scholarly journals Do Newer Antidepressant Drugs Really Have Reduced Side Effects? Examining a Random “Real World” Sample of 300+ Receivers of Medications

2020 ◽  
Vol 6 (1) ◽  
pp. 75-100
Author(s):  
Nicholas Norman Adams
Keyword(s):  
Side Effects ◽  
Real World ◽  
Side Effect ◽  
Antidepressant Drug ◽  
Antidepressant Drugs ◽  
Primary Treatment ◽  
Self Report ◽  
Real World Data ◽  
Reported Study ◽  
Atypical Antidepressants

Newer antidepressant drugs are frequently cited as having reduced side effect profiles to that of their older counterparts. However, recent studies have begun to dispute this claim, citing selective sampling, short clinical trials, and clinical trial environments as influencing reported outcomes. At present, little research on antidepressant side effects draws on RWD (Real-World Data). Despite this, interest in examining RWD samples for antidepressant drug side effects is increasing as of 2020. The reported study asked a random sample of 300+ individuals taking a variety of different antidepressant medications to complete online drug side effect self-report scales with previously high validity. Newer antidepressants belonging to the atypical antidepressant drug class were reported as having only slightly reduced side effects of weight gain compared with older SSRI-class medications. No reduced side effects of increased depression, anxiety, sexual dysfunction (SD), sleepiness, or suicidal ideation (SI) were found for the newer atypical-class medications vs older SSRI-class agents. Medication adherence did not differ significantly between SSRI and atypical classes. No evidence for reduced side effects was found for newer SSRI and atypical antidepressants vs older same-class drugs when comparing six new and old medications drawn from atypical and SSRI classes. However, atypical antidepressants were associated with increased use of adjunct medications to bolster primary treatment.

Defensive Medicine

2021 ◽  
pp. 99-124
Author(s):  
Michael J. Saks ◽  
Stephan Landsman
Keyword(s):  
Medical Practice ◽  
Real World ◽  
Healthcare Providers ◽  
Defensive Medicine ◽  
Self Report ◽  
Healthcare Industry ◽  
Clinical Scenario ◽  
Real World Data ◽  
Considerable Uncertainty ◽  
Legal Response

“Defensive Medicine: A Response to the Legal Response?” discusses the origins, meaning, purposes, and uncertain existence of defensive medicine. The concept has been most useful for those promoting changes in the law to economically benefit the healthcare industry. In the span of several decades, healthcare providers reversed their stance on whether or not they practice defensively. Why would providers commit defensive medicine? Why would they admit to practices that are universally seen as unethical, illegal (fraud), and unsound medical practice? Different types of empirical research have tried to determine whether defensive medicine occurs and, if so, its extent, cost, and effects on patients: physician self-report surveys, clinical scenario surveys, and multivariate analyses of real-world data. The chapter explores the possibility that defensive practices mostly occur in those situations where considerable uncertainty about diagnosis exists and the risk of serious harm is great if the patient is not treated correctly.

scholarly journals P232 Effectiveness of adalimumab biosimilar switching: real world data from a London rheumatology centre

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Shivanee Vigneswaran ◽  
Megan Galloway ◽  
Samuel Hanlon ◽  
Aoife Tynan ◽  
Animesh Singh
Keyword(s):  
Side Effects ◽  
Disease Activity ◽  
Real World ◽  
Biologic Therapy ◽  
Underlying Disease ◽  
Real World Data ◽  
Biologic Drugs ◽  
Control Activity ◽  
World Data ◽  
Long Term Treatment

Abstract Background Biologic drugs have revolutionised the management of many rheumatological diseases with remission or low disease activity now the realistic targets for treatment. However, given the chronic nature of most rheumatological disease and the need for long term treatment, there has been a significant increase in the cost associated with disease treatment. The advent of biosimilars offers an attractive target in reducing drug costs for payers. Biosimilar medications are thought to be equally efficacious as originator drugs. Real world data in adalimumab biosimilar switching is limited. In this audit we aim to examine the real-world outcomes from switching from originator Humira to biosimilar Amgevita in a London teaching hospital. Methods A list of all adult rheumatology patients on Amgevita was obtained through pharmacy records. All patients had been switched from Humira to Amgevita from February 2019. Using clinic letters and an in-house biologics database, data was collected on the underlying disease and the date of switch. Outcomes reviewed were disease activity scores pre and post switch, documented side effects and flare of disease activity following switch including decision to revert to originator Humira or change treatment. Results There was a total of 289 adult patients on Humira who switched to Amgevita. Of these patients, 28 in total discontinued treatment - 13 with rheumatoid arthritis, 10 with psoriatic arthritis and 5 with ankylosing spondylitis. 22 had to be switched back to Humira, with a further 4 patients approved to switchback and awaiting to restart. Two additional patients were switched to alternative biologic therapy due to inefficacy. A further 3 patients refused to switch onto Amgevita. Sixteen patients had documented flares, with one requiring admission and ten requiring local or systemic corticosteroid therapy to control activity. Seven patients had documented side effects which included chest pain, headache, rash and site reactions and one patient developed shingles post switch. Conclusion A total of 9.6% of patients switched to Amgevita had disease flare or side effects resulting in a switchback to Humira or alternative biologic therapy. For a biosimilar to be approved, efficacy and safety profiles needs to be comparable to the originator biological therapy and usually looks at two treatment naïve groups, rather than direct switch. Thereby, data on switches in therapy is limited. One systematic review looking at 11,053 patients with inflammatory arthritis treated with Etanercept and switched to Benepali, found 768 reverting to original therapy giving a lower total of 6.9%. We find that although no previous data of Amgevita, our figure of 9.6% appears high in the context of previously controlled inflammatory disease with Humira. Disclosures S. Vigneswaran None. M. Galloway None. S. Hanlon None. A. Tynan None. A. Singh None.

Hostility Conflict and Reporting of Side Effects by Psychiatric Outpatients

1980 ◽  
Vol 47 (1) ◽  
pp. 319-324 ◽  
Author(s):  
Robert W. Downing ◽  
Karl Rickels
Keyword(s):  
Side Effects ◽  
Side Effect ◽  
Self Report ◽  
Partial Replication ◽  
Drug Trials ◽  
Psychiatric Outpatients ◽  
Double Blind ◽  
The Relationship ◽  
Report Measure

The Irritability, Indirect Hostility, Verbal Hostility, and Resentment scales from the Buss-Durkee Hostility Inventory, along with a newly constructed scale intended as a self-report measure of Hostility Conflict, were administered to 84 non-psychotic, primarily anxious psychiatric outpatients receiving an active anxiolytic and participating in one of several 4-wk. double-blind drug trials. Patients who complained of one or more side effects after 2 wk. of treatment were classified as side reactors; the remaining patients, as non-side reactors. Compared to non-side reactors, the side reactors obtained higher hostility conflict scores and lower scores on the Irritability and Indirect Hostility scales. Also, the relationship between side effect status and hostility conflict was stronger in those patients who obtained higher scores on the Irritability, Indirect Hostility, and Verbal Hostility scales and among patients obtaining lower scores on the Resentment scale. Findings were regarded as providing partial replication of and further verification of earlier results.

scholarly journals What side effects are problematic for patients prescribed antipsychotic medication? The Maudsley Side Effects (MSE) measure for antipsychotic medication

2017 ◽  
Vol 47 (13) ◽  
pp. 2369-2378 ◽  
Author(s):  
T. Wykes ◽  
J. Evans ◽  
C. Paton ◽  
T. R. E. Barnes ◽  
D. Taylor ◽  
...  
Keyword(s):  
Side Effects ◽  
Antipsychotic Medication ◽  
Side Effect ◽  
Self Report ◽  
Psychotic Symptoms ◽  
Service Users ◽  
Good Reliability ◽  
Starting Point ◽  
Two Samples ◽  
Life Impact

BackgroundCapturing service users’ perspectives can highlight additional and different concerns to those of clinicians, but there are no up to date, self-report psychometrically sound measures of side effects of antipsychotic medications.AimTo develop a psychometrically sound measure to identify antipsychotic side effects important to service users, the Maudsley Side Effects (MSE) measure.MethodAn initial item bank was subjected to a Delphi exercise (n = 9) with psychiatrists and pharmacists, followed by service user focus groups and expert panels (n = 15) to determine item relevance and language. Feasibility and comprehensive psychometric properties were established in two samples (N43 and N50). We investigated whether we could predict the three most important side effects for individuals from their frequency, severity and life impact.ResultsMSE is a 53-item measure with good reliability and validity. Poorer mental and physical health, but not psychotic symptoms, was related to side-effect burden. Seventy-nine percent of items were chosen as one of the three most important effects. Severity, impact and distress only predicted ‘putting on weight’ which was more distressing, more severe and had more life impact in those for whom it was most important.ConclusionsMSE is a self-report questionnaire that identifies reliably the side-effect burden as experienced by patients. Identifying key side effects important to patients can act as a starting point for joint decision making on the type and the dose of medication.

Clinical validation of the self-reported Glasgow Antipsychotic Side-effect Scale using the clinician-rated UKU side-effect scale as gold standard reference

2020 ◽  
Vol 34 (8) ◽  
pp. 820-828
Author(s):  
Marlene Schouby Bock ◽  
Oona Nørgaard Van Achter ◽  
David Dines ◽  
Maria Simonsen Speed ◽  
Christoph U Correll ◽  
...  
Keyword(s):  
Side Effects ◽  
Positive Predictive Value ◽  
Negative Predictive Value ◽  
Predictive Value ◽  
Gold Standard ◽  
Side Effect ◽  
Self Report ◽  
Measurement Based Care ◽  
Gold Standard Reference ◽  
Antipsychotic Side Effects

Background: Antipsychotics are key for the treatment of psychotic and several non-psychotic disorders. Unfortunately, antipsychotic medications are associated with side effects, which may reduce quality of life and treatment adherence. Therefore, regular screening of antipsychotic side effects is essential. The Glasgow Antipsychotic Side-effect Scale is a patient self-report scale developed for this purpose. However, the Glasgow Antipsychotic Side-effect Scale has only been validated against another self-report side effect measure, which is suboptimal. Objective: We aimed to validate the Glasgow Antipsychotic Side-effect Scale using the clinician-rated Udvalg for Kliniske Undersøgelser side-effect rating scale as the gold standard reference. Results: 81 antipsychotic-treated outpatients with schizophrenia-spectrum disorders (age = 42±13 years; males = 43%, schizophrenia = 77%, illness duration: median = 11 years) completed the Glasgow Antipsychotic Side-effect Scale and were subsequently scored on the Udvalg for Kliniske Undersøgelser by trained raters. Sensitivity, specificity, positive predictive value and negative predictive value were calculated for paired Glasgow Antipsychotic Side-effect Scale and Udvalg for Kliniske Undersøgelser items. Sensitivity of Glasgow Antipsychotic Side-effect Scale items ranged from 33–96%, with 19 (86%) having >75% sensitivity. Lowest sensitivity emerged for “nocturnal enuresis” (33%), “galactorrhea” (50%) and “hyperkinesia” 14–99%, with 14 items (64%) having >75% specificity, being lowest for “asthenia” (14%), “polyuria/polydipsia” (35%), “sedation” (41%), “akathisia” (53%), “dystonia” (65%), “hyperkinesia” (68%), “hypokinesia” (70%) and “accommodation” (70%). Positive predictive value ranged from 7–85%, with six items (27%) having a positive predictive value >75%. Negative predictive value ranged from 40–98%, with 21 items (95%) having a negative predictive value >75%. The mean time to complete the Glasgow Antipsychotic Side-effect Scale was 4±2 minutes. Conclusion: The Glasgow Antipsychotic Side-effect Scale demonstrated satisfactory validity as a self-rated tool for antipsychotic side effects and may aid measurement-based care and decision-making.

Establishing a physical health monitoring service for patients on depot antipsychotic medication

2016 ◽  
Vol 33 (S1) ◽  
pp. S564-S564
Author(s):  
M. Gill ◽  
M. McCauley
Keyword(s):  
Side Effects ◽  
Physical Health ◽  
Antipsychotic Medication ◽  
Health Monitoring ◽  
Side Effect ◽  
Blood Test ◽  
Best Practice ◽  
Self Report ◽  
Physical Parameters ◽  
Depot Antipsychotic

IntroductionPatients with major mental illness are recognised to be at risk of premature death for a multitude of reasons. Those with schizophrenia and bipolar disorder are at highest risk.ObjectivesInternational best practice recommends monitoring of blood tests, physical parameters such as weight, BMI, waist circumference and blood pressure, and side effects of patients prescribed antipsychotic medication. A clinic was established to target these interventions.AimsThis initiative aimed to improve the physical health monitoring of patients prescribed depot antipsychotic medication in a catchment area of approximately 36,000 in Ireland.MethodsA twice-yearly, multidisciplinary monitoring clinic was established. A protocol was drawn up, following a literature review and inspection of current international guidelines, and a proforma assisted as an aide-mémoire. A self-report questionnaire, the Glasgow Antipsychotic Side Effect Scale, was used to enquire about side effects.ResultsEvaluation took place in descriptive form with audit used to examine outcomes. Full blood test monitoring improved from 9% of patients to 61% in one year, with 78% of patients having had at least one blood test recorded. Prior to the clinic's establishment, only one patient had had any physical parameters recorded, but this improved to 96% recorded after the clinics were run. Side effect documentation also improved.ConclusionsThe clinic was well-received and led to improved teamwork. Future recommendations include organising the clinic so as to include simultaneous blood testing. A similar project is being planned to target all patients attending who are prescribed antipsychotic medication.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals Sofosbuvir/velpatasvir is an effective treatment for patients with hepatitis C and advanced fibrosis or cirrhosis in a real-world setting in Taiwan

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yu-Ting Huang ◽  
Yung-Yu Hsieh ◽  
Wei-Ming Chen ◽  
Shui-Yi Tung ◽  
Kuo-Liang Wei ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Real World ◽  
Population Analysis ◽  
Asian Population ◽  
Primary Treatment ◽  
Virologic Response ◽  
Chang Gung Memorial Hospital ◽  
Advanced Fibrosis ◽  
Real World Data ◽  
The Impact

Abstract Introduction Real-world data regarding the impact of hepatic fibrosis on the effectiveness of sofosbuvir/velpatasvir (SOF/VEL) treatment is limited in the Asian population. Methods We analyzed data for all 823 patients with hepatitis C virus treated with SOF/VEL from June 2019 to September 2020 at Chang Gung Memorial Hospital in Chiayi, Taiwan. The degree of fibrosis was determined using the fibrosis-4 (FIB-4) index, with advanced fibrosis or cirrhosis defined as a FIB-4 score of > 3.25. The primary treatment outcome was the rate of sustained virologic response 12 weeks after treatment cessation (SVR). Adverse events (AEs) were also evaluated. Results SVR rates did not significantly differ (p > 0.05) between patients with FIB-4 scores of ≤ 3.25 and those with scores of > 3.25. In the per protocol analysis, 99.2% (593/598) of the FIB-4 ≤ 3.25 group and 100% (172/172) of the FIB-4 > 3.25 group achieved SVR; in the evaluable population analysis, 93.4% (593/635) of the FIB-4 ≤ 3.25 group and 91.5% (172/188) of the FIB-4 > 3.25 group achieved SVR. Five patients with FIB-4 scores of ≤ 3.25 did not attain SVR: two relapsed and three had no response. The most common AEs were comparable (p > 0.05) for the FIB-4 ≤ 3.25 group and the FIB-4 > 3.25 group and included abdominal discomfort (4.4% vs. 5.9%), fatigue (4.1% vs. 5.9%), and skin itching (3.6% vs. 3.2%). Laboratory abnormalities were more common in the FIB-4 > 3.25 group (p < 0.001). Six patients with FIB-4 scores of > 3.25 had total bilirubin elevation > 3 × the upper normal limit (UNL). Alanine transaminase elevation > 5 × the UNL was observed in two patients with FIB-4 scores of ≤ 3.25 and one patient with a FIB-4 score of > 3.25. No AEs resulted in treatment discontinuation. Conclusions SOF/VEL treatment is well tolerated and achieves high SVR rates for patients of Taiwanese ethnicity with HCV, regardless of cirrhosis status.

Breast cancer patients’ quality of life: Real-world data.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e23115-e23115
Author(s):  
Paris A. Kosmidis ◽  
Barbara Athanasakou ◽  
Thanos Kosmidis
Keyword(s):  
Breast Cancer ◽  
Side Effects ◽  
Cancer Patients ◽  
Real World ◽  
Breast Cancer Patients ◽  
Real World Data ◽  
Security Controls ◽  
Real World Evidence ◽  
Systemic Treatments ◽  
Platinum Based Chemotherapy

e23115 Background: CareAcross is a digital platform dedicated to support, inform and engage with cancer patients. It also collects medical and other data, and generates real world evidence. Methods: In an effort to collect and analyze information from breast cancer patients regarding side effects in relation to their treatments and supplements intake, we contacted 4837 patients in the UK, Germany, France, Spain and Italy. 474 had triple negative breast cancer (TNBC) and the remaining 4363 other breast cancer subtypes (non-TNBC). All data was collected anonymously, with strong privacy and security controls. Results: Different regimens were given either as adjuvant or as systemic treatments. AC treatment was given to 9% of TNBC vs 4% of non-TNBC patients; FEC-T to 20% vs 13%, FEC to 10% vs 8%, taxanes to 37% vs 20% and platinum-based chemotherapy to 12% vs 2%, respectively. Among non-TNBC patients, 12% received Trastuzumab and 53% received hormonal treatment. Eighty four TNBC and 696 non-TNBC patients were asked regarding side effects as well as vitamins and supplements intake. Among them, 76 TNBC patients reported an average of 2.8 side effects (95% CI 1.0-8.0) vs 577 non-TNBC patients reporting an average of 2.8 side effects (95% CI 1.0-13.0); p < 0.92. Similarly, an average of 5.0 vitamins and supplements was reported by 64 TNBC patients (95% CI 10.0-17.0) and an average of 3.8 was reported by 555 non-TNBC patients (95% CI 1.0-29.0); p < 0.023. Toxicity and supplements are tabulated below. Conclusions: The real world evidence obtained through an international analysis shows that TNBC patients receive more toxic treatments due to the aggressive disease, as expected. However, TNBC patients experience similar toxicities with non-TNBC patients, but their consumption of vitamins and supplements is much higher. [Table: see text]

scholarly journals P272 How well are conventional DMARDs tolerated in PsA: a real-world study

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Issrah Jawad ◽  
Muhammad K Nisar
Keyword(s):  
Side Effects ◽  
Real World ◽  
Retention Rate ◽  
Cost Effective ◽  
University Teaching ◽  
Duration Of Treatment ◽  
Real World Data ◽  
Nice Guidelines ◽  
Gi Symptoms ◽  
Conventional Dmards

Abstract Background NICE guidelines recommend the first line use of DMARDs in psoriatic arthritis (PsA). However, studies show that many conventional treatments like methotrexate are poorly tolerated. There is hitherto no published real-world data addressing the tolerability of DMARDs in PsA. Our objective was therefore to assess the drug management in PsA with focus on tolerability and the reasons for therapy cessation. Methods We conducted a retrospective analysis of all PsA patients enrolled in electronic database up to April 2019 at our university teaching hospital. We had access to full patient records including details on co-morbidities, drugs and disease management. Results 335 patients were identified with a formal diagnosis of PsA. Mean age of the cohort was 46 years (13-81) and 58% were female. 9% of the individuals had diabetes and 18% had concurrent cardiovascular disease. 1/10th reported to be current smokers and 8% had a diagnosis of depression. 48% of the group had clinically active disease. Same percentage were taking a single DMARD. 10% had trialled 3 or more drugs. 62% of patients had discontinued one or more DMARDs prior. The mean duration before discontinuing a DMARD was 9.9 months. Methotrexate was the best tolerated and on average discontinued after 13.4 months (range: 4 days to 10.9 years). Sulfasalazine and hydroxychloroquine were discontinued after an average of 8.4 (11 days to 4.27 years) and 12.5 months (1.3 months to 2.88 years) respectively. Leflunomide was the least tolerated DMARD and stopped after an average of 5.5 months (7 days to 2.53 years). The main reason for stopping a medication was gastro-intestinal symptoms which accounted for 42% of all the reported side effects. This applied to both methotrexate (43%) and sulfasalazine (46%) discontinuation. The leading reasons for discontinuing hydroxychloroquine were jointly GI symptoms and other side effects at 43% each. Leflunomide was stopped in 50% of cases due to neurological symptoms. Conclusion To our knowledge, this is the first report confirming poor retention rate of oral DMARDs in a real world PsA cohort managed over 20 years. In the context of chronic disease, the median duration of treatment is short. Our analysis did not include patients who suffer from side effects but continue therapy thereby impacting treatment adherence and hence the true scale of the issue is likely higher. Though NICE guidelines stipulate the need of an adequate trial of minimum two DMARDs prior to therapy escalation, these drugs are not well tolerated and thus pose a challenge to clinicians. One potential solution is earlier adoption of biological therapies, which are increasingly cost effective and have been shown to be better tolerated. Disclosures I. Jawad None. M.K. Nisar None.

scholarly journals Self-Reported Antidepressant Drug Side Effects, Medication Adherence, and Its Associated Factors among Patients Diagnosed with Depression at the Psychiatric Hospital of Nepal

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Nirmal Raj Marasine ◽  
Sabina Sankhi ◽  
Rajendra Lamichhane ◽  
Nabin Raj Marasini ◽  
Nim Bahadur Dangi
Keyword(s):  
Medication Adherence ◽  
Side Effects ◽  
Psychiatric Hospital ◽  
Associated Factors ◽  
Antidepressant Drug ◽  
Antidepressant Drugs ◽  
Psychiatric Hospitals ◽  
Bivariate Analysis ◽  
Drug Side Effects ◽  
Cross Sectional

Objective. The present study is aimed at evaluating the side effects of antidepressant drugs, medication adherence (MA), and associated factors among patients diagnosed with depression at a psychiatric hospital in western Nepal. Methods. A prospective cross-sectional study was conducted among 174 patients visiting the outpatient clinic of a psychiatric hospital. The antidepressant side effect checklist (ASEC) was used to classify the reported antidepressant drug side effects into mild, moderate, and severe types. The Naranjo adverse drug reaction (ADR) probability scale was employed to assess the ADRs, and the Morisky Green Levine Adherence (MGLA) score was employed to determine the rate of medication adherence. Descriptive statistics and bivariate analysis were used, and a P value < 0.05 was taken as statistically significant in the multivariate analysis. Results. The patients were mostly female (55.74%), with a median (IQR) age of 32 (20) years. Approximately 74.13% of the patients experienced antidepressant side effects, where insomnia (17.05%) and anxiety (17.05%) were the most common. More than half of the patients (52.29%) had a low level of adherence. Females were 1.01 times more likely to be nonadherent to their antidepressant medications compared to males, adjusted odds ratio (AOR): 1.001 (0.31-1.63). Similarly, illiterate patients tended to be more nonadherent compared to literates, AOR: 1.342 (0. 93-2.82), and unemployed individuals were 1.5 times more likely to be nonadherent to their medications compared to employed individuals, AOR: 1.46 (1.16-4.13). Likewise, patients with severe side effects were more prone to develop nonadherence than those with moderate side effects, AOR: 1.173 (0.42-3.25). A significant association was found between the Naranjo score and medication adherence. Conclusions. This study suggests that antidepressant drug side effects were more prevalent and medication adherence was extremely poor among depressive patients in psychiatric hospitals. Factors such as gender, occupation, education, side effects, and ADRs attributed to poor medication adherence in patients.

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