Vulvovaginitis and balanitis in patients with diabetes treated with dapagliflozin

Johnsson, Kristina; Ptaszynska, Agata; Schmitz, Bridget; Sugg, Jennifer; Parikh, Shamik; List, James F.

doi:10.1016/j.jdiacomp.2013.04.012

Cited by 191 publications

(152 citation statements)

References 19 publications

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“…Several prior studies have demonstrated higher incidences of genital infections in women [24,25]. It has been proposed that women with diabetes are at greater risk of genital infection owing to higher glucose levels in the vulvovaginal tissues than occurs in nondiabetic women [26].…”

Section: Risk Factors For Adrsmentioning

confidence: 99%

Real-world evidence for the safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (STELLA-ELDER): final results of a post-marketing surveillance study

Yokote

Terauchi

Nakamura

et al. 2016

Expert Opinion on Pharmacotherapy

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Objective: To investigate the real-world safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (T2DM). Research design and methods: Japanese patients (≥65 years old) who were first prescribed ipragliflozin within 3 months after its launch in April 2014 were registered in this post-marketing surveillance (PMS). Final data collection was in July 2015. Survey items included demographics, treatments, adverse drug reactions (ADRs), vital signs, and laboratory variables. Results: The PMS included 8505 patients (4181 males/4324 females). The mean age and diabetes duration were 72.3 years and 10.6 years, respectively. In 84.3% of patients, ipragliflozin was prescribed at 50 mg/day, which was continued unchanged. Overall, 16.91% of patients experienced 1880 ADRs, and 165 ADRs were classified as serious in 127 patients (1.49%). ADRs of special interest included skin complications, volume depletion, polyuria/pollakiuria, genital infection, urinary tract infection, renal disorders, hypoglycemia, cerebrovascular disease, cardiovascular disease, malignant tumor, fracture, and ketone body-related events. Conclusions: This 1-year PMS revealed probable ADRs in elderly Japanese patients with T2DM prescribed ipragliflozin in real-world settings, with no new safety concerns. The risk factors for ADRs varied but could be rationalized. The results should help physicians to identify possible treatment-emergent ADRs in ipragliflozin-treated patients.ARTICLE HISTORY

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Section: Risk Factors For Adrsmentioning

confidence: 99%

Real-world evidence for the safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (STELLA-ELDER): final results of a post-marketing surveillance study

Yokote

Terauchi

Nakamura

et al. 2016

Expert Opinion on Pharmacotherapy

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show abstract

“…All events were mild and clinically manageable, suggesting that luseogliflozin is generally well tolerated from the perspective of urinary tract and genital infections. On the other hand, studies on dapagliflozin demonstrated a higher incidence of urinary tract and genital infections in female patients and in patients with a history of such infections [15,16]. Considering the low percentage of female patients (28.8%), exclusion of patients with urinary tract and genital infections, the limited number of patients with a history of these infections in this study, and the difference of methods to detect these infections from that of dapagliflozin, further investigation is needed.…”

Section: Discussionmentioning

confidence: 81%

Fifty-two-week long-term clinical study of luseogliflozin as monotherapy in Japanese patients with type 2 diabetes mellitus inadequately controlled with diet and exercise

et al. 2015

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“…Both drugs are associated with a low rate of hypoglycemia (9,10), and dapagliflozin, owing to its ability to increase the renal excretion of glucose (calorie loss), produces reductions in body weight (30) and an increase in genital and urinary tract infections (31,32). In the current study, the incidence of genital and urinary tract infections was low in the triple-therapy group.…”

Section: Discussionmentioning

confidence: 99%

Dual Add-on Therapy in Type 2 Diabetes Poorly Controlled With Metformin Monotherapy: A Randomized Double-Blind Trial of Saxagliptin Plus Dapagliflozin Addition Versus Single Addition of Saxagliptin or Dapagliflozin to Metformin

et al. 2014

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OBJECTIVEThis study compared the efficacy and safety of dual add-on of saxagliptin plus dapagliflozin versus saxagliptin and dapagliflozin added on alone in patients with type 2 diabetes poorly controlled with metformin. RESEARCH DESIGN AND METHODSThis was a double-blind trial in adults with HbA 1c ‡8.0% and £12.0% (64-108 mmol/mol), randomized to saxagliptin (SAXA) (5 mg/day) plus dapagliflozin (DAPA) (10 mg/day; n = 179), or SAXA (5 mg/day) and placebo (n = 176), or DAPA (10 mg/day) and placebo (n = 179) on background metformin extended release (MET) ‡1,500 mg/day. Primary objective compared changes from baseline in HbA 1c with SAXA+DAPA+MET versus SAXA+MET and DAPA+MET. RESULTSPatients had a mean baseline HbA 1c of 8.9% (74 mmol/mol), diabetes duration of 7.6 years, and a BMI of 32 kg/m 2 . At week 24, the adjusted mean change from the baseline HbA 1c was -1.5% (-16.1 mmol/mol) with SAXA+DAPA+MET versus -0.9% (-9.6 mmol/mol) with SAXA+MET (difference 20.59% [-6.4 mmol/mol], P < 0.0001) and -1.2% (-13.1 mmol/mol) with DAPA+MET (difference 20.27% [3.0 mmol/mol], P < 0.02). The proportion of patients achieving HbA 1c <7% (53 mmol/mol) was 41% with SAXA+DAPA+MET versus 18% with SAXA+MET and 22% with DAPA+MET. Urinary and genital infections occurred in £1% of patients receiving SAXA+DAPA+MET. Hypoglycemia was infrequent, with no episodes of major hypoglycemia. CONCLUSIONSIn this first report of adding a well-tolerated combination of saxagliptin plus dapagliflozin to background metformin therapy in patients poorly controlled with metformin, greater improvements in glycemic control were obtained with triple therapy by the dual addition of saxagliptin and dapagliflozin than dual therapy with the addition of saxagliptin or dapagliflozin alone.

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Vulvovaginitis and balanitis in patients with diabetes treated with dapagliflozin

Cited by 191 publications

References 19 publications

Real-world evidence for the safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (STELLA-ELDER): final results of a post-marketing surveillance study

Real-world evidence for the safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (STELLA-ELDER): final results of a post-marketing surveillance study

Fifty-two-week long-term clinical study of luseogliflozin as monotherapy in Japanese patients with type 2 diabetes mellitus inadequately controlled with diet and exercise

Dual Add-on Therapy in Type 2 Diabetes Poorly Controlled With Metformin Monotherapy: A Randomized Double-Blind Trial of Saxagliptin Plus Dapagliflozin Addition Versus Single Addition of Saxagliptin or Dapagliflozin to Metformin

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