Long-term treatment for endometriosis with dienogest: efficacy, side effects and tolerability

Figures & data

Table 1. Baseline characteristics of the study population.

	n = 114
Age (years)	34 ± 6.9
Age at menarche	12.4 ± 1.7
Dysmenorrhea since adolescence	94 (82.5%)
Parous	20 (17.5%)
Previous hormonal treatment	93 (81.6%)
Surgery for endometriosis	24 (21.1%)
Endometriosis Phenotype
OMA	23 (20.2%)
DIE	38 (33.3%)
Mixed phenotypes	53 (46.5%)
Mean months of treatment [range]	20.0 ± 12.7 [2 − 72]
EAP
Dysmenorrhea	109 (95.6%)
VAS	8.1 ± 2.4
Severe (VAS > 7)	95 (87.2%)
Dyspareunia	92 (80.7%)
VAS	7.2 ± 3.2
Severe (VAS > 7)	65 (70.7%)
Dyschezia	21 (18.4%)
VAS	6.2 ± 2.7
Severe (VAS > 7)	10 (47.6%)
Dysuria	38 (33.3%)
VAS	6.1 ± 3.1
Severe (VAS > 7)	15 (39.5%)
Chronic pelvic pain	79 (69.3%)
VAS	6.3 ± 3.5
Severe (VAS > 7)	40 (50.6%)

EAP: endometriosis-associated pain; OMA: ovarian endometrioma; DIE: deep infiltrating endometriosis.

Figure 1. VAS change of EAP from baseline to 12-months follow up. Data represent in box and whiskers plot.

Table 2. Delta Change of VAS for endometriosis-associated pain (EAP) in study population and according to endometriosis phenotypes (mean ± standard deviation). CPP, chronic pelvic pain.

	All cases	OMA	DIE	Mixed	p value
Dysmenorrhea	−7.2 (±3.1)	−5.8 (±3.2)	−8.2 (±1.7)	−7.3 (±3.6)	.014*
CPP	−2.8 (±4.5)	−2.7 (±4.4)	−2.9 (±4.4)	−2.8 (±4.7)	.997
Dyspareunia	−2.9 (±4.2)	−0.4 (±3.5)	−3.9 (±3.8)	−3.2 (±4.6)	.025^#
Dyschezia	−0.2 (±3.5)	0.5 (±2.5)	−0.4 (±3.4)	−0.5 (±4.0)	.693
Dysuria	−1.9 (±3.2)	−0.3 (±3.3)	−2.0 (±3.6)	−2.6 (±3.3)	.035^§

*DIE and Mixed vs OMA; ^#DIE and Mixed vs OMA; ^§DIE and Mixed vs OMA.

Table 3. Side effects at 12 months follow up. Data are presented as frequencies n (%).

		new symptom			preexisting symptom
Side Effects	No	Few/mild	Often/moderate	Daily/severe	worsening	unchanged	improvement
hydric retention	65 (70.7)	13 (14.1)	10 (10.9)	4 (4.3)	/	/	/
AUB	71 (77.2)	11 (12)	8 (8.7)	2 (2.2)	/	/	/
reduced sexual drive	70 (76.1)	9 (9.8)	4 (4.3)	1 (1.1)	6 (6.5)	2 (2.1)	/
breast tenderness	71 (77.1)	10 (10.9)	7 (7.6)	2 (2.2)	/	2 (2.1)	/
headache	58 (63)	5 (5.4)	9 (9.8)	1 (1.1)	3 (3.2)	9 (9.7)	7 (7.6)
abdominal bloating	61 (66.3)	3 (3.3)	11 (12)	3 (3.3)	1 (1.1)	9 (9.7)	4 (4.3)
mood disorders	74 (80.4)	3 (3.3)	9 (9.8)	4 (4.3)	/	2 (2.1)	/
vaginal dryness	77 (83.7)	3 (3.3)	7 (7.6)	4 (4.3)	/	1 (1.1)	/
hot flushes	80 (87)	5 (5.4)	2 (2.2)	3 (3.3)	2 (2.1)	/	/
acne	79 (85.9)	5 (5.4)	5 (5.4)	/	/	/	3 (3.2)
hair loss	81 (88)	4 (4.3)	3 (3.3)	2 (2.2)	/	2 (2.1)	/
insomnia	84 (91.3)	8 (8.7)	/	/	/	/	/
seborrhea	85 (92.4)	1 (1.1)	2 (2.2)	3 (3.3)	/	1 (1.1)	/
hirsutism	86 (93.5)	3 (3.3)	2 (2.2)	1 (1.1)	/	/	/

Figure 2. Flow chart diagram of study population follow up.

Figure 3. Side effects occurrence as frequency (%) at 12, 24 and 36 months follow up.

Data availability statement

The data that support the findings of this study are available from the corresponding author (F.P) upon reasonable request.