SYNJARDYXR(empagliflozin and metformin hydrochloride extended-release) tablets(十二)
0.02
eGFR (mL/min/1.73 m2) 0.16 -- 1.48
Hypoglycemia
The incidence of hypoglycemia by study is shown in Table 4. The incidence of hypoglycemia increased when empagliflozin was administered with insulin or sulfonylurea [see WARNINGS AND PRECAUTIONS (5.6)].
Table 4 Incidence of Overalla and Severeb Hypoglycemic Events in Placebo-Controlled Clinical Studiesc
aOverall hypoglycemic events: plasma or capillary glucose of less than or equal to 70 mg/dL
bSevere hypoglycemic events: requiring assistance regardless of blood glucose
cTreated set (patients who had received at least one dose of study drug)
dInsulin dose could not be adjusted during the initial 18 week treatment period
Monotherapy
(24 weeks) Placebo
(n=229) Empagliflozin 10 mg
(n=224) Empagliflozin 25 mg
(n=223)
Overall (%) 0.4% 0.4% 0.4%
Severe (%) 0% 0% 0%
In Combination with
Metformin
(24 weeks) Placebo + Metformin
(n=206) Empagliflozin 10 mg +
Metformin
(n=217) Empagliflozin 25 mg +
Metformin
(n=214)
Overall (%) 0.5% 1.8% 1.4%
Severe (%) 0% 0% 0%
In Combination with
Metformin + Sulfonylurea
(24 weeks) Placebo
(n=225) Empagliflozin 10 mg +
Metformin + Sulfonylurea
(n=224) Empagliflozin 25 mg +
Metformin + Sulfonylurea
(n=217)
Overall (%) 8.4% 16.1% 11.5%
Severe (%) 0% 0% 0%
In Combination with
Pioglitazone +/- Metformin
(24 weeks) Placebo
(n=165) Empagliflozin 10 mg +
Pioglitazone +/- Metformin
(n=165) Empagliflozin 25 mg +
Pioglitazone +/- Metformin
(n=168)
Overall (%) 1.8% 1.2% 2.4%
Severe (%) 0% 0% 0%
In Combination with Basal Insulin +/-
Metformin
(18 weeksd) Placebo
(n=170) Empagliflozin 10 mg
(n=169) Empagliflozin 25 mg
(n=155)
Overall (%) 20.6% 19.5% 28.4%
Severe (%) 0% 0% 1.3%
In Combination with MDI Insulin +/-
Metformin
(18 weeksd) Placebo
(n=188) Empagliflozin 10 mg
(n=186) Empagliflozin 25 mg
(n=189)
Overall (%) 37.2% 39.8% 41.3%
Severe (%) 0.5% 0.5% 0.5%
Genital Mycotic Infections
In the pool of five placebo-controlled clinical trials, the incidence of genital mycotic infections (e.g., vaginal mycotic infection, vaginal infection, genital infection fungal, vulvovaginal candidiasis, and vulvitis) was increased in patients treated with empagliflozin compared to placebo, occurring in 0.9%, 4.1%, and 3.7% of patients randomized to placebo, empagliflozin 10 mg, and empagliflozin 25 mg, respectively. Discontinuation from study due to genital infection occurred in 0% of placebo-treated patients and 0.2% of patients treated with either empagliflozin 10 or 25 mg.
Genital mycotic infections occurred more frequently in female than male patients (see Table 2).
Phimosis occurred more frequently in male patients treated with empagliflozin 10 mg (less than 0.1%) and empagliflozin 25 mg (0.1%) than placebo (0%).
Urinary Tract Infections
In the pool of five placebo-controlled clinical trials, the incidence of urinary tract infections (e.g., urinary tract infection, asymptomatic bacteriuria, and cystitis) was increased in patients treated with e |
