EQ-5D AND QUALITY OF LIFE OF OSTEOPOROSIS AT-RISK PATIENTS IN A SWEDISH OSTEOPOROSIS PATIENT REGISTRY

Arun Krishna1, Dan Mellström2, Zhiyi Li3, Chun-Po Steve Fan3, Stina Salomonsson4, Ewa Waern2

1 Merck & Co. Inc, US, 2Centre for Bone and Arthritis Research at Sahlgrenska Academy, University of Gothenburg, Göteborg, Sweden, 3AsclepiusAnalytics Ltd., Hong Kong, 4Merck & Co. Inc., Sweden

Background• Osteoporosis (OP) can be associated with profound physical,

psychological, and social disability in addition to skeletal fracture, musculoskeletal pain, kyphosis, and loss of weight• Studies of health-related quality of life (HRQoL) in OP have been

largely limited to cohorts of patients with established OP and prevalent fractures • Costs and effects of OP-related fracture study (KOFOR-study) in

Sweden showed the decrease in quality of life compared for having hip, vertebral, and wrist fracture was 0.17, 0.26, and 0.06, respectively (Borgström 2005, Ström 2008)

• Previous study on HRQoL among patients who’re at risk for OP was limited and results were ambiguous• The causal relationship between OP and HRQoL was unclear in

a study on 325 female subjects who had been referred for bone mass measurement (Dhillon 2005)

DataSwedish Osteoporosis Patient Registry Data• Collected from Göteborg region in West Sweden (~2 million

inhabitants); available from 1991 to 2009• Patients referred to the clinic for DXA to estimate BMD and

diagnosis of OP by GPs, Gynacologists,etc. • Questionnaire including:• Prior History of Fracture• Baseline OP characteristics (Smoking, alcohol, back pain, family

history)• EQ-5D (added in 2004)• Treatment (Currently and previously taken and reasons)• Co morbid conditions and concomitant medication• BMD scan results (HIP and LUMBAR SPINE)• Diagnosis (Normal, Osteopenia, established OP, OP, OP (Men))

Table 2. Analysis of HRQoL by age, gender, medication use, and types of visit

EQ-5D• EQ-5D is a standardised measure of health status developed by the

EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.• The EQ-5D-3L descriptive system comprises the following 5

dimensions: mobility, self-care, usual activities pain/discomfort and anxiety/depression.

• Each dimension has 3 levels: no problems, some problems, extreme problems.

• The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions (Figure1)• EQ-5D-3L descriptive system may be converted into a single

summary index by applying a formula that essentially attaches values (also called weights) to each of the levels in each dimension.• HRQoL was calculated using response from EQ-5D using European

weights.

Conclusions• In a Swedish OP registry, the average HRQoL based on EQ-5D was 0.7. • 34% reported some or extreme problems in mobility; 8% reported some or extreme problems in self-care; 28% reported some or extreme

problems in activities; 75% reported some or extreme problems in pain/discomfort; and 43% reported some or extreme problems in anxiety/depression.

• Clinical factors that were identified to impact patient reported QoL:• Previous fractures (post age 40), especially in arm, hip and vertebral; Falls during last year; Back pain; Comorbidities (especially asthma,

arthritis, and hypertension); Elder age; and Male.

Table 1. Patient selection

Objective• To assess health-related quality of life (HRQ0L) among all patients

who’re at risk for osteoporosis• To identify and quantify risk factors affecting HRQ0L among all

patients who’re at risk for osteoporosis

WCO-IOF-ESCEO

Seville, SpainApril 2 - 5

Study Design and Methods• A descriptive study using Swedish patient registry data• Inclusion criteria: All patients in the registry with EQ-5D measurement

• Cross-sectional study due to the fact that each patient in the study had only one EQ-5D measurement• EQ-5D/HRQoL compared by• Age (≤65 vs. >65), Gender (Female vs. Male), Medication use (Without vs.

With OP medication), and Types of visit (First vs. Subsequent)• Fracture (Yes vs. No), and further by type (e.g. wrist, ankle etc)

• In additional, multivariate analysis conducted using GLM, controlling for additional comorbidities

Poster P385

Figure 1. EQ-5D survey

N % Patient profile Female 2,884 89.0% Age (mean, std) 66 11.9 Height (cm) (mean, std) 164 8.3 Weight (kg) (mean, std) 67 16.6 Never smoked 1,519 46.9% Currently suffering from daily back pain 1,531 47.3% Falls

Number of falls during the last year None 489 15.1% 1 1,570 48.5% 2 917 28.3% 3 155 4.8% 4 95 2.9% 5 14 0.4% BMD at the time of patient visit T-score Lumbar spine Normal (T-score≥ 1) 939 29.5% Osteopenia (-2.5< T-score < -1) 1,288 40.5% Osteoporosis (T-score≤ -2.5) 957 30.1% Total hip Normal (T-score≥ 1) 1,115 35.4% Osteopenia (-2.5< T-score < -1) 1,563 49.6% Osteoporosis (T-score≤ -2.5) 474 15.0% Patient-reported drug treatment received at the time of patient visit BIS 771 23.8% Teriparatide 19 0.6% Raloxifene 186 5.7% Estrogen 664 20.5% Calcium + D-vitamin 1,822 56.2%

Results• 3,240 patients completed the EQ-5D questionnaire. • 89% were female, average age was 66 [SD=11.9] (Table 1)• For EQ-5D measures, 34.1% reported problems in mobility, 8.0% in self-care,

27.8% in usual activities, 74.7% in pain/discomfort, and 43.3% in anxiety/depression. Average HRQoL was 0.7 [SD=0.2]. (Table 2)• Compared with patients receiving OP medication (bisphosphonates, raloxifene,

teriparatide, estrogen), those without reported more pain or discomfort (77% vs. 73%; p=0.01). New patients had lower HRQoL than returning patients (0.68 vs. 0.72; p<0.01). (Table 2)• Patients with a history of fractures had lower HRQoL than those without

fractures (0.69 vs. 0.71; p<0.01). Among those with fractures, lower HRQoL was indicated in patients with hip (0.62), vertebral (0.63) and arm (0.66) fractures. (Table 3)• Based on GLM, other factors affecting HRQoL included elder age, history of falls

and comorbidities (hypertension, arthritis, and asthma). (Not shown)

All patients

Age group Gender Medication use Types of visit

Young (<=65) Old (>65) P-value Female Male P-value Without

OP MedWith OP

Med P-value First visit Subsequent visit P-value

N 3,240 1,472 1,768 2,884 356 1,811 1,429 1,569 1,671 EQ5D Mobility 0.0000 0.0015 0.0898 0.0054 1= I have no problems in walking about 65.9% 73% 60% 67% 59% 67% 65% 63% 68% 2= I have some problems in walking about 33.7% 27% 39% 33% 40% 33% 35% 36% 31% 3= I am confined to bed 0.4% 0% 0% 0% 1% 1% 0% 1% 0% Self-care 0.2318 0.0007 0.4582 0.1427 1= I have no problems with self-care 92.0% 93% 91% 93% 87% 92% 92% 91% 93% 2= I have some problems washing or dressing myself 7.1% 7% 8% 7% 12% 7% 7% 8% 6% 3= I am unable to wash or dress myself 0.9% 1% 1% 1% 1% 1% 1% 1% 1% Activities 0.5015 0.0091 0.3243 0.0084 1= I have no problems with performing my usual activities 72.2% 73% 71% 73% 66% 71% 74% 70% 75%

2= I have some problems with performing my usually activities

24.1% 23% 25% 24% 28% 25% 23% 26% 22%

3= I am unable to perform my usual activities 3.6% 4% 4% 3% 6% 4% 3% 4% 3% Pain/discomfort 0.0022 0.8770 0.0146 0.0001 1= I have no pain or discomfort 25.3% 28% 23% 25% 26% 27% 23% 23% 28% 2= I have moderate pain or discomfort 62.9% 60% 65% 63% 62% 61% 66% 63% 62% 3= I have extreme pain or discomfort 11.7% 12% 12% 12% 12% 12% 11% 14% 10% Anxiety/Depression 0.1356 0.0829 0.1370 0.0000 1= I am not anxious or depressed 56.7% 57% 57% 56% 61% 55% 59% 52% 61% 2= I am moderately anxious or depressed 39.9% 39% 40% 41% 35% 41% 38% 44% 36% 3= I am extremely anxious or depressed 3.5% 4% 3% 3% 4% 4% 3% 4% 3% Mean QOL Score Euro 0.70 0.71 0.69 0.0010 0.70 0.69 0.2455 0.70 0.71 0.9553 0.68 0.72 0.0000

Table 3. Analysis of HRQoL by fracture Fracture Types of fracture

No Fracture Fracture P-value Wrist Ankle Arm Vertebral Hip

N 1,782 1,458 655 274 190 287 199 EQ5D Mobility 0.0000 1= I have no problems in walking about 70% 61% 66% 58% 51% 51% 39% 2= I have some problems in walking about 30% 39% 34% 42% 48% 48% 61% 3= I am confined to bed 0% 0% 0% 0% 2% 1% 1% Self-care 0.1023 1= I have no problems with self-care 93% 91% 93% 93% 85% 89% 81% 2= I have some problems washing or dressing myself 6% 8% 7% 7% 12% 10% 17% 3= I am unable to wash or dress myself 1% 1% 1% 0% 3% 1% 3% Activities 0.0029 1= I have no problems with performing my usual activities 74% 69% 73% 70% 61% 58% 57% 2= I have some problems with performing my usually activities 23% 26% 25% 27% 33% 36% 32% 3= I am unable to perform my usual activities 3% 4% 3% 2% 6% 7% 12% Pain/discomfort 0.4603 1= I have no pain or discomfort 26% 24% 29% 23% 24% 12% 21% 2= I have moderate pain or discomfort 62% 64% 61% 63% 61% 70% 61% 3= I have extreme pain or discomfort 11% 12% 11% 14% 15% 18% 18% Anxiety/Depression 0.2354 1= I am not anxious or depressed 58% 56% 59% 57% 56% 48% 54% 2= I am moderately anxious or depressed 39% 40% 38% 38% 37% 49% 40% 3= I am extremely anxious or depressed 3% 4% 3% 6% 7% 3% 6%Mean QOL Score Euro 0.71 0.69 0.0008 0.72 0.69 0.66 0.63 0.62