INCIDENCE OF GENITAL MYCOTIC INFECTIONS DECLINES OVER TIME IN PATIENTS WITH TYPE 2 DIABETES MELLITUS TREATED WITH CANAGLIFLOZIN OVER 2 YEARS
AACE ePoster Library. Davies M. 05/13/15; 97800; 267
Michael Davies
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Abstract
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Objective: Sodium glucose co-transporter 2 inhibitors, such as canagliflozin (CANA), improve glycemic control by lowering the renal threshold for glucose reabsorption and increasing urinary glucose excretion; a mechanism of action associated with increased incidence of genital mycotic infections (GMIs). The incidence of GMIs was evaluated over a 2-y period in patients with type 2 diabetes mellitus (T2DM) treated with CANA.
Methods: In this active-controlled Phase 3 study, patients aged 18–80 y with T2DM (mean baseline A1C 7.8%) received CANA 100 mg (n = 483) or 300 mg (n = 485), or glimepiride (GLIM; n = 482) up-titrated to 6 mg or 8 mg per day. Blinded therapy was administered once daily on a background of metformin for 52 wks, followed by a 52-wk extension. Incidence of GMIs was evaluated overall and at 3-mo intervals.
Results: The cumulative incidence of GMIs over 2 y was higher for CANA 100 mg and 300 mg than GLIM in females (13.9% and 15.6% vs 2.7%) and males (9.5% and 9.1% vs 1.9%). In patients treated with CANA, the highest incidence of GMIs occurred at Months 0–3 (CANA 100 mg and 300 mg: females, 7.4% and 7.8%; males, 3.6% and 3.3%) after which the incidence of GMIs decreased. In females, incidence of GMIs decreased during Months >3–6 to 3.3% and 4.5% for CANA 100 mg and 300 mg, then stabilized through Months >9–12, before decreasing further (Months >12–15: 2.2% and 2.6%); it then remained low until study completion (Months >21–24: 0.6% and 1.2%). In males, incidence of GMIs decreased slightly between Months >3–6 (CANA 100 mg and 300 mg: 2.9% and 3.1%), decreased to 0.4% and 1.9% between Months >6–9, and then remained low until study completion (Months >21–24: 0.5% and 0.6%). GMIs were generally mild to moderate in intensity, and responded to standard treatment. Risk factors for GMI were a history of GMIs in females and being uncircumcised in males. During the 2-y period, a total of 4/968 patients (0.4%) treated with CANA (3 women and 1 man) discontinued treatment due to a GMI.
Discussion: In this 2 y study of patients with T2DM, CANA was associated with a higher incidence of GMIs than GLIM. The highest incidence of GMIs with CANA occurred during the first 3 mo of treatment and then decreased over time. GMIs were generally mild to moderate in intensity and few led to study discontinuation. These data suggest that the risk of GMIs with CANA use is mostly increased early after treatment initiation.
Conclusion: The incidence of GMIs associated with CANA occurred primarily during the first 3 mo of treatment and decreased over time in patients with T2DM.
Methods: In this active-controlled Phase 3 study, patients aged 18–80 y with T2DM (mean baseline A1C 7.8%) received CANA 100 mg (n = 483) or 300 mg (n = 485), or glimepiride (GLIM; n = 482) up-titrated to 6 mg or 8 mg per day. Blinded therapy was administered once daily on a background of metformin for 52 wks, followed by a 52-wk extension. Incidence of GMIs was evaluated overall and at 3-mo intervals.
Results: The cumulative incidence of GMIs over 2 y was higher for CANA 100 mg and 300 mg than GLIM in females (13.9% and 15.6% vs 2.7%) and males (9.5% and 9.1% vs 1.9%). In patients treated with CANA, the highest incidence of GMIs occurred at Months 0–3 (CANA 100 mg and 300 mg: females, 7.4% and 7.8%; males, 3.6% and 3.3%) after which the incidence of GMIs decreased. In females, incidence of GMIs decreased during Months >3–6 to 3.3% and 4.5% for CANA 100 mg and 300 mg, then stabilized through Months >9–12, before decreasing further (Months >12–15: 2.2% and 2.6%); it then remained low until study completion (Months >21–24: 0.6% and 1.2%). In males, incidence of GMIs decreased slightly between Months >3–6 (CANA 100 mg and 300 mg: 2.9% and 3.1%), decreased to 0.4% and 1.9% between Months >6–9, and then remained low until study completion (Months >21–24: 0.5% and 0.6%). GMIs were generally mild to moderate in intensity, and responded to standard treatment. Risk factors for GMI were a history of GMIs in females and being uncircumcised in males. During the 2-y period, a total of 4/968 patients (0.4%) treated with CANA (3 women and 1 man) discontinued treatment due to a GMI.
Discussion: In this 2 y study of patients with T2DM, CANA was associated with a higher incidence of GMIs than GLIM. The highest incidence of GMIs with CANA occurred during the first 3 mo of treatment and then decreased over time. GMIs were generally mild to moderate in intensity and few led to study discontinuation. These data suggest that the risk of GMIs with CANA use is mostly increased early after treatment initiation.
Conclusion: The incidence of GMIs associated with CANA occurred primarily during the first 3 mo of treatment and decreased over time in patients with T2DM.
Objective: Sodium glucose co-transporter 2 inhibitors, such as canagliflozin (CANA), improve glycemic control by lowering the renal threshold for glucose reabsorption and increasing urinary glucose excretion; a mechanism of action associated with increased incidence of genital mycotic infections (GMIs). The incidence of GMIs was evaluated over a 2-y period in patients with type 2 diabetes mellitus (T2DM) treated with CANA.
Methods: In this active-controlled Phase 3 study, patients aged 18–80 y with T2DM (mean baseline A1C 7.8%) received CANA 100 mg (n = 483) or 300 mg (n = 485), or glimepiride (GLIM; n = 482) up-titrated to 6 mg or 8 mg per day. Blinded therapy was administered once daily on a background of metformin for 52 wks, followed by a 52-wk extension. Incidence of GMIs was evaluated overall and at 3-mo intervals.
Results: The cumulative incidence of GMIs over 2 y was higher for CANA 100 mg and 300 mg than GLIM in females (13.9% and 15.6% vs 2.7%) and males (9.5% and 9.1% vs 1.9%). In patients treated with CANA, the highest incidence of GMIs occurred at Months 0–3 (CANA 100 mg and 300 mg: females, 7.4% and 7.8%; males, 3.6% and 3.3%) after which the incidence of GMIs decreased. In females, incidence of GMIs decreased during Months >3–6 to 3.3% and 4.5% for CANA 100 mg and 300 mg, then stabilized through Months >9–12, before decreasing further (Months >12–15: 2.2% and 2.6%); it then remained low until study completion (Months >21–24: 0.6% and 1.2%). In males, incidence of GMIs decreased slightly between Months >3–6 (CANA 100 mg and 300 mg: 2.9% and 3.1%), decreased to 0.4% and 1.9% between Months >6–9, and then remained low until study completion (Months >21–24: 0.5% and 0.6%). GMIs were generally mild to moderate in intensity, and responded to standard treatment. Risk factors for GMI were a history of GMIs in females and being uncircumcised in males. During the 2-y period, a total of 4/968 patients (0.4%) treated with CANA (3 women and 1 man) discontinued treatment due to a GMI.
Discussion: In this 2 y study of patients with T2DM, CANA was associated with a higher incidence of GMIs than GLIM. The highest incidence of GMIs with CANA occurred during the first 3 mo of treatment and then decreased over time. GMIs were generally mild to moderate in intensity and few led to study discontinuation. These data suggest that the risk of GMIs with CANA use is mostly increased early after treatment initiation.
Conclusion: The incidence of GMIs associated with CANA occurred primarily during the first 3 mo of treatment and decreased over time in patients with T2DM.
Methods: In this active-controlled Phase 3 study, patients aged 18–80 y with T2DM (mean baseline A1C 7.8%) received CANA 100 mg (n = 483) or 300 mg (n = 485), or glimepiride (GLIM; n = 482) up-titrated to 6 mg or 8 mg per day. Blinded therapy was administered once daily on a background of metformin for 52 wks, followed by a 52-wk extension. Incidence of GMIs was evaluated overall and at 3-mo intervals.
Results: The cumulative incidence of GMIs over 2 y was higher for CANA 100 mg and 300 mg than GLIM in females (13.9% and 15.6% vs 2.7%) and males (9.5% and 9.1% vs 1.9%). In patients treated with CANA, the highest incidence of GMIs occurred at Months 0–3 (CANA 100 mg and 300 mg: females, 7.4% and 7.8%; males, 3.6% and 3.3%) after which the incidence of GMIs decreased. In females, incidence of GMIs decreased during Months >3–6 to 3.3% and 4.5% for CANA 100 mg and 300 mg, then stabilized through Months >9–12, before decreasing further (Months >12–15: 2.2% and 2.6%); it then remained low until study completion (Months >21–24: 0.6% and 1.2%). In males, incidence of GMIs decreased slightly between Months >3–6 (CANA 100 mg and 300 mg: 2.9% and 3.1%), decreased to 0.4% and 1.9% between Months >6–9, and then remained low until study completion (Months >21–24: 0.5% and 0.6%). GMIs were generally mild to moderate in intensity, and responded to standard treatment. Risk factors for GMI were a history of GMIs in females and being uncircumcised in males. During the 2-y period, a total of 4/968 patients (0.4%) treated with CANA (3 women and 1 man) discontinued treatment due to a GMI.
Discussion: In this 2 y study of patients with T2DM, CANA was associated with a higher incidence of GMIs than GLIM. The highest incidence of GMIs with CANA occurred during the first 3 mo of treatment and then decreased over time. GMIs were generally mild to moderate in intensity and few led to study discontinuation. These data suggest that the risk of GMIs with CANA use is mostly increased early after treatment initiation.
Conclusion: The incidence of GMIs associated with CANA occurred primarily during the first 3 mo of treatment and decreased over time in patients with T2DM.
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