J Clin Med Res

Journal of Clinical Medicine Research, ISSN 1918-3003 print, 1918-3011 online, Open Access

Article copyright, the authors; Journal compilation copyright, J Clin Med Res and Elmer Press Inc

Journal website https://www.jocmr.org

Original Article

Volume 13, Number 5, May 2021, pages 309-316

Influence of Luseogliflozin on Vaginal Bacterial and Fungal Populations in Japanese Patients With Type 2 Diabetes

Figure 1. Changes in the sum of the concentration scores prior to and after luseogliflozin treatment. (a) Premenopausal group. (b) Postmenopausal group.

**Table 1.** Effects of Luseogliflozin on Body Weight, BMI, HbA1c and Serum Lipid Parameters (N= 36)
	Before	After 6 months	P-value
Data are expressed as mean ± SD. BMI: body mass index; HbA1c: hemoglobin A1c; LDL-C: low-density lipoprotein cholesterol; HDL-C: high-density lipoprotein cholesterol.
Body weight (kg)	68.7 ± 13.5	66.7 ± 13.1	0.0081
BMI	28.3 ± 5.3	27.5 ± 5.1	0.0014
HbA1c (%)	7.2 ± 0.7	7.0 ± 0.7	0.0249
Total cholesterol (mg/dL)	176 ± 34	182 ± 40	0.1682
LDL-C (mg/dL)	95 ± 28	95 ± 33	0.7701
HDL-C (mg/dL)	63 ± 14	68 ± 17	0.0078
Triglyceride (mg/dL)	131 ± 86	131 ± 131	0.9742

Table 1. Effects of Luseogliflozin on Body Weight, BMI, HbA1c and Serum Lipid Parameters (N= 36)

Before

After 6 months

P-value

Data are expressed as mean ± SD. BMI: body mass index; HbA1c: hemoglobin A1c; LDL-C: low-density lipoprotein cholesterol; HDL-C: high-density lipoprotein cholesterol.

Body weight (kg)

68.7 ± 13.5

66.7 ± 13.1

0.0081

BMI

28.3 ± 5.3

27.5 ± 5.1

0.0014

HbA1c (%)

7.2 ± 0.7

7.0 ± 0.7

0.0249

Total cholesterol (mg/dL)

176 ± 34

182 ± 40

0.1682

LDL-C (mg/dL)

95 ± 28

95 ± 33

0.7701

HDL-C (mg/dL)

63 ± 14

68 ± 17

0.0078

Triglyceride (mg/dL)

131 ± 86

131 ± 131

0.9742

**Table 2.** Effects of Luseogliflozin on the Intravaginal Fungal Populations
Fungi	Prior to treatment	After luseogliflozin treatment	P value
Colony concentration scores: numbers of fungus-positive cases for the scores.
Premenopausal group (n = 12)
Candida albicans	2 (1+:2)	2	1	0	1 (4+:1)	0	1 (4+:1)	2	8	0.256
Candida glabrata	2 (1+:2)	2	0	0	2 (4+:2)	0	0	2	8	0.166
Postmenopausal group (n = 24)
Candida albicans	0	0	0	0	0	0	5 (2+:3, 4+:2)	5	14	0.0355
Candida krusei	0	0	0	0	0	0	1 (4+:1)	1	4	0.328

Table 2. Effects of Luseogliflozin on the Intravaginal Fungal Populations

Fungi

Prior to treatment

After luseogliflozin treatment

P value

Total colonies

Sum of colony concentration score

Disappeared colonies

Decreased colonies

Increased colonies

Unchanged colonies

Newly detected colonies

Total colonies

Sum of colony concentration score

Colony concentration scores: numbers of fungus-positive cases for the scores.

Premenopausal group (n = 12)

Candida albicans

2 (1+:2)

1 (4+:1)

0.256

Candida glabrata

2 (1+:2)

2 (4+:2)

0.166

Postmenopausal group (n = 24)

Candida albicans

5 (2+:3, 4+:2)

0.0355

Candida krusei

1 (4+:1)

0.328

**Table 3.** Effects of Luseogliflozin on the Intravaginal Gram-Negative Bacterial Populations
Gram-negative bacilli	Prior to treatment	After luseogliflozin treatment	P value
Colony concentration scores: numbers of bacterium-positive cases for the scores.
Premenopausal group (n = 12)
E. coli	2 (1+:2)	2	1	0	1 (2+:1)	0	5 (3+:1, 4+:4)	6	21	0.0201
K. pneumoniae	1 (1+:1)	1	1	0	0	0	0	0	0	0.3388
Gardnerella vaginalis	1 (1+:1)	1	1	0	0	0	0	0	0	0.3388
Citrobacter freundii	1 (1+:1)	1	1	0	0	0	0	0	0	0.3388
Postmenopausal group (n = 24)
E. coli	15 (1+:10, 2+:5)	20	8	0	6 (4+:6)	1 (1+:1)	2 (2+:2)	9	29	0.2236
K. pneumoniae	2 (1+:2)	2	1	0	1 (4+:1)	0	2 (4+:2)	3	12	0.1251
Citrobacter farmeri	0	0	0	0	0	0	1 (4+:1)	1	4	0.3277
Enterobacter cloacae	0	0	0	0	0	0	1 (4+:1)	1	4	0.3277
Citrobacter freundii	0	0	0	0	0	0	1 (4+:1)	1	4	0.3277
Acinetobacter baumannii	1 (1+:1)	1	0	0	1 (4+:1)	0	0	1	4	0.3277
Morganella morganii	2 (1+:1, 2+:1)	3	2	0	0	0	0	0	0	0.1852
Enterobacter aerogenes	1 (2+:1)	2	1	0	0	0	0	0	0	0.3277
Gardnerella. vaginalis	1 (1+:1)	1	1	0	0	0	0	0	0	0.3277
Proteus vulgaris	1 (1+:1)	1	1	0	0	0	0	0	0	0.32

Table 3. Effects of Luseogliflozin on the Intravaginal Gram-Negative Bacterial Populations

Gram-negative bacilli

Prior to treatment

After luseogliflozin treatment

P value

Total colonies

Sum of colony concentration score

Disappeared colonies

Decreased colonies

Increased colonies

Unchanged colonies

Newly detected colonies

Total colonies

Sum of colony concentration score

Colony concentration scores: numbers of bacterium-positive cases for the scores.

Premenopausal group (n = 12)

E. coli

2 (1+:2)

1 (2+:1)

5 (3+:1, 4+:4)

0.0201

K. pneumoniae

1 (1+:1)

0.3388

Gardnerella vaginalis

1 (1+:1)

0.3388

Citrobacter freundii

1 (1+:1)

0.3388

Postmenopausal group (n = 24)

E. coli

15 (1+:10, 2+:5)

6 (4+:6)

1 (1+:1)

2 (2+:2)

0.2236

K. pneumoniae

2 (1+:2)

1 (4+:1)

2 (4+:2)

0.1251

Citrobacter farmeri

1 (4+:1)

0.3277

Enterobacter cloacae

1 (4+:1)

0.3277

Citrobacter freundii

1 (4+:1)

0.3277

Acinetobacter baumannii

1 (1+:1)

1 (4+:1)

0.3277

Morganella morganii

2 (1+:1, 2+:1)

0.1852

Enterobacter aerogenes

1 (2+:1)

0.3277

Gardnerella. vaginalis

1 (1+:1)

0.3277

Proteus vulgaris

1 (1+:1)

0.32

**Table 4.** Effects of Luseogliflozin on the Intravaginal Gram-Positive Bacterial Populations
Gram-positive bacilli	Prior to treatment	After luseogliflozin treatment	P value
Colony concentration scores: numbers of bacterium-positive cases for the scores. MRSA: methicillin-resistant Staphylococcus aureus.
Premenopausal group (n = 12)
Enterococcus faecalis	1 (1+:1)	1	1	0	0	0	7 (1+:1, 4+:6)	7	25	0.0077
Group B streptococcus	2 (2+:2)	4	1	0	1 (4+:1)	0	2 (4+:2)	3	12	0.2199
Staphylococcus epidermidis	4 (1+:4)	4	3	0	1 (3+:1)	0	2 (1+:1, 3+:1)	3	7	0.4909
Staphylococcus haemolyticus	0	0	0	0	0	0	1 (4+:1)	1	4	0.3388
Staphylococcus lentus	0	0	0	0	0	0	1 (4+:1)	1	4	0.3388
Staphylococcus spp.	5 (1+:4, 2+:1)	6	5	0	0	0	0	0	0	0.0261
Enterococcus gallinarum	1 (4+:1)	4	1	0	0	0	0	0	0	0.3388
α-Staphylococcus	1 (2+:1)	2	1	0	0	0	0	0	0	0.3388
Corynebacterium spp	1 (1+:1)	1	1	0	0	0	0	0	0	0.3388
Staphylococcus aureus	1 (1+:1)	1	1	0	0	0	0	0	0	0.3388
Postmenopausal group (n = 24)
Enterococcus faecalis	7 (1+:7)	7	3	0	4 (4+:4)	0	5 (4+:5)	9	36	0.0051
Group B streptococcus	2 (1+:1, 2+:1)	3	1	0	0	1 (1+:1)	5 (1+:1, 2+:1, 3+:1, 4+:2)	6	15	0.3277
Staphylococcus epidermidis	9 (1+:9)	9	6	0	3 (3+:1, 4+:2)	0	2 (1+:1, 2+:1)	5	14	0.3955
Staphylococcus haemolyticus	0	0	0	0	0	0	3 (2+:1, 4+:2)	3	10	0.0961
MRSA	1 (2+:1)	2	0	0	1 (4+:1)	0	1 (1+:1)	2	5	0.1852
Corynebacterium spp	5 (1+:4, 2+:1)	6	5	0	0	0	1 (4+:1)	1	4	0.6921
Staphylococcus cohnii	0	0	0	0	0	0	1 (4+:1)	1	4	0.3277
Staphylococcus simulans	0	0	0	0	0	0	1 (4+:1)	1	4	0.3277
Staphylococcus sciuri	0	0	0	0	0	0	1 (4+:1)	1	4	0.3277
Staphylococcus lugdunensis	0	0	0	0	0	0	1 (2+:1)	1	2	0.3277
Staphylococcus spp.	6 (1+:5, 2+:1)	7	6	0	0	0	0	0	0	0.0161
Staphylococcus aureus	3 (1+:3)	3	3	0	0	0	0	0	0	0.0829

Table 4. Effects of Luseogliflozin on the Intravaginal Gram-Positive Bacterial Populations

Gram-positive bacilli

Prior to treatment

After luseogliflozin treatment

P value

Total colonies

Sum of colony concentration score

Disappeared colonies

Decreased colonies

Increased colonies

Unchanged colonies

Newly detected colonies

Total colonies

Sum of colony concentration score

Colony concentration scores: numbers of bacterium-positive cases for the scores. MRSA: methicillin-resistant Staphylococcus aureus.

Premenopausal group (n = 12)

Enterococcus faecalis

1 (1+:1)

7 (1+:1, 4+:6)

0.0077

Group B streptococcus

2 (2+:2)

1 (4+:1)

2 (4+:2)

0.2199

Staphylococcus epidermidis

4 (1+:4)

1 (3+:1)

2 (1+:1, 3+:1)

0.4909

Staphylococcus haemolyticus

1 (4+:1)

0.3388

Staphylococcus lentus

1 (4+:1)

0.3388

Staphylococcus spp.

5 (1+:4, 2+:1)

0.0261

Enterococcus gallinarum

1 (4+:1)

0.3388

α-Staphylococcus

1 (2+:1)

0.3388

Corynebacterium spp

1 (1+:1)

0.3388

Staphylococcus aureus

1 (1+:1)

0.3388

Postmenopausal group (n = 24)

Enterococcus faecalis

7 (1+:7)

4 (4+:4)

5 (4+:5)

0.0051

Group B streptococcus

2 (1+:1, 2+:1)

1 (1+:1)

5 (1+:1, 2+:1, 3+:1, 4+:2)

0.3277

Staphylococcus epidermidis

9 (1+:9)

3 (3+:1, 4+:2)

2 (1+:1, 2+:1)

0.3955

Staphylococcus haemolyticus

3 (2+:1, 4+:2)

0.0961

MRSA

1 (2+:1)

1 (4+:1)

1 (1+:1)

0.1852

Corynebacterium spp

5 (1+:4, 2+:1)

1 (4+:1)

0.6921

Staphylococcus cohnii

1 (4+:1)

0.3277

Staphylococcus simulans

1 (4+:1)

0.3277

Staphylococcus sciuri

1 (4+:1)

0.3277

Staphylococcus lugdunensis

1 (2+:1)

0.3277

Staphylococcus spp.

6 (1+:5, 2+:1)

0.0161

Staphylococcus aureus

3 (1+:3)

0.0829