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

• Published in: Wiener Klinische Wochenschrift Vol. 124; no. 1-2; pp. 25 - 31
• Main Authors: Ringe, Johann D., Schäfer, Susanne, Wimmer, Antonie M., Giesecke, Thorsten
• Format: Journal Article
• Language: English
• Published: Vienna Springer-Verlag 2012
• Subjects: Aged; Analgesics, Opioid - administration & dosage; Dose-Response Relationship, Drug; Endocrinology; Female; Gastroenterology; Germany; Humans; Hydromorphone - administration & dosage; Internal Medicine; Male; Medicine; Medicine & Public Health; Original Article; Osteoarthritis - drug therapy; Osteoarthritis - etiology; Osteoporosis - complications; Osteoporosis - drug therapy; Pain - etiology; Pain - prevention & control; Pain Measurement - drug effects; Pneumology/Respiratory System; Treatment Outcome; Germany; Hydromorphone; Opioid; Osteoporosis; Dosing; OROS; Osteoarthritis
• ISSN: 0043-5325; 1613-7671
• DOI: 10.1007/s00508-011-0076-y

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.