[AF] Consulta Dapagliflozina

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Renal Effects

    Dapagliflozin Propanediol
    Dysuria
    Increased frequency of urination
    Malignant tumor of urinary bladder
    Renal failure
    Renal impairment
    Urinary tract infectious disease
    Volume depletion, renal, due to output loss (renal deficit)
        Dysuria
            a) Incidence: 1.6% to 2.1% [1]
            b) Discomfort with urination was reported in 1.6% and 2.1% of
patients treated with dapagliflozin propanediol 5 mg (n=1145) and 10 mg
(n=1193), respectively, compared with 0.7% of patients who received placebo
(n=1393) in 12 clinical studies, including 4 studies as monotherapy and 8
studies as add-on to background antidiabetic therapy or as combination
therapy with metformin, of 12 to 24 weeks duration [1].
        Increased frequency of urination
            a) Incidence: 2.9% to 3.8% [1]
            b) Increased urination, including pollakiuria, polyuria, and
increased urine output, was reported in 2.9% and 3.8% of patients treated
with dapagliflozin propanediol 5 mg (n=1145) and 10 mg (n=1193),
respectively, compared with 1.7% of patients who received placebo (n=1393)
in 12 clinical studies, including 4 studies as monotherapy and 8 studies as
add-on to background antidiabetic therapy or as combination therapy with
metformin, of 12 to 24 weeks duration [1].
        Malignant tumor of urinary bladder
            a) Incidence: 0.17% [1]
            b) Newly diagnosed cases of bladder cancer were reported in
0.17% (10 of 6045) of patients treated with dapagliflozin propanediol
compared with 0.03% (1 of 3512) patients who received placebo or comparator
agent across 22 clinical studies. After excluding patients who were exposed
to study drug for less than 1 year at diagnosis of bladder cancer, 4 cases
remained in patients treated with dapagliflozin propanediol and no cases for
patients who received placebo or comparator. While bladder cancer risk
factors and hematuria were balanced between treatment arms at baseline, a
relationship between dapagliflozin propanediol therapy and the emergence of
bladder cancer has not been determined. Use of dapagliflozin propanediol is
not recommended in patients with active bladder cancer [1].
        Renal failure
            a) Summary
            1) Renal adverse reactions, including renal failure, increased
serum creatinine, and decreased estimated GFR, were reported in patients
treated with dapagliflozin propanediol. Elderly patients and patients with
pre-existing renal impairment were more susceptible to these events.
Monitoring of renal function prior to initiating dapagliflozin propanediol
and periodically thereafter is recommended. Therapy with dapagliflozin
propanediol should not be initiated in patients with moderate renal
impairment and should be discontinued in patients who persistently have an
estimated GFR of less than 60 mL/min/1.73 m(2) during treatment [1].
            b) At least one renal impairment-related adverse reactions,
including renal failure and increased blood creatinine, was reported in 1.8%
and 1.9% of patients treated with dapagliflozin propanediol 5 mg (n=767) and
10 mg (n=859), respectively, compared with 1.7% of patients who received
placebo (n=785) in 6 long-term extension studies of patients with type 2
diabetes for up to 104 weeks duration. In elderly patients (65 years of age
or older), renal impairment-related adverse reactions were reported in 3.1%
and 3.8% of elderly patients treated with dapagliflozin propanediol 5 mg
(n=162) and 10 mg (n=159), respectively, compared with 2.1% of elderly
patients who received placebo (n=190) in these studies. In patients with
pre-existing renal impairment (estimated GFR of 30 or greater and less than
60 mL/min/1.73 m(2)), renal impairment-related adverse reactions were
reported in 8% and 12% of renally impaired patients treated with
dapagliflozin propanediol 5 mg (n=88) and 10 mg (n=75), respectively,
compared with 6.5% of renally impaired patients who received placebo (n=77)
in these studies. Of the patients who were both elderly and had a history of
renal impairment, renal impairment-related adverse reactions were reported
in 7% and 11.4% of patients treated with dapagliflozin propanediol 5 mg
(n=43) and 10 mg (n=35), respectively, compared with 4.9% of patients who
received placebo (n=41) in these studies [1].
            c) At least one renal impairment-related adverse reactions,
including renal failure and increased blood creatinine, was reported in 6.7%
of patients treated with dapagliflozin propanediol 10 mg (n=2026) compared
with 4.2% of patients who received placebo (n=1956) in 9 long-term extension
studies of patients with type 2 diabetes for up to 104 weeks duration. In
elderly patients (65 years of age or older), renal impairment-related
adverse reactions were reported in 14% of elderly patients treated with
dapagliflozin propanediol 10 mg (n=620) compared with 7.9% of elderly
patients who received placebo (n=655) in these studies. In patients with
pre-existing renal impairment (estimated GFR of 30 or greater and less than
60 mL/min/1.73 m(2)), renal impairment-related adverse reactions were
reported in 28.3% of renally impaired patients treated with dapagliflozin
propanediol 10 mg (n=251) compared with 16.1% of renally impaired patients
who received placebo (n=249) in these studies. Of the patients who were both
elderly and had a history of renal impairment, renal impairment-related
adverse reactions were reported in 35.1% of patients treated with
dapagliflozin propanediol 10 mg (n=134) compared with 19.1% of patients who
received placebo (n=141) in these studies [1].
        Renal impairment
            a) Summary
            1) Renal adverse reactions, including renal failure, increased
serum creatinine, and decreased estimated GFR, were reported in patients
treated with dapagliflozin propanediol. Elderly patients and patients with
pre-existing renal impairment were more susceptible to these events.
Monitoring of renal function prior to initiating dapagliflozin propanediol
and periodically thereafter is recommended. Therapy with dapagliflozin
propanediol should not be initiated in patients with moderate renal
impairment and should be discontinued in patients who persistently have an
estimated GFR of less than 60 mL/min/1.73 m(2) during treatment [1].
            b) At least one renal impairment-related adverse reaction,
including renal failure and increased blood creatinine, was reported in 1.8%
and 1.9% of patients treated with dapagliflozin propanediol 5 mg (n=767) and
10 mg (n=859), respectively, compared with 1.7% of patients who received
placebo (n=785) in 6 long-term extension studies of patients with type 2
diabetes for up to 104 weeks duration. In elderly patients (65 years of age
or older), renal impairment-related adverse reactions were reported in 3.1%
and 3.8% of elderly patients treated with dapagliflozin propanediol 5 mg
(n=162) and 10 mg (n=159), respectively, compared with 2.1% of elderly
patients who received placebo (n=190) in these studies. In patients with
pre-existing renal impairment (estimated GFR of 30 or greater and less than
60 mL/min/1.73 m(2)), renal impairment-related adverse reactions were
reported in 8% and 12% of renally impaired patients treated with
dapagliflozin propanediol 5 mg (n=88) and 10 mg (n=75), respectively,
compared with 6.5% of renally impaired patients who received placebo (n=77)
in these studies. Of the patients who were both elderly and had a history of
renal impairment, renal impairment-related adverse reactions were reported
in 7% and 11.4% of patients treated with dapagliflozin propanediol 5 mg
(n=43) and 10 mg (n=35), respectively, compared with 4.9% of patients who
received placebo (n=41) in these studies [1].
            c) At least one renal impairment-related adverse reaction,
including renal failure and increased blood creatinine, was reported in 6.7%
of patients treated with dapagliflozin propanediol 10 mg (n=2026) compared
with 4.2% of patients who received placebo (n=1956) in 9 long-term extension
studies of patients with type 2 diabetes for up to 104 weeks duration. In
elderly patients (65 years of age or older), renal impairment-related
adverse reactions were reported in 14% of elderly patients treated with
dapagliflozin propanediol 10 mg (n=620) compared with 7.9% of elderly
patients who received placebo (n=655) in these studies. In patients with
pre-existing renal impairment (estimated GFR of 30 or greater and less than
60 mL/min/1.73 m(2)), renal impairment-related adverse reactions were
reported in 28.3% of renally impaired patients treated with dapagliflozin
propanediol 10 mg (n=251) compared with 16.1% of renally impaired patients
who received placebo (n=249) in these studies. Of the patients who were both
elderly and had a history of renal impairment, renal impairment-related
adverse reactions were reported in 35.1% of patients treated with
dapagliflozin propanediol 10 mg (n=134) compared with 19.1% of patients who
received placebo (n=141) in these studies [1].
        Urinary tract infectious disease
            a) Incidence: 4.3% to 5.7% [1]
            b) Urinary tract infections, including cystitis, Escherichia
urinary tract infection, genitourinary tract infection, pyelonephritis,
trigonitis, urethritis, kidney infection, and prostatitis were reported in
5.7% and 4.3% of patients treated with dapagliflozin propanediol 5 mg
(n=1145) and 10 mg (n=1193), respectively, compared with 3.7% of patients
who received placebo (n=1393) in 12 clinical studies, including 4 studies as
monotherapy and 8 studies as add-on to background antidiabetic therapy or as
combination therapy with metformin, of 12 to 24 weeks duration [1].
        Volume depletion, renal, due to output loss (renal deficit)
            a) Summary
            1) Adverse reactions related to volume depletion, dehydration,
hypovolemia, hypotension, or orthostatic hypotension, have been reported in
patients treated with dapagliflozin propanediol. Patients with renal
impairment, elderly patients, and patients taking loop diuretics have an
increased risk for these events. Assess and correct volume status in these
patients before starting dapagliflozin propanediol therapy. Monitor for
signs and symptoms of hypotension following treatment initiation [1]
            b) Volume depletion resulting in reported of dehydration,
hypovolemia, hypotension, or orthostatic hypotension was reported in 0.6%
and 0.8% of patients treated with dapagliflozin propanediol 5 mg (n=1145)
and 10 mg (n=1193), respectively, compared with 0.4% of patients who
received placebo (n=1393) in 12 clinical studies, including 4 studies as
monotherapy and 8 studies as add-on to background antidiabetic therapy or as
combination therapy with metformin, of 12 to 24 weeks duration. In patients
taking loop diuretics, adverse effects from volume depletion were reported
in 9.7% of patients treated with dapagliflozin 10 mg (n=31) compared with
1.8% of patients who received placebo (n=55). In elderly patients (65 years
of age or older), effects of volume depletion were reported in 0.5% and 1.5%
of elderly patients treated with dapagliflozin propanediol 5 mg (n=216) and
10 mg (n=204), respectively, compared with 0.4% of elderly patients who
received placebo (n=276) [1].
            c) Volume depletion resulting in reports of dehydration,
hypovolemia, hypotension, or orthostatic hypotension was reported in 1.1% of
patients treated with dapagliflozin propanediol 10 mg (n=2360) compared with
0.7% of patients who received placebo (n=2295) in pooled data from 13
clinical studies, including 3 studies as monotherapy, 9 studies as add-on to
background antidiabetic therapy, and 1 study as combination therapy with
metformin, for a mean of 22 weeks duration. In patients taking loop
diuretics, effects of volume depletion were reported in 2.5% of patients
treated with dapagliflozin 10 mg (n=236) compared with 1.5% of patients who
received placebo (n=267). In patients with moderate renal impairment
(estimated GFR of 30 or greater and less than 60 mL/min/1.73 m(2)), effects
of volume depletion were reported in 1.9% of renally impaired patients
treated with dapagliflozin propanediol 10 mg (n=265) compared with 1.5% of
renally impaired patients who received placebo (n=268). In elderly patients
(65 years of age or older), effects of volume depletion were reported in
1.7% of elderly patients treated with dapagliflozin propanediol 10 mg
(n=665) compared with 0.8% of elderly patients who received placebo (n=711)
in these studies [1].


Rosario Cáceres Fernández-Bolaños  

Centro de Información del Medicamento y Atención Farmacéutica

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