title: Use of OROS® hydromorphone in the treatment of osteoarthritis and osteoporosis: A pooled analysis of three non-interventional studies focusing on different starting doses.
abstract: OBJECTIVE
  To determine the effect of a lower starting dose of OROS® hydromorphone compared with a higher starting dose.
  
  
  METHODS
  Data from the first 15 days of treatment were compared in a combined analysis of three prospective, non-interventional studies.
  
  
  METHODS
  Non-interventional, carried out in daily routine settings.
  
  
  METHODS
  Patients had chronic severe pain due to osteoarthritis or from fragility fractures related to osteoporosis.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
authors: Direktor der Med. Klinik 4, Allgemeine Innere und Westdeutsches Osteoporose Zentrum, Klinikum Leverkusen GmbH, Leverkusen, Germany.
authors: Johann D
authors: JD
authors: Ringe
authors: Susanne
authors: S
authors: Schäfer
authors: Antonie M
authors: AM
authors: Wimmer
authors: Thorsten
authors: T
authors: Giesecke
mesh_terms: D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D005260:Female; D005858:Germany; D006801:Humans; D004091:Hydromorphone / Q000008:administration & dosage*; D008297:Male; D010003:Osteoarthritis / Q000188:drug therapy* / Q000209:etiology; D010024:Osteoporosis / Q000150:complications / Q000188:drug therapy*; D010146:Pain / Q000209:etiology / Q000517:prevention & control*; D010147:Pain Measurement / Q000187:drug effects; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D004091:Hydromorphone