Switching to low-dose oral prolonged-release oxycodone/naloxone from WHO-Step I drugs in elderly patients with chronic pain at high risk of early opioid discontinuation

Figures & data

Table 1 Demographic and baseline characteristics of the study population (N=186)

Variable	Value
Age, years, mean (SD)	80.7 (4.7)
Age >85 years, n (%)	38 (20.4)
Women, n (%)	120 (64.5)
Active cancer, n (%)	17 (9.1)
Average pain intensity (NRS), mean (SD)	7.1 (1.0)
Severe pain,a n (%)	129 (69.4)
Predominant cause of pain, n (%)
Osteoarthritis	34 (18.3)
Radiculopathy	69 (37.1)
Vertebral compression, collapse, spondylolisthesis	16 (8.6)
Neuropathies	57 (30.6)
Diabetic	20 (10.8)
Post-herpetic	19 (10.2)
Other neuropathies	18 (9.7)
Other causes	10 (5.4)
Around-the-clock analgesics, n (%)	92 (49.5)
NSAIDs	87 (46.8)
Acetaminophen	5 (2.7)
OTC NSAIDs or acetaminophen on-demand only	63 (33.9)
Adjuvants, n (%)	47 (25.3)
Anticonvulsants	31 (16.7)
Glucocorticoids	16 (8.6)
Use of rescue analgesicb in patients (n=123) receivingaround-the-clock analgesics and/or adjuvants, n (%)	77 (62.6)
Daily doses, mean (SD)	2.0 (0.7)
BFI, mean (SD)	64.1 (24.4)
Use of laxatives, n (%)	166 (89.2)
Weekly doses, mean (SD)	4.7 (1.7)

Notes:

a Severe pain defined as NRS ≥7.

b Oral acetaminophen (paracetamol) 500–1,000 mg taken in addition to current analgesics or adjuvants.

Abbreviations: BFI, Bowel Function Index; NRS, numerical rating scale; NSAIDs, nonsteroidal anti-inflammatory drugs; OTC, over-the-counter; SD, standard deviation.

Figure 1 Changes in average pain severity score measured on an 11-point NRS during the 60-day treatment with OXN-PR.

Notes: *P=0.02 T60 vs T30 result; **P<0.0001 T30 vs T15 result.

Abbreviations: NRS, numerical rating scale; OXN-PR, prolonged-release oxycodone/naloxone; T0, baseline; T15, day 15; T30, day 30; T60, day 60.

Figure 2 Waterfall image of individual changes in pain severity after 30 days of treatment with OXN-PR.

Notes: Decreases in pain severity from baseline ≥30% indicate analgesic efficacy (below the dashed line). A 30%–49% (dash-dot line), 50%–69%, and 70%–100% (below the dotted line) decrease in pain severity was reported by 18%, 41%, and 32% patients, respectively. Only 9% patients reported lack of analgesic efficacy or worsened pain after OXN-PR.
Abbreviation: OXN-PR, prolonged-release oxycodone/naloxone.

Figure 3 Changes in bowel function according to the Bowel Function Index during the 60-day treatment with OXN-PR.

Note: **P<0.0001 T30 vs T15 result.
Abbreviations: OXN-PR, prolonged-release oxycodone/naloxone; T0, baseline; T15, day 15; T30, day 30; T60, day.

Figure 4 Changes in (A) average pain severity score measured on an 11-point NRS and (B) bowel function in the age subgroups 75–85 years (n=148) and >85 years (n=38).

Notes: **P<0.0001 T30 vs T15 result. No differences between subgroups at all time points.
Abbreviations: NRS, numerical rating scale; T0, baseline; T15, day 15; T30, day 30; T60, day 60.

Figure 5 PGIC scale analysis after 15 days (T15), 30 days (T30), and 60 days (T60) with OXN-PR.

Note: “Extremely worsened” of the PGIC scale is not shown, as no patient reported extreme worsening.
Abbreviations: PGIC, Patient Global Impression of Change; OXN-PR, prolonged-release oxycodone/naloxone.