Adverse drug events affecting medication persistence with rivastigmine patch application

Figures & data

Figure 1 Dose titration of rivastigmine patch in Japan.

Table 1 Background of patients administered rivastigmine

Age	Male	Female	Total
60–69 years (mean±SD)	5 (65.2±2.5)	3 (67.0±2.2)	8 (65.9±2.5)
70–79 years (mean±SD)	29 (76.1±2.6)	64 (76.1±2.6)	81 (76.1±2.6)
80–89 years (mean±SD)	48 (83.9±2.5)	134 (84.2±2.6)	167 (84.1±2.6)
≥90 years (mean±SD)	5 (90.6±0.5)	22 (93.1±2.4)	26 (92.7±2.4)
Total (mean±SD)	87 (80.6±6.2)	225 (82.5±5.8)	312* (82.0±6.0)

Note:

* All patients of Japanese decent.

Table 2 Frequency of ADEs due to rivastigmine in patients with AD (n=312)

Category of ADEs	Male	Female	Total	Frequency of ADEsa (%)
Cutaneous application site reactions	54	132	186	59.6
Gastrointestinal disorders	7	22	29	9.3
Metabolic/nutritional disorders	1	6	7	2.2
Psychiatric disorders	7	8	15	4.8
Nervous system disorders	2	2	4	1.3
Hallucinations	0	1	1	0.3
Other symptoms	0	2	2	0.6
Total	61	148	209	67.0

Note:

a With >1 manifestation.

Abbreviations: AD, Alzheimer’s disease; ADE, adverse drug event.

Table 3 Number of patients who ADEs by rivastigmine dose (n=209)

Dose	Male	Female	Total	Frequency of ADEs (%)
4.5 mg	10	32	42	20.1
9.0 mg	20	52	72	34.4
13.5 mg	11	21	32	15.3
18.0 mg	20	43	63	30.1
Total	61	148	209

Abbreviation: ADE, adverse drug event.

Table 4 Main reasons for discontinuing rivastigmine patch application (n=118)

Main reason	Male	Female	Total	Frequency of discontinuing rivastigmine (%)
Cutaneous application site reactions	19	55	74	62.7
Gastrointestinal disorders	2	3	5	4.2
Metabolic/nutritional disorders	0	0	0	0
Psychiatric disorders	1	5	6	5.1
Nervous system disorders	0	0	0	0
Other symptoms	0	1	1	0.8
Others	8	24	32	27.1
Total	30	88	118

Table 5 Frequency of specific application site reactions that led to discontinuation (n=74)

Main reason for discontinuation	Male	Female	Total	Frequency of discontinuing rivastigmine (%)
Contact dermatitis	15	41	56	75.7
Pruritus	4	12	16	21.6
Erythema	0	2	2	2.7
Total	19	55	74

Figure 2 Flowchart of discontinuing rivastigmine patch application due to cutaneous application site reactions.

Abbreviation: ADE, adverse drug event.

Table 6 Doses at the time of discontinuation due to cutaneous application site reactions (n=74)

Dose	Male	Female	Total	Frequency of discontinuing rivastigmine (%)
4.5 mg	5	17	22	29.7
9.0 mg	10	27	37	50.0
13.5 mg	4	6	10	13.5
18.0 mg	0	5	5	6.8
Total	19	55	74

Note: Patch size: 4.5 mg =2.5 cm², 9.0 mg =5.0 cm², 13.5 mg =7.5 cm², 18.0 mg =10.0 cm².