Trial reportWiener klinische Wochenschrift2012
Use of OROS® hydromorphone in the treatment of osteoarthritis and osteoporosis: A pooled analysis of three non-interventional studies focusing on different starting doses.
Trial report in Wiener klinische Wochenschrift, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed, 6 citations in OpenAlex.
- Opioid Prescribing in the Elderly: A Systematic Review.The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians · 2020Review
- A prospective multicentre study to evaluate the efficacy and tolerability of osmotic release oral system (OROS) hydromorphone in opioid-naive cancer patients: Results of the Korean South West Oncology Group study.Pain research & managementArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo determine the effect of a lower starting dose of OROS® hydromorphone compared with a higher starting dose.
designData from the first 15 days of treatment were compared in a combined analysis of three prospective, non-interventional studies.
settingNon-interventional, carried out in daily routine settings. PATIENTS: Patients had chronic severe pain due to osteoarthritis or from fragility fractures related to osteoporosis.
interventionsOROS-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.
resultsTreatment 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.
conclusionsA 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.
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