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Prescribing practice of pregabalin/gabapentin in pain therapy: an evaluation of German claim data.

ABSTRACT: OBJECTIVES:To analyse the prevalence and incidence of pregabalin and gabapentin (P/G) prescriptions, typical therapeutic uses of P/G with special attention to pain-related diagnoses and discontinuation rates. DESIGN:Secondary data analysis. SETTING:Primary and secondary care in Germany. PARTICIPANTS:Four?million patients in the years 2009-2015 (anonymous health insurance data). INTERVENTION:None. PRIMARY AND SECONDARY OUTCOME MEASURES:P/G prescribing rates, P/G prescribing rates associated with pain therapy, analysis of pain-related diagnoses leading to new P/G prescriptions and the discontinuation rate of P/G. RESULTS:In 2015, 1.6% of insured persons received P/G prescriptions. Among the patients with pain first treated with P/G, as few as 25.7% were diagnosed with a typical neuropathic pain disorder. The remaining 74.3% had either not received a diagnosis of neuropathic pain or showed a neuropathic component that was pathophysiologically conceivable but did not support the prescription of P/G. High discontinuation rates were observed (85%). Among the patients who had discontinued the drug, 61.1% did not receive follow-up prescriptions within 2?years. CONCLUSION:The results show that P/G is widely prescribed in cases of chronic pain irrespective of neuropathic pain diagnoses. The high discontinuation rate indicates a lack of therapeutic benefits and/or the occurrence of adverse effects.

SUBMITTER: Viniol A

PROVIDER: S-EPMC6475154 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Prescribing practice of pregabalin/gabapentin in pain therapy: an evaluation of German claim data.

Viniol Annika A Ploner Tina T Hickstein Lennart L Haasenritter Jörg J Klein Karl Martin KM Walker Jochen J Donner-Banzhoff Norbert N Becker Annette A

BMJ open 20190330 3

<h4>Objectives</h4>To analyse the prevalence and incidence of pregabalin and gabapentin (P/G) prescriptions, typical therapeutic uses of P/G with special attention to pain-related diagnoses and discontinuation rates.<h4>Design</h4>Secondary data analysis.<h4>Setting</h4>Primary and secondary care in Germany.<h4>Participants</h4>Four million patients in the years 2009-2015 (anonymous health insurance data).<h4>Intervention</h4>None.<h4>Primary and secondary outcome measures</h4>P/G prescribing ra ...[more]

PMID: 30928920

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Project description:Introduction:Gabapentinoids are increasingly used in preoperative premedication despite controversial results. The aim of our study was to evaluate the effects of preemptive use of gabapentin or pregabalin on postoperative shoulder pain and rehabilitation quality after laparoscopic cholecystectomy. Methods:This is a clinical trial comparing the effects of a preoperative premedication with 600?mg of gabapentin or 150?mg of pregabalin versus placebo on postoperative pain and recovery quality after laparoscopic cholecystectomy. Premedication was taken 2 hours before the surgery beginning. Ninety patients were included and randomized into 3 groups (gabapentin, pregabalin, and placebo). The anesthetic protocol was the same for all patients. Primary endpoint was the shoulder pain intensity at the 48th postoperative hour. Secondary endpoints were postoperative nausea and vomiting (PONV), sleep quality during the first night, and the onset time for the first standing position. Results:During the first 48 postoperative hours, the gabapentin and pregabalin groups had significantly lower shoulder pain than the placebo group (p < 0.05). In gabapentinoids groups, the incidence of PONV was lower and the sleep quality during the first postoperative night was better with significant results. Mean Spiegel scores were 22.43?±?1.45, 22.30?±?1.44, and 17.17?±?1.66, respectively, in pregabalin, gabapentin, and placebo groups (p < 0.05). The delay for the first standing position was 14.9?±?4.9 hours in the pregabalin group, 9.7?±?3.6 hours in the gabapentin group, and 21.6?±?2.1 hours in the placebo group. No superiority was found between gabapentin and pregabalin. Conclusion:Preemptive premedication with gabapentinoids can enhance postoperative rehabilitation quality after laparoscopic cholecystectomy by reducing postoperative shoulder pain, decreasing PONV incidence, and improving sleep quality during the first postoperative night. This trial is registered with ClinicalTrial.gov (NCT03241875).

Project description:ImportanceOptimal pharmacologic treatment for chronic sciatica (CS) is currently unclear. While gabapentin (GBP) and pregabalin (PGB) are both used to treat CS, equipoise exists. Nevertheless, pharmaceutical regulation authorities typically subsidize one drug over the other. This hinders interchange wherever the favored drug is either ineffective or ill-tolerated.ObjectiveTo assess GBP vs PGB head to head for the treatment of CS.Design, setting, and participantsA preplanned interim analysis of a randomized, double-blind, double-dummy crossover trial of PGB vs GBP for management of CS at half the estimated final sample size was performed in a single-center, tertiary referral public hospital. A total of 20 patients underwent randomization from March 2016 to March 2018, and 2 were excluded with 1 lost to follow-up and the other requiring urgent surgery unrelated to the study. Patients attending a specialist neurosurgery clinic with unilateral CS were considered for trial recruitment. Chronic sciatica was defined as pain lasting for at least 3 months radiating into 1 leg only to, at, or below the knee level. Imaging (magnetic resonance imaging with or without computed tomography) corroborating a root-level lesion concordant with symptoms and/or signs was determined by the trial clinician. Inclusion criteria included patients who had not used GBP and PGB and were 18 years or older. Analyses were intention to treat and began February 2018.InterventionsRandomly assigned participants received GBP (400 mg to 800 mg 3 times a day) then PGB (150 mg to 300 mg twice daily) or vice versa, each taken for 8 weeks. Crossover followed a 1-week washout.Main outcomes and measuresThe primary outcome was pain intensity (10-point visual analog scale) at baseline and 8 weeks. Secondary outcomes included disability (using the Oswestry Disability Index) and severity/frequency of adverse events.ResultsThe total trial population (N = 18) consisted mostly of men (11 [61%]) with a mean (SD) age of 57 (16.5) years. A third of the cohort were smokers (5 [28%]), and more than half consumed alcohol (12 [67%]). Gabapentin was superior to PGB, with fewer and less severe adverse events. Both GBP (mean [SD], 7.54 [1.39] to 5.82 [1.72]; P < .001) and PGB (mean [SD], 7.33 [1.30] to 6.38 [1.88]; P = .002) displayed significant visual analog pain intensity scale reduction and Oswestry Disability Index reduction (mean [SD], 59.22 [16.88] to 48.54 [15.52]; P < .001 for both). Head to head, GBP showed superior visual analog pain intensity scale reduction (mean [SD], GBP: 1.72 [1.17] vs PGB: 0.94 [1.09]; P = .035) irrespective of sequence order; however, Oswestry Disability Index reduction was unchanged. Adverse events for PGB were more frequent (PGB, 31 [81%] vs GBP, 7 [19%]; P = .002) especially when PGB was taken first.Conclusions and relevancePregabalin and GBP were both significantly efficacious. However, GBP was superior with fewer and less severe adverse events. Gabapentin should be commenced before PGB to permit optimal crossover of medicines.Trial registrationanzctr.org.au Identifier: ACTRN12613000559718.

Project description:BackgroundPregabalin and gabapentin improve neuropathic pain symptoms but there are emerging concerns regarding their misuse. This is more pronounced among patients with substance use disorder, particularly involving opioids. Co-ingestion of gabapentinoids with opioids is increasingly identified in opioid related deaths, however, the molecular mechanism behind this is still unclear. We have sought to determine whether pregabalin or gabapentin directly modulates acute μ receptor signaling, or μ receptor activation by morphine.MethodsThe effects of pregabalin and gabapentin were assessed in HEK 293 cells stably transfected with the human μ receptor. Their effect on morphine induced hyperpolarization, cAMP production and ERK phosphorylation were studied using fluorescent-based membrane potential assay, bioluminescence based CAMYEL assay and ELISA assay, respectively. Pregabalin/gabapentin effects on morphine-induced hyperpolarization were also investigated in AtT20 cells.ResultsPregabalin or gabapentin (1 µM, 100 µM each) did not activate the µ receptor or affect K channel activation or ERK phosphorylation produced by morphine. Neither drug affected the desensitization of K channel activation produced by prolonged (30 min) application of morphine. Gabapentin (1 µM, 100 µM) and pregabalin (1 µM) did not affect inhibition of forskolin-stimulated cAMP production by morphine. However, pregabalin (100 µM) potentiated forskolin mediated cAMP production, although morphine still inhibited cAMP levels with a similar potency to control.DiscussionPregabalin or gabapentin did not activate or modulate µ receptor signaling in three different assays. Our data do not support the hypothesis that gabapentin or pregabalin augment opioid effects through direct or allosteric modulation of the µ receptor. Pregabalin at a high concentration increases cAMP production independent of morphine. The mechanism of enhanced opioid-related harms from co-ingestion of pregabalin or gabapentin with opioids needs further investigation.

Project description:BackgroundGabapentin and pregabalin are commonly prescribed medications to treat pain in patients with diabetic neuropathy. Gabapentin and pregabalin can cause fluid retention, which is hypothesized to be associated with cardiovascular diseases. However, whether long-term use of gabapentin and pregabalin is associated with adverse cardiovascular diseases remains unknown. This study aims to examine the association between gabapentin use, pregabalin use and several adverse cardiovascular events.MethodsThis retrospective cohort study used propensity score matching within patient electronic health records (EHRs) from a multicenter database with 106 million patients from 69 health care organizations in the US. The study population comprised 210,064 patients who had a diagnosis of diabetic neuropathy and were prescribed diabetic neuropathy medications in their EHRs. The exposure cohort comprised patients who were prescribed gabapentin or pregabalin to treat diabetic neuropathy. The comparison cohort comprised patients who were not prescribed either gabapentin or pregabalin but were prescribed other drugs to treat diabetic neuropathy. The outcomes of interest were myocardial infarcts, strokes, heart failure, peripheral vascular disease, and venous thromboembolic events. We calculated hazard ratios (HRs) and 95% confidence intervals (CIs) for 3-month and 5-year risk for adverse cardiovascular events between the propensity score-matched cohorts.ResultsBoth gabapentin and pregabalin were associated with increased risk of 5-year adverse cardiovascular events compared with the comparison group. In patients prescribed gabapentin, the highest risk was observed for deep venous thrombosis (HR: 1.58, 95% CI 1.37-1.82), followed by pulmonary embolism (HR: 1.5, 95% CI 1.27-1.76), peripheral vascular disease (HR: 1.37, 95% CI 1.27-1.47), stroke (HR: 1.31, 95% CI 1.2-1.43), myocardial infarction (HR: 1.25, 95% CI 1.14-1.38) and heart failure (HR: 1.14, 95% CI 1.07-1.21). In patients prescribed pregabalin, the highest risk was observed for deep venous thrombosis (HR: 1.57, 95% CI 1.31-1.88), followed by peripheral vascular disease (HR: 1.35, 95% CI 1.22-1.49), myocardial infarction (HR: 1.29, 95% CI 1.13-1.47), pulmonary embolism (HR: 1.28, 95% CI 1.04-1.59), stroke (HR: 1.26, 95% CI 1.12-1.42), and heart failure (HR: 1.2, 95% CI 1.11-1.3). There were significant associations between short-term (3 month) gabapentin use and heart failure, myocardial infarction, peripheral vascular disease, deep venous thrombosis, and pulmonary embolism. Short-term (3 month) pregabalin use was associated with deep venous thrombosis, peripheral vascular disease.ConclusionIn patients with diabetic neuropathy who were prescribed gabapentin and pregabalin, there is an increased risk for heart failure, myocardial infarction, peripheral vascular disease, stroke, deep venous thrombosis, and pulmonary embolism with long-term use. Our findings suggest that increased risk for adverse cardiovascular events, along with other side effects, the efficacy of pain control and the degree of tolerance of the patient, should be considered when prescribing gabapentin and pregabalin long-term in patients with diabetic neuropathy.

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Prescribing practice of pregabalin/gabapentin in pain therapy: an evaluation of German claim data.

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Prescribing practice of pregabalin/gabapentin in pain therapy: an evaluation of German claim data.

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