida, genital candidiasis, genital infection, genital infection male, penile infection, vulvitis, vaginitis bacterial, vulval abscess.
d) Urinary tract infection includes the following referred terms, listed in order of frequency reported: urinary tract infection, cystitis. Escherichia urinary tract infection, genitourinary tract infection, pyelonephritis, trigonitis, urethritis, kidney infection and prostatitis.
e) Volume depletion includes e.g. the predefined preferred terms: dehydration, hypovolaemia, hypotension.
f) Polyuria includes the preferred terms: pollakiuria, polyuria, urine output increased.
g) Mean changes from baseline in haematocrit were 2.30% for FORXIGA®, 10 mg versus -0.33% for placebo. Haematocrit values >55% were reported in 1.3% of the subjects created with FORXIGA® 10 mg vs 0.4% of placebo subjects.
h) Mean percent changes from baseline for dapagliflozin 10mg versus placebo, respectively was: total cholesterol 2,5% versus 0.0%; HDL cholesterol 6.0% versus 2.7%; LDL cholesterol 2.9% versus -1.0%; triglycerides 2.7% versus -0.7%.
j) Adverse reaction was identified through postmarketing surveillance. Rash includes the following preferred terms, listed in order of frequency in clinical trials: rash, rash generalised, rash pruritic, rash macular, rash maculo-papular, rash pustular, rash vesicular, and rash erythematous. In active- and placebo-controlled clinical trials (dapagliflozin, N=5936, All control, N=3403), the frequency of rash was similar for dapagliflozin (1.4%) and all control (1.4%), respectively.
*Reported in ≥2% of subjects and ≥1% more and at least 3 more subjects treated with FORXIGA® 10 mg compared to placebo.
**Reported by the investigator as possibly related, probably related or related to study treatment and reported in ≥0.2% of subjects and ≥0.1% more and at least 3 more subjects treated with FORXIGA® 10 mg compared to placebo.
Urinary tract infections (UTIs) and genital infections (GIs)
Type 2 diabetes is associated with an increased incidence/prevalence of Gls and UTIs.37-41
FORXIGA® works by eliminating glucose through the kidneys and is therefore associated with a higher incidence of Gls and UTls compared to placebo.1* Where they occurred, most Gls and UTls were mild to moderate, rarely led to discontinuation and generally responded with a single course of standard treatment.1
FORXIGA® 10 mg: percentage of UTIs and GIs vs. placebo
Renal function remained stable (estimated by eGFR) with FORXIGA® up to 2 years versus placebo.41†
FORXIGA® is not recommended for use in patients with moderate to severe renal impairment (patients with creatinine clearance [CrCI] < 60 ml/min or estimated glomerular filtration rate [eGFR] < 60 ml/min/ 1.73m2).1
* Genital infections includes, e.g. the predefined preferred terms: vulvovaginal mycotic infection, vaginal infection, balanitis, genital infection fungal, vulvovaginal candidiasis, vulvovaginitis, balanitis candida, genital candidiasis, genital infection, genital infection male, penile infection, vulvitis, vaginitis bacterial, vulval abscess.1
† Small initial decrease in mean baseline eGFR by week 1, followed by a gradual return to baseline.41