Long-term treatment patterns of prophylactic and acute migraine medications and incidence of opioid-related adverse events in patients with migraine

Objectives To describe long-term treatment patterns in migraine patients initiating prophylactic therapy and to evaluate acute medication use and adverse events associated with opioids. Methods This study used the 2005–2014 IBM MarketScan® databases to evaluate migraine patients initiating prophylactic medication. Outcome measures included persistence with prophylactic migraine medications over 2–5 years. Acute medication use and gastrointestinal-related adverse events and opioid abuse following opioid use were evaluated. Cox proportional hazards models were used to evaluate predictors of non-persistence and predictors of gastrointestinal-related AEs and opioid abuse associated with long-term opioid use. Results In total, 147,832 patients were analyzed. Non-persistence was observed in 90% of patients; 39% switched, 30% restarted, and 31% discontinued treatment. Over the follow-up, 59.9% of patients received triptans, 66.6% non-steroidal anti-inflammatory drugs, 77.4% opioids, and 2.6% ergotamines. Among opioid users, 16.6% experienced nausea/vomiting, 12.2% had constipation, and 10.4% had diarrhea. Opioid abuse was reported in <1% of opioid users. Gastrointestinal-related adverse events increased with increasing number of days’ supply of opioids. Conclusions Non-persistence to prophylactic treatment was frequent among migraine patients. Opioid use was common in migraine patients and the risk of gastrointestinal-related adverse events and opioid abuse increased with long-term use of opioids. These results suggest a need for more effective prophylactic migraine treatments.

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Reducing the Toxicity of Long-Term Glucocorticoid Treatment in Large Vessel Vasculitis

Current Rheumatology Reports ◽

10.1007/s11926-020-00961-0 ◽

2020 ◽

Vol 22 (12) ◽

Author(s):

Andriko Palmowski ◽

Frank Buttgereit

Keyword(s):

Adverse Events ◽

Takayasu Arteritis ◽

Term Treatment ◽

Large Vessel Vasculitis ◽

Large Vessel ◽

Serious Adverse Events ◽

Glucocorticoid Treatment ◽

Long Term Treatment ◽

Higher Doses

Abstract Purpose While glucocorticoids (GCs) are effective in large vessel vasculitis (LVV), they may cause serious adverse events (AEs), especially if taken for longer durations and at higher doses. Unfortunately, patients suffering from LVV often need long-term treatment with GCs; therefore, toxicity needs to be expected and countered. Recent Findings GCs remain the mainstay of therapy for both giant cell arteritis and Takayasu arteritis. In order to minimize their toxicity, the following strategies should be considered: GC tapering, administration of conventional synthetic (e.g., methotrexate) or biologic (e.g., tocilizumab) GC-sparing agents, as well as monitoring, prophylaxis, and treatment of GC-related AEs. Several drugs are currently under investigation to expand the armamentarium for the treatment of LVV. Summary GC treatment in LVV is effective but associated with toxicity. Strategies to minimize this toxicity should be applied when treating patients suffering from LVV.

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Pomaglumetad Methionil (LY2140023 Monohydrate) and Aripiprazole in Patients with Schizophrenia: A Phase 3, Multicenter, Double-Blind Comparison

Schizophrenia Research and Treatment ◽

10.1155/2014/758212 ◽

2014 ◽

Vol 2014 ◽

pp. 1-11 ◽

Cited By ~ 24

Author(s):

David H. Adams ◽

Lu Zhang ◽

Brian A. Millen ◽

Bruce J. Kinon ◽

Juan-Carlos Gomez

Keyword(s):

Weight Gain ◽

Adverse Events ◽

Term Treatment ◽

Phase 3 ◽

Serious Adverse Events ◽

Double Blind ◽

Treatment Groups ◽

Long Term Treatment ◽

Blind Comparison

We tested the hypothesis that long-term treatment with pomaglumetad methionil would demonstrate significantly less weight gain than aripiprazole in patients with schizophrenia. In this 24-week, multicenter, randomized, double-blind, Phase 3 study, 678 schizophrenia patients were randomized to either pomaglumetad methionil (n=516) or aripiprazole (n=162). Treatment groups were also compared on efficacy and various safety measures, including serious adverse events (SAEs), discontinuation due to adverse events (AEs), treatment-emergent adverse events (TEAEs), extrapyramidal symptoms (EPS), and suicide-related thoughts and behaviors. The pomaglumetad methionil group showed significantly greater weight loss at Week 24 (Visit 12) compared with the aripiprazole group (−2.8 ± 0.4 versus 0.4 ± 0.6;P<0.001). However, change in Positive and Negative Syndrome Scale (PANSS) total scores for aripiprazole was significantly greater than for pomaglumetad methionil (−15.58 ± 1.58 versus −12.03 ± 0.99;P=0.045). The incidences of SAEs (8.2% versus 3.1%;P=0.032) and discontinuation due to AEs (16.2% versus 8.7%;P=0.020) were significantly higher for pomaglumetad methionil compared with aripiprazole. No statistically significant differences in the incidence of TEAEs, EPS, or suicidal ideation or behavior were noted between treatment groups. In conclusion, long-term treatment with pomaglumetad methionil resulted in significantly less weight gain than aripiprazole. This trial is registered with ClinicalTrials.govNCT01328093.

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Spotlight on eltrombopag in pediatric ITP in China: a long-term observational study in real-world practice

Blood Advances ◽

10.1182/bloodadvances.2020004110 ◽

2021 ◽

Vol 5 (19) ◽

pp. 3799-3806

Author(s):

Xiaoling Cheng ◽

LingLing Fu ◽

Jingyao Ma ◽

Hao Gu ◽

Zhenping Chen ◽

...

Keyword(s):

Adverse Events ◽

Pediatric Patients ◽

Complete Response ◽

Term Treatment ◽

Serious Adverse Events ◽

Platelet Counts ◽

Chronic Itp ◽

Long Term Treatment ◽

Concomitant Medications

Abstract Immune thrombocytopenia (ITP) is an autoimmune bleeding disorder with isolated thrombocytopenia and risk of hemorrhage. Treatment with eltrombopag increases and maintains hemostatic platelet counts; however, to date, long-term data are lacking on the outcome of children with ITP who are treated with eltrombopag. This prospective, observational, longitudinal cohort study evaluated the efficacy and safety of eltrombopag in pediatric patients with persistent or chronic ITP. For the 116 pediatric patients enrolled, duration of eltrombopag treatment was at least 3 months. Median effective dose was 25 mg/day, 50 mg/day, and 50 mg/day, respectively, for children age 5 years or younger, 6 to 11 years, or 12 years or older. In all, 89 patients (76.7%) achieved overall response, 53 (45.7%) achieved complete response, and 36 (31.0%) achieved response. Median platelet counts increased by week 1 and were sustained throughout the treatment period. During treatment with eltrombopag, the proportion of patients with grade 1 to 4 bleeding symptoms decreased from 83.61% at baseline to 9.88% at 6 months when only grade 1 was reported. Forty-three patients (37.1%) reported using concomitant medications at study entry, which was reduced to 1 patient (2.5%) who needed concomitant medications at 12 months. All adverse events were grade 1 or 2 according to Common Terminology Criteria for Adverse Events. No serious adverse events, cataracts, malignancies, or thromboses were reported during the study. Long-term treatment with eltrombopag was generally safe, well tolerated, and effective in maintaining platelet counts and reducing bleeding in most pediatric patients with persistent or chronic ITP. Combined with future studies, these findings will help establish how eltrombopag should best be used in the management of pediatric patients with East Asian ancestry.

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Pharmacotherapy for substance use disorders within correctional facilities

10.1093/med/9780199360574.003.0046 ◽

2015 ◽

Author(s):

Sarah E. Wakeman ◽

Josiah D. Rich

Keyword(s):

Substance Use ◽

Substance Use Disorders ◽

Behavioral Interventions ◽

Opioid Dependence ◽

Addiction Treatment ◽

Term Treatment ◽

Opiate Dependence ◽

Opioid Use ◽

Long Term Treatment

Drug addiction treatment is increasingly complex. Only 5% of prisons and 34% of jails offer any detoxification services, and only 1% of jails offer methadone for opioid withdrawal. Even fewer facilities offer medication assisted therapy (MAT) for alcohol or substance use disorders despite the tremendous evidence base supporting the use of medications to treat addiction. Untreated opioid dependence both within corrections and in the community is associated with HIV, Hepatitis C, crime, and death by overdose. Substantial evidence argues that these risks are reduced through long-term treatment with agonist medications such as methadone and buprenorphine. Only a minority of prisoners receive any addiction treatment while incarcerated. Those that do are usually offered behavioral interventions, which when used alone have extremely poor outcomes. Although there are limited studies on the outcomes of drug treatment during incarceration, there are nearly 50 years of evidence documenting the efficacy of methadone given in the community in reducing opioid use, drug-related health complications, overdose, death, criminal activity, and recidivism. Buprenorphine is similarly an effective, safe, and cost-effective long-term treatment for opioid dependence that reduces other opioid use and improves health and quality of life outcomes. There is a growing role for MAT in jails, and to a lesser degree in prisons for the treatment of alcohol and opiate dependence. This chapter presents the current state of evidence based practice in correctional MAT models.

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Safety of Repeated Administration of Parenteral Ketamine for Depression

Pharmaceuticals ◽

10.3390/ph13070151 ◽

2020 ◽

Vol 13 (7) ◽

pp. 151

Author(s):

David Feifel ◽

David Dadiomov ◽

Kelly C. Lee

Keyword(s):

Adverse Events ◽

Bladder Dysfunction ◽

Response Rate ◽

Repeated Administration ◽

Term Treatment ◽

Psychotic Symptoms ◽

Electronic Survey ◽

Treatment Of Depression ◽

Long Term Treatment

The objective of this study was to investigate the safety of repeated parenteral ketamine for depression. An electronic survey inquiring about the frequency of adverse events was distributed to providers of parenteral ketamine for depression. In addition, the investigators conducted a search of published studies describing six or more repeated parenteral ketamine treatments administered to individuals for depression, and extracted reported adverse events. The survey was sent to 69 providers, of which 36 responded (52% response rate); after eliminating those that were incomplete, 27 were included in the analysis. The providers in the analysis collectively reported treating 6630 patients with parenteral ketamine for depression, one-third of whom received more than 10 treatments. Only 0.7% of patients experienced an adverse effect that required discontinuation of ketamine. Psychological distress during the treatment was the most frequent cause. Other adverse events were extremely rare (such as bladder dysfunction (0.1%), cognitive decline (0.03%) and psychotic symptoms (0.03%)). Among the 20 published reports of repeated parenteral ketamine treatments, rates of significant adverse events resulting in discontinuation were low (1.2%). The rate of adverse effects reported in the survey and the published literature is low, and suggests that long-term treatment of depression with ketamine is reasonably safe.

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Influence of Immunogenicity on the Efficacy of Long-Term Treatment with TNFαBlockers in Rheumatoid Arthritis and Spondyloarthritis Patients

BioMed Research International ◽

10.1155/2015/604872 ◽

2015 ◽

Vol 2015 ◽

pp. 1-10 ◽

Cited By ~ 16

Author(s):

Inesa Arstikyte ◽

Giedre Kapleryte ◽

Irena Butrimiene ◽

Algirdas Venalis

Keyword(s):

Rheumatoid Arthritis ◽

Adverse Events ◽

Clinical Characteristics ◽

Term Treatment ◽

High Serum ◽

Treatment Discontinuation ◽

Increased Risk ◽

Long Term Treatment ◽

Biologic Drug

Objective. To analyze the clinical relevance of the levels of TNFαblockers and anti-drug antibodies (anti-drug Ab) in patients with rheumatoid arthritis (RA) and spondyloarthritis (SpA) treated with adalimumab (ADA), etanercept (ETA), or infliximab (INF) for a prolonged period of time.Methods. Clinical characteristics (disease activity, and adverse events), serum TNFαblockers, and anti-drug Ab levels were evaluated in 62 RA and 81 SpA patients treated with TNFαblockers for a median of 28 months.Results. Anti-ADA Ab were detected in 1 (4.0%) and anti-INF Ab in 14 out of 57 (24.6%) RA and SpA patients. Patient with anti-ADA Ab and 57.1% patients with anti-INF Ab were considered nonresponders to treatment. Anti-ETA Ab were not found in any of 61 ETA treated patients. Anti-ADA and anti-INF Ab levels differ between responders and nonresponders(P>0.05). Three (5.3%) patients with high serum anti-INF Ab levels developed infusion related reactions. Patients with anti-INF Ab more often required changing to another biologic drug (OR 11.43 (95% CI 1.08–120.93)) and treatment discontinuation (OR 9.28 (95% CI 1.64–52.52)).Conclusion. Patients not responding to treatment had higher serum anti-ADA and anti-INF Ab concentrations. Anti-INF Ab formation is related to increased risk of infusion related reactions, changing to another biologic drug, and treatment discontinuation.

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The treatment with pasireotide in Cushing’s disease: effect of long-term treatment on clinical picture and metabolic profile and management of adverse events in the experience of a single center

Journal of Endocrinological Investigation ◽

10.1007/s40618-019-01077-8 ◽

2019 ◽

Vol 43 (1) ◽

pp. 57-73 ◽

Cited By ~ 2

Author(s):

C. Simeoli ◽

R. Ferrigno ◽

M. C. De Martino ◽

D. Iacuaniello ◽

F. Papa ◽

...

Keyword(s):

Adverse Events ◽

Cushing’S Disease ◽

Clinical Picture ◽

Metabolic Profile ◽

Term Treatment ◽

Cushing's Disease ◽

Single Center ◽

Long Term Treatment ◽

Disease Effect

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High-dose desvenlafaxine in outpatients with major depressive disorder

CNS Spectrums ◽

10.1017/s1092852912000508 ◽

2012 ◽

Vol 17 (3) ◽

pp. 121-130 ◽

Cited By ~ 4

Author(s):

James M. Ferguson ◽

Karen A. Tourian ◽

Gregory R. Rosas

Keyword(s):

Major Depressive Disorder ◽

Adverse Events ◽

Depressive Disorder ◽

Dose Range ◽

Term Treatment ◽

High Dose ◽

Major Depressive ◽

Long Term Treatment ◽

The Mean

ObjectiveThis study investigated the safety and efficacy of long-term treatment with high-dose desvenlafaxine (administered as desvenlafaxine succinate) in major depressive disorder (MDD).MethodsIn this multicenter, open-label study, adult outpatients with MDD aged 18–75 were treated with flexible doses of desvenlafaxine (200–400 mg/d) for ≤ 1 year. Safety assessments included monitoring of treatment-emergent adverse events (TEAEs), patient discontinuations due to adverse events, electrocardiograms, vital signs, and laboratory determinations. The primary efficacy measure was mean change from baseline in the 17-item Hamilton Rating Scale for Depression [HAM-D(17)] total score.ResultsThe mean daily desvenlafaxine dose range over the duration of the trial was 267–356 mg (after titration). The most frequent TEAEs in the safety population (n = 104) were nausea (52%) and headache (41%), dizziness (31%), insomnia (29%), and dry mouth (27%). All TEAEs were mild or moderate in severity. Thirty-four (33%) patients discontinued from the study because of TEAEs; nausea (12%) and dizziness (9%) were the most frequently cited reasons. The mean change in HAM-D(17) total score for the intent-to-treat population (n = 99) was −9.9 at the last on-therapy visit in the last-observation-carried-forward analysis and −14.0 at month 12 in the observed cases analysis.ConclusionHigh-dose desvenlafaxine (200–400 mg/d) was generally safe and effective in the long-term treatment of MDD.

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Intravitreal bevacizumab monotherapy in myopic choroidal neovascularisation: 5-year outcomes for the PAN-American Collaborative Retina Study Group

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2017-310411 ◽

2017 ◽

Vol 102 (4) ◽

pp. 455-459 ◽

Cited By ~ 3

Author(s):

Jay Chhablani ◽

Remya Mareen Paulose ◽

Andres F Lasave ◽

Lihteh Wu ◽

Cristian Carpentier ◽

...

Keyword(s):

Visual Acuity ◽

Adverse Events ◽

Real Life ◽

Intravitreal Bevacizumab ◽

Term Treatment ◽

Choroidal Neovascularisation ◽

Long Term Treatment ◽

The Mean

PurposeTo report the long-term anatomical and visual outcomes of intravitreal bevacizumab (IVB) monotherapy in naive choroidal neovascularisation (CNV) caused by myopia.MethodsRetrospective analysis of naive CNV secondary to myopia that underwent antivascular endothelial growth factor monotherapy was performed. Collected data included demographic details, clinical examination details including visual acuity at presentation and follow-up with imaging and treatment details. Main outcome measures were resolution of CNV activity at the last visit. Secondary outcomes included change in visual acuity, number of injections and adverse events.ResultsThirty-three eyes of 31 subjects with a mean age of 51.48±16.4 years were included. The mean follow-up was 66.47 months. 27 eyes had type 2 CNV and the rest seven eyes had type 1 CNV. The mean number of IVB injections per eye was 4.9. Mean visual acuity at baseline reduced from 0.65±0.33 logMAR units (Snellen equivalent=20/89) to 0.73±0.50 logMAR units (20/107) at final follow-up (p=0.003). The mean central macular thickness decreased from 309.31±86 µm at baseline to 267.5±70.89 µm at the last visit (p=0.03). However, visual acuity was maintained (±1 line of baseline) in 13 eyes (39.4%), ≥2 line improvement in nine (27.3%) eyes and more than two lines worsening in 11 eyes (33.3%). Foveal atrophy was observed at baseline and last visit in 6 (12.5%) and 14 (29.1%), respectively (p=0.007). No systemic adverse events were observed.ConclusionIVB monotherapy is safe and effective for long-term treatment of CNV secondary to myopia in real life.

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