Skip to main content
SpringerLink
Log in

Use of OROS® hydromorphone in the treatment of osteoarthritis and osteoporosis: A pooled analysis of three non-interventional studies focusing on different starting doses

Anwendung von OROS® Hydromorphon in der Behandlung von Arthrose- und Osteoporoseschmerzen; eine gepoolte Analyse von drei nicht-interventionellen Studien mit verschiedenen Startdosen

  • Original article
  • Published:
Wiener klinische Wochenschrift Aims and scope Submit manuscript

Zusammenfassung

ZIEL: Vergleich der Wirksamkeit einer niedrigeren Anfangsdosis von OROS® Hydromorphon zu einer höheren Anfangsdosis. Design: In einer gepoolten Analyse von drei prospektiven, nicht-interventionellen Studien wurden Daten von den ersten 15 Tagen der Behandlung verglichen. STUDIE: Prospektiv, nicht-interventionell unter Alltagsbedingungen. PATIENTEN: Patienten mit starken chronischen Arthrose- bzw. Osteoporoseschmerzen MEDIKATION: In OROS-ANA-4001 und OROS-ANA-4002 erhielten die Patienten zu Therapiebeginn 8 mg OROS® Hydromorphon einmal täglich; in OROS-ANA-4003 4 mg Hydromorphon einmal täglich. ZIELPARAMETER: Post-hoc Analyse bezüglich Wirksamkeit, Verträglichkeit, Schmerzstärke und allgemeine Therapiezufriedenheit mit einer reduzierten Anfangsdosis von OROS® Hydromorphon bei Opioid-naiven Patienten im Vergleich mit Patienten, die vorher mit Opioiden behandelt wurden, sowie ein Vergleich von Patienten im Alter >65 Jahre und Patienten im Alter ≤65 Jahre. ERGEBNISSE: Therapiezufriedenheit und Schmerzkontrolle verbesserten sich in jeder Studie; die Therapiezufriedenheit verbesserte sich in einem höheren Prozentsatz bei Patienten in der niedrigeren Anfangsdosis-Gruppe. Gastrointestinale Störungen waren die häufigsten behandlungsbedingten Nebenwirkungen. Das Auftreten von Übelkeit war in beiden Studien ähnlich. Obstipation, Verstopfung, Erbrechen Erschöpfung und Pruritus traten unter der niedrigeren Anfangsdosis weniger häufig auf. Eine niedrigere Anfangsdosis führte bei älteren und opioidnaiven Patienten seltener zu unerwünschten Ereignissen, zu behandlungsbedingten unerwünschten Ereignissen und zu Therapieabbrüchen aufgrund von unerwünschten Ereignissen. SCHLUSSFOLGERUNG: Eine niedrigere Anfangsdosis führte zu einer besseren Verträglichkeit, und selteneren Therapieabbrüchen bei vergleichbarer Schmerzkontrolle mit hoher Therapiezufriedenheit.

Summary

OBJECTIVE: To determine the effect of a lower starting dose of OROS® hydromorphone compared with a higher starting dose. DESIGN: Data from the first 15 days of treatment were compared in a combined analysis of three prospective, non-interventional studies. SETTING: Non-interventional, carried out in daily routine settings. PATIENTS: Patients had chronic severe pain due to osteoarthritis or from fragility fractures related to osteoporosis. INTERVENTIONS: OROS-ANA-4001 and OROS-ANA-4002 had a daily starting dose of 8 mg of OROS® hydromorphone; OROS-ANA-4003 had a daily starting dose of 4 mg. MAIN OUTCOME MEASURE(S): A post-hoc analysis to assess the effect of a low starting dose of OROS® hydromorphone on tolerability, pain control, and treatment satisfaction overall and for subgroups of opioid-naïve patients versus patients previously treated with opioids, and patients aged >65 years versus patients aged ≤65 years. RESULTS: Treatment satisfaction and pain control improved in all studies; treatment satisfaction improved in a higher percentage of patients in the lower starting dose group. Gastrointestinal disorders were the most frequent treatment-emergent adverse events. Incidence of nausea was comparable between studies. Incidence of constipation, vomiting, fatigue, and pruritus was less frequent with the lower starting dose. In elderly and opioid-naïve patients, a lower starting dose was associated with lower overall incidence of adverse events, treatment-related adverse events, and those leading to discontinuation. CONCLUSIONS: A lower starting dose was associated with better tolerability and a lower number of treatment terminations at a comparable level of pain control with high treatment satisfaction.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

References

  • Gupta S, Hawker GA, Laporte A, Croxford R, Coyte PC. The economic burden of disabling hip and knee osteoarthritis (OA) from the perspective of individuals living with this condition. Rheumatology (Oxford) 2005;44(12):1531–7

    Article  CAS  Google Scholar 

  • Ethgen O, Kahler KH, Kong SX, Reginster JY, Wolfe F. The effect of health related quality of life on reported use of health care resources in patients with osteoarthritis and rheumatoid arthritis: a longitudinal analysis. J Rheumatol 2002;29(6):1147–55

    PubMed  Google Scholar 

  • Rabenda V, Manette C, Lemmens R, Mariani AM, Struvay N, Reginster JY. Direct and indirect costs attributable to osteoarthritis in active subjects. J Rheumatol 2006;33(6):1152–8

    PubMed  Google Scholar 

  • Furlan AD, Sandoval JA, Mailis-Gagnon A, Tunks E. Opioids for chronic noncancer pain: a meta-analysis of effectiveness and side effects. CMAJ 2006;174(11):1589–94

    Article  PubMed  Google Scholar 

  • Ballantyne J, Mao J. Opioid therapy for chronic pain. N Engl J Med 2003;349(20):1943–53

    Article  PubMed  CAS  Google Scholar 

  • Otis J, Rothman M. A phase III study to assess the clinical utility of low-dose fentanyl transdermal system in patients with chronic non-malignant pain. Curr Med Res Opin 2006;22(8):1493–501

    Article  PubMed  CAS  Google Scholar 

  • Palangio M, Northfelt DW, Portenoy RK, et al. Dose conversion and titration with a novel once-daily, OROS osmotic technology, extended-release hydromorphone formulation in the treatment of chronic malignant or non-malignant pain. J Pain Symptom Manage 2002;23(5):355–68

    Article  PubMed  CAS  Google Scholar 

  • Drover DR, Angst MS, Valle M, et al. Input characteristics and bioavailability after administration of immediate and a new extended-release formulation of hydromorphone in healthy volunteers. Anesthesiology 2001;97(4):827–36

    Article  Google Scholar 

  • Angst MS, Drover DR, Lotsch J, et al. Pharmacodynamics of orally administered sustained-release hydromorphone in humans. Anesthesiology 2001;94(1):63–73

    Article  PubMed  CAS  Google Scholar 

  • Sathyan G, Xu E, Thipphawong J, Gupta SK. Pharmacokinetic profile of a 24-hour controlled-release OROS® formulation of hydromorphone in the presence and absence of food. BMC Clin Pharmacol 2007;7:2

    Article  PubMed  Google Scholar 

  • Sathyan G, Sivakumar K, Thipphawong J. Pharmacokinetic profile of a 24-hour controlled release OROS® formulation of hydromorphone in the presence of alcohol. Curr Med Res Opin 2008;24(1):297–305

    Article  PubMed  CAS  Google Scholar 

  • Hanna M, Thipphawong J, DO-118 Study Group. A randomized, double-blind comparison of OROS® hydromorphone and SR morphine for patients with chronic cancer pain. BMC Palliative Care 2008;7:17

    PubMed  Google Scholar 

  • Wallace M, Rauck RL, Moulin D, Thipphawong J, Khanna S, Tudor IC. Once-daily OROS® hydromorphone for the management of chronic non-malignant pain: a dose-conversion and titration study. Int J Clin Pract 2007;61(10):1671–6

    Article  PubMed  CAS  Google Scholar 

  • Hale M, Tudor JC, Khanna S, Thipphawong J. Efficacy and tolerability of once-daily OROS® hydromorphone and twice-daily extended-release oxycodone in patients with chronic, moderate to severe osteoarthritis pain: results of a 6-week, randomized, open-label, noninferiority analysis. Clin Ther 2007;29(5):874–88

    Article  PubMed  CAS  Google Scholar 

  • Hale M, Khan A, Kutch M, Li S. Once-daily OROS® hydromorphone ER compared with placebo in opioid-tolerant patients with chronic low back pain. Curr Med Res Opin 2010;26(6):1505–18

    Article  PubMed  CAS  Google Scholar 

  • Binsfeld H, Szczepanski L, Waechter S, Richarz U, Sabatowski R. A randomized study to demonstrate noninferiority of once-daily OROS® hydromorphone with twice-daily sustained-release oxycodone for moderate to severe chronic noncancer pain. Pain Pract 2010;10(5):404–15

    Article  PubMed  Google Scholar 

  • Ringe JD, Djelani M, Giesecke T. Convenience of dose regimen with OROS® hydromorphone and use of breakthrough medication in patients with chronic severe pain due to osteoporosis and osteoarthritis. Poster presented at Deutsche Gesellschaft zum Studium des Schmerzes EV. (DGSS) meeting 7–10 October 2009, Berlin, Germany

  • Horlemann J, Djelani M, Giesecke T. Initial treatment with OROS® hydromorphone in patients with chronic severe pain due to osteoporosis and arthritis in a daily routine setting. Poster presented at Deutsche Gesellschaft sum Studium des Schmerzes EV. (DGSS) meeting 7–10 October 2009, Berlin, Germany

  • Ringe JD, Djelani M, Giesecke T. OROS® hydromorphone in elderly patients with chronic severe pain due to osteoporosis and osteoarthritis in a daily routine setting. Poster presented at Deutsche Gesellschaft zum Stadium des Schmerzes EV. (DGSS) meeting 7–10 October 2009, Berlin, Germany

  • Giesecke T, Djelani M. Tolerability and treatment satisfaction with OROS® hydromorphone 4 mg compared to higher starting doses in patients with chronic severe pain due to chronic osteoporosis and arthritis. Poster presented at Deutsche Geselleschaft xum Studium des Schmerzes EV. (DGSS) meeting 7–10 October 2009, Berlin, Germany

  • Guy W. Clinical Global Impression. ECDEU Assessment Manual for Psychopharmacology, revised National Institute of Mental Health, Rockville, MD. 1976

  • Patanwala AE, Jarzyna DL, Miller MD, Erstad BL. Comparison of opioid requirements and analgesic response in opioid-tolerant versus opioid-naïve patients after total knee arthroplasty. Pharmacotherapy 2008;28(12):1453–60

    Article  PubMed  Google Scholar 

  • de Leon-Casasola OA, Myers DP, Donaparthi S, et al. A comparison of postoperative epidural analgesia between patients with chronic cancer taking high doses of oral opioids versus opioid-naïve patients. Anesth Analg 1993;76(2):302–7

    PubMed  CAS  Google Scholar 

  • Benyamin R, Trescot AM, Datta S, et al. Opioid complications and side effects. Pain Physician 2008;11(2):S105–20

    PubMed  Google Scholar 

  • Gana TJ, Pascual ML, Fleming RR, et al. Extended-release tramadol in the treatment of osteoarthritis: a multicenter, randomized, double-blind, placebo-controlled clinical trial. Curr Med Res Opin 2006;22(7):1391–401

    Article  PubMed  CAS  Google Scholar 

  • Koizumi W, Toma H, Watanabe K, et al. Efficacy and tolerability of cancer pain management with controlled-release oxycodone tablets in opioid-naïve cancer pain patients, starting with 5 mg tablets. Jpn J Clin Oncol 2004;34(10):608–14

    Article  PubMed  Google Scholar 

  • Giesecke T, Bornhövd K. Treatment satisfaction after treatment initiation with transdermal fentanyl 12.5 µG/H (Durogesic® SMAT12) in patients with chronic non-malignant pain. Abstracts of pain in the 5th Congress of the European Federation of IASP Chapters (EFIC), 13–16 September 2006, Istanbul, Turkey

  • Stumpf M, Bornhövd K. Treatment-initiation with transdermal fentanyl 12.5 µG/H compared to transdermal fentanyl ≥25 µG/H (Durogesic® SMAT) in patients with chronic non-malignant pain. Abstracts of pain in the 5th Congress of the European Federation of IASP Chapters (EFIC), 13–16 September 2006, Istanbul, Turkey

  • Klepstad P, Dale O, Skorpen F, Borchgrevink PC, Kaasa S. Genetic variability and clinical efficacy of morphine. Acta Anaesthesiol Scand 2005;49(7):902–8

    Article  PubMed  CAS  Google Scholar 

  • Ross JR, Rutter D, Welsh K, et al. Clinical response to morphine in cancer patients and genetic variation in candidate genes. Pharmacogenomics J 2005;5(5):324–36

    Article  PubMed  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Direktor der Med. Klinik 4, Allgemeine Innere und Westdeutsches Osteoporose Zentrum (WOZ), Klinikum Leverkusen GmbH, Leverkusen, Germany

    Johann D. Ringe

  2. AMS Advanced Medical Services GmbH, Mannheim, Germany

    Susanne Schäfer

  3. Janssen-Cilag GmbH, Neuss, Germany

    Antonie M. Wimmer & Thorsten Giesecke

Authors
  1. Johann D. Ringe
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Susanne Schäfer
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Antonie M. Wimmer
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Thorsten Giesecke
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Antonie M. Wimmer.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Ringe, J., Schäfer, S., Wimmer, A. et al. Use of OROS® hydromorphone in the treatment of osteoarthritis and osteoporosis: A pooled analysis of three non-interventional studies focusing on different starting doses. Wien Klin Wochenschr 124, 25–31 (2012). https://doi.org/10.1007/s00508-011-0076-y

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00508-011-0076-y

Keywords

Search

Navigation