keyword
https://read.qxmd.com/read/36558987/post-marketing-surveillance-of-statins-a-descriptive-analysis-of-psychiatric-adverse-reactions-in-eudravigilance
#1
JOURNAL ARTICLE
Gabriela Pop, Andreea Farcaș, Anca Butucă, Claudiu Morgovan, Anca Maria Arseniu, Manuela Pumnea, Minodora Teodoru, Felicia Gabriela Gligor
Statins are included in the category of high-frequency prescription drugs, and their use is on an upward trend worldwide. In 2012, the FDA issued a warning about possible cognitive adverse drug reactions (ADRs) related to statins, some of which are listed in the Summary of Product Characteristics, but there are still concerns about their potential risk of psychiatric events. The aim of this research was to investigate spontaneous reports containing psychiatric ADRs associated with statins by analyzing the EudraVigilance (EV) database...
December 10, 2022: Pharmaceuticals
https://read.qxmd.com/read/35037597/the-preventive-effect-of-the-combination-of-atorvastatin-and-nortriptyline-in-migraine-type-headache-a-randomized-triple-blind-placebo-controlled-trial
#2
RANDOMIZED CONTROLLED TRIAL
Amir Sherafat, Adeleh Sahebnasagh, Roya Rahmany, Farhad Mohammadi, Fatemeh Saghafi
BACKGROUND AND PURPOSE: Migraine ranked as the eighth cause of disability worldwide. Statins with anti-inflammatory and vasodilatory endothelial effects have been introduced as an option for the prevention of migraine-type headaches. The current study aimed to assess the efficacy and tolerability of atorvastatin for the prevention of migraine in adults. METHOD: This prospective, triple-blind, randomized controlled clinical trial was performed in adult migraineurs from mid-July 2019 to late-April 2020...
April 2022: Neurological Research
https://read.qxmd.com/read/34915854/clinical-and-psychological-factors-in-coronary-heart-disease-patients-with-statin-associated-muscle-side-effects
#3
RANDOMIZED CONTROLLED TRIAL
Kari Peersen, John Munkhaugen, Elise Sverre, Oscar Kristiansen, Morten Fagerland, Nils Tore Vethe, Joep Perk, Einar Husebye, Toril Dammen
BACKGROUND: To compare clinical and psychological factors among patients with self-perceived statin-associated muscle symptoms (SAMS), confirmed SAMS, and refuted SAMS in coronary heart disease patients (CHD). METHODS: Data were obtained from a cross-sectional study of 1100 CHD outpatients and a study of 71 CHD outpatients attending a randomized, double-blinded, placebo-controlled, crossover study to test effects of atorvastatin 40 mg/day on muscle symptom intensity...
December 16, 2021: BMC Cardiovascular Disorders
https://read.qxmd.com/read/34172006/implementation-of-a-top-five-list-to-identify-medical-overuse-in-general-practice-according-to-patients-viewpoint-in-2019-in-france
#4
JOURNAL ARTICLE
Agnès Hazard, Marion Debin, Corentin Hervé, Caroline Guerrisi, Camille Bonnet, Mathilde François
BACKGROUND: There is a current trend to reassess the adequacy of care. Establishing top five lists by involving patients is one way to address medical overuse. The objective of this study was to establish a patients' top five list in general practice in France. The secondary objective was to identify selection criteria. METHOD: Patients from the web-based cohort GrippeNet.fr were invited to establish their top five list from 15 care procedures previously selected by general practitioners on the basis of medical overuse...
June 26, 2021: BMC Family Practice
https://read.qxmd.com/read/33818621/assessment-of-patient-preferred-language-to-achieve-goal-aligned-deprescribing-in-older-adults
#5
JOURNAL ARTICLE
Ariel R Green, Hélène Aschmann, Cynthia M Boyd, Nancy Schoenborn
Importance: How clinicians communicate about deprescribing, the structured process of reducing or stopping unnecessary, potentially harmful, or goal-discordant medicines, may be associated with the extent to which older adults are willing to do it. Objective: To examine older adults' preferences regarding different rationales a clinician may use to explain why a patient should stop an unnecessary or potentially harmful medication. Design, Setting, and Participants: This cross-sectional survey study was conducted from March 25 to April 19, 2020, among a nationally representative, probability-based online survey panel (KnowledgePanel)...
April 1, 2021: JAMA Network Open
https://read.qxmd.com/read/33351170/pcsk9-inhibitors-and-neurocognitive-adverse-drug-reactions-analysis-of-individual-case-safety-reports-from-the-eudravigilance-database
#6
JOURNAL ARTICLE
Gabriella di Mauro, Alessia Zinzi, Cristina Scavone, Annamaria Mascolo, Mario Gaio, Liberata Sportiello, Carmen Ferrajolo, Concetta Rafaniello, Francesco Rossi, Annalisa Capuano
INTRODUCTION: Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9Is) were associated with a risk of neurocognitive adverse drug reactions (ADRs). OBJECTIVE: We aimed to investigate the occurrence of neuropsychiatric ADRs related to PCSK9Is. METHODS: We analyzed Individual Case Safety Reports (ICSRs) sent through the European pharmacovigilance database that reported alirocumab or evolocumab as the suspected drug and at least one neurological or psychiatric ADR...
March 2021: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/32772925/a-top-5-list-for-french-general-practice
#7
JOURNAL ARTICLE
Agnès Hazard, Lucie Fournier, Louise Rossignol, Nathalie Pelletier Fleury, Corentin Hervé, Thibaud Pitel, Cécile Pino, Olivier Saint-Lary, Thomas Hanslik, Thierry Blanchon, Mathilde François
BACKGROUND: Medical overuse is an issue that has recently gained attention. The "Choosing Wisely" campaign invited each specialty in each country to create its own top five lists of care procedures with a negative benefit-risk balance to promote dialogue between patients and physicians. This study aims to create such a list for French general practice. METHODS: A panel of general practitioners (GPs) suggested care procedures that they felt ought to be prescribed less...
August 9, 2020: BMC Family Practice
https://read.qxmd.com/read/32519982/cumulative-non-hdl-cholesterol-burden-in-patients-with-hypertriglyceridemia-receiving-long-term-fibrate-therapy-real-life-data-from-a-lipid-clinic-cohort
#8
JOURNAL ARTICLE
Meral Kayıkçıoğlu, Shafa Shahbazova, Firdovsi İbrahimov, Levent Hürkan Can
OBJECTIVE: Though epidemiological data suggest that an elevated triglyceride (TG) level may be a risk factor for coronary artery disease (CAD), there is still insufficient clinical evidence. This study was designed to evaluate the real-life efficacy and side effects of fibrate treatment for hypertriglyceridemia seen in a lipid clinic, as well as cardiovascular and diabetic outcomes. METHODS: This retrospective study evaluated patients who were followed-up for a diagnosis of hypertriglyceridemia at the lipid outpatient clinic of the Ege University Cardiology Department between 1997 and 2018...
June 2020: Türk Kardiyoloji Derneği Arşivi: Türk Kardiyoloji Derneğinin Yayın Organıdır
https://read.qxmd.com/read/31699235/an-82-year-old-man-with-sleep-onset-insomnia-breathing-arrest-and-heart-failure
#9
JOURNAL ARTICLE
Torben de la Motte, Matthias Schwab, Torsten Schultze, Otto W Witte, Sven Rupprecht
An 82-year-old man presented with 6 months of difficulties of falling asleep. He described a feeling of fading breath culminating in breathing arrest when he becomes drowsy. These recurrent events prevented him from falling asleep. Symptoms would only appear when he went to sleep but not during wakefulness. Medical history comprised several episodes of acute decompensated heart failure due to supraventricular tachyarrhythmia with need for hospitalization during the last 2 years. He additionally had two-vessel coronary artery disease with myocardial infarction, pulmonary hypertension, chronic atrial fibrillation, peripheral arterial disease, and chronic kidney disease (stage 3)...
November 2019: Chest
https://read.qxmd.com/read/29986042/risk-of-neuropsychiatric-adverse-effects-of-lipid-lowering-drugs-a-mendelian-randomization-study
#10
JOURNAL ARTICLE
Jahad Alghamdi, Sabine Matou-Nasri, Faisal Alghamdi, Saleh Alghamdi, Majid Alfadhel, Sandosh Padmanabhan
Background: Recent studies have highlighted the possible risk of neuropsychiatric adverse effects during treatment with lipid-lowering medications. However, there are still controversies that require a novel genetic-based approach to verify whether the impact of lipid-lowering drug treatment results in neuropsychiatric troubles including insomnia, depression, and neuroticism. Thus, we applied Mendelian randomization to assess any potential neuropsychiatric adverse effects of conventional lipid-lowering drugs such as statins, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, and ezetimibe...
December 1, 2018: International Journal of Neuropsychopharmacology
https://read.qxmd.com/read/28988251/efficacy-and-safety-of-a-generic-rosuvastatin-in-a-real-world-setting-prospective-observational-clinical-study-in-lebanese-patients
#11
MULTICENTER STUDY
Mohamad Betto, Jocelyne Fares, Nada Saliba, Hajar Ballout
BACKGROUND: No published studies have assessed the efficacy and safety of rosuvastatin generics. OBJECTIVES: Primary objective to assess the safety and efficacy of a generic rosuvastatin in reducing plasma low-density-lipoprotein cholesterol (LDL-C) in Lebanese dyslipidemic patients. Changes in high-density lipoprotein cholesterol, triglycerides and adverse effects were secondary objectives. DESIGN: Prospective, observational, non-comparative...
September 2017: Annals of Saudi Medicine
https://read.qxmd.com/read/28889804/metabolic-and-inflammatory-markers-associations-with-individual-depressive-symptoms
#12
JOURNAL ARTICLE
F Lamers, Y Milaneschi, P de Jonge, E J Giltay, B W J H Penninx
BACKGROUND: Literature has shown that obesity, metabolic syndrome and inflammation are associated with depression, however, evidence suggests that these associations are specific to atypical depression. Which of the atypical symptoms are driving associations with obesity-related outcomes and inflammation is unknown. We evaluated associations between individual symptoms of depression (both atypical and non-atypical) and body mass index (BMI), metabolic syndrome components and inflammatory markers...
May 2018: Psychological Medicine
https://read.qxmd.com/read/25439449/safety-profile-of-subjects-treated-to-very-low-low-density-lipoprotein-cholesterol-levels-30-mg-dl-with-rosuvastatin-20-mg-daily-from-jupiter
#13
RANDOMIZED CONTROLLED TRIAL
Brendan M Everett, Samia Mora, Robert J Glynn, Jean MacFadyen, Paul M Ridker
Recent US guidelines expand the indications for high-intensity statin therapy, yet data on the safety of attaining very low-density lipoprotein cholesterol (LDL-C) levels are scarce. Among 16,304 participants in the Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) with on-treatment LDL-C levels, we identified 767 who did and 7,387 who did not achieve LDL-C <30 mg/dl on rosuvastatin 20 mg daily and 718 participants who did and 7,436 who did not achieve LDL-C reductions of ≥70% on rosuvastatin, and 8,150 allocated to placebo...
December 1, 2014: American Journal of Cardiology
https://read.qxmd.com/read/24743876/association-of-statin-use-with-sleep-disturbances-data-mining-of-a-spontaneous-reporting-database-and-a-prescription-database
#14
JOURNAL ARTICLE
Mitsutaka Takada, Mai Fujimoto, Kohei Yamazaki, Masashi Takamoto, Kouichi Hosomi
BACKGROUND: Particular interest has been generated regarding the possible influence of statin use on sleep quality. However, no conclusive evidence exists that a particular statin is more likely to be associated with sleep disturbances versus others. It remains uncertain whether different statins produce different risks for sleep disturbance. OBJECTIVE: To examine the association between statin use and the risk of sleep disturbances, we conducted data mining using the US Food and Drug Administration Adverse Event Reporting System (FAERS) and a large organized database of prescriptions constructed by a database vendor (Japan Medical Information Research Institute, Inc...
June 2014: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/23312495/-systemic-glucocorticoid-therapy-associated-measures
#15
REVIEW
L Sailler, G Pugnet, P Arlet
Long-term treatment with glucocorticoids results in many adverse effects. Prevention of osteoporosis is well codified, but prevention of other adverse effects is not. If there is some consensus on the prevention of glucocorticoid-induced adverse events, there are also many habits since interventional studies are lacking. A low caloric and low carbohydrate diet as well as a regular physical training are certainly necessary to avoid lipodystrophy, weight gain and diabetes mellitus. Some patients benefit from the repeated intervention of a dietetic or nutrition specialist...
May 2013: La Revue de Médecine Interne
https://read.qxmd.com/read/19489170/safety-profile-of-fluvastatin
#16
JOURNAL ARTICLE
T K Peters
Statins are regarded as a well-tolerated class of drugs, particularly when compared with some of the older lipid-modifying agents, which have poor rates of compliance. Despite some early concern, the incidence of lens opacities observed in clinical studies involving statin use is no different from that in a normal ageing population. Similarly, the occurrence of insomnia with lipophilic agents appears to have been overemphasised and is not a clinically significant problem, irrespective of the statin under study...
December 1994: British Journal of Clinical Practice. Supplement
https://read.qxmd.com/read/19026028/statin-associated-psychiatric-adverse-events-a-case-non-case-evaluation-of-an-italian-database-of-spontaneous-adverse-drug-reaction-reporting
#17
JOURNAL ARTICLE
Marco Tuccori, Francesco Lapi, Arianna Testi, Daniela Coli, Ugo Moretti, Alfredo Vannacci, Domenico Motola, Francesco Salvo, Alma Lisa Rivolta, Corrado Blandizzi, Alessandro Mugelli, Mario Del Tacca
BACKGROUND: The inhibitors of HMG-CoA reductase ('statins') are widely prescribed hypolipidaemic drugs, which have been evaluated in several clinical trials involving hundreds of thousands of patients. From a safety perspective, both clinical trials and post-marketing surveillance have demonstrated that statins are generally well tolerated, with rare serious adverse drug reactions (ADRs) that affect mainly muscle, liver and kidney. However, recent interest has been focused on a potential risk of psychiatric ADRs associated with statins, including memory loss, depression, suicidality, aggression and antisocial behaviour...
2008: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/17535079/comparison-of-the-effects-of-policosanol-and-atorvastatin-on-lipid-profile-and-platelet-aggregation-in-patients-with-dyslipidaemia-and-type-2-diabetes-mellitus
#18
JOURNAL ARTICLE
Gladys Castaño, Lilia Fernández, Rosa Mas, José Illnait, Meylin Mesa, J C Fernández
BACKGROUND: Diabetes mellitus and hypercholesterolaemia increase the risk for coronary heart disease, with type 2 diabetes mellitus being the most prevalent form of diabetes, frequently accompanied by dyslipidaemia. The main goal of dyslipidaemia control in nondiabetic and diabetic patients is to lower elevated low-density lipoprotein-cholesterol (LDL-C) levels. Policosanol is a cholesterol-lowering drug, purified from sugarcane wax, with a therapeutic range of 5-20 mg/day, which significantly reduces LDL-C levels...
2003: Clinical Drug Investigation
https://read.qxmd.com/read/8729586/safety-profile-of-fluvastatin
#19
REVIEW
T K Peters
Statins are regarded as a well-tolerated class of drugs, particularly when compared with some of the older lipid-modifying agents, which have poor rates of compliance. Despite some early concern, the incidence of lens opacities observed in clinical studies involving statin use is no different from that in a normal ageing population. Similarly, the occurrence of insomnia with lipophilic agents appears to have been overemphasised and is not a clinically significant problem, irrespective of the statin under study...
January 1996: British Journal of Clinical Practice. Supplement
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