Dose Equivalence of Immediate-Release Hydromorphone and Once-Daily Osmotic-Controlled Extended-Release Hydromorphone: A Randomized, Double-Blind Trial Incorporating a Measure of Assay Sensitivity

Cruciani, Ricardo A.; Katz, Nathaniel; Portenoy, Russell K.

doi:10.1016/j.jpain.2012.01.007

Cited by 6 publications

(4 citation statements)

References 16 publications

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“…Moreover, existence of a significant linear relationship between hydromorphone plasma concentration and the analgesic effect on painful stimuli has been reported and OROS hydromorphone administered once‐daily yielded effects that were comparable to the same daily dose of IR formulation administered in multiple doses . In this study, the mean ratio of AUC 0‐inf (ER/IR tablets) was 109.4%, indicating that the bioavailability may be comparable between both formulations, although 95% CIs of the ratios of AUC 0‐inf geometric means for the ER and IR tablets were relatively wide (79.6∼150.5).…”

Section: Discussionmentioning

confidence: 62%

Single‐dose evaluation of safety, tolerability and pharmacokinetics of newly formulated hydromorphone immediate‐release and hydrophilic matrix extended‐release tablets in healthy Japanese subjects without co‐administration of an opioid antagonist

Toyama

Uchida

Ishizuka

et al. 2015

The Journal of Clinical Pharma

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This single dose, open-label study investigated the safety, tolerability and pharmacokinetics of single oral doses of newly formulated immediate-release (IR) and hydrophilic matrix extended-release (ER) hydromorphone tablets in healthy Japanese subjects without co-administration of an opioid antagonist under fasting and fed conditions. Plasma and urinary concentrations of hydromorphone and metabolites were measured by liquid-chromatography tandem mass-spectroscopy. Following administration of the ER tablet, plasma concentrations of hydromorphone slowly increased with a median tmax of 5.0 h and the Cmax decreased to 37% of the IR tablet, while the AUC0-inf was comparable with that of the IR tablet when administered at the same dose. The degree of fluctuation in the plasma concentration for the ER tablet was much lower than that of the IR tablet and certain levels of plasma concentrations were maintained after 24 h of ER dosing. The AUC0-inf and Cmax increased with food for both IR and ER tablets. The AUC0-inf of hydromorphone-3-glucoside was one-tenth of that of hydromorphone-3-glucuronide. A single oral administration of the hydromorphone tablets would be well-tolerated in healthy Japanese subjects despite a lack of co-administration of an opioid antagonist and the newly developed ER hydromorphone tablets may have the appropriate PK characteristics for once-daily dosing.

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Section: Discussionmentioning

confidence: 62%

Single‐dose evaluation of safety, tolerability and pharmacokinetics of newly formulated hydromorphone immediate‐release and hydrophilic matrix extended‐release tablets in healthy Japanese subjects without co‐administration of an opioid antagonist

Toyama

Uchida

Ishizuka

et al. 2015

The Journal of Clinical Pharma

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show abstract

“…It is long acting because of its preparation rather than because of its innate nature. 2,3 Given that the casings did not pass beyond the stomach region, the nature of drug delivery in this patient was difficult to understand. The equivalent dose of methadone for an MEDD of 440 mg is approximately 30 to 40 mg.…”

Section: Discussionmentioning

confidence: 99%

What Is Your Gut Feeling About Opioid Rotation?

Didwaniya

Reddy

Gottumukkala

et al. 2015

JCO

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“…Two studies examined BTP frequency; both reported a decrease in BTP frequency with hydromorphone. Ten studies on hydromorphone reported results on the BTP medication frequency; 4 of these showed frequency was decreased from baseline, 1 showed an increase in BTP medication frequency from baseline, and 4 reported no difference in BTP medication frequency either from baseline or between hydromorphone and the comparator (either placebo or another opioid) …”

Section: Resultsmentioning

confidence: 99%

“…Ten studies on hydromorphone reported results on the BTP medication frequency; 4 of these showed frequency was decreased from baseline, 1 showed an increase in BTP medication frequency from baseline, and 4 reported no difference in BTP medication frequency either from baseline or between hydromorphone and the comparator (either placebo or another opioid). [24][25][26][27][28][29][30][31][32][33] The single study that looked at end-of-dose pain examined OROS â hydromorphone and found decreases from baseline (which consisted of use of IR oxycodone) for all the target outcomes. 27 Morphine.…”

Section: Results Of Target Outcomesmentioning

confidence: 99%

End‐of‐Dose Pain in Chronic Pain: Does it Vary with the Use of Different Long‐Acting Opioids?

Zimmermann

Richarz

2013

Pain Practice

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A large percentage of patients with chronic pain on around-the-clock (ATC) opioids may experience increased pain occurring at the end of a scheduled dose, also known as end-of-dose pain. Despite the significant prevalence and impact of end-of-dose pain in patients using extended-release (ER) opioids, there are no detailed analyses examining how the frequency of end-of-dose pain is linked to the formulations of long-acting opioids. Consequently, we performed a systematic review to evaluate how many published studies on patients with chronic cancer or noncancer pain identified end-of-dose pain. As only a few studies mentioned end-of-dose pain explicitly, we used breakthrough pain (BTP) as a surrogate parameter. We determined if any opioid formulation had a greater association with the frequency of BTP, the use of rescue medication for BTP, and the frequency of end-of-dose pain. Of the 39 studies entered in the final analysis, 14 studies across different formulations showed that ER opioids were effective in the prevention of BTP. The opioids most frequently studied were hydromorphone (26%), followed by morphine (23%), and transdermal buprenorphine (23%). Only 5% of the studies used immediate-release preparations. Overall, most studies showed that patients using ER preparations experienced fewer episodes of BTP compared with patients on placebo or an active comparator. This could reflect the favorable duration of action of these opioids compared with short-acting formulations. Future studies should examine the incidence of end-of-dose pain and use of rescue medicine in a longitudinal manner in patients with chronic pain taking short- vs. long-acting ATC opioids.

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Dose Equivalence of Immediate-Release Hydromorphone and Once-Daily Osmotic-Controlled Extended-Release Hydromorphone: A Randomized, Double-Blind Trial Incorporating a Measure of Assay Sensitivity

Cited by 6 publications

References 16 publications

Single‐dose evaluation of safety, tolerability and pharmacokinetics of newly formulated hydromorphone immediate‐release and hydrophilic matrix extended‐release tablets in healthy Japanese subjects without co‐administration of an opioid antagonist

Single‐dose evaluation of safety, tolerability and pharmacokinetics of newly formulated hydromorphone immediate‐release and hydrophilic matrix extended‐release tablets in healthy Japanese subjects without co‐administration of an opioid antagonist

What Is Your Gut Feeling About Opioid Rotation?

End‐of‐Dose Pain in Chronic Pain: Does it Vary with the Use of Different Long‐Acting Opioids?

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