scholarly journals Impact of opioid rescue medication for breakthrough pain on the efficacy and tolerability of long-acting opioids in patients with chronic non-malignant pain

2009 ◽  
Vol 103 (4) ◽  
pp. 576-585 ◽  
Author(s):  
J. Devulder ◽  
A. Jacobs ◽  
U. Richarz ◽  
H. Wiggett
Keyword(s):  
Rescue Medication ◽  
Breakthrough Pain ◽  
Long Acting

General principles of management

2019 ◽  
pp. 25-42
Author(s):  
Andrew Davies
Keyword(s):  
Bone Disease ◽  
Rescue Medication ◽  
Breakthrough Pain ◽  
Metastatic Bone Disease ◽  
Optimal Treatment ◽  
Common Phenomenon ◽  
Related Factors ◽  
Incident Type ◽  
Analgesic Regimen ◽  
Incident Pain

Breakthrough pain is not a single entity, but a spectrum of very different entities. In most cases, the underlying cause of the pain is a direct effect of the cancer. There is emerging evidence to suggest certain oncological treatments may be effective in managing certain types of breakthrough pain. Optimal treatment of breakthrough pain depends on a variety of pain-related factors. Optimal treatment of breakthrough pain depends on a variety of patient-related factors. Avoidance or treatment of precipitating factors should be considered in patients with incident-type breakthrough pain. Movement-related/incident pain, secondary to metastatic bone disease, is a common phenomenon. Modification of the background analgesic regimen has been shown to be a useful approach in managing breakthrough pain. Multimodal approaches are often required. The cornerstone of the management of breakthrough pain episodes is the use of so-called rescue medication. The management of end-of-dose failure involves modification of the background analgesic regimen. The use of rescue medication depends on the type of breakthrough pain and acceptance depends on factors such as the route of administration of medication.

Rolapitant for control of chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic cancer.

2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 223-223 ◽  
Author(s):  
Bernardo Leon Rapoport ◽  
Lee Steven Schwartzberg ◽  
Sujata Arora ◽  
Daniel Powers ◽  
Karin Jordan ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Receptor Antagonist ◽  
Rescue Medication ◽  
Gynecologic Cancer ◽  
Complete Response ◽  
Double Blind ◽  
Neurokinin 1 ◽  
Long Acting ◽  
Type 3 ◽  
And Control

223 Background: Rolapitant, a long-acting neurokinin-1 receptor antagonist, protected against CINV in patients receiving highly or moderately emetogenic chemotherapy (HEC or MEC). Methods: In 3 double-blind phase 3 studies, patients were randomized to receive oral rolapitant 180 mg or placebo before administration of HEC or MEC. All patients received a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone. In a post hoc analysis of 3 pooled studies (2 HEC and 1 MEC), we assessed the efficacy and safety of rolapitant in patients with gynecologic (ovarian, uterine, or cervical) cancer. Endpoints included complete response (CR; no emesis and no use of rescue medication), no emesis, no nausea (maximum visual analogue scale [VAS] < 5 mm), and complete protection (CP; no emesis, no use of rescue medication, and no significant nausea [maximum VAS < 25 mm]) in the overall (0–120 h), acute (≤ 24 h), and delayed (> 24–120 h) phases. Results: Of 201 patients with gynecologic cancer (60% ovarian, 28% uterine, and 12% cervical cancer), 55% received cisplatin-based HEC and 44% received MEC (99% of whom received carboplatin-based therapy). In the overall and delayed phases, improved rates of CR, no emesis, no nausea, and CP were observed with rolapitant compared with control (Table). The overall incidence of treatment-emergent adverse events was similar in the rolapitant and control groups (45% vs 54%). Conclusions: Rolapitant protected against overall and delayed CINV in patients with gynecologic cancer receiving HEC or MEC. Clinical trial information: NCT01500226, NCT01499849, NCT01500213. [Table: see text]

scholarly journals Quantitative analysis of efficacy and safety of LABA/LAMA fixed-dose combinations in the treatment of stable COPD

2022 ◽  
Vol 16 ◽  
pp. 175346662110660
Author(s):  
Yiwen Gong ◽  
Yinghua Lv ◽  
Hongxia Liu ◽  
Qingshan Zheng ◽  
Lujin Li
Keyword(s):  
Adverse Events ◽  
Rescue Medication ◽  
Primary Outcome ◽  
Medication Use ◽  
Fixed Dose ◽  
Efficacy And Safety ◽  
Copd Exacerbations ◽  
Safety Outcomes ◽  
Secondary Outcomes ◽  
Long Acting

Objective: This study aimed to quantitatively compare the efficacy and safety of long-acting β2-agonist (LABA)/long-acting muscarinic antagonist (LAMA) fixed-dose combinations (FDCs) for the treatment of stable chronic obstructive pulmonary disease (COPD), especially in terms of their loss of efficacy in lung function. Methods: Randomized controlled clinical trials of LABA/LAMA FDCs for the treatment of stable COPD were comprehensively searched for in public databases. Pharmacodynamic models were established to describe the time course of the primary outcome [trough forced expiratory volume in the first second (FEV1)]. Secondary outcomes [COPD exacerbations, St. George’s Respiratory Questionnaire (SGRQ), Transition Dyspnoea Index (TDI), and rescue medication use] and safety outcomes [mortality, serious adverse events (SAEs), and withdrawals due to adverse events (AEs)] were also compared via a meta-analysis. Results: A total of 22 studies involving 16,486 participants were included in this study. The results showed that in terms of primary outcome (change from baseline in trough FEV1), the efficacy of vilanterol/umeclidinium was the highest, while the efficacy of formoterol/aclidinium was the lowest, with a maximum effect value (Emax) of 0.185 L [95% confidence interval (CI): 0.173–0.197 L] and 0.119 L (95% CI: 0.103–0.135 L), respectively. The efficacy of other drugs, such as formoterol/glycopyrronium, indacaterol/glycopyrronium, and olodaterol/tiotropium, were comparable, and their Emax values were 0.150–0.177 L. Except for vilanterol/umeclidinium, the other four LABA/LAMA FDCs showed a certain degree of loss of efficacy. Compared with the efficacy at 2 days, the trough FEV1 (L) relative to baseline at 24 weeks decreased by 0.029–0.041 L. In terms of secondary outcomes, the efficacy of different LABA/LAMA FDCs was similar in TDI and rescue medication use. However, formoterol/aclidinium was better in preventing the COPD exacerbations, while vilanterol/umeclidinium was the best in terms of SGRQ. In addition, different LABA/LAMA FDCs and placebo had similar safety outcomes. Conclusion: The present findings may provide necessary quantitative information for COPD medication guidelines.

Efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with gastrointestinal and colorectal cancers.

2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 222-222
Author(s):  
Rudolph M. Navari ◽  
Karin Jordan ◽  
Bernardo Leon Rapoport ◽  
Ian D. Schnadig ◽  
Martin Chasen ◽  
...  
Keyword(s):  
Active Control ◽  
Rescue Medication ◽  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Colorectal Cancers ◽  
Dexamethasone Therapy ◽  
Neurokinin 1 ◽  
Long Acting ◽  
Type 3 ◽  
Significant Nausea

222 Background: Rolapitant (VARUBI) is a selective, long-acting neurokinin-1 receptor antagonist (RA) for the prevention of CINV. Rolapitant effectively prevented CINV in phase 3 trials of patients (pts) receiving highly or moderately emetogenic chemotherapy (HEC, MEC). While MEC and HEC regimens are commonly used to treat pts with gastrointestinal and colorectal cancers (GI/CRC), very few studies have evaluated the effectiveness of a neurokinin-1 RA regimen in these pts. We assessed the incidence of CINV and efficacy of rolapitant in a subset of pts with GI/CRC. Methods: This is a post hoc analysis of 3 similarly-designed, randomized, placebo-controlled trials. Pts with cancer of the esophagus, stomach, colon/rectum, or anus received a single oral dose of 180 mg oral rolapitant or placebo prior to HEC or MEC. All pts received a 5-hydroxytryptamine type 3 (5-HT3) RA and dexamethasone (active control). The HEC studies included cisplatin, and the MEC study carboplatin, oxaliplatin, irinotecan, epirubicin, and doxorubicin. Endpoints included complete response (CR; no emesis and no use of rescue medication), no emesis, no nausea (maximum visual analogue scale [VAS] < 5 mm), no significant nausea (maximum VAS < 25mm) and complete protection (CP; no emesis, no use of rescue medication, and no significant nausea) in the overall (0-120 h), acute (≤ 24 h), and delayed (> 24-120 h) phases. Results: Out of 188 GI/CRC pts, 101 pts received rolapitant and 87 received active control. Pts treated with rolapitant had significantly higher rates of CR, no nausea, no emesis, and CP in the overall phase (P < 0.05). Rolapitant was well-tolerated and overall incidence of treatment-emergent adverse events comparable in both groups. Conclusions: Addition of rolapitant to 5-HT3RA and dexamethasone therapy significantly improved CR, no nausea, no emesis, and CP in pts with GI/CRC receiving emetogenic chemotherapy. Clinical trial information: NCT01500226, NCT01499849, NCT01500213. [Table: see text]

Adherence and usage patterns of inhaled corticosteroids‐long-acting beta-agonists by using inhaler-monitoring technology

2020 ◽  
Vol 41 (4) ◽  
pp. 256-264
Author(s):  
Richard H. Stanford ◽  
Carlyne M. Averell ◽  
Phaedra T. Johnson ◽  
Erin K. Buysman ◽  
Maureen H. Carlyle
Keyword(s):  
Rescue Medication ◽  
Claims Data ◽  
Inhaled Corticosteroids ◽  
Medication Use ◽  
Two Phase ◽  
Once Daily ◽  
Beta Agonists ◽  
Pharmacy Claims ◽  
Long Acting

Background: Results of previous research indicate that adherence to prescribed inhaled corticosteroid‐long-acting beta2-agonist (ICS-LABA) asthma controller medications is suboptimal, yet actual daily-use patterns are unclear and may be influenced by regimen complexity or dosing frequency. Objective: To investigate real-world use of asthma medications by using inhaler sensors for the ICS-LABA controllers: twice-daily fluticasone propionate (FP) plus salmeterol (SAL) and once-daily fluticasone furoate (FF) plus vilanterol (VI); and albuterol rescue medication. Methods: This longitudinal, two-phase, observational study included adults with asthma-prescribed FP-SAL (phase I) or FF-VI (phase II), and albuterol metered-dose inhalers. The participants completed baseline and follow-up surveys, and used clip-on inhaler sensors to monitor real-time inhaler use over the 6-month study period. Pharmacy claims data for the 6-month follow-up period were used to assess refills of ICS-LABA and albuterol inhalers. Results: Patients who used twice-daily FP-SAL received a sufficient dose (≥2 actuations/day) approximately one third of the time, those on once-daily FF-VI received a sufficient dose (≥1 actuation/day) ∼60% of the time. Patients who used once-daily FF-VI were more likely to take their medication as prescribed versus those who used twice-daily FP-SAL. There were no significant differences in the percentage of albuterol-free days (FP-SAL, 68.06% [n = 241]; FF-VI, 72.67% [n = 127]; p = 0.230). Exploratory outcomes are reported in this article's Online Supplemental Material. Claims-based measures of adherence were higher than sensor-based measures, hence claims data may have overestimated adherence, whereas sensors may have more accurately measured patients' medication use. Conclusion: These data supported the use of inhaler sensors as tools to directly and accurately measure ICS-LABA adherence and rescue medication use, and the adherence benefits of once-daily versus twice-daily ICS-LABA regimens.

scholarly journals The Current Consideration, Approach, and Management in Postcesarean Delivery Pain Control: A Narrative Review

2021 ◽  
Vol 2021 ◽  
pp. 1-20
Author(s):  
L. Sangkum ◽  
T. Thamjamrassri ◽  
V. Arnuntasupakul ◽  
T. Chalacheewa
Keyword(s):  
Cesarean Delivery ◽  
Breakthrough Pain ◽  
Preoperative Evaluation ◽  
Multimodal Analgesia ◽  
Anesthetic Techniques ◽  
Treatment Protocols ◽  
Analgesic Regimen ◽  
Pain Outcomes ◽  
Patients At Risk ◽  
Long Acting

Optimal postoperative analgesia has a significant impact on patient recovery and outcomes after cesarean delivery. Multimodal analgesia is the core principle for cesarean delivery and pain management. For a standard analgesic regimen, the use of long-acting neuraxial opioids (e.g., morphine) and adjunct drugs, such as scheduled acetaminophen and nonsteroidal anti-inflammatory drugs, is recommended unless contraindicated. Oral or intravenous opioids should be reserved for breakthrough pain. In addition to the aforementioned use of multimodal analgesia, preoperative evaluation is critical to individualize the analgesic regimen according to the patient requirements. Risk factors for severe postoperative pain or analgesia-related adverse effects will require modifications to the standard analgesic regimen (e.g., the use of ketamine, gabapentinoids, or regional anesthetic techniques). Further investigation is required to determine analgesic drugs or dose alterations based on preoperative predictions for patients at risk of severe pain. Outcomes beyond pain and analgesic use, such as functional recovery, should be determined to evaluate analgesic treatment protocols.

scholarly journals Real-world outcomes in patients with chronic obstructive pulmonary disease initiating long-acting mono bronchodilator therapy

2018 ◽  
Vol 12 ◽  
pp. 175346661877275 ◽  
Author(s):  
Lindsay G.S. Bengtson ◽  
Michael DePietro ◽  
Jeffrey McPheeters ◽  
Kathleen M. Fox
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Healthcare Costs ◽  
Rescue Medication ◽  
Medication Use ◽  
Treatment Patterns ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Bronchodilator Therapy ◽  
Long Acting

Background: Randomized clinical trials have shown long-acting mono bronchodilator therapy to be efficacious in improving lung function and dyspnea, while reducing exacerbations; however, less is known regarding the effectiveness in routine clinical practice. This study examined treatment patterns, rescue medication use, healthcare resource utilization and costs, and exacerbations in patients with chronic obstructive pulmonary disease (COPD) who initiated long-acting mono bronchodilator therapy in real-world settings. Methods: This retrospective study used US claims data from adult patients with COPD initiating long-acting mono bronchodilator therapy between 1 January 2008 and 31 January 2015. Patients were required to have continuous health plan enrollment 12 months prior to (baseline period) and 12 months following therapy initiation (follow-up period). Outcomes, including treatment patterns, rescue medication use, exacerbations, and healthcare utilization and costs, were measured until the earliest of treatment augmentation or discontinuation, death, health plan disenrollment, or the end of the study period. Results were analyzed descriptively for all measures. Baseline and follow-up measures of all-cause and COPD-related healthcare costs and exacerbations [per patient per month (PPPM)] were compared using paired t tests. Results: Among 27,394 patients with a mean follow up of 6.3 months, 18.2% augmented, 74.2% discontinued, and 7.6% continued long-acting mono bronchodilator therapy. Rescue medication use was prevalent during the follow-up period, with an average of 1.0 short-acting β agonist (SABA) fills/month and 0.8 short-acting muscarinic antagonist (SAMA) fills/month, among patients with at least one fill for the medication of interest. PPPM mean number of exacerbations was more than triple (0.17 versus 0.05, p < 0.001) and PPPM exacerbation-related costs were more than double over the follow-up period compared with baseline ($1070 versus $485). COPD-related costs accounted for 50% of all-cause costs during the follow-up period and were significantly higher compared with baseline ($1206 versus $592, p < 0.001). Conclusions: Patients initiating long-acting mono bronchodilator therapy had high rates of medication discontinuation or augmentation. Patients used more rescue medications and experienced significantly more COPD exacerbations with higher healthcare costs compared with baseline. Further research is warranted to determine whether more aggressive initial therapy would result in symptom improvement.

Non-opioid analgesics

2019 ◽  
pp. 83-90
Author(s):  
Andrew Davies
Keyword(s):  
Rescue Medication ◽  
Breakthrough Pain ◽  
Opioid Analgesics ◽  
Muscle Spasm ◽  
Procedural Pain ◽  
Diverse Group ◽  
Heterogeneous Condition ◽  
Conflicting Evidence ◽  
Inflammatory Drugs ◽  
Incident Pain

Breakthrough pain is a heterogeneous condition. Non-opioid analgesics are a diverse group of drugs. Non-opioid analgesics may have a role in the management of breakthrough pain. Data on the use of most non-opioid analgesics is limited. Paracetamol and non-steroidal anti-inflammatory drugs are generally used as around-the-clock medication, although they may also be used as rescue medication. Systematic reviews of oral NSAIDs have confirmed benefits in cancer pain. Midazolam has been used in the treatment of refractory incident pain secondary to bone metastases and there is the potential for its use in the management of breakthrough pain secondary to muscle spasm. Ketamine is employed in anaesthetic doses in the management of procedural pain and in the management of predominantly non-malignant breakthrough pain. There is conflicting evidence for the use of nitrous oxide in the management of breakthrough pain.

Sublingual Fentanyl (Abstral®) for Breakthrough Cancer Pain

2009 ◽  
Vol 05 (01) ◽  
pp. 10
Author(s):  
Giovambattista Zeppetella ◽  
Keyword(s):  
Cancer Pain ◽  
Effective Dose ◽  
Rescue Medication ◽  
Breakthrough Pain ◽  
Opioid Therapy ◽  
Pharmacological Management ◽  
Patients With Cancer ◽  
The Individual ◽  
Sublingual Fentanyl ◽  
Valuable Role

The sublingual fentanyl tablet is indicated for the management of breakthrough pain in patients with cancer who are already receiving opioid therapy for their background cancer pain. The pharmacokinetic, efficacy, tolerability and safety profile of the sublingual fentanyl tablet suggests that it has a valuable role to play in the symptomatic pharmacological management of breakthrough pain. The effective dose of the sublingual fentanyl tablet cannot be predicted from previous around-the-clock (ATC) or rescue medication; therefore, titration is required to determine the effective dose according to the needs of the individual patient.

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