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British Journal of Clinical Pharmacology Oct 2017Aprepitant and fosaprepitant, commonly used for the prevention of chemotherapy-induced nausea and vomiting, alter cytochrome P450 activity. This systematic review... (Meta-Analysis)
Meta-Analysis Review
AIMS
Aprepitant and fosaprepitant, commonly used for the prevention of chemotherapy-induced nausea and vomiting, alter cytochrome P450 activity. This systematic review evaluates clinically significant pharmacokinetic drug interactions with aprepitant and fosaprepitant and describes adverse events ascribed to drug interactions with aprepitant or fosaprepitant.
METHODS
We systematically reviewed the literature to September 11, 2016, to identify articles evaluating drug interactions involving aprepitant/fosaprepitant. The clinical significance of each reported pharmacokinetic drug interaction was evaluated based on the United States Food and Drug Administration guidance document on conducting drug interaction studies. The probability of an adverse event reported in case reports being due to a drug interaction with aprepitant/fosaprepitant was determined using the Drug Interaction Probability Scale.
RESULTS
A total of 4377 publications were identified. Of these, 64 met inclusion eligibility criteria: 34 described pharmacokinetic drug interactions and 30 described adverse events ascribed to a drug interaction. Clinically significant pharmacokinetic interactions between aprepitant/fosaprepitant and bosutinib PO, cabazitaxel IV, cyclophosphamide IV, dexamethasone PO, methylprednisolone IV, midazolam PO/IV, oxycodone PO and tolbutamide PO were identified, as were adverse events resulting from an interaction between aprepitant/fosaprepitant and alcohol, anthracyclines, ifosfamide, oxycodone, quetiapine, selective serotonin reuptake inhibitors/serotonin-norepinephrine reuptake inhibitors and warfarin.
CONCLUSIONS
The potential for a drug interaction with aprepitant and fosaprepitant should be considered when selecting antiemetic therapy.
Topics: Antiemetics; Antineoplastic Agents; Aprepitant; Cytochrome P-450 CYP2C9 Inducers; Cytochrome P-450 CYP3A Inhibitors; Drug Interactions; Ethanol; Humans; Injection Site Reaction; Morpholines; Nausea; Oxycodone; Quetiapine Fumarate; Selective Serotonin Reuptake Inhibitors; Serotonin and Noradrenaline Reuptake Inhibitors; Vomiting
PubMed: 28470980
DOI: 10.1111/bcp.13322 -
Palliative Medicine Jul 2011Oxycodone is often used as an opioid analgesic for moderate to severe cancer-related pain, but its use varies across Europe. This systematic literature review forms the... (Review)
Review
BACKGROUND
Oxycodone is often used as an opioid analgesic for moderate to severe cancer-related pain, but its use varies across Europe. This systematic literature review forms the basis of guidelines for oxycodone use within the European Palliative Care Research Collaborative opioid guidelines project conducted on behalf of the European Association for Palliative Care.
OBJECTIVES
The objective of this study was to identify and assess the quality of evidence for the use of oxycodone for cancer pain in adults.
METHODS
The Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, MedLine, EMBASE and CINAHL were systematically searched in addition to hand searching of relevant journals. Studies were included if they reported a clinical outcome relevant to the use of oxycodone in adult patients with moderate to severe cancer pain. Any form and route of oxycodone was included except intrathecal. No direct comparator was required for inclusion and studies were excluded if patients had previously switched from another strong opioid because of intolerable adverse effects or poor efficacy. This is a narrative systematic review, using the GRADE approach to assess the quality of studies and to formulate guidelines.
RESULTS
Twenty-nine original studies were identified including a meta-analysis and 14 randomized controlled trials. The identified meta-analysis included three trials comparing oxycodone to morphine and one comparing oxycodone to hydromorphone. Four other randomized trials compared oxycodone with other opioids. The remaining randomized controlled trials compared different routes of administration or formulations of oxycodone. No additional studies that would have been suitable for addition to the meta-analysis were identified.
CONCLUSIONS
There is no evidence from the included trials of a significant difference in analgesia or adverse effects between oxycodone and morphine or hydromorphone. The evidence was graded as high quality on the basis of a well-conducted meta-analysis, with no limitations likely to affect the outcome, in addition to consistency in the results of the other studies. The research was conducted using participants relevant to cancer and palliative care populations. Oxycodone can be recommended as an alternative to morphine or hydromorphone for cancer-related pain.
Topics: Analgesics, Opioid; Europe; Humans; Neoplasms; Oxycodone; Pain; Pain Measurement; Practice Guidelines as Topic; Randomized Controlled Trials as Topic; Severity of Illness Index
PubMed: 21708852
DOI: 10.1177/0269216311401948 -
Journal of Pain and Symptom Management Nov 2017Opioid-induced constipation (OIC) is one of the most frequent and severe adverse events (AEs) after treatment with opioids. Recent studies have indicated that... (Comparative Study)
Comparative Study Meta-Analysis Review
Opioid-Induced Constipation Relief From Fixed-Ratio Combination Prolonged-Release Oxycodone/Naloxone Compared With Oxycodone and Morphine for Chronic Nonmalignant Pain: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
CONTEXT
Opioid-induced constipation (OIC) is one of the most frequent and severe adverse events (AEs) after treatment with opioids. Recent studies have indicated that fixed-ratio combination prolonged-release oxycodone/naloxone (OXN PR) could decrease OIC with similar pain relief compared with other opioids.
OBJECTIVES
We systematically reviewed (PROSPERO registration numbers: CRD42016036244) the constipation relief of OXN PR compared with other opioids regardless of formulation, prolonged release, or extended release used for the relief of chronic pain.
METHODS
Relevant studies were identified by searching PubMed, EMBASE, Web of Science, and the Cochrane library from inception to May 2016, with an update to December 2016. We quantitatively analyzed OIC (assessed by bowel function index [BFI]), pain intensity, and AEs.
RESULTS
A total of 167 articles were identified from the databases. Finally seven studies with 3217 patients were included in our meta-analysis, including 1322 patients in OXN PR treatment groups and 1885 patients in prolonged-release oxycodone (OXY PR) or prolonged-release morphine (MOR PR) control group. The relative risk (RR) of OIC was decreased in OXN PR (RR 0.52, 95% CI 0.44; 0.62). Whether BFI was better or worse at baseline, the mean difference (MD) of BFI -17.48 95% CI -21.60; -13.36) was better after treatment with OXN PR with clinical importance at the end of intervention; moreover, the BFI of the OXN PR-treated group was closer to normal BFI scores. However, clinical BFI change from baseline to the end measurement only existed in patients when the baseline BFI was high (mean [SDs] 61.0 [23.39]-67.40 [19.51]), and the MD of the BFI was -15.96 (95% CI -25.56; -15.48). The RR of AEs was also smaller (RR 0.80; 95% CI 0.69-0.93), but the severity or duration of AEs was not reported. Pain intensity was also significantly decreased in the OXN PR treatment groups (MD -3.84, 95% CI -7.14; -0.55), although there was no clinically meaningful difference.
CONCLUSION
For people with chronic pain, treatment with OXN PR decreases the incidence of OIC and provides intermediate-term bowel function improvement with clinical importance; in addition, pain relief is not weakened. The OIC after treatment with OXN PR for cancer-related pain and over the long term remains unknown.
Topics: Analgesics, Opioid; Chronic Pain; Constipation; Delayed-Action Preparations; Drug Combinations; Drug Therapy, Combination; Humans; Morphine; Naloxone; Oxycodone; Randomized Controlled Trials as Topic
PubMed: 28736104
DOI: 10.1016/j.jpainsymman.2017.07.025 -
Pain Management Sep 2018Tapentadol is a novel atypical opioid. Anecdotal evidence suggests that tapentadol has a lower toxicity than conventional opioids. (Review)
Review
BACKGROUND
Tapentadol is a novel atypical opioid. Anecdotal evidence suggests that tapentadol has a lower toxicity than conventional opioids.
OBJECTIVES
To evaluate all single-drug mortality due to tapentadol and assess serious adverse events caused by tapentadol.
METHODS
The Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) reporting guidelines, an evidence-based minimum set of items for reporting in systematic reviews, were followed in this systematic review.
RESULTS
24 peer-reviewed papers were identified. They indicate that tapentadol toxicity can cause mortality and serious adverse effects.
CONCLUSION(S)
At least four confirmed fatalities, and serious adverse effects have been documented for individuals abusing or using tapentadol as prescribed. Serious adverse effects of tapentadol use may include respiratory depression, confusion, coma, hallucination/delusion, seizures, tachycardia, hypertension, agitation, tremor, miosis, hypotension, dyspnea, electrolyte abnormality, atrial fibrillation or severe upper abdominal pain. Tapentadol is unlikely to cause serotonin syndrome. The toxicity of tapentadol is significantly less than pure mu opioids, such as oxycodone.
Topics: Analgesics, Opioid; Drug-Related Side Effects and Adverse Reactions; Humans; Phenols; Tapentadol
PubMed: 30079795
DOI: 10.2217/pmt-2018-0027 -
Medicine Apr 2016The adverse events (AEs) of oxycodone in cancer-related pain were controversial, so we conducted a meta-analysis to determine it. PubMed, Embase, CBM, CNKI, WanFang... (Meta-Analysis)
Meta-Analysis Review
The adverse events (AEs) of oxycodone in cancer-related pain were controversial, so we conducted a meta-analysis to determine it. PubMed, Embase, CBM, CNKI, WanFang database, The Cochrane library, Web of Science, and the reference of included studies were searched to recognize pertinent studies. Relative risk (RR) with 95% confidence intervals (CIs) for all AEs were all extracted. The fixed-effects model was used to calculate pooled RRs and 95% CIs. Power calculation was performed using macro embedded in SAS software after all syntheses were completed. We identified 11 eligible trials involving 1211 patients: 604 patients included in oxycodone group and 607 patients involved in control group. Our quantitative analysis included 8 AEs, and the pooled analyses indicated that oxycodone compared with other opioids in cancer-related pain were not significantly decreased RRs of all AEs (dizziness RR = 0.94, 95% CI: 0.69-1.30, Z = 0.35, P = 0.72; nausea RR = 0.88, 95% CI: 0.72-1.07, Z = 1.26, P = 0.21; vomiting RR = 0.89, 95% CI: 0.70-1.15, Z = 0.9, P = 0.37; sleepiness RR = 0.86, 95% CI: 0.38-1.36, Z = 0.36, P = 0.72; constipation RR = 0.98, 95% CI: 0.81-1.19, Z = 0.21, P = 0.83; anorexia RR = 0.97, 95% CI = 0.58-1.62, Z = 0.11, P = 0.91; pruritus RR = 0.76, 95% CI: 0.44-1.30, Z = 1.01, P = 0.31; dysuria RR = 0.33, 95% CI: 0.07-1.62, Z = 1.36, P = 0.1)]. The subgroup analysis shown that Ox controlled-release (CR) had less sleepiness compared with MS-contin (Mc) CR (RR = 0.47, 95% CI: 0.25-0.90, P = 0.02). The power analysis suggests that all AEs have low statistical power. The present meta-analysis detected that no statistically significant difference were found among oxycodone and other opioids in all AEs, but Ox CR may had less sleepiness compared with Mc CR when subgroup analysis were conducted.
Topics: Analgesics, Opioid; Delayed-Action Preparations; Humans; Neoplasms; Oxycodone; Pain; Randomized Controlled Trials as Topic
PubMed: 27082588
DOI: 10.1097/MD.0000000000003341 -
The Cochrane Database of Systematic... 2000Oxycodone is a strong opioid agonist which is useful for the management of severe pain. It is becoming increasingly important to assess the relative efficacy and harm... (Review)
Review
BACKGROUND
Oxycodone is a strong opioid agonist which is useful for the management of severe pain. It is becoming increasingly important to assess the relative efficacy and harm caused by different treatments. This can be determined when an analgesic is compared with control under similar clinical circumstances.
OBJECTIVES
To quantitatively assess the analgesic efficacy and adverse effects of single-dose oxycodone and oxycodone plus paracetamol in randomised trials in acute postoperative pain.
SEARCH STRATEGY
Published reports were identified from Medline, Biological Abstracts, Embase, the Cochrane Library and the Oxford Pain Relief Database. Additional studies were identified from the reference lists of retrieved reports.
SELECTION CRITERIA
The inclusion criteria were: full journal publication, clinical trial, random allocation of adult patients to treatment groups, double blind design, moderate to severe baseline pain, postoperative administration of study drugs, treatment arms which included oxycodone or oxycodone plus paracetamol and placebo (or active control for which comparable efficacy data exist), and oral, intramuscular or intravenous administration of study drugs.
DATA COLLECTION AND ANALYSIS
Summed pain intensity and pain relief data over 4-6 hours were extracted and converted into dichotomous information yielding the number of patients obtaining at least 50% pain relief. Estimates of relative benefit and number-needed-to-treat were calculated. Single-dose adverse effect data were collected.
MAIN RESULTS
Seventy-seven reports were identified. Seven reports met the inclusion criteria; all assessed oral oxycodone. For efficacy, a significant benefit of active drug over placebo was shown for all doses of oxycodone and oxycodone plus paracetamol, except oxycodone 5 mg. For adverse effects, the number of patients reporting adverse effects was extracted for each dose of active drug versus placebo. When these data were pooled for the individual doses significantly more adverse effects with active drug than with placebo were shown for all doses, except oxycodone 5 mg and its combination with paracetamol 325 mg. This was also shown for drowsiness/somnolence. Significantly more nausea, vomiting and dizziness/lightheadedness were reported with oxycodone 10 mg plus paracetamol (650 mg and 1000 mg) than with placebo.
REVIEWER'S CONCLUSIONS
Single-dose oral oxycodone, with or without paracetamol, appears to be of comparable efficacy to intramuscular morphine and non-steroidal anti-inflammatory drugs. Central nervous system adverse effects were common.
Topics: Acetaminophen; Acute Disease; Analgesics, Non-Narcotic; Analgesics, Opioid; Drug Therapy, Combination; Humans; Oxycodone; Pain, Postoperative; Randomized Controlled Trials as Topic
PubMed: 11034756
DOI: 10.1002/14651858.CD002763 -
Cancer Treatment Reviews Apr 2024Cancer-related pain often requires opioid treatment with opioid-induced constipation (OIC) as its most frequent gastrointestinal side-effect. Both for prevention and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Cancer-related pain often requires opioid treatment with opioid-induced constipation (OIC) as its most frequent gastrointestinal side-effect. Both for prevention and treatment of OIC osmotic (e.g. polyethylene glycol) and stimulant (e.g. bisacodyl) laxatives are widely used. Newer drugs such as the peripherally acting µ-opioid receptor antagonists (PAMORAs) and naloxone in a fixed combination with oxycodone have become available for the management of OIC. This systematic review and meta-analysis aims to give an overview of the scientific evidence on pharmacological strategies for the prevention and treatment of OIC in cancer patients.
METHODS
A systematic search in PubMed, Embase, Web of Science and the Cochrane Library was completed from inception up to 22 October 2022. Randomized and non-randomized studies were systematically selected. Bowel function and adverse drug events were assessed.
RESULTS
Twenty trials (prevention: five RCTs and three cohort studies; treatment: ten RCTs and two comparative cohort studies) were included in the review. Regarding the prevention of OIC, three RCTs compared laxatives with other laxatives, finding no clear differences in effectivity of the laxatives used. One cohort study showed a significant benefit of magnesium oxide compared with no laxative. One RCT found a significant benefit for the PAMORA naldemedine compared with magnesium oxide. Preventive use of oxycodone/naloxone did not show a significant difference in two out of three other studies compared to oxycodone or fentanyl. A meta-analysis was not possible. Regarding the treatment of OIC, two RCTs compared laxatives, of which one RCT found that polyethylene glycol was significantly more effective than sennosides. Seven studies compared an opioid antagonist (naloxone, methylnaltrexone or naldemedine) with placebo and three studies compared different dosages of opioid antagonists. These studies with opioid antagonists were used for the meta-analysis. Oxycodone/naloxone showed a significant improvement in Bowel Function Index compared to oxycodone with laxatives (MD -13.68; 95 % CI -18.38 to -8.98; I = 58 %). Adverse drug event rates were similar amongst both groups, except for nausea in favour of oxycodone/naloxone (RR 0.51; 95 % CI 0.31-0.83; I = 0 %). Naldemedine (NAL) and methylnaltrexone (MNTX) demonstrated significantly higher response rates compared to placebo (NAL: RR 2.07, 95 % CI 1.64-2.61, I = 0 %; MNTX: RR 3.83, 95 % CI 2.81-5.22, I = 0 %). With regard to adverse events, abdominal pain was more present in treatment with methylnaltrexone and diarrhea was significantly more present in treatment with naldemedine. Different dosages of methylnaltrexone were not significantly different with regard to both efficacy and adverse drug event rates.
CONCLUSIONS
Magnesium oxide and naldemedine are most likely effective for prevention of OIC in cancer patients. Naloxone in a fixed combination with oxycodone, naldemedine and methylnaltrexone effectively treat OIC in cancer patients with acceptable adverse events. However, their effect has not been compared to standard (osmotic and stimulant) laxatives. More studies comparing standard laxatives with each other and with opioid antagonists are necessary before recommendations for clinical practice can be made.
Topics: Humans; Laxatives; Analgesics, Opioid; Narcotic Antagonists; Constipation; Oxycodone; Opioid-Induced Constipation; Magnesium Oxide; Cohort Studies; Naloxone; Polyethylene Glycols; Neoplasms; Drug-Related Side Effects and Adverse Reactions; Quaternary Ammonium Compounds; Naltrexone
PubMed: 38452708
DOI: 10.1016/j.ctrv.2024.102704 -
The Cochrane Database of Systematic... Aug 2021This is an update of the original Cochrane Review first published in Issue 10, 2016. For people with advanced cancer, the prevalence of pain can be as high as 90%.... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This is an update of the original Cochrane Review first published in Issue 10, 2016. For people with advanced cancer, the prevalence of pain can be as high as 90%. Cancer pain is a distressing symptom that tends to worsen as the disease progresses. Evidence suggests that opioid pharmacotherapy is the most effective of these therapies. Hydromorphone appears to be an alternative opioid analgesic which may help relieve these symptoms.
OBJECTIVES
To determine the analgesic efficacy of hydromorphone in relieving cancer pain, as well as the incidence and severity of any adverse events.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase and clinical trials registers in November 2020. We applied no language, document type or publication status limitations to the search.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) that compared hydromorphone with placebo, an alternative opioid or another active control, for cancer pain in adults and children. Primary outcomes were participant-reported pain intensity and pain relief; secondary outcomes were specific adverse events, serious adverse events, quality of life, leaving the study early and death.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data. We calculated risk ratio (RR) and 95% confidence intervals (CI) for binary outcomes on an intention-to-treat (ITT) basis. We estimated mean difference (MD) between groups and 95% CI for continuous data. We used a random-effects model and assessed risk of bias for all included studies. We assessed the evidence using GRADE and created three summary of findings tables.
MAIN RESULTS
With four new identified studies, the review includes a total of eight studies (1283 participants, with data for 1181 participants available for analysis), which compared hydromorphone with oxycodone (four studies), morphine (three studies) or fentanyl (one study). All studies included adults with cancer pain, mean age ranged around 53 to 59 years and the proportion of men ranged from 42% to 67.4%. We judged all the studies at high risk of bias overall because they had at least one domain with high risk of bias. We found no studies including children. We did not complete a meta-analysis for the primary outcome of pain intensity due to skewed data and different comparators investigated across the studies (oxycodone, morphine and fentanyl). Comparison 1: hydromorphone compared with placebo We identified no studies comparing hydromorphone with placebo. Comparison 2: hydromorphone compared with oxycodone Participant-reported pain intensity We found no clear evidence of a difference in pain intensity (measured using a visual analogue scale (VAS)) in people treated with hydromorphone compared with those treated with oxycodone, but the evidence is very uncertain (3 RCTs, 381 participants, very low-certainty evidence). Participant-reported pain relief We found no studies reporting participant-reported pain relief. Specific adverse events We found no clear evidence of a difference in nausea (RR 1.13 95% CI 0.74 to 1.73; 3 RCTs, 622 participants), vomiting (RR 1.18, 95% CI 0.72 to 1.94; 3 RCTs, 622 participants), dizziness (RR 0.91, 95% CI 0.58 to 1.44; 2 RCTs, 441 participants) and constipation (RR 0.92, 95% CI 0.72 to 1.19; 622 participants) (all very low-certainty evidence) in people treated with hydromorphone compared with those treated with oxycodone, but the evidence is very uncertain. Quality of life We found no studies reporting quality of life. Comparison 3: hydromorphone compared with morphine Participant-reported pain intensity We found no clear evidence of a difference in pain intensity (measured using the Brief Pain Inventory (BPI) or VAS)) in people treated with hydromorphone compared with those treated with morphine, but the evidence is very uncertain (2 RCTs, 433 participants; very low-certainty evidence). Participant-reported pain relief We found no clear evidence of a difference in the number of clinically improved participants, defined by 50% or greater pain relief rate, in the hydromorphone group compared with the morphine group, but the evidence is very uncertain (RR 0.99, 95% CI 0.84 to 1.18; 1 RCT, 233 participants; very low-certainty evidence). Specific adverse events At 24 days of treatment, morphine may reduce constipation compared with hydromorphone, but the evidence is very uncertain (RR 1.56, 95% CI 1.12 to 2.17; 1 RCT, 200 participants; very low-certainty evidence). We found no clear evidence of a difference in nausea (RR 0.94, 95% CI 0.66 to 1.30; 1 RCT, 200 participants), vomiting (RR 0.87, 95% CI 0.58 to 1.31; 1 RCT, 200 participants) and dizziness (RR 1.15, 95% CI 0.71 to 1.88; 1 RCT, 200 participants) (all very low-certainty evidence) in people treated with hydromorphone compared with those treated with morphine, but the evidence is very uncertain. Quality of life We found no studies reporting quality of life. Comparison 4: hydromorphone compared with fentanyl Participant-reported pain intensity We found no clear evidence of a difference in pain intensity (measured by numerical rating scale (NRS)) at 60 minutes in people treated with hydromorphone compared with those treated with fentanyl, but the evidence is very uncertain (1 RCT, 82 participants; very low-certainty evidence). Participant-reported pain relief We found no studies reporting participant-reported pain relief. Specific adverse events We found no studies reporting specific adverse events. Quality of life We found no studies reporting quality of life.
AUTHORS' CONCLUSIONS
The evidence of the benefits and harms of hydromorphone compared with other analgesics is very uncertain. The studies reported some adverse events, such as nausea, vomiting, dizziness and constipation, but generally there was no clear evidence of a difference between hydromorphone and morphine, oxycodone or fentanyl for this outcome. There is insufficient evidence to support or refute the use of hydromorphone for cancer pain in comparison with other analgesics on the reported outcomes. Further research with larger sample sizes and more comprehensive outcome data collection is required.
Topics: Adult; Analgesics, Opioid; Cancer Pain; Child; Humans; Hydromorphone; Male; Middle Aged; Morphine; Neoplasms; Oxycodone
PubMed: 34350974
DOI: 10.1002/14651858.CD011108.pub3 -
Journal of Opioid Management 2017We performed a systematic review to answer the question, "Does the introduction of an opioid analgesic with abuse deterrent properties result in reduced overall abuse of... (Review)
Review
OBJECTIVE
We performed a systematic review to answer the question, "Does the introduction of an opioid analgesic with abuse deterrent properties result in reduced overall abuse of the drug in the community?"
DESIGN
We included opioid analgesics with abuse deterrent properties (hydrocodone, morphine, oxycodone) with results restricted to the metasearch term "delayed onset," English language, use in humans, and publication years 2009-2016. All articles that contained data evaluating misuse, abuse, overdose, addiction, and death were included. The results were categorized using the Bradford-Hill criteria.
RESULTS
We included 44 reports: hydrocodone (n = 7), morphine (n = 5), or oxycodone (n = 32) with Food and Drug Administration-approved Categories 1, 2, or 3 abuse deterrent labeling. The data currently available support the Hill criteria of strength (effect size), consistency (reproducibility), temporality, plausibility, and coherence. There was insufficient or no information available for the criteria of biological gradient, experiment, and analogy. We also assessed confounding factors and bias, which indicated that both were present and substantial in magnitude.
CONCLUSIONS
Our analysis found that only oxycodone extended release (ER) had information available to evaluate abuse deterrence in the community. In Australia, Canada, and the United States, reformulation of oxycodone ER was followed by marked reduction in measures of abuse. The precise extent of reduced abuse cannot be calculated because of heterogeneous data sets, but the reported reductions ranged from 10 to 90 percent depending on the measure and the duration of follow-up.
Topics: Abuse-Deterrent Formulations; Analgesics, Opioid; Delayed-Action Preparations; Drug Compounding; Humans; Opioid-Related Disorders; Protective Factors; Risk Factors; Time Factors
PubMed: 29308584
DOI: 10.5055/jom.2017.0415 -
Current Medical Research and Opinion Jul 2011To conduct a systematic review of evidence supporting the efficacy and safety profiles of nonsteroidal anti-inflammatory drugs (NSAIDs) introduced in the last decade for... (Review)
Review
OBJECTIVE
To conduct a systematic review of evidence supporting the efficacy and safety profiles of nonsteroidal anti-inflammatory drugs (NSAIDs) introduced in the last decade for the treatment of patients with osteoarthritis (OA), including their analgesic effects, ability to improve function, and adverse event profiles relative to current standards of care.
RESEARCH DESIGN AND METHODS
Systematic search of the literature for NSAIDs approved by the FDA (2000-2010).
RESULTS
One new orally-administered NSAID molecule (meloxicam), two orally-administered NSAID formulations (naproxen plus lansoprazole; oxycodone/ibuprofen), and three topical NSAID formulations (diclofenac patch, gel, and solution) were approved by the FDA (2000-2010). A systematic literature review found evidence to support efficacy in treating patients with OA for all agents except oxycodone/ibuprofen, which has not been studied in this patient population, although ibuprofen and immediate-release oxycodone have been studied individually for OA pain. Evidence quality was inconsistent, with several agents lacking long-term, controlled trials against active comparators, and functional end points inconsistently met. Although low-dose meloxicam and naproxen plus lansoprazole offer a reduced risk of adverse gastrointestinal (GI) events, cardiovascular and renal risks remain similar to traditional oral NSAID therapy. Further, only lower doses of meloxicam appear to carry a reduced risk of GI events. Diclofenac patch, gel, and solution preparations offer the potential for reduced GI, cardiovascular, and renal adverse events. The level of evidence available to support the efficacy and safety of these agents for long-term treatment of patients with OA differs, with some having only short-term trials, while others have longer-duration trials with active comparators.
CONCLUSIONS
By expanding the treatment armamentarium, newly-approved NSAID agents may improve the ability of clinicians to tailor analgesic therapy for their diverse patient populations and to achieve realistic functional improvements. The comparisons in this article were limited to drugs that received approval after 2000 and should be considered accordingly.
Topics: Administration, Oral; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Humans; Osteoarthritis; Standard of Care; Transdermal Patch
PubMed: 21561395
DOI: 10.1185/03007995.2011.568058