23 results on '"Pergolizzi, Joseph V."'
Search Results
2. Perspectives on Intravenous Oxycodone for Control of Postoperative Pain.
- Author
-
Pergolizzi JV Jr, Seow-Choen F, Wexner SD, Zampogna G, Raffa RB, and Taylor R Jr
- Subjects
- Administration, Intravenous, Female, Humans, Analgesics, Opioid administration & dosage, Oxycodone administration & dosage, Pain Management methods, Pain, Postoperative drug therapy
- Abstract
Intravenous (IV) analgesia has particular advantages in the immediate postoperative period. For example, IV administration results in a faster onset of pain relief and results in more predictable pharmacokinetics than does administration by other routes. It also allows for convenient dosing before or during surgery, permitting the initiation of effective analgesia in the early phase of the postoperative period. In addition, when patients are able to tolerate oral intake, they can be switched from IV to oral dosing based on maintaining the predictable analgesia established by the IV route. IV morphine is widely used for the control of postoperative pain, but there is a trend toward the use of oxycodone. Oxycodone (which may be mediated partly through kappa- as well as mu-opioid receptors) offers several potential advantages. Published studies comparing IV oxycodone to other IV opioids for postsurgical pain report that oxycodone is a safe and effective analgesic. Some studies show that IV oxycodone may be associated with greater pain control, fewer or less severe adverse events, and faster onset of action, although the results are not consistent across all studies. Oxycodone has been reported to be safe in the geriatric and other special populations when adequate clinical adjustments are made. Thus, the clinical reports and oxycodone's pharmacologic profile make intravenous oxycodone a potentially important "new" old drug for postoperative pain control., (© 2015 World Institute of Pain.) more...
- Published
- 2016
- Full Text
- View/download PDF
Catalog
3. A Subgroup Analysis Found no Diminished Response to Buprenorphine Transdermal System Treatment for Chronic Low Back Pain Patients Classified with Depression.
- Author
-
Yarlas A, Miller K, Wen W, Lynch SY, Munera C, Dain B, Pergolizzi JV Jr, Raffa R, and Ripa SR
- Subjects
- Administration, Cutaneous, Adult, Chronic Pain drug therapy, Chronic Pain psychology, Double-Blind Method, Female, Humans, Male, Middle Aged, Pain Measurement, Quality of Life, Treatment Outcome, Analgesics, Opioid administration & dosage, Buprenorphine administration & dosage, Depression complications, Low Back Pain drug therapy, Low Back Pain psychology
- Abstract
Background: Chronic pain (CP) patients with depression typically exhibit worse post-treatment outcomes than nondepressed CP patients. The cause is often assumed to reflect a differential response to treatment, neglecting other potential explanations, such as the continuation of differences in pretreatment outcomes. This post hoc analysis examines whether worse post-treatment outcomes for depressed patients with chronic low back pain (CLBP) are driven by reduced treatment efficacy., Methods: Data were from opioid-naïve adult patients with moderate-to-severe CLBP who participated in a randomized, placebo-controlled, double-blind clinical trial of Butrans(®) (buprenorphine) Transdermal System (BTDS) for pain relief. Depression screening was based on baseline SF-36v2 Mental Health subscale scores. Patient-reported measures of pain severity, pain interference, quality of life, sleep problems, and functional disability were administered at screening and during the study. Differential treatment efficacy for each outcome was examined using analysis of covariance models that included interaction terms between treatment arm and depression status., Results: At baseline, patients classified as depressed showed greater pain interference, lower quality of life, more sleep problems, and greater functional disability than nondepressed patients; the two groups did not differ in pain severity. No statistically significant interactions between treatment arm and depression status were observed. The direction of improvement post-treatment favored the depressed group on nine of seventeen outcomes., Conclusions: Results do not support a differential response to BTDS treatment between depressed and nondepressed CLBP patients across a variety of patient-reported outcomes. These findings raise the question of whether depressed mood actually moderates the effectiveness of treatment in CP patients., (© 2015 Optum. Pain Practice published by Wiley Periodicals, Inc. on behalf of World Institute of Pain.) more...
- Published
- 2016
- Full Text
- View/download PDF
4. Buprenorphine Transdermal System Improves Sleep Quality and Reduces Sleep Disturbance in Patients with Moderate-to-Severe Chronic Low Back Pain: Results from Two Randomized Controlled Trials.
- Author
-
Yarlas A, Miller K, Wen W, Lynch SY, Ripa SR, Pergolizzi JV, and Raffa RB
- Subjects
- Administration, Cutaneous, Adult, Aged, Double-Blind Method, Female, Humans, Male, Middle Aged, Pain Measurement, Sleep Wake Disorders etiology, Treatment Outcome, Analgesics, Opioid administration & dosage, Analgesics, Opioid therapeutic use, Buprenorphine administration & dosage, Buprenorphine therapeutic use, Low Back Pain complications, Low Back Pain drug therapy, Sleep drug effects, Sleep Wake Disorders prevention & control
- Abstract
Objective: To evaluate the impact of buprenorphine (Butrans®) transdermal System (BTDS) treatment on sleep outcomes for patients with moderate-to-severe chronic low back pain (CLBP)., Methods: Two enriched-enrollment, randomized-withdrawal, double-blind, controlled trials examined BTDS treatment for patients with moderate-to-severe CLBP. Trial I evaluated BTDS 10 and 20 mcg/hour against a placebo control among opioid-naïve patients. Trial II compared BTDS 20 mcg/hour against a lower-dose control (BTDS 5 mcg/hour) among opioid-experienced patients. The patient-reported Medical Outcomes Study Sleep Scale (MOS-SS) assessed overall sleep quality (Sleep Problems Index [SPI]), Disturbance, and other sleep outcomes. In each trial, MOS-SS scores were compared between target treatment and control arms during the 12-week double-blind phase. Correspondence of changes in sleep outcomes and pain severity and the degree to which pain reduction mediates treatment impact on sleep outcomes were examined., Results: Medical Outcomes Study Sleep Scale scores were collected from 541 (Trial I) and 441 (Trial II) patients prior to randomization and from 369 (Trial I) and 274 (Trial II) patients at week 12. Patients receiving target treatment showed statistically significantly more improvement in SPI and Disturbance scores at 12 weeks than their respective controls (Ps < 0.05). Improvements in SPI and Disturbance for target treatment arms were statistically larger those of the controls by week 4 of the double-blind phase. The clinical significance of these differences was not determined. Pain reduction predicted improvements in sleep outcomes., Conclusion: Buprenorphine Transdermal System improved sleep quality and disturbance for opioid-naïve and opioid-experienced patients with moderate-to-severe CLBP. Benefits of BTDS for these sleep outcomes emerged within 4 weeks and were maintained over the entire 12-week treatment period., (© 2015 Optum. Pain Practice published by Wiley Periodicals, Inc. on behalf of World Institute of Pain.) more...
- Published
- 2016
- Full Text
- View/download PDF
5. Treatment Considerations for Cancer Pain: A Global Perspective.
- Author
-
Pergolizzi JV, Gharibo C, and Ho KY
- Subjects
- Aged, Analgesics therapeutic use, Humans, Pain etiology, Quality of Life, Singapore, Neoplasms complications, Pain Management methods, Practice Guidelines as Topic
- Abstract
Cancer pain is prevalent, undertreated, and feared by patients with cancer. In April 2013, a panel of pain experts convened in Singapore to address the treatment of cancer pain. They discussed the various types of cancer pain, including breakthrough pain, which is sometimes clinically confused with analgesic gaps. Reasons for undertreating cancer pain include attitudes of patients, clinicians, and factors associated with healthcare systems. The consequences of not treating cancer pain may include reduced quality of life for patients with cancer (who now live longer than ever), functional decline, and increased psychological stress. Early analgesic intervention for cancer pain may reduce the risk of central sensitization and chronification of pain. To manage pain in oncology patients, clinicians should assess pain during regular follow-up visits using validated pain measurement tools and follow prescribing guidelines, if necessary referring patients with cancer to pain specialists. Many patients with cancer require opioids for pain relief. Pain associated with cancer may also relate to cancer treatments, such as chemotherapy-induced peripheral neuropathy. Many patients with cancer are what might be considered "special populations," in that they may be elderly, frail, comorbid, or have end-stage organ failure. Specific pain therapy guidelines for those populations are reviewed. Patients with cancer with a history of or active substance abuse disorder deserve pain control but may require close medical supervision. While much "treatment inertia" exists in cancer pain control, cancer pain can be safely and effectively managed and should be carried out to alleviate suffering and improve outcomes., (© 2014 World Institute of Pain.) more...
- Published
- 2015
- Full Text
- View/download PDF
6. Intranasal ketorolac as part of a multimodal approach to postoperative pain.
- Author
-
Pergolizzi JV Jr, Taylor R Jr, and Raffa RB
- Subjects
- Administration, Intranasal, Ambulatory Surgical Procedures methods, Analgesics administration & dosage, Analgesics, Opioid administration & dosage, Humans, Pain, Postoperative diagnosis, Randomized Controlled Trials as Topic methods, Anti-Inflammatory Agents, Non-Steroidal administration & dosage, Ketorolac administration & dosage, Pain Management methods, Pain, Postoperative drug therapy
- Abstract
Despite recent advances in the knowledge of pain mechanisms and pain management, postoperative pain continues to be a problem. Inadequately managed postsurgical pain has both clinical and economic consequences such as longer recovery times, delayed ambulation, higher incidence of complications, increased length of hospital stay, and potential to develop into chronic pain. Generally, opioids are the mainstay option for pain management in patients with moderate-to-severe postsurgical pain; however, opioids have significant side effects and have abuse potential. To improve patient and economic outcomes after surgery, postoperative pain guidelines have suggested incorporating a multi-modal/multi-mechanistic approach to pain treatment. A multi-modal approach is the simultaneous use of a combination of two or more (usually opioid and non-opioid) analgesics that provide two different mechanisms of actions. Utilizing a multi-modal approach may result in a greater reduction in pain vs. single therapies in addition to minimizing opioid use, thus reducing opioid related side effects. However, not all approaches may be effective for all types of patients and not all analgesics may be a viable option for outpatient settings, ambulatory surgery, or the fast-track surgical procedures. In this report, we present a review of the literature with a focus on intranasal ketorolac in order to provide a timely update regarding past, present, and future multi-modal treatment options for postoperative pain., (© 2014 World Institute of Pain.) more...
- Published
- 2015
- Full Text
- View/download PDF
7. DEA reschedules hydrocodone combination products.
- Author
-
Pergolizzi JV Jr
- Subjects
- Analgesics therapeutic use, Attitude to Health, Drug Combinations, Humans, Pain Management, United States, Acetaminophen therapeutic use, Analgesics, Opioid therapeutic use, Drug and Narcotic Control, Hydrocodone therapeutic use, Medical Marijuana therapeutic use, Opioid-Related Disorders prevention & control, Pain drug therapy
- Published
- 2015
- Full Text
- View/download PDF
8. Predicting medication persistence to buprenorphine transdermal system.
- Author
-
Pergolizzi JV, Ben-Joseph R, Chang CL, and Hess G
- Subjects
- Administration, Cutaneous, Adult, Aged, Databases, Factual, Drug Therapy, Combination statistics & numerical data, Female, Humans, Male, Middle Aged, Pain Measurement, Time Factors, Transdermal Patch, Analgesics, Non-Narcotic therapeutic use, Analgesics, Opioid therapeutic use, Anti-Inflammatory Agents, Non-Steroidal therapeutic use, Buprenorphine therapeutic use, Chronic Pain drug therapy, Medication Adherence statistics & numerical data
- Abstract
Objectives: Persistence, the duration a patient remains on therapy, in chronic, symptomatic conditions plays an important role in therapy effectiveness. Understanding the duration and patient factors associated with prescribed medication persistence is, therefore, an important step toward better treatment and health outcomes for patients. In the following study, an analysis of such factors associated with buprenorphine transdermal system (BTDS) persistence was conducted utilizing a large US private practitioner and pharmacy claims database and is herein reported., Methods: Patients aged ≥ 18 years initiating BTDS during January 1, 2011-November 30, 2011 were identified in the IMS Private Practitioner Medical Claims and Pharmacy Claims databases. An index date was defined as the first prescription of BTDS during the studied interval. During the preindex period, Charlson Comorbidity Index (CCI), chronic pain-related conditions, and prior medication use were assessed. Concomitant medications and various treatment patterns (eg, last dose strength and dose adjustments) were assessed in the postindex 6-month period. Persistence was measured as the duration of BTDS from initiation to the 1st >28-day refill gap in the postindex 6-month period. Descriptive statistical and survival analysis was used to assess the predictors of BTDS persistence., Results: During the study period, 10,457 patients newly treated with BTDS were identified. Patients' mean (± SD) age was 54.5 (± 15.2) years; 69.9% were women, and the mean (± SD) CCI was 1 (± 1.4). Utilizing a hierarchical approach, patients were separated into different cohorts based on the initial analgesic prescription identified during postindex period with 91.7%, 34.7%, and 59.0% of the patients using opioids, NSAIDs and adjuvant analgesics, respectively. Multivariate regression analyses showed that patients with prior opioid and adjuvant analgesic use were 21% and 5% less likely to discontinue BTDS (P < 0.05), respectively, as compared to patients not using these agents. Patients with concomitant use of adjuvant analgesics were 15% less likely to discontinue therapy (P < 0.05) as compared to patients without concomitant use of these agents. Long-term BTDS persistence was also observed in patients who had a dose change or a last dose strength >5 mcg/hour. Sensitivity analyses for those with 30-day prior opioid use and patients with ≥ 2 claims of BTDS confirmed these findings., Conclusions: Prior and concomitant use of adjuvant analgesics, prior use of opioids, and dose adjustments were associated with significantly longer persistence among patients initiating BTDS. The results suggest that patients are less likely to discontinue BTDS early if practitioners account for prior treatment history and dose titration., (© 2014 World Institute of Pain.) more...
- Published
- 2015
- Full Text
- View/download PDF
9. Ketorolac tromethamine - routes and clinical implications.
- Author
-
Vadivelu N, Gowda AM, Urman RD, Jolly S, Kodumudi V, Maria M, Taylor R Jr, and Pergolizzi JV Jr
- Subjects
- Administration, Intranasal, Administration, Intravenous, Administration, Oral, Analgesics therapeutic use, Analgesics, Opioid therapeutic use, Anesthetics, Local therapeutic use, Anti-Inflammatory Agents, Non-Steroidal therapeutic use, Drug Therapy, Combination, Gastrointestinal Hemorrhage chemically induced, Humans, Injections, Intramuscular, Ketorolac Tromethamine therapeutic use, Nerve Block, Treatment Outcome, Anti-Inflammatory Agents, Non-Steroidal administration & dosage, Ketorolac Tromethamine administration & dosage, Pain, Postoperative drug therapy
- Abstract
Opioids have long been used for analgesic purposes for a wide range of procedures. However, the binding of these drugs to opiate receptors has created various challenges to the clinician due to unfavorable side effect profiles and the potential for tolerance and abuse. In 1989, ketorolac became an approved nonsteroidal inflammatory drug (NSAID) for injectable use as an analgesic. Over the last 20 years, numerous studies have been conducted involving ketorolac. These studies have provided additional information about various routes of administration and their effect on the efficacy and the side effect profile of ketorolac. Moreover, ketorolac has been compared with several widely used analgesics. This review evaluates both the potential benefits and potential drawbacks of ketorolac generally, and specifically discusses routes of administration, including their advantages and disadvantages when compared to several traditional analgesics in both inpatient and outpatient settings., (© 2014 World Institute of Pain.) more...
- Published
- 2015
- Full Text
- View/download PDF
10. Acetaminophen (paracetamol) oral absorption and clinical influences.
- Author
-
Raffa RB, Pergolizzi JV Jr, Taylor R Jr, Decker JF, and Patrick JT
- Subjects
- Acetaminophen metabolism, Administration, Oral, Analgesics administration & dosage, Analgesics metabolism, Analgesics, Non-Narcotic metabolism, Analgesics, Opioid administration & dosage, Analgesics, Opioid metabolism, Animals, Anti-Inflammatory Agents, Non-Steroidal administration & dosage, Anti-Inflammatory Agents, Non-Steroidal metabolism, Drug Overdose, Gastrointestinal Absorption physiology, Humans, Acetaminophen administration & dosage, Analgesics, Non-Narcotic administration & dosage, Gastrointestinal Absorption drug effects
- Abstract
Acetaminophen (paracetamol) is a widely used nonopioid, non-NSAID analgesic that is effective against a variety of pain types, but the consequences of overdose can be severe. Because acetaminophen is so widely available as a single agent and is increasingly being formulated in fixed-ratio combination analgesic products for the potential additive or synergistic analgesic effect and/or reduced adverse effects, accidental cumulative overdose is an emergent concern. This has rekindled interest in the sites, processes, and pharmacokinetics of acetaminophen oral absorption and the clinical factors that can influence these. The absorption of oral acetaminophen occurs primarily along the small intestine by passive diffusion. Therefore, the rate-limiting step is the rate of gastric emptying into the intestines. Several clinical factors can affect absorption per se or the rate of gastric emptying, such as diet, concomitant medication, surgery, pregnancy, and others. Although acetaminophen does not have the abuse potential of opioids or the gastrointestinal bleeding or organ adverse effects of NSAIDs, excess amounts can produce serious hepatic injury. Thus, an understanding of the sites and features of acetaminophen absorption--and how they might be influenced by factors encountered in clinical practice--is important for pain management using this agent. It can also provide insight for design of formulations that would be less susceptible to clinical variables., (© 2013 World Institute of Pain.) more...
- Published
- 2014
- Full Text
- View/download PDF
11. Abuse-deterrent formulations of opioid analgesics.
- Author
-
Pergolizzi JV Jr and LeQuang JA
- Subjects
- Chemistry, Pharmaceutical, Humans, Analgesics, Opioid chemistry, Opioid-Related Disorders prevention & control
- Published
- 2014
- Full Text
- View/download PDF
12. Transversus abdominis block: clinical uses, side effects, and future perspectives.
- Author
-
Taylor R Jr, Pergolizzi JV, Sinclair A, Raffa RB, Aldington D, Plavin S, and Apfel CC
- Subjects
- Humans, Treatment Outcome, Abdomen innervation, Abdominal Muscles innervation, Autonomic Nerve Block methods, Pain, Postoperative therapy
- Abstract
Poorly controlled acute pain during the postoperative setting after abdominal surgery can be detrimental to the patient. Current pain management practices for the postoperative abdominal surgery patient rely heavily on opioids, which are associated with many unwanted side effects. Recently, interest surrounding regional anesthesia has been growing owing to its demonstrated efficacy and safety outcomes. More specifically, the transversus abdominis plane (TAP) block procedure has attracted attention owing to its ability to successfully block peripheral pain signaling in the abdomen, its ease of use, few complications, and its greater acceptability. A majority of the studies published has demonstrated the successful reduction in pain in many abdominal surgical procedures using local anesthetics during the TAP block. However, the short duration of the pain block causes the patient to still rely on other analgesics throughout the additional postoperative days. Preliminary studies using continuous infusion catheters placed in the TAP has been one of the ways to prolong the nerve block in the abdomen; however, technical and operational issues currently limit the widespread adoption of this method. In this review, current studies will be presented and summarized to update the field on the potential benefits of the TAP block procedure, in addition to providing insight into the future direction of the drugs that could be used for TAP block., (© 2012 The Authors. Pain Practice © 2012 World Institute of Pain.) more...
- Published
- 2013
- Full Text
- View/download PDF
13. Development of federally mandated risk evaluation and mitigation strategies (REMS) for transmucosal immediate-release fentanyl products.
- Author
-
Pergolizzi JV, Gharibo CG, Gudin JA, and Nalamachu SR
- Subjects
- Administration, Mucosal, Humans, United States, Analgesics, Opioid administration & dosage, Fentanyl administration & dosage, Pain drug therapy, Pharmacovigilance, Risk Management methods
- Published
- 2013
- Full Text
- View/download PDF
14. Compounding pharmacies: who is in charge?
- Author
-
Pergolizzi JV Jr, Labhsetwar S, and LeQuang JA
- Subjects
- Humans, Drug Compounding standards, Pharmacies legislation & jurisprudence, Pharmacies standards
- Abstract
Compounding pharmacies play an increasing and increasingly important role in our healthcare system, but recent media attention has exposed limited regulatory control over these organizations at the same time their role is expanding. Compounding pharmacies are not regulated in the same manner as pharmaceutical companies and are governed largely by Chapter <797>, a monograph on the pharmaceutical compounding of sterile products, issued but not enforced by the U.S. Pharmacopeial Convention. Not all states require adherence to Chapter <797>, and those that do may choose not to enforce it stringently. Furthermore, Chapter <797> is not a strong standard--for example, it does not require documentation of drug lot numbers or cross-references for patient identification. Thus, there have long been many potential quality issues associated with compounding pharmacies. As these compounding pharmacies provide important products and services, better regulation is urgently needed. Moreover, clinicians should be better aware that some injectable products they use may have been prepared by a compounding pharmacy., (© 2013 The Authors Pain Practice © 2013 World Institute of Pain.) more...
- Published
- 2013
- Full Text
- View/download PDF
15. A review of duloxetine 60 mg once-daily dosing for the management of diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain due to chronic osteoarthritis pain and low back pain.
- Author
-
Pergolizzi JV Jr, Raffa RB, Taylor R Jr, Rodriguez G, Nalamachu S, and Langley P
- Subjects
- Duloxetine Hydrochloride, Humans, Low Back Pain complications, Low Back Pain drug therapy, Musculoskeletal Pain etiology, Osteoarthritis complications, Osteoarthritis drug therapy, Analgesics administration & dosage, Chronic Pain drug therapy, Diabetic Neuropathies drug therapy, Fibromyalgia drug therapy, Musculoskeletal Pain drug therapy, Thiophenes administration & dosage
- Abstract
Background: Duloxetine is a selective dual neuronal serotonin (5-Hydroxytryptamine, 5-HT) and norepinephrine reuptake inhibitor (SSNRI). It is indicated in the United States for treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), and several chronic pain conditions, including management of diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain due to chronic osteoarthritis (OA) pain and chronic low back pain (LBP). Its use for antidepressant and anxiolytic actions has been extensively reviewed previously. We here review the evidence for the efficacy of 60 mg once-daily dosing of duloxetine for chronic pain conditions., Method: The literature was searched for clinical trials in humans conducted in the past 10 years involving duloxetine., Results: There were 199 results in the initial search. Studies not in the English language were excluded. We then included only studies of diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain (OA and LBP). Studies of painful symptoms reported in mental health studies were excluded. This resulted in 32 studies. Articles that did not include a 60 mg/day daily dose as a study arm were excluded. This resulted in 30 studies, broken down as follows: 12 for diabetic peripheral neuropathy, 9 for fibromyalgia, 6 for LBP, and 3 for OA pain., Conclusions: The studies reviewed report that duloxetine 60 mg once-daily dosing is an effective option for the management of diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain due to chronic OA pain and chronic LBP. As these pains are often comorbid with MDD or GAD, duloxetine might possess the pharmacologic properties to be a versatile agent able to address several symptoms in these patients. With adequate attention to FDA prescribing guidance regarding safety and drug-drug interactions, duloxetine 60 mg once-daily dosing appears to be an effective option in the appropriate pain patient population., (© 2012 The Authors. Pain Practice © 2012 World Institute of Pain.) more...
- Published
- 2013
- Full Text
- View/download PDF
16. Continuous multimechanistic postoperative analgesia: a rationale for transitioning from intravenous acetaminophen and opioids to oral formulations.
- Author
-
Pergolizzi JV Jr, Raffa RB, Tallarida R, Taylor R, and Labhsetwar SA
- Subjects
- Acetaminophen chemistry, Acetaminophen metabolism, Acetaminophen therapeutic use, Administration, Oral, Analgesia adverse effects, Analgesics, Non-Narcotic chemistry, Analgesics, Non-Narcotic metabolism, Analgesics, Non-Narcotic therapeutic use, Analgesics, Opioid therapeutic use, Drug Therapy, Combination, Humans, Infusions, Intravenous, Pain Management, Acetaminophen administration & dosage, Analgesics, Non-Narcotic administration & dosage, Analgesics, Opioid administration & dosage, Pain, Postoperative drug therapy
- Abstract
Good surgical outcomes depend in part on good pain relief, allowing for early mobilization, optimal recovery, and patient satisfaction. Postsurgical pain has multiple mechanisms, and multimechanistic approaches to postoperative analgesia are recommended and may be associated with improved pain relief, lowered opioid doses, and sometimes a lower rate of opioid-associated side effects. Acetaminophen (paracetamol) is a familiar agent for treating many types of pain, including postsurgical pain. Oral acetaminophen has been shown to be safe and effective in a variety of acute pain models. Combination products using a fixed-dose of acetaminophen and an opioid have also been effective in treating postsurgical pain. Combination products with acetaminophen have demonstrated an opioid-sparing effect, which inconsistently results in a reduced rate of opioid-associated side effects. Intravenous (IV) acetaminophen and an opioid analgesic administered in the perioperative period may be followed by an oral acetaminophen and opioid combination in the postoperative period. Transitioning from an IV acetaminophen and opioid formulation to a similar but oral formulation of the same drugs appears to be a reasonable step in that both analgesic therapies are known to be safe and effective. For postsurgical analgesia with any acetaminophen product, patient education is necessary to be sure that the patient does not concurrently take any over-the-counter products containing acetaminophen and accidentally exceed dose limits., (© 2011 The Authors. Pain Practice © 2011 World Institute of Pain.) more...
- Published
- 2012
- Full Text
- View/download PDF
17. Economic impact of potential drug-drug interactions among osteoarthritis patients taking opioids.
- Author
-
Pergolizzi JV Jr, Labhsetwar SA, Puenpatom RA, Ben-Joseph R, Ohsfeldt R, and Summers KH
- Subjects
- Aged, Female, Health Services economics, Hospitalization economics, Humans, Male, Middle Aged, Office Visits economics, Analgesics, Opioid economics, Analgesics, Opioid therapeutic use, Drug Interactions, Osteoarthritis drug therapy, Osteoarthritis economics
- Abstract
Patients with osteoarthritis (OA) taking at least one CYP450-metabolized opioid concurrently with another CYP450-metabolized medication experience a drug-drug exposure (DDE), which puts them at risk of a pharmacokinetic drug-drug interaction (PK DDI). This study compared patients with and without such an incident DDE to determine healthcare utilization and associated payments. Using a retrospective database analysis, the impact of DDEs was evaluated in terms of associated clinical events, healthcare services utilization (office visits, outpatient visits, ED visits, hospitalization), and payments in patient populations based on age (those under age 65 and those 65 years of age and older), during the 6 months after exposure. DDE patients had significantly more inpatient hospitalizations than no-DDE patients. Mean total payments at 6 months were significantly higher for both younger and older patients with DDE compared to similar patients without DDE ($9,469, SD = $12,192 vs. $8,382, SD = $14,078, respectively, for younger patients, resulting in a difference of $1,087, P < 0.004, and $9,829, SD = $11,721 vs. $8,622, SD = $10,131, respectively, for older patients, resulting in a difference of $1,207, P = 0.001). In both age groups, DDE patients had significantly higher payments for nonopioid prescription drugs ($1,824 SD = $2,420 vs. $1,362, SD = $1,891, respectively, for younger patients, resulting in a difference of $462, P < 0.001, and $2,197 SD = $2,332 vs. $2,013, SD = $2,437, respectively, for older patients, resulting in a difference of $184, P = 0.020). Overall, patients with OA who experienced DDEs had significantly greater utilization rates of healthcare resources and higher associated payments in the 6-month observation period following the exposure, compared to patients without DDEs, consistent with the risk of PK DDIs associated with DDEs., (© 2011 The Authors. Pain Practice © 2011 World Institute of Pain.) more...
- Published
- 2012
- Full Text
- View/download PDF
18. Economic impact of potential CYP450 pharmacokinetic drug-drug interactions among chronic low back pain patients taking opioids.
- Author
-
Pergolizzi JV Jr, Labhsetwar SA, Amy Puenpatom R, Ben-Joseph R, Ohsfeldt R, and Summers KH
- Subjects
- Aged, Analgesics, Opioid pharmacokinetics, Analgesics, Opioid therapeutic use, Cytochrome P-450 Enzyme System metabolism, Female, Health Services economics, Hospitalization economics, Humans, Male, Middle Aged, Office Visits economics, Retinoic Acid 4-Hydroxylase, Analgesics, Opioid economics, Drug Interactions, Low Back Pain drug therapy, Low Back Pain economics
- Abstract
Chronic low back pain (cLBP) patients who take at least 1 CYP450-metabolized opioid analgesic agent concurrent with at least 1 other CYP450-metabolized medication experience a drug-drug exposure (DDE), which puts them at risk for a pharmacokinetic drug-drug interaction (PK DDI). This study compared utilization of healthcare resources and associated payments in cLBP patients with and without incident DDEs with the potential to cause PK DDIs. A retrospective database analysis examined the associated clinical events, healthcare utilization (measured in terms of claims for office visits, outpatient visits, emergency department visits, and hospitalization), and cost to the health plan, as defined as the sum of health plan payments for resources used. Patients were grouped into 2 cohorts by age (those under 65 and those 65 years and over). In the 6 months after exposure, total healthcare payments were significantly higher for DDE patients than those without DDEs (no-DDE), in both in the younger ($7,086, SD = $8,370) and $6,353, SD = $8,352, respectively, P < 0.001) and the older cohorts ($7,806 vs. $7,043, respectively, P = 0.013). Younger and older patients with DDE had significantly higher prescription payments than those without DDE ($2,041, SD = $2,706 vs. $1,565, SD = $2,349, respectively, P < 0.001 for younger and $2,482, SD = $2,481 vs. $2,286, SD = $2,521, respectively, P = 0.044 for older patients). Both older and younger patients with DDE had significantly more claims for office visits and higher associated payments than similar patients without DDE. Patients in the study who experienced DDEs that placed them at risk for PK DDIs had significantly greater utilization rates of healthcare resources and higher associated payments in the 6-month observation period following exposure., (© 2011 The Authors. Pain Practice © 2011 World Institute of Pain.) more...
- Published
- 2012
- Full Text
- View/download PDF
19. Exposure to potential CYP450 pharmacokinetic drug-drug interactions among osteoarthritis patients: incremental risk of multiple prescriptions.
- Author
-
Pergolizzi JV Jr, Labhsetwar SA, Puenpatom RA, Joo S, Ben-Joseph R, and Summers KH
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Databases, Factual, Drug Interactions, Female, Humans, Male, Middle Aged, Osteoarthritis metabolism, Retrospective Studies, Sex Factors, Cytochrome P-450 Enzyme System metabolism, Osteoarthritis drug therapy, Polypharmacy
- Abstract
Patients taking more than one drug metabolized through the cytochrome P450 (CYP450) enzyme system experience a drug-drug exposure (DDE), which puts them at risk for a potential pharmacokinetic drug-drug interaction (DDI), defined as two or more drugs interacting in such a way that the effectiveness and/or toxicity of one or all drugs are changed. Any patient subjected to a DDE is at risk for a potentially serious DDI, the epidemiology of which has not been thoroughly studied. Many drugs are metabolized primarily via the CYP450 enzyme system, including certain opioids used to manage moderate to severe chronic pain. We conducted a retrospective analysis of a large commercial claims database and a Medicare database to assess the prevalence of DDEs among patients with osteoarthritis taking CYP450-metabolized opioids. The overall prevalence of DDEs in this population was 26%, with females more likely to experience DDEs than males (28.4% vs. 21.0%, respectively). The number of unique concurrent prescriptions at baseline, gender, age, and Charlson Comorbidity Index were statistically significant predictors of DDEs (P < 0.05). This study challenged previous assumptions about DDEs in that advanced age was not positively associated with the risk of DDE. However, the number of prescriptions the patient received in the 90-day window prior to the index date was a risk factor. For patients taking at least two medications in the 90-day period prior to the index date, every additional prescription taken increased their risk for a DDE during the observation period by 138% (on average). The risk of DDE during the study period was threefold greater for patients with one medication in the 90-day period before index date compared with similar patients with no prescriptions in that same period before the index date. DDEs are more common than may be generally believed in patients with osteoarthritis, regardless of age, and can occur even in patients taking few medications. When selecting an opioid analgesic to treat osteoarthritis, physicians should consider the potential for exposure of these patients to drugs that could interact unfavorably. , (© 2010 The Authors. Pain Practice © 2010 World Institute of Pain.) more...
- Published
- 2011
- Full Text
- View/download PDF
20. Prevalence of exposure to potential CYP450 pharmacokinetic drug-drug interactions among patients with chronic low back pain taking opioids.
- Author
-
Pergolizzi JV Jr, Labhsetwar SA, Puenpatom RA, Joo S, Ben-Joseph RH, and Summers KH
- Subjects
- Adolescent, Adult, Age Factors, Aged, Analgesics, Opioid metabolism, Drug Interactions, Female, Humans, Logistic Models, Male, Middle Aged, Prevalence, Young Adult, Analgesics, Opioid therapeutic use, Cytochrome P-450 Enzyme System metabolism, Enzyme Inhibitors pharmacokinetics, Low Back Pain drug therapy, Low Back Pain enzymology, Low Back Pain epidemiology
- Abstract
Drug-drug interactions (DDIs) have been defined as two or more drugs interacting in such a way that the effectiveness and/or toxicity of one or all drugs are changed. Patients taking more than one drug metabolized through the cytochrome P450 (CYP450) enzyme system, including some, but not all, opioids experience a drug-drug exposure (DDE), which may result in a potentially dangerous DDI. Using a retrospective analysis of a large commercial claims database and a Medicare database, we evaluated DDEs that have the potential to cause DDIs among chronic low back pain (cLBP) patients on long-term opioid analgesia, which metabolizes through the CYP450 enzyme system, concomitant with other CYP450-metabolized drug(s). The overall prevalence of DDEs among cLBP patients was 27%. Women had a higher prevalence of DDEs (30.6% vs. 22% for men). Patients aged 45 to 55 and 56 to 64 years had the highest prevalence of DDEs (30.4% and 29.8%, respectively), followed by patients 34 to 45 years (27.9%). For patients>65 years, the prevalence of DDEs was 23.1%. In general, the prevalence of DDEs was fairly consistent across age ranges in this population. This study suggests that DDEs are common in the cLBP population. When selecting an opioid to treat cLBP, physicians should consider the potential for exposure of these patients to drugs that might unfavorably interact and, for that reason, the use of opioids that do not rely on the CYP450 system as their primary means of metabolism might be worthy of consideration., (© 2010 The Authors. Pain Practice © 2010 World Institute of Pain.) more...
- Published
- 2011
- Full Text
- View/download PDF
21. Preliminary observations of a novel topical oil with analgesic properties for treatment of acute and chronic pain syndromes.
- Author
-
Pergolizzi JV, Pappagallo M, Raffa RB, Gharibo C, Phillips RB, Desjonquères S, and Tabor A
- Subjects
- Administration, Topical, Adolescent, Adult, Aged, Clinical Trials as Topic methods, Double-Blind Method, Female, History, 20th Century, Humans, Male, Middle Aged, Oils, Volatile history, Pain classification, Pain etiology, Pain Measurement methods, Product Surveillance, Postmarketing, Young Adult, Analgesics therapeutic use, Oils, Volatile therapeutic use, Pain drug therapy
- Abstract
Objective: Essential oxygen oil (OxyRub from CreoMed Inc., Naples, FL, U.S.A.) is a novel topical analgesic currently commercially available in Europe and now available in the U.S.A. It represents an important alternative to other treatments (nonsteroidal anti-inflammatory drugs, acetaminophen, menthol, camphor) for managing mild to moderate acute and chronic pain. Several clinical trials of this oil will be reviewed., Results: One large (n = 455) open-label trial found essential oxygen oil to be a safe and effective analgesic for a broad range of patients with acute and chronic pain. In that study, 80% of patients reported that their pain decreased by more than 75%. A double-blind placebo-controlled study (n = 50) found significant pain reduction for tendonitis in patients using essential oxygen oil. Another trial of essential oxygen oil vs. placebo (n = 50) with various pain diagnoses found that 98% of patients with various pain diagnoses reported "very good" pain relief in the oil group compared to 48% in the placebo group. Furthermore, a randomized controlled trial in 10 women to measure oxygen microcirculatory effect in the skin showed an increased microcirculatory effect with improved oxygenation (increased partial pressure of oxygen in the skin) after application of essential oxygen oil. In all studies, the oil was well tolerated. None of these studies has been previously published., Conclusions: Based on studies completed, essential oxygen oil has shown itself to be safe, has demonstrated positive analgesic effects for the treatment of acute and chronic pain, and has improved oxygen content in the skin as well as other dermatological parameters. more...
- Published
- 2010
- Full Text
- View/download PDF
22. Treatment of 94 outpatients with chronic discogenic low back pain with the DRX9000: a retrospective chart review.
- Author
-
Macario A, Richmond C, Auster M, and Pergolizzi JV
- Subjects
- Adult, Aged, Analgesics therapeutic use, Combined Modality Therapy, Equipment Design, Female, Humans, Intervertebral Disc Displacement therapy, Low Back Pain drug therapy, Low Back Pain etiology, Male, Middle Aged, Pain Measurement, Retrospective Studies, Traction methods, Treatment Outcome, Intervertebral Disc Displacement complications, Low Back Pain therapy, Lumbar Vertebrae, Traction instrumentation
- Abstract
Background: This study's goal was a retrospective chart audit of 100 outpatients with discogenic low back pain (LBP) lasting more than 12 weeks treated with a 2-month course of motorized spinal decompression via the DRX9000 (Axiom Worldwide, Tampa, FL, U.S.A.)., Methods: Patients at a convenience sample of four clinics received 30-minute DRX9000 sessions daily for the first 2 weeks tapering to 1 session/week. Treatment protocol included lumbar stretching, myofascial release, or heat prior to treatment, with ice and/or muscle stimulation afterwards. Primary outcome was verbal numerical pain intensity rating (NRS) 0 to 10 before and after the 8-week treatment., Results: Of the 100 initial subjects, three withdrew their protected health information, and three were excluded because their LBP duration was less than 12 weeks. The remaining 94 subjects (63% female, 95% white, age = 55 (SD 16) year, 52% employed, 41% retired, LBP median duration of 260 weeks) had diagnoses of herniated disc (73% of patients), degenerative disc disease (68%), or both (27%). Mean NRS equaled 6.05 (SD 2.3) at presentation and decreased significantly to 0.89 (SD 1.15) at end of 8-week treatment (P < 0.0001). Analgesic use also appeared to decrease (charts with data = 20) and Activities of Daily Living improved (charts with data = 38). Follow-up (mean 31 weeks) on 29/94 patients reported mean 83% LBP improvement, NRS of 1.7 (SD 1.15), and satisfaction of 8.55/10 (median 9)., Conclusions: This retrospective chart audit provides preliminary data that chronic LBP may improve with DRX9000 spinal decompression. Randomized double-blind trials are needed to measure the efficacy of such systems. more...
- Published
- 2008
- Full Text
- View/download PDF
23. Systematic literature review of spinal decompression via motorized traction for chronic discogenic low back pain.
- Author
-
Macario A and Pergolizzi JV
- Subjects
- Chronic Disease, Humans, Intervertebral Disc Displacement complications, Low Back Pain etiology, Traction instrumentation, Decompression methods, Intervertebral Disc Displacement therapy, Low Back Pain therapy, Traction methods
- Abstract
Objective: The objective of this study was to systematically review the literature to assess the efficacy of nonsurgical spinal decompression achieved with motorized traction for chronic discogenic lumbosacral back pain., Design: Computer-aided systematic literature search of MEDLINE and the Cochrane collaboration for prospective clinical trials on adults with low back pain in the English literature from 1975 to October 2005. Methodologic quality for each study was assessed. Studies were included if the intervention group received motorized spinal decompression and the comparison group received sham or another type of nonsurgical treatment., Results: Data from 10 studies were fully analyzed. Seven studies were randomized controlled trials using various apparatus types. Because of this low number, we also analyzed three nonrandomized case series studies of spinal decompression systems. As the overall quality of studies was low and the patient groups heterogeneous, a meta-analysis was not appropriate and a qualitative review was undertaken. Sample sizes averaged 121 patients (range 27-292), with six of the seven randomized studies reporting no difference with motorized spinal decompression and one study reporting reduced pain but not disability. The three unrandomized studies (no control group) of motorized spinal decompression found a 77% to 86% reduction in pain., Conclusions: These data suggest that the efficacy of spinal decompression achieved with motorized traction for chronic discogenic low back pain remains unproved. This may be, in part, due to heterogeneous patient groups and the difficulties involved in properly blinding patients to the mechanical pulling mechanism. Scientifically more rigorous studies with better randomization, control groups, and standardized outcome measures are needed to overcome the limitations of past studies. more...
- Published
- 2006
- Full Text
- View/download PDF
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.