Clin Orthop Surg.  2020 Mar;12(1):86-93. 10.4055/cios.2020.12.1.86.

Factors Affecting Quality of Life and Satisfaction in Patients with Arthritis after Change to a Fixed-Dose Naproxen/Esomeprazole Combination Drug

• Park D
• Kwon Y

• KMID: 2470055
• DOI: http://doi.org/10.4055/cios.2020.12.1.86

Abstract

BACKGROUND
In drug therapy for patients with arthritis, a naproxen/esomeprazole combination drug may be a tolerable choice because it can minimize gastrointestinal and cardiovascular adverse effects. The aim of this study was to investigate the changes in quality of life (QOL), medication adherence, and satisfaction after switch from the existing drug to the combination drug. In addition, we analyzed the correlation between the above-mentioned variables and the stratified demographic and medical data of the patients.
METHODS
A prospective, noninterventional, observational study was conducted in 30 hospitals between May 2014 and July 2016. In total, 2,308 patients with osteoarthritis, 99 patients with rheumatoid arthritis, and 76 patients with ankylosing spondylitis were enrolled. Demographic information (age, sex, body mass index [BMI], alcohol consumption, and smoking) and medical information (type of arthritis, duration of disease, and comorbidities) were collected via a self-administered questionnaire. Patients were observed for more than three months after switching to the combination drug. Data on the QOL (EuroQoL 5-Dimension questionnaire [EQ-5D questionnaire]), medication adherence (Morisky Medication Adherence Scale [MMAS]), and satisfaction were collected at the first and last visits.
RESULTS
A total of 2,483 patients enrolled at 30 hospitals completed the questionnaire. After the switch to the combination drug, the mean EQ-5D score improved from 0.72 ± 0.17 to 0.79 ± 0.14 (p < 0.001), and significant improvement was associated with female sex (p = 0.016), shorter disease duration (p < 0.001), and absence of comorbidities (p < 0.001). The mean MMAS score was 6.38 ± 1.77, indicating medium adherence. Satisfaction was significantly higher in female patients (p < 0.001), in patients with a shorter disease duration (p < 0.001), osteoarthritis (p = 0.003), and no comorbidities (p < 0.001). Serious drug-related adverse effects did not occur.
CONCLUSIONS
The overall QOL was improved with medium adherence after the switch to the combination drug. On the basis of the analysis of stratified data, sex, age, drinking, smoking, disease duration, comorbidities, and BMI might be associated with QOL, satisfaction, and adherence.

Keyword

Nonsteroidal anti-inflammatory drugs; Arthritis; Naproxen; Quality of life

MeSH Terms

Alcohol Drinking
Arthritis*
Arthritis, Rheumatoid
Body Mass Index
Comorbidity
Drinking
Drug Therapy
Female
Humans
Medication Adherence
Naproxen
Observational Study
Osteoarthritis
Prospective Studies
Quality of Life*
Smoke
Smoking
Spondylitis, Ankylosing
Naproxen
Smoke

Reference

1. Paulose-Ram R, Hirsch R, Dillon C, Gu Q. Frequent monthly use of selected non-prescription and prescription non-narcotic analgesics among U.S. adults. Pharmacoepidemiol Drug Saf. 2005; 14(4):257–266.

2. Lanas A, Ferrandez A. Inappropriate prevention of NSAID-induced gastrointestinal events among long-term users in the elderly. Drugs Aging. 2007; 24(2):121–131.

3. Smith SR, Deshpande BR, Collins JE, Katz JN, Losina E. Comparative pain reduction of oral non-steroidal anti-inflammatory drugs and opioids for knee osteoarthritis: systematic analytic review. Osteoarthritis Cartilage. 2016; 24(6):962–972.

4. Korean Knee Society Subcommittee on Osteoarthritis Guidelines. Guidelines for the treatment of osteoarthritis of the knee. J Korean Knee Soc. 2010; 22(1):69–74.

5. Lanza FL, Chan FK, Quigley EM. Practice Parameters Committee of the American College of Gastroenterology. Guidelines for prevention of NSAID-related ulcer complications. Am J Gastroenterol. 2009; 104(3):728–738.

6. Kearney PM, Baigent C, Godwin J, Halls H, Emberson JR, Patrono C. Do selective cyclo-oxygenase-2 inhibitors and traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trials. BMJ. 2006; 332(7553):1302–1308.

7. Datto C, Hellmund R, Siddiqui MK. Efficacy and tolerability of naproxen/esomeprazole magnesium tablets compared with non-specific NSAIDs and COX-2 inhibitors: a systematic review and network analyses. Open Access Rheumatol. 2013; 5:1–19.

8. La Montagna G, Tirri G, Cacace E, et al. Quality of life assessment during six months of NSAID treatment [Gonarthrosis and Quality of Life (GOAL) Study]. Clin Exp Rheumatol. 1998; 16(1):49–54.

9. Fagnani F, Bouvenot G, Valat JP, et al. Medico-economic analysis of diacerein with or without standard therapy in the treatment of osteoarthritis. Pharmacoeconomics. 1998; 13(1 Pt 2):135–146.

10. Gabriel SE, Campion ME, O'Fallon WM. Patient preferences for nonsteroidal antiinflammatory drug related gastrointestinal complications and their prophylaxis. J Rheumatol. 1993; 20(2):358–361.

11. Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001; 33(5):337–343.

12. Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care. 2003; 41(5):582–592.

13. Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008; 10(5):348–354.

14. Laine L, Connors L, Griffin MR, Curtis SP, Kaur A, Cannon CP. Prescription rates of protective co-therapy for NSAID users at high GI risk and results of attempts to improve adherence to guidelines. Aliment Pharmacol Ther. 2009; 30(7):767–774.

15. Kim HC, Lee MC, Moon YW, et al. The pattern of use of oral NSAIDs with or without co-prescription of gastroprotective agent for arthritic knee by Korean practitioners. Knee Surg Relat Res. 2011; 23(4):203–207.

16. Sturkenboom MC, Burke TA, Dieleman JP, Tangelder MJ, Lee F, Goldstein JL. Underutilization of preventive strategies in patients receiving NSAIDs. Rheumatology (Oxford). 2003; 42 Suppl 3:iii23–iii31.

17. Abraham NS, El-Serag HB, Johnson ML, et al. National adherence to evidence-based guidelines for the prescription of nonsteroidal anti-inflammatory drugs. Gastroenterology. 2005; 129(4):1171–1178.

18. Stockl K, Cyprien L, Chang EY. Gastrointestinal bleeding rates among managed care patients newly started on cox-2 inhibitors or nonselective NSAIDs. J Manag Care Pharm. 2005; 11(7):550–558.

19. Warner TD, Mitchell JA. COX-2 selectivity alone does not define the cardiovascular risks associated with non-steroidal anti-inflammatory drugs. Lancet. 2008; 371(9608):270–273.

20. Chan FK, Abraham NS, Scheiman JM, Laine L. First International Working Party on Gastrointestinal and Cardiovascular Effects of Nonsteroidal Anti-inflammatory Drugs and Anti-platelet Agents. Management of patients on nonsteroidal anti-inflammatory drugs: a clinical practice recommendation from the First International Working Party on Gastrointestinal and Cardiovascular Effects of Nonsteroidal Anti-inflammatory Drugs and Anti-platelet Agents. Am J Gastroenterol. 2008; 103(11):2908–2918.

21. Hochberg MC, Fort JG, Svensson O, Hwang C, Sostek M. Fixed-dose combination of enteric-coated naproxen and immediate-release esomeprazole has comparable efficacy to celecoxib for knee osteoarthritis: two randomized trials. Curr Med Res Opin. 2011; 27(6):1243–1253.

22. Scheiman JM, Hindley CE. Strategies to optimize treatment with NSAIDs in patients at risk for gastrointestinal and cardiovascular adverse events. Clin Ther. 2010; 32(4):667–677.

23. Eusebi LH, Rabitti S, Artesiani ML, et al. Proton pump inhibitors: risks of long-term use. J Gastroenterol Hepatol. 2017; 32(7):1295–1302.

24. Latimer N, Lord J, Grant RL, et al. Cost effectiveness of COX 2 selective inhibitors and traditional NSAIDs alone or in combination with a proton pump inhibitor for people with osteoarthritis. BMJ. 2009; 339:b2538.

25. Yeomans N, Wilson I, Langstrom G, et al. Quality of life in chronic NSAID users: a comparison of the effect of omeprazole and misoprostol. Scand J Rheumatol. 2001; 30(6):328–334.