Real-world safety and effectiveness of rotigotine in patients with Parkinson’s disease: analysis of a post-marketing surveillance study in Japan

Figures & data

Figure 1. Patient disposition.

Table 1. Demographic characteristics.

				N(%)							N(%)
	Items							Items
				603	(100.0)						603	(100.0)
	Sex		Male	263	(43.6)			Modified Hoehn and Yahr Scale before treatment	0		0	(0.0)
			Female	340	(56.4)			Mean　3.07 SD　0.93 Minimum　1.0 Median　3.00 Maximum　5.0	1		20	(3.3)
	Pregnancy^a		No	340	(100.0)				1.5		16	(2.7)
			Yes	0	(0.0)				2		69	(11.4)
	Age 1		<35 years	0	(0.0)				2.5		75	(12.4)
	Mean　71.6 SD　9.1 Minimum　40 Median　73.0 Maximum　92		<35–45 years	8	(1.3)				3		229	(38.0)
			<45–55 years	19	(3.2)				4		126	(20.9)
			<55–65 years	94	(15.6)				5		43	(7.1)
			<65–75 years	237	(39.3)				Not reported		25	(4.1)
			<75–85 years	216	(35.8)			UPDRS Part III total score before treatment	<10		29	(4.8)
			≥85 years	29	(4.8)			Mean　33.4 SD　17.4 Minimum　2 Median　31.0 Maximum　88	<10–20		89	(14.8)
	Age 2		<80 years	491	(81.4)				<20–30		127	(21.1)
			≥80 years	112	(18.6)				<30–40		119	(19.7)
	Visit		inpatient	90	(14.9)				<40–50		84	(13.9)
			Outpatient	513	(85.1)				<50–60		29	(4.8)
	Purpose of use		PD	602	(99.8)				<60–70		32	(5.3)
			Others	1	(0.2)				≥70		21	(3.5)
	Duration of disease		<1 year	11	(1.8)				Uncalculatable		73	(12.1)
	Mean　7.6 SD　5.5 Minimum　0 Median　6.0 Maximum　34		<1–5 years	181	(30.0)			Prior treatment	No		53	(8.8)
			<5–10 years	192	(31.8)			(PD treatment)	Yes		550	(91.2)
			<10–15 years	107	(17.7)					Levodopa^b	521	(86.4)
			<15–20 years	51	(8.5)					Other dopamine agonist^b	294	(48.8)
			≥20 years	18	(3.0)					MAOB inhibitor^b	153	(25.4)
			Unknown	42	(7.0)					COMT inhigitor^b	120	(19.9)
			uncalculatable	1	(0.2)					Amantadine^b	87	(14.4)
	History of treatment with l-dopa		No	45	(7.5)					Anti–choline drug^b	40	(6.6)
			Yes	553	(91.7)					Droxidopa^b	41	(6.8)
			Unknown	4	(0.7)					zonisamide^b	92	(15.3)
			Not reported	1	(0.2)					Adenosine A2A Receptor Antagonist^b	65	(10.8)
	History of treatment with other dopamine agonists		No	208	(34.5)			Concomitant therapy	No		34	(5.6)
			Yes	386	(64.0)			(PD treatment)	Yes		569	(94.4)
			Unknown	8	(1.3)					Levodopa^b	553	(91.7)
			Not reported	1	(0.2)					Other dopamine agonist^b	242	(40.1)
	Complication		No	232	(38.5)					MAOB inhibitor^b	168	(27.9)
			Yes	371	(61.5)					COMT inhigitor^b	141	(23.4)
		Liver dysfunction^b	No	581	(96.4)					Amantadine^b	92	(15.3)
			Yes	22	(3.6)					Anti-choline drug^b	41	(6.8)
		Kidney dysfunction^b	No	584	(96.8)					Droxidopa^b	41	(6.8)
			Yes	19	(3.2)					Zonisamide^b	108	(17.9)
		Others^b	No	238	(39.5)					Adenosine A2A Receptor Antagonist^b	98	(16.3)
			Yes	365	(60.5)			a) Applicable to female patients only
	Hypersensitivity	No		544	(90.2)			b) Includes multiple answers by one patient
		Yes		34	(5.6)
		Unknown		25	(4.1)

Figure 2. Levels of levodopa equivalent dose (LED).

Table 2. Adverse drug reactions with an incidence of ≥1%.

Number of study sites		109
Number of patients		603
Number of patients experiencing adverse drug reactions		207
Incidence of adverse drug reactions		305
Percent of patients experiencing adverse drug reactions		34.3%
Adverse drug reactions		Patients experiencing adverse drug reactions by severity (%)
		Serious		Non-serious		Total
Application site pruritus		0	(0.0)	62	(10.3)	62	(10.3)
Application site erythema		0	(0.0)	47	(7.8)	47	(7.8)
Application site dermatitis		0	(0.0)	34	(5.6)	34	(5.6)
Dyskinesia		0	(0.0)	13	(2.2)	13	(2.2)
Hallucination, visual		0	(0.0)	11	(1.8)	11	(1.8)
Somnolence		0	(0.0)	11	(1.8)	11	(1.8)
Application site rash		0	(0.0)	11	(1.8)	11	(1.8)
Hallucination		1	(0.2)	9	(1.5)	10	(1.7)
Nausea		0	(0.0)	9	(1.5)	9	(1.5)
Edema peripheral		0	(0.0)	6	(1.0)	6	(1.0)
MedDRA/J Version19.1

Table 3. Adverse drug reactions by age subgroups.

Age (years)	N	Adverse drug reactions		p value
		n	Incidence rate (%)
<35	0	–	–	p = 0.1162^a
<35–45	8	1	12.5
<45–55	19	11	57.9
<55–65	94	33	35.1
<65–75	237	88	37.1
<75–85	216	67	31.0
≥85	29	7	24.1
<80	491	173	35.2	p = 0.3778^b
≥80	112	34	30.4

^aCochrane–Armitage trend test.

^bFisher's exact test.

Figure 3. Change in UPDRS Part III Total Score (ON time).

Figure 4. UPDRS Part III Scores (ON time) (total of 5 questions related to activities of daily living).

Figure 5. Overall improvement overall improvement was assessed by the physician comprehensively at 6 months, 12 months post-treatment, or at discontinuation.