scholarly journals Long-Term Effectiveness and Tolerability of Pain Treatment with Tapentadol Prolonged Release

2020 ◽  
Vol 1;24 (1;1) ◽  
pp. E75-E85
Keyword(s):  
Quality Of Life ◽  
Chronic Pain ◽  
Neuropathic Pain ◽  
Knee Pain ◽  
Prolonged Release ◽  
Low Back ◽  
State Of Health ◽  
Open Label

BACKGROUND: The central analgesic tapentadol prolonged release (PR) has proven effective and generally well tolerated in a broad range of chronic pain conditions. Long-term data of its use are still scarce. OBJECTIVES: To evaluate long-term effectiveness, tolerability, and safety of tapentadol PR in patients with severe chronic osteoarthritis (OA) knee pain or low back pain (LBP) who responded to tapentadol in 1 of 4 preceding 12-week phase 3b clinical trials. STUDY DESIGN: Open-label, uncontrolled, observational extension study of up to 72 weeks. SETTING: Fourteen centers in Spain. Protocol approval by the reference ethics committee for all the participating centers. METHODS: Eligible patients started the extension trial on the tapentadol PR dosage optimized for them in the preceding trial; dose adjustments were permitted throughout the extension. Treatment effectiveness outcomes included changes in pain intensity, sleep, state of health, quality of life, patient and clinician global impression of change, and patients’ satisfaction with treatment. Patients with OA knee pain also answered the Western Ontario and McMaster Universities OA index, and patients with LBP with a possible neuropathic pain component completed neuropathic pain-related questionnaires. RESULTS: Eighty-three patients were enrolled: 40 with OA knee pain, 43 with LBP. The full analysis set consisted of 81 patients. Mean pain intensity remained relatively stable over the 72-week extension period with mean increases from baseline of 0.44 (95% confidence interval [CI], -0.1,1.0; Numeric Rating Scale) for all patients, 0.2 (95% CI, -0.5, 0.9) for patients with OA, and 0.68 (95% CI, -0.2, 1.6) for patients with LBP. State of health and quality of life baseline ratings were maintained; overall impression of change was “improved.” Most patients (88.9%) reported at least good treatment satisfaction at the end of treatment. Mean daily tapentadol PR doses slightly increased from 313.3 ± 139.5 mg at baseline to 315.7 ± 140.1 mg at end of study. Uptitration was required for 8.4% of the patients, 4.8% had a dose reduction during the trial. Adverse events considered probably/likely or certainly related to tapentadol PR treatment by the investigator were documented for 18.1% of all patients, most commonly constipation (7.2%). Seven patients (8.4%) experienced adverse events leading to premature discontinuation. LIMITATIONS: An open-label design, stable concomitant analgesics (World Health Organization step I), and dose adjustments were allowed during the study. All patients had benefitted from tapentadol PR in preceding trials. CONCLUSIONS: Sustained pain relief and quality of life for up to 72 treatment weeks under relatively stable dosing, as well as the good safety profile, indicate the usefulness of tapentadol PR for patients who suffer from severe chronic OA knee pain and LBP with limited risk for tolerance development. KEY WORDS: Tapentadol prolonged release, extension study, long-term, chronic pain, osteoarthritis, low back pain, efficacy, safety

Chronic pain, functionality and quality of life in cancer survivors

2020 ◽  
pp. 204946372097273
Author(s):  
João Poço Gonçalves ◽  
Dalila Veiga ◽  
António Araújo
Keyword(s):  
Quality Of Life ◽  
Chronic Pain ◽  
Neuropathic Pain ◽  
Cancer Survivors ◽  
Long Term Effects ◽  
Average Life ◽  
Average Life Span ◽  
Oncological Disease

The increasing number of cancer survivors associated to a longer average life-span after diagnosis of an oncological disease facilitates the observation of deleterious long-term effects of both oncological disease and its treatment. Among these effects, chronic pain emerges as one of the most prevalent and, with its onset, there is a decrease in these patients’ functionality and quality of life. The main focus in oncological disease treatment has been tumour eradication and average life expectancy extension after diagnosis, neglecting these deleterious long-term effects. This study aims at assessing the prevalence and characteristics of chronic pain in cancer survivors as well as pain interference in their quality of life and functionality. The study selected cancer survivors (n = 85) after dismissal from oncology service to assess the presence and characteristics of chronic pain, their health-related quality of life (HRQoL) and pain-related disability through a combination of different questionnaires. Chronic pain prevalence was 23.5%. In total, 85% of patients reported neuropathic pain descriptors and 45% presented diagnostic criteria for neuropathic pain. Of these patients, 45% were followed-up for pain surveillance and 35% underwent analgesic medication. There was a median pain disability index of 20.50 (14.50–35.00) and an average HRQoL of 0.5338 in chronic pain patients and 0.8872 in patients without pain. We found that chronic pain was the main negative predictor of HRQoL and was associated with decreased functionality. This study also concluded that these patients often were not offered the appropriate long-term medical follow-up. These findings highlight a need to raise awareness among health professionals to the importance of timely diagnosis and treatment of pain and its impact on HRQoL and functionality of long-term cancer survivors as well as the need to change clinical practice in order to improve healthcare provided to these patients.

scholarly journals P0003ADHERENCE BENEFITS OF ADV7103, AN INNOVATIVE PROLONGED-RELEASE ORAL COMBINATION PRODUCT, IN PATIENTS WITH DISTAL RENAL TUBULAR ACIDOSIS

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Aurélia Bertholet-Thomas ◽  
Catherine Guittet ◽  
Maria Asunción Manso-Silván ◽  
Victor Navas Serrano ◽  
Luc André Granier ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Renal Tubular Acidosis ◽  
Potassium Citrate ◽  
Distal Renal Tubular Acidosis ◽  
Prolonged Release ◽  
Open Label ◽  
Advanced Therapy ◽  
Renal Tubular

Abstract Background and Aims Distal renal tubular acidosis (dRTA) is a rare disorder leading to impaired net acid excretion by the kidney inducing hyperchloremic metabolic acidosis and hypokalemia. The therapeutic effect of the standard of care is of short duration and requires multiple day and night administrations; it is also often accompanied by gastrointestinal discomfort and poor palatability impacting medication adherence. ADV7103, the first advanced therapy for dRTA, consists of a combination of prolonged-release potassium citrate and prolonged-release potassium bicarbonate granules providing round-the-clock alkali and potassium coverage with twice daily administration. Long-term adherence with ADV7103 is reported, along with acceptability of the product. Method B22CS is a multicentre, open-label long-term extension study, evaluating safety, tolerability, acceptability and efficacy of ADV7103 in adult and paediatric patients with dRTA. Adherence was assessed at each study visit up to 24 months, based on accountability of study drug retrieval, laboratory results, and interview of the patients in a diary and expressed as the proportion of patients that presented adherence lower than 50%, between 50% and 74%, between 75 and 90%, and higher than to 90%. Treatment acceptability as well as quality of life of the patients and their parents were assessed using a 100-mm visual analogue scales (VAS). Results Table 1 shows the evolution of compliance between Month 6 and Month 24. Overall, of the 29 patients remaining in the study after 24 months, 18 (62%) had adherence rates >90%, 5 (17%) had adherence rates of 75-90%, 6 (21%) had adherence rates of 50-74%, and there were no patients with adherence <50%. Adherence was good in all age groups, with rates of ≥75% in 100% of adults, 63% of adolescents 85% of children, and 67% of infants and toddlers. Compared to the alkalising treatments they had before the study, more than 80% of the patients perceived both the improvement of the formulation and of the number of daily doses at scores ≥ 75 mm. The overall improvement of quality of life reported by the patients was of 89 ± 19 mm and that reported by their parents was of 90 ± 14 mm after 24 months of treatment. Conclusion Adherence to treatment was maintained at a high level throughout the 24 months of the study confirming the good acceptance of ADV7103 therapy.

scholarly journals Buprenorphine: Far Beyond the “Ceiling”

Biomolecules ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. 816
Author(s):  
Rosmara Infantino ◽  
Consalvo Mattia ◽  
Pamela Locarini ◽  
Antonio Luigi Pastore ◽  
Sabatino Maione ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Pain ◽  
Neuropathic Pain ◽  
Drug Abuse ◽  
Side Effects ◽  
National Health System ◽  
Analgesic Drugs ◽  
Third Line ◽  
Dynamic Profile

Chronic pain, including neuropathic pain, represents an untreated disease with important repercussions on the quality of life and huge costs on the national health system. It is well known that opioids are the most powerful analgesic drugs, but they represent the second or third line in neuropathic pain, that remain difficult to manage. Moreover, these drugs show several side effects that limit their use. In addition, opioids possess addictive properties that are associated with misuse and drug abuse. Among available opioids compounds, buprenorphine has been suggested advantageous for a series of clinical reasons, including the effectiveness in neuropathic pain. Some properties are partly explained by its unique pharmacological characteristics. However, questions on the dynamic profile remain to be answered. Pharmacokinetics optimization strategies, and additional potentialities, are still to be explored. In this paper, we attempt to conceptualize the potential undiscovered dynamic profile of buprenorphine.

scholarly journals Opioid Analgesia: Perspectives on Right Use and Utility

2007 ◽  
Vol 3;10 (5;3) ◽  
pp. 479-491 ◽  
Author(s):  
Jane C. Ballantyne
Keyword(s):  
Quality Of Life ◽  
Chronic Pain ◽  
Side Effects ◽  
Clinical Decision Making ◽  
Analgesic Efficacy ◽  
Clinical Decision ◽  
Opioid Analgesia ◽  
Opioid Treatment

The ability of opioids to effectively and safely control acute and cancer pain has been one of several arguments used to support extending opioid treatment to patients with chronic pain, against a backdrop of considerable caution that has been based upon fears of addiction. Of course, opioids may cause addiction, but the “principle of balance” may justify that “…efforts to address abuse should not interfere with legitimate medical practice and patient care.” Yet, situations are increasingly encountered in which opioid-maintained patients are refractory to analgesia during periods of pain, or even during the course of chronic treatment. The real question is whether analgesic efficacy of opioids can be maintained over time. Overall, the evidence supporting long-term analgesic efficacy is weak. The putative mechanisms for failed opioid analgesia may be related to tolerance or opioid-induced hyperalgesia. Advances in basic sciences may help in understanding these phenomena, but the question of whether long-term opioid treatment can improve patients’ function or quality of life remains a broader issue. Opioid side effects are well known, but with chronic use, most (except constipation) subside. Still, side effects can negatively affect the outcomes and continuity of therapy. This paper addresses 1) what evidence supports the long-term utility of opioids for chronic pain; 2) how side effects may alter quality of life; 3) the nature of addiction and why it is different in pain patients, and 4) on what grounds could pain medication be denied? These questions are discussed in light of patients’ rights, and warrant balancing particular responsibilities with risks. These are framed within the Hippocratic tradition of “producing good for the patient and protecting from harm,” so as to enable 1) more informed clinical decision making, and 2) progress towards right use and utility of opioid treatment for chronic pain. Key Words: Opioids, chronic pain, addiction, side effects, utility, ethics

scholarly journals Nine-year prospective efficacy and safety of brain-responsive neurostimulation for focal epilepsy

Neurology ◽  
2020 ◽  
Vol 95 (9) ◽  
pp. e1244-e1256 ◽  
Author(s):  
Dileep R. Nair ◽  
Kenneth D. Laxer ◽  
Peter B. Weber ◽  
Anthony M. Murro ◽  
Yong D. Park ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Seizure Frequency ◽  
Focal Epilepsy ◽  
Responder Rate ◽  
Seizure Freedom ◽  
Open Label ◽  
Cognitive Domains ◽  
Signed Rank

ObjectiveTo prospectively evaluate safety and efficacy of brain-responsive neurostimulation in adults with medically intractable focal onset seizures (FOS) over 9 years.MethodsAdults treated with brain-responsive neurostimulation in 2-year feasibility or randomized controlled trials were enrolled in a long-term prospective open label trial (LTT) to assess safety, efficacy, and quality of life (QOL) over an additional 7 years. Safety was assessed as adverse events (AEs), efficacy as median percent change in seizure frequency and responder rate, and QOL with the Quality of Life in Epilepsy (QOLIE-89) inventory.ResultsOf 256 patients treated in the initial trials, 230 participated in the LTT. At 9 years, the median percent reduction in seizure frequency was 75% (p < 0.0001, Wilcoxon signed rank), responder rate was 73%, and 35% had a ≥90% reduction in seizure frequency. We found that 18.4% (47 of 256) experienced ≥1 year of seizure freedom, with 62% (29 of 47) seizure-free at the last follow-up and an average seizure-free period of 3.2 years (range 1.04–9.6 years). Overall QOL and epilepsy-targeted and cognitive domains of QOLIE-89 remained significantly improved (p < 0.05). There were no serious AEs related to stimulation, and the sudden unexplained death in epilepsy (SUDEP) rate was significantly lower than predefined comparators (p < 0.05, 1-tailed χ2).ConclusionsAdjunctive brain-responsive neurostimulation provides significant and sustained reductions in the frequency of FOS with improved QOL. Stimulation was well tolerated; implantation-related AEs were typical of other neurostimulation devices; and SUDEP rates were low.ClinicalTrials.gov identifierNCT00572195.Classification of evidenceThis study provides Class IV evidence that brain-responsive neurostimulation significantly reduces focal seizures with acceptable safety over 9 years.

Sign in / Sign up

Export Citation Format

Share Document