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.
