hydrocodone and Low-Back-Pain

While a collaborative relationship is optimal for pain management, there may be times when saying No is the best treatment. This review--and easy-to-use "decision tree"--can help with both.

Topics: Acetaminophen; Analgesics, Non-Narcotic; Analgesics, Opioid; Chronic Pain; Decision Support Techniques; Decision Trees; Drug Therapy, Combination; Humans; Hydrocodone; Low Back Pain; Male; Middle Aged; Morphine; Pain Management; Pain Measurement; Physician-Patient Relations; Risk Assessment

This study aimed to assess the tolerability of the extended use (≤35 days) of MNK-155, a biphasic (immediate-release/extended-release) hydrocodone bitartrate/N-acetyl-p-aminophenol (acetaminophen) (IR/ER HB/APAP) 7.5/325-mg fixed-dose combination analgesic agent, in patients with chronic noncancer pain (CNCP) caused by osteoarthritis or chronic low back pain. IR/ER HB/APAP tablets deliver 25% of the HB dose and 50% of the APAP dose by IR and the remainder by ER over a 12-hour dosing interval. Although IR/ER HB/APAP is being developed for the management of moderate to severe acute pain, this model of CNCP was used for assessing tolerability over a term longer than would be possible in a model of acute pain.. This Phase III, multicenter, open-label study enrolled patients with moderate to severe OA (knee or hip) pain despite the use of nonopioid or opioid analgesic agents, or with moderate to severe CLBP present for several hours per day for ≥3 months. Patients received a 3-tablet initial dose of IR/ER HB/APAP (total dose, 22.5/975 mg) on day 1, followed by 2 tablets of IR/ER HB/APAP (total dose, 15/650 mg) q12h for up to 35 days. Tolerability, the primary end point, was assessed using time to treatment discontinuation, the prevalence of treatment-emergent adverse events (TEAEs), vital sign measurements, pulse oximetry, clinical laboratory tests, and compliance. Secondary outcomes included the modified Brief Pain Inventory-Short Form, the Western Ontario and McMaster Universities Arthritis Index, and The Roland-Morris Low Back Pain and Disability Questionnaire.. Of the 153 patients enrolled (95 women [62.1%]; mean age, 53.9 [14.5] years; OA, n = 73; CLBP, n = 80), 37 (24.2%) discontinued the study early (mean time to discontinuation, 21.3 days). Thirteen patients (8.5%) discontinued because of TEAEs. A total of 88 patients (57.5%) reported ≥1 TEAE, 65 (42.5%) of whom experienced AEs considered by the investigator as treatment related. The most frequent TEAEs were nausea (16.3%), somnolence (14.4%), and constipation (11.1%). Eight severe TEAEs were experienced by 6 (3.9%) patients and included single occurrences of nausea, fatigue, nasopharyngitis, elevated liver enzymes, headache, nightmare, and ejaculation delay. No serious treatment-related AEs were reported. Clinically significant changes in laboratory values were reported in 13 patients, 6 of whom had abnormal liver function test results that did not meet Hy's law criteria for acute liver failure. Most laboratory abnormalities were mild and transient. Measures of pain intensity, function, and quality of life improved from baseline but in an open-label study these changes cannot be attributed to treatment.. The safety profile of IR/ER HB/APAP during extended use was consistent with those of other low-dose opioid/APAP combination products. IR/ER HB/APAP is intended for acute pain; its efficacy for relief of CNCP would require further evaluation in an active- or placebo-controlled study. ClinicalTrials.gov Identifier: NCT01722864.

Topics: Acetaminophen; Adult; Aged; Analgesics, Non-Narcotic; Analgesics, Opioid; Chronic Pain; Delayed-Action Preparations; Drug Combinations; Female; Humans; Hydrocodone; Low Back Pain; Male; Middle Aged; Osteoarthritis, Hip; Osteoarthritis, Knee; Pain Measurement; Quality of Life; Tablets

This multicenter, randomized, double-blind, placebo-controlled study with an enriched enrollment, randomized withdrawal design was conducted to evaluate the analgesic efficacy and safety of single-entity, once-daily hydrocodone 20 to 120 mg tablets (HYD) in opioid-naive and opioid-experienced patients with uncontrolled moderate to severe chronic low back pain (CLBP).. The primary endpoint was week 12 pain intensity scores (11-point scale, 0 = no pain) using a mixed effect model with repeated measures incorporating a pattern mixture model framework. Responder analysis was a secondary endpoint. Safety was assessed.. Out of 905 patients who were treated with HYD during the open-label titration period, 588 (65%) were randomized to continue to receive HYD (n = 296, 20 - 120 mg taken once daily, average daily dose 57 mg) or a matching placebo (n = 292). HYD demonstrated superior pain reduction (p = 0.0016); this result was supported by sensitivity analyses using different approaches to handling missing data. Proportions of patients achieving ≥ 30 and ≥ 50% improvement in pain from screening to week 12 also favored HYD (p = 0.0033 and 0.0225, respectively). HYD was generally well tolerated.. HYD was shown to be an efficacious treatment for CLBP in this study. There were no new or unexpected safety concerns detected.

Topics: Adult; Analgesics, Opioid; Chronic Disease; Double-Blind Method; Female; Humans; Hydrocodone; Low Back Pain; Male; Middle Aged; Tablets; Treatment Outcome

To evaluate the durability of pain relief provided by a new formulation of single-entity, hydrocodone extended-release (ER) (Zohydro(®) ER) throughout the 12-hour dosing interval by examining patterns of rescue medication use.. Phase 3, enriched enrollment, randomized withdrawal study with an open-label, conversion/titration phase (≤6 weeks) followed by a placebo-controlled, double-blind treatment phase (12 weeks).. Fifty-seven study sites in the United States enrolled patients.. One hundred and fifty-one opioid-experienced subjects with moderate to severe chronic low back pain who were treated with hydrocodone ER once every 12 hours.. Post hoc analysis of rescue medication use by frequency and distribution of use following the morning and evening dose of hydrocodone ER.. No rescue medication was used following the morning or evening dose of hydrocodone ER during 36.0% and 76.7% of the dosing days, respectively. Time distribution of rescue medication use showed that 79.3% of all rescue medication doses were administered following the morning dose, with the highest rate of usage (46.2%) occurring 4-8 hours postdose, followed by 18.7% and 14.4% usage 0-4 and 8-12 hours postdose, respectively. Examination of the three 4-hour intervals following the evening dose of hydrocodone ER revealed similar minimal rescue medication use (5.6-8.2%).. End-of-dose failure was not observed based on the use of rescue medication after administration of single-entity, twice daily, hydrocodone ER capsules (Zohydro ER).

Topics: Adolescent; Adult; Aged; Analgesics, Opioid; Chronic Pain; Double-Blind Method; Drug Administration Schedule; Female; Humans; Hydrocodone; Longitudinal Studies; Low Back Pain; Male; Middle Aged; Pain Measurement; Placebo Effect; Treatment Outcome; United States; Young Adult

A single-agent, extended-release formulation of hydrocodone (HC) has been developed for treatment of chronic moderate-to-severe pain. This study was designed to examine the safety and efficacy of HC extended release in opioid-experienced adults with moderate-to-severe chronic low back pain (CLBP).. This multicenter, enriched enrollment, randomized withdrawal study comprised an open-label conversion/titration phase (≤6 weeks) followed by placebo-controlled, double-blind treatment (12 weeks). During the conversion/titration phase, subjects (N = 510) converted from their current opioid and were titrated to a stabilized dose of HC extended release (20-100 mg every 12 hours). During treatment, subjects (N = 151 per group) received HC extended release or placebo; rescue medication was permitted. The primary efficacy end point was mean change in average pain intensity from baseline to day 85. Response rates (30% pain improvement) and satisfaction (Subject Global Assessment of Medication) were assessed.. Demographic and baseline characteristics were similar between groups. Mean ± SD change in average pain intensity score from baseline to day 85 was significantly lower in the HC extended-release treatment group vs placebo (0.48 ± 1.56 vs 0.96 ± 1.55; P = 0.008). Significantly more responders were in the treatment group (68% vs 31%; P < 0.001). Mean Subject Global Assessment of Medication scores increased significantly (0.8 ± 1.3 vs 0.0 ± 1.4; P < 0.0001), indicating greater satisfaction with HC extended release. The adverse event profile was consistent with other opioids.. Extended-release HC is well tolerated and effective, without acetaminophen-associated risks of liver toxicity, for treatment of CLBP.

Topics: Adolescent; Adult; Aged; Analgesics, Opioid; Chronic Pain; Delayed-Action Preparations; Double-Blind Method; Drug Tolerance; Female; Humans; Hydrocodone; Low Back Pain; Male; Middle Aged; Pain Measurement; Severity of Illness Index; Young Adult

Patients with chronic noncancer pain frequently report symptoms of depression and anxiety (negative affect), which are associated with higher ratings of pain intensity and a greater likelihood of being prescribed chronic opioid therapy. The purpose of this secondary analysis was to test the hypothesis that initial levels of negative affect can predict treatment-related outcomes in a double-blind, placebo-controlled study of extended-release (ER) hydromorphone among opioid-tolerant patients with chronic low back pain.. Four hundred fifty-nine (N = 459) patients participated in the titration/conversion phase of a multicenter study, of which 268 were randomized to receive once-daily hydromorphone or placebo. All patients completed the Hospital Anxiety and Depression Scale (HADS) at baseline and were divided evenly into Low (N = 157), Moderate (N = 155), and High (N = 147) negative affect groups based on their scores. Group differences in numerical pain intensity measures at home and in the clinic, Roland-Morris Disability ratings, and measures of symptoms from the Subjective Opiate Withdrawal Scale (SOWS) throughout the trial were analyzed.. Two hundred sixty-eight of the initial 459 subjects who entered the 2 to 4-week titration/conversion phase (pretreatment) were successfully randomized to either placebo or ER hydromorphone; a total of 110 patients then completed this double-blind phase of the study. Those in the Moderate and High negative affect groups tended to drop out more often during the titration/conversion phase because of the adverse effects or lack of efficacy of their prescribed opioid than those in the Low negative mood group (P < 0.05). Overall, those patients in the Moderate and High groups reported significantly higher pain intensity scores in at-home and in-clinic pain intensity ratings (P < 0.05), greater disability on the Roland-Morris Scale (P < 0.01), and more withdrawal symptoms on the SOWS (P < 0.05) than those in the Low group. Higher negative affect scores also predicted less favorable ratings of the study drug during the titration phase (P < 0.05). Interestingly, the High negative affect group showed the most improvement in pain in the placebo condition (P < 0.05).. Negative affect is associated with diminished benefit during a trial of opioid therapy and is predictive of dropout in a controlled clinical trial.

Topics: Affective Symptoms; Analgesics, Opioid; Anxiety; Chronic Pain; Depression; Double-Blind Method; Female; Humans; Hydrocodone; Low Back Pain; Male; Middle Aged; Treatment Outcome

Hydrocodone is frequently prescribed for moderate to severe pain. Nicotine has analgesic properties and it is hypothesized that cigarette smoking might decrease the dosage of hydrocodone needed for the relief of chronic pain. This would be a topic of importance to clinicians as it relates to individualized medicine and pharmacotherapy for chronic pain management. Smokers and nonsmokers were assigned randomly to one of two groups to receive hydrocodone daily for 30 days. This study concluded that the dose of hydrocodone consumed did not statistically differ between the two Groups. Smokers however, had significantly less pain relief than nonsmokers.

Topics: Adolescent; Adult; Analgesics, Opioid; Chronic Pain; Drug Synergism; Female; Humans; Hydrocodone; Low Back Pain; Male; Middle Aged; Nicotine; Nicotinic Agonists; Smoking; Young Adult

The objectives for presenting these medico-legal forensic case reports are the following: 1) detail three cases where chronic opioid analgesic therapy (COAT) was alleged to cause iatrogenic addiction and/or re-addiction; 2) detail the plaintiff's and defendant's medical experts' opinions on these allegations; and 3) through analyzing these cases, develop some recommendations for future prevention of such allegations during COAT.. Case Reports.. Medico-legal issues surrounding the allegation of iatrogenic addiction were identified in each case.. Before starting COAT, physicians should obtain and document patient informed consent for the risk of addiction/re-addiction with COAT treatment. Patients with a history of addictions pre-COAT should be placed on adherence monitoring immediately on beginning COAT.

Topics: Adult; Analgesics, Opioid; Back Injuries; Expert Testimony; Female; Forensic Medicine; Humans; Hydrocodone; Iatrogenic Disease; Informed Consent; Low Back Pain; Male; Malpractice; Middle Aged; Morphine; Opioid-Related Disorders; Pain; Patient Compliance; Physical Examination; Shoulder Pain; Terminology as Topic

Nicotine is reported to have analgesic properties. Patients with chronic pain who smoke could therefore, be expected to require less analgesia than non-smokers because of the possible synergism of the two substances. One hundred healthy patients were studied who had non-radicular low back pain for greater than three months. Each patient failed conservative therapies, which consisted of muscle relaxants, physical therapy and/or NSAIDS. Our study population consisted of two groups of 50 patients. Each group included: I, cigarette smokers; and II, non-smokers. Each patient received 0-40 mg/24hrs of hydrocodone as needed for pain relief for the duration of this four week study. Numeric pain intensity scores (0-10), mean total hydrocodone dosing, and quantitative blood nicotine and hydrocodone levels were assessed at the beginning and end of this study. Patients kept daily diaries and recorded pain scores and self hydrocodone dosing upon awakening, in the afternoon, and at bed time. Parametric and nonparametric statistical analysis was performed using the appropriate test with p < or = 0.05 necessary to reject the null hypothesis There were no differences in demographics between the two groups. Smokers had higher end of study pain scores and required more hydrocodone than non-smokers but had significantly lower serum levels of hydrocodone than non-smokers. The results of this study suggest that cigarette smoking adversely affects serum hydrocodone levels. Prescribing physicians should be aware that in some cigarette smokers, serum hydrocodone levels might not be detectible.

Topics: Adult; Analgesics, Opioid; Chronic Disease; Dipyrone; Female; Humans; Hydrocodone; Low Back Pain; Male; Middle Aged; Nicotine; Pain Measurement; Smoking

Introduced in 1997, the combination of hydrocodone and ibuprofen is the only fixed-dose combination analgesic containing an opioid and ibuprofen that has been approved by the US Food and Drug Administration.. This study compared the efficacy and tolerability of combination hydrocodone 7.5 mg and ibuprofen 200 mg (HC/IB) with those of combination oxycodone 5 mg and acetaminophen 325 mg (OX/AC) in the treatment of moderate or severe acute low back pain.. This was a multicenter, randomized, double-blind, parallel-group, repeat-dose study lasting up to 8 days. The recommended dosing of the study medications was 1 tablet every 4 to 6 hours, not to exceed 5 tablets per day. If adequate pain relief was not obtained, patients were permitted to take up to 4 doses per day of supplemental analgesic medication-the nonopioid component of the assigned study medication (ibuprofen 200 mg or acetaminophen 325 mg). Measures of efficacy included mean daily pain relief scores (0 = no relief, 1 = slight relief, 2 = moderate relief, 3 = good relief, and 4 = complete relief), mean daily number of tablets and doses of study medication, mean daily number of tablets and doses of supplemental analgesic medication, global evaluation (poor, fair, good, very good, or excellent), and results on the modified 36-item Short-Form Health Survey (SF-36). All efficacy measures were analyzed on an intent-to-treat basis. Tolerability was evaluated based on adverse events reported spontaneously or elicited by the in vestigators using nonsuggestive questioning, as well as on the number of patients discontinuing treatment because of adverse events.. The study enrolled 147 patients (75 HC/IB, 72 OX/AC). The most common cause of low back pain was muscular/ligamentous injury (97/147; 66.0%), followed by degenerative disk disease (27/147; 18.4%). At baseline, 80 patients (54.4%) reported experiencing moderate pain, and 67 patients (45.6%) reported experiencing severe pain. There were no significant differences between HC/IB and OX/AC with regard to mean ( +/- SD) daily pain relief scores (2.40 +/- 1.06 vs 2.50 +/- 1.01, respectively), mean daily number of tablets of study medication (1.80 +/- 1.70 vs 2.20 +/- 1.60), mean daily number of doses of study medication (1.80 +/- 1.65 vs 2.10 +/- 1.58), mean daily number of tablets of supplemental analgesic medication (0.60 +/- 1.13 vs 0.50 +/- 0.99), mean daily number of doses of supplemental analgesic medication (0.60 +/- 1.07 vs 0.50 +/- 0.90), global evaluations, or mean scores on the modified SF-36. In addition, there were no significant differences in the proportion of patients experiencing adverse events with HC/IB (47; 62.7%) and OX/AC (45; 62.5%). Adverse events were consistent with those generally associated with the component analgesics and predominantly involved the central nervous system and gastrointestinal system.. The results of this study suggest that HC/IB and OX/AC are similarly effective and tolerable in relieving moderate or severe acute low back pain. Additional controlled longitudinal trials are necessary to evaluate the clinical utility of HC/IB in treating acute low back pain.

Topics: Acetaminophen; Adult; Analgesics, Non-Narcotic; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Double-Blind Method; Drug Combinations; Female; Humans; Hydrocodone; Ibuprofen; Low Back Pain; Male; Middle Aged; Oxycodone; Pain Measurement

We describe the case of a 75-year-old female with chronic low back pain (CLBP), on opioids for more than 15 years. She presented with an acute episode of nausea, vomiting, abdominal pain, and shortness of breath. After a complete work-up, it was concluded that her presenting symptoms were likely due to her high levels of CLBP and high dose opioids. At the time of intervention, her opioid dosage was between 50-90 MME (Morphine milligram equivalent) (Norco 8 × 7.5 mg/day + Fentanyl 12 mcg patch). She was subsequently seen by the physician for seven outpatient internal medicine appointments over nine months and received Pain Neuroscience Education (PNE) in conjunction with monitored tapering of opioids and other medication associated with her CLBP. This case report demonstrates how a physician might deliver PNE as a viable nonpharmacological treatment option for the tapering of long-term opioids for chronic pain.

Topics: Acetaminophen; Aged; Analgesics, Opioid; Chronic Pain; Female; Fentanyl; Humans; Hydrocodone; Low Back Pain; Patient Education as Topic; Physicians

Topics: Analgesics, Opioid; Chronic Pain; Cocaine; Cocaine-Related Disorders; Drug Monitoring; Female; Humans; Hydrocodone; Immunoassay; Low Back Pain; Middle Aged; Opioid-Related Disorders; Sensitivity and Specificity; Substance Abuse Detection

Topics: Analgesics, Opioid; Chronic Pain; Drug Tolerance; Female; Humans; Hydrocodone; Low Back Pain; Male; Severity of Illness Index

Topics: Analgesics, Opioid; Chronic Pain; Drug Tolerance; Female; Humans; Hydrocodone; Low Back Pain; Male; Severity of Illness Index