Long-term efficacy and safety of oxycodone–naloxone prolonged release in geriatric patients with moderate-to-severe chronic noncancer pain: a 52-week open-label extension phase study

Figures & data

Table 1 Demographic and baseline characteristics of the study population

Demographic and baseline characteristics	N=60
Age, years (median; range)	81.7±5.7 (83; 70–94)
Patients >80 years, n (%)	36 (60)
Females/males, n (%)	48/12 (80.0/20.0)
Pain intensity, mean NRS scorea	6.7±1.2
Pain intensity at rest, NRS score	6.0±1.9
Pain intensity on movement, NRS score	8.1±0.9
Daily pain intensity, NRS score	7.6±1.0
Nocturnal pain intensity, NRS score	5.2±2.2
Previous analgesic treatment, n (%)
Step I WHO drugs
NSAIDs	7 (11.7)
Acetaminophen	39 (65.0)
WHO step 2 drugs
Codeine	5 (8.3)
Tramadol	17 (28.3)
Rescue analgesics, n (%)	51 (85.0)
Cognitive state, MMSE score (median)	25.7±2.7 (26)
Daily functioning, Barthel Index score (median)	53.9±13.9 (55.0)
Brief Pain Inventory, composite scoreb (median)	6.0±1.6 (6.4)
Bowel function, BFI score (median)	35.9±19.1 (40.0)

Notes: All values are expressed as numbers (percent) or mean ± standard deviation, if not otherwise reported. The sum of percentages may not be equal to 100 due to rounding.

a Expressed as mean of each single day assessment for the four daily items.

b Pain interference composite score comprising the seven Brief Pain Inventory measures of interference of pain in the patient’s daily life.

Abbreviations: BFI, Bowel Function Index; MMSE, Mini-Mental State Examination; NRS, Numerical Rating Scale; NSAIDs, nonsteroidal anti-inflammatory drugs; WHO, World Health Organization.

Figure 1 Flowchart of patient disposition throughout the study.

Table 2 Pain intensity (NRS score) during the 52 weeks of oxycodone/naloxone prolonged-release treatment

Parameter	T0	T4	T52	P-valueb
Pain at rest, mean ± SD	6.0±1.9	2.8±1.7*	1.7±1.4**	<0.0001
Pain on movement, mean ± SD	8.0±1.0	4.4±2.0*	3.5±1.2***	<0.0001
Pain at daytime, mean ± SD	7.5±1.1	3.9±2.3*	3.4±1.3#	<0.0001
Pain at nighttime, mean ± SD	5.3±2.2	2.2±1.9*	1.1±1.3*	<0.0001
Pain intensity, mean ± SDa	6.7±1.2	3.3±1.8**	2.4±1.1**	<0.0001

Notes: Included in this analysis were all patients completing the 52-weeks treatment (n=50).

a Expressed as mean of each single day assessment for the four daily items;

b 52 weeks versus baseline;

* P<0.0001 versus previous observation;

** P=0.0003 versus previous observation;

*** P=0.0024 versus previous observation;

# P=0.0670 versus previous observation.

Abbreviations: NRS, Numerical Rating Scale; SD, standard deviation.

Figure 2 Distribution of OXN-PR daily dosages throughout the observation (expressed in oxycodone equivalents).

Abbreviation: OXN-PR, prolonged-release oxycodone–naloxone.

Figure 3 Value of secondary outcomes (BPI, MMSE, and Barthel Index) at different time points of the observations.

Abbreviations: BPI, Brief Pain Inventory; MMSE, Mini-Mental State Examination.

Figure 4 Value of Bowel Function Index at different time points of the observations.

Figure 5 Prevalence and severity of commonly observed opioid-related side effects and tremor at the different points of the observation.

Notes: Symptom severity rated on an 11-point scale (0= absent; 1–3= mild; 4–6= moderate; 7–10= severe).