Identification of anticancer drugs associated with atrial fibrillation: analysis of the WHO pharmacovigilance database

2020 ◽  
Author(s):  
Joachim Alexandre ◽  
Joe-Elie Salem ◽  
Javid Moslehi ◽  
Marion Sassier ◽  
Camille Ropert ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Anticancer Drugs ◽  
Kinase Inhibitors ◽  
Descriptive Analysis ◽  
Individual Case ◽  
World Health ◽  
European Medicines Agency ◽  
Individual Case Safety Report ◽  
Pharmacovigilance Database ◽  
Haematologic Malignancies

Abstract Aims The explosion of novel anticancer therapies has meant emergence of cardiotoxicity signals including atrial fibrillation (AF). Reliable data concerning the liability of anticancer drugs in inducing AF are scarce. Using the World Health Organization individual case safety report database, VigiBase®, we aimed to determine the association between anticancer drugs and AF. Methods and results A disproportionality analysis evaluating the multivariable-adjusted reporting odds ratios for AF with their 99.97% confidence intervals was performed for 176 U.S. Food and Drug Administration (FDA)- or European Medicines Agency (EMA)-labelled anticancer drugs in VigiBase®, followed by a descriptive analysis of AF cases for the anticancer drugs identified in VigiBase®. ClinicalTrial registration number: NCT03530215. A total of 11 757 AF cases associated with at least one anticancer drug were identified in VigiBase® of which 95.8% were deemed serious. Nineteen anticancer drugs were significantly associated with AF of which 14 (74%) are used in haematologic malignancies and 9 (45%) represented new AF associations not previously confirmed in literature including immunomodulating agents (lenalidomide, pomalidomide), several kinase inhibitors (nilotinib, ponatinib, midostaurin), antimetabolites (azacytidine, clofarabine), docetaxel (taxane), and obinutuzumab, an anti-CD20 monoclonal antibody. Conclusion Although cancer malignancy itself may generate AF, we identified 19 anticancer drugs significantly associated with a significant increase in AF over-reporting. This pharmacovigilance study provides evidence that anticancer drugs themselves could represent independent risk factors for AF development. Dedicated prospective clinical trials are now required to confirm these 19 associations. This list of suspected anticancer drugs should be known by physicians when confronted to AF in cancer patients, particularly in case of haematologic malignancies.

scholarly journals Coadministration of tizanidine and ciprofloxacin: a retrospective analysis of the WHO pharmacovigilance database

2021 ◽  
Author(s):  
Annette Rudolph ◽  
Hendrike Dahmke ◽  
Hugo Kupferschmidt ◽  
Andrea Burden ◽  
Stefan Weiler
Keyword(s):  
Real World ◽  
Safety Issue ◽  
Demographic Data ◽  
Fatal Outcome ◽  
Individual Case ◽  
World Health ◽  
Global Database ◽  
The Usa ◽  
Pharmacovigilance Database ◽  
The Impact

Abstract Purpose Tizanidine, an alpha-adrenergic substance with antinociceptive and antihypertensive effects, is extensively metabolized via cytochrome P450 (CYP) 1A2. Therefore, coadministration with potent CYP1A2 inhibitors, such as ciprofloxacin, is contraindicated. However, both drugs are broadly utilized in various countries. Their concomitant use bears an inherent high risk for clinically significant symptoms, especially in multimorbid patients experiencing polypharmacy. This study aims to investigate the impact of coadministration of tizanidine and ciprofloxacin using real-world pharmacovigilance data and to raise awareness of this potentially underestimated safety issue. Methods We conducted a retrospective study including Individual Case Safety Reports (ICSR) registered until March 1, 2017, in the World Health Organization (WHO) global database. Demographic data, drug administration information, the course of the adverse drug reaction (ADR), its severity, and outcomes were analyzed for cases reporting ciprofloxacin comedication. Results In 91 (2.0%) of the identified 4192 worldwide ICSR on tizanidine, coadministration of ciprofloxacin was reported. Most of the patients were female (n = 59, 64.8%) with a median age of 54 years (range 13–85 years). The countries contributing most reports were the USA (n = 54, 59.3%) and Switzerland (n = 16, 17.6%). ADRs reported most often affected the nervous system and the cardiac function, especially with large tizanidine doses or drugs with CNS and cardiovascular depressant effects. In two cases, a fatal outcome was reported. Conclusion Despite the existing formal contraindication, the concomitant use of tizanidine and ciprofloxacin can be observed in real-world clinical practice. Reactions mainly affected the central nervous and the cardiovascular system resulting in potentially severe adverse effects. The concomitant use of tizanidine and ciprofloxacin should absolutely be avoided.

Atrial fibrillation in patients treated with intravenous zoledronic or pamidronic acid: a pharmacoepidemiological study

2021 ◽  
Vol 184 (3) ◽  
pp. 441-448
Author(s):  
Luc Pijnenburg ◽  
Joe-Elie Salem ◽  
Bénédicte Lebrun-Vignes ◽  
Jean Sibilia ◽  
Rose-Marie Javier ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Zoledronic Acid ◽  
Pamidronic Acid ◽  
Real Life ◽  
World Health ◽  
Disproportionality Analysis ◽  
Pharmacoepidemiological Study ◽  
Systematic Analysis ◽  
The World ◽  
Pharmacovigilance Database

Objective Atrial fibrillation (AF) may be triggered by intravenous bisphosphonates (IVBPs) such as zoledronic acid or pamidronic acid. Our objective was to confirm the association between AF and IVBPs in a real-life large pharmacovigilance database. Design A systematic analysis of VigiBase, the World Health Organization's pharmacovigilance database. Methods Analysis of adverse events reported as ‘atrial fibrillation’ (according to the Medical Dictionary for Drug Regulatory Activities) associated with the use of zoledronic acid or pamidronic acid, in VigiBase, the World Health Organization's global Individual Case Safety Report (ICSR) database. All ICSRs reporting AF associated with zoledronic acid or pamidronic acid were included in a disproportionality analysis determining the lower end of the 95% credibility interval for the information component (IC025), showing a statistical association when >0. Results 530 ICSRs reporting on the association between AF and IVBPs were extracted. Bayesian disproportionality analysis detected a significant association between AF and use of zoledronic acid (IC025 = 1.83) and pamidronic acid (IC025 = 2.16). Further analysis of these ICSRs determined that AF was severe in 85.0% of cases and with a mortality of 17.7%. The risk of severe AF was increased (OR: 2.98 (95% CI: 1.17–7.57), P = 0.02) following zoledronic acid vs pamidronic acid, after adjustment for age and gender. Conclusions This is the first VigiBase pharmacoepidemiological study confirming the association between IVBPs and AF. Most AF were severe, with a high frequency of lethal outcome. The risk of severe AF was increased following zoledronic acid use compared to pamidronic acid, advocating for a cautious use of IVBPs.

IL-4/13 Blockade and sleep-related adverse drug reactions in over 37,000 Dupilumab reports from the World Health Organization Individual Case Safety reporting pharmacovigilance database (VigiBase™): a big data and machine learning analysis (Preprint)

2021 ◽  
Author(s):  
Roobaea Alroobaea ◽  
Saeed Rubaiee ◽  
Abdulkader S. Hanbazazah ◽  
Haitham Jahrami ◽  
Sergio Garbarino ◽  
...  
Keyword(s):  
Atopic Dermatitis ◽  
Side Effects ◽  
Sleep Disturbances ◽  
Individual Case ◽  
World Health ◽  
Drug Reactions ◽  
The World ◽  
Pharmacovigilance Database ◽  
Health Organization ◽  
Sleep Deficit

BACKGROUND Atopic dermatitis displays a relevant sleep burden sustained by clinical (i.e., itch), psychological (i.e., inadequate coping strategies) and therapeutic (i.e. frequent loss of drug response) triggers. Dupilumab, the first biologic approved for atopic dermatitis, showed excellent effects on improving pruritus and sleep after only two weeks of treatment but, in some cases, may have paradoxical effects. OBJECTIVE The rate of sleep-related side-effects remains unknown. More specifically, adverse-drug reactions (ADRs) related to dupilumab have been investigated during the safety phase of randomized clinical trials or in small retrospective epidemiological surveys, but little is known about sleep-related ADRs in real-life settings. Therefore, we took advantage of a global large-scale pharmacovigilance database, carrying out a comprehensive data mining analysis to look at different sleep-related ADRs reported among patients under anti IL-4/13 therapy. METHODS We analysed individual case study reports (ICSRs) in VigiBase, the World Health Organization (WHO) global pharmacovigilance database of ADRs collected by national drug authorities in >140 countries (>90% of the world population). We looked for patterns of potentially sleep-related ADRs and we applied a disproportionality analysis based on Bayesian Confidence Propagation Neural Network (BCPNN). A meta-analytical approach was used to synthesize the overall effect size of sleep-related ADRs potentially associated to Dupilumab administration. RESULTS From inception up to March 9, 2021, 94,065 ADRs from 37,848 unique reports were included and analyzed in the present paper: 1,294 of them (1.4%) concerned sleep disturbances (n=27). Most of sleep-related complaints were generic sleep disorders (n=630), followed by insomnia (n=312), somnolence (n=81), lethargy (n=60), night sweats (n=30), middle insomnia (n=39), hypersomnia (n=25), poor quality sleep (n=21), initial insomnia (n=17), sleep apnoea syndrome (n=13), nightmares (n=11) and sleep deficit (n=11). Interestingly, restlessness and restless leg syndrome, nocturnal dyspnoea, narcolepsy and bruxism were reported in 7, 6, 5, 4 and 3 cases, respectively. Only sleep deficit (OR 15.67 [CrI 8.61-28.51]; IC 3.24 [CrI 2.26-3.97]), generic sleep disorder (OR 6.22 [CrI 5.74-6.73]; IC 2.60 [CrI 2.48-2.71]), and nocturnal dyspnoea (OR 3.68 [CrI 1.53-8.87]; IC 1.56 [CrI 0.03-2.56]) achieved the statistical significance threshold. CONCLUSIONS In this work, we identified over 37,000 unique case-reports of Dupilumab side-effects reported on the WHO pharmacovigilance database. We specifically categorised those related to sleep issues, which were 1,294. Our findings from large numbers of cases provide data supporting the clinical observations that Dupilumab is usually effective in improving sleep quality and sleep disturbances/impairments but sometimes may impair circadian rhythm and sleep. Further work is needed to closely scrutinise the impact of Dupilumab on sleep, in terms of underlying mechanisms, and to better understand residual sleep disorders in patients with atopic dermatitis and other allergic diseases treated with Dupilumab. Thus, sleep monitoring may be helpful for dermatologists in managing atopic dermatitis patients treated with dupilumab. The limitations of spontaneous reporting systems including underreporting and reporting bias, heterogeneity of sources and impossibility to infer any causal relationship merit consideration and further research is needed.

Anti-cancer drugs associated with sudden death and ventricular arrhythmias: a cardio-oncology pharmacovigilance analysis

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Mirabel ◽  
P Karapetiantz ◽  
E Marijon ◽  
C Le Beller ◽  
Z Reda Al-Sayed ◽  
...  
Keyword(s):  
Sudden Death ◽  
Anticancer Drugs ◽  
Ventricular Arrhythmias ◽  
Lower Boundary ◽  
Individual Case ◽  
World Health ◽  
System Organ Class ◽  
Cancer Drugs ◽  
Drug Label ◽  
Anti Cancer

Abstract Background Experimental data have shown that some anticancer drugs can affect cardiac repolarization and induce life-threatening cardiac arrhythmias. Objective To identify anti-cancer drugs associated with the occurrence of sudden death (SD) and ventricular arrhythmias using the World Health Organization individual case safety report (ICSR) database, Vigibase. Methods The system organ class MEDRA was used to identify cases as ICSR with the terms sudden death, sudden cardiac death, cardiac arrest, ventricular fibrillation, ventricular tachycardia, ventricular arrhythmia and torsades de pointes (named as SD events) from Nov 1967 to Nov 2019. We used the ATC code L01 which regroups 219 antineoplastic agents. A disproportionality analysis was performed to estimate of relative Odds Ratio (ROR). Signals were considered significant when the lower boundary of the 99.97% confidence interval (ROR0.25) was ≥1. Results Among the 2,170,203 adverse events associated with anticancer drugs, 11,979 (0.55%) concerned SD events. A total of 49 molecules were significantly associated with SD events, among which 4 were withdrawn from market. These molecules were mainly anti-metabolites (20.0%), chemicals such as arsenic (17.8%,), anthracyclins (8.9%) and alkaloids (8.9%). When agents were grouped according to their mode of actions, the highest risks were observed for platinum-based drugs (n=1628 cases, ROR0.25=1.2) and anthracyclins (n=1323 cases, ROR0.25=1.3). While the risk for SD or severe arrhythmias was reported in the drug label for 29 agents (64.4%), we found that this risk was not identified or mentioned for 16 agents (35.5%). Conclusions We identified 49 anticancer drugs that are significantly associated with SD events overreporting. Appropriate monitoring and preventive measures should be considered for patients receiving these drugs. Funding Acknowledgement Type of funding source: None

scholarly journals The Safety Profile of General and Local Anaesthetic Agents: Data Collected during 20 Years of Spontaneous Reporting Activities in the Campania Region (Southern Italy)

2021 ◽  
Vol 14 (12) ◽  
pp. 1261
Author(s):  
Francesca Gargano ◽  
Cristina Scavone ◽  
Gabriella di Mauro ◽  
Alberto Della Corte ◽  
Alice Zoccoli ◽  
...  
Keyword(s):  
Spontaneous Reporting ◽  
Southern Italy ◽  
Descriptive Analysis ◽  
Local Anaesthetics ◽  
Individual Case ◽  
Favourable Outcome ◽  
System Organ Class ◽  
Campania Region ◽  
Anaesthetic Agents ◽  
Pharmacovigilance Database

Background: General and local anaesthetics are widely used during surgery. These drugs have peculiar safety profiles, being commonly associated with mild and reversible local adverse drug reactions (ADRs), but also with more severe and systemic ADRs, including respiratory and cardiovascular depression and anaphylaxis. Methods and Objectives: We carried out a descriptive analysis of Individual Case Safety Reports (ICSRs) sent to the Campania Regional Centre of Pharmacovigilance (Southern Italy) from 2001 to 2021 that reported general or local anaesthetics as suspected drugs, with the aim of describing their overall characteristics, focussing on the ADRs’ seriousness and distribution by System Organ Class (SOC) and Preferred Term (PT). Results: A total of 110 ICSRs documenting general or local anaesthetics were sent to the Italian pharmacovigilance database during 20 years of spontaneous reporting activities in the Campania region. ADRs mainly occurred in patients with a median age of 48 years and in a slightly higher percentage of men. ADRs were more commonly classified as not serious and had a favourable outcome. In terms of ADRs’ distribution by SOC and PT, both general and local anaesthetics were associated with general and cutaneous disorders, with common ADRs that included lack of efficacy, rash, and erythema. In addition, general anaesthetics were associated with the occurrence of respiratory ADRs, while local anaesthetics were associated with the occurrence of nervous ADRs. Conclusion: Even though a limited number of ICSRs documenting anaesthetics-induced ADRs were retrieved from the Italian spontaneous reporting database in the Campania region, we believe that the continuous monitoring of these drugs is highly recommended, especially among the frail population.

scholarly journals Cardiac Inflammation after COVID-19 mRNA Vaccines: A Global Pharmacovigilance Analysis

2021 ◽  
Author(s):  
Laurent Chouchana ◽  
Alice Blet ◽  
Mohammad Al-Khalaf ◽  
Tahir S Kafil ◽  
Girish Nair ◽  
...  
Keyword(s):  
Adverse Event Reporting System ◽  
Individual Case ◽  
Global Scale ◽  
Adverse Event Reporting ◽  
World Health ◽  
Medical Attention ◽  
Safety Signal ◽  
Individual Case Safety Report ◽  
Disproportionate Reporting ◽  
The U.S

Background To counter the COVID-19 pandemic, mRNA vaccines, namely tozinameran and elasomeran, have been authorized in several countries. These next generation vaccines have shown high efficacy against COVID-19 and demonstrated a favorable safety profile. As widespread vaccinations efforts are taking place, incidents of myocarditis and pericarditis cases following vaccination have been reported. This safety signal has been recently confirmed by the European Medicine Agency and the U.S. Food and Drug Administration. This study aimed to investigate and analyze this safety signal using a dual pharmacovigilance database analysis. Methods This is as an observational study of reports of inflammatory heart reactions associated with mRNA COVID-19 vaccines reported in the World Health Organization's global individual case safety report database (up to June 30th 2021), and in the U.S. Vaccine Adverse Event Reporting System (VAERS, up to May 21st 2021). Cases were described, and disproportionality analyses using reporting odds-ratios (ROR) and their 95% confidence interval (95%CI) were performed to assess relative risk of reporting according to patient sex and age. Results At a global scale, the inflammatory heart reactions most frequently reported were myocarditis (1241, 55%) and pericarditis (851, 37%), the majority requiring hospitalization (n=796 (64%)). Overall, patients were young (median age 33 [21-54] years). The main age group was 18-29 years old (704, 31%), and mostly males (1555, 68%). Pericarditis onset was delayed compared to myocarditis with a median time to onset of 8 [3-21] vs. 3 [2-6] days, respectively (p=0.001). Regarding myocarditis, an important disproportionate reporting in males (ROR, 9.4 [8.3-10.6]) as well as in adolescents (ROR, 22.3 [19.2-25.9]) and 18-29 years old (ROR, 6.6 [5.9-7.5]) compared to older patients were observed. Conclusions The inflammatory heart reactions, namely myocarditis and pericarditis, have been reported world-wide shortly following COVID-19 mRNA vaccination. An important disproportionate reporting among adolescents and young adults, particularly in males, was observed especially for myocarditis. Guidelines must take this specific risk into account and to optimize vaccination protocols according to sex and age. While the substantial benefits of COVID-19 vaccination still prevail over risks, clinicians and the public should be aware of these reactions and seek appropriate medical attention.

Safety Profiles and Pharmacovigilance Considerations for Recently Patented Anticancer Drugs: Advanced Thyroid Cancer

2019 ◽  
Vol 14 (3) ◽  
pp. 226-241
Author(s):  
Emanuela Vaccher ◽  
Ornella Schioppa ◽  
Ferdinando Martellotta ◽  
Giulia Fornasier ◽  
Elisa Giacomin ◽  
...  
Keyword(s):  
Thyroid Cancer ◽  
Thyroid Carcinoma ◽  
Anticancer Drugs ◽  
Safety Profile ◽  
Tyrosine Kinases ◽  
Kinase Inhibitors ◽  
Differentiated Thyroid Carcinoma ◽  
Systematic Analysis ◽  
Pharmacovigilance Database ◽  
Advanced Thyroid Cancer

Background: Thyroid cancer is the most common endocrine neoplasia and represents approximately 1.5% to 2.1% of all cancers diagnosed annually worldwide. Iodine Refractory Differentiated Thyroid Carcinoma (RR-DTC) and advanced/metastatic medullary thyroid carcinoma are relatively uncommon yet prognostically significant thyroid cancers. Gene rearrangements resulting in the aberrant activity of tyrosine kinases have been identified as drivers of oncogenesis in a variety of cancers, including thyroid cancer. Many Multi-Kinase Inhibitors (MKIs) which are now FDA-/EMA approved for thyroid cancer have shown clinical benefit in patients with advanced cancer. Treatmentrelated toxicities occur frequently with these drugs and can be severe or life-threatening. Objective: This review summarizes the role of targeted therapy with MKIs in the management of RRDTC and advanced/metastatic MTC patients, focusing on side-effect profiles of these drugs, with a presentation of several recent patents published in this field. Methods: We review the scientific literature on advanced thyroid cancer and analyze the International Pharmacovigilance database (FAERS, Eudravigilance, and WHO Vigibase) for adverse drug reactions. Results: This systematic analysis highlights the difference in the safety profile of the recent drugs used in the treatment of advanced thyroid cancer and the recent discoveries for diagnosis or treatment of the thyroid cancer. Conclusion: It is essential to investigate the safety profile of recent anticancer drugs for advanced thyroid cancer to allow health professionals to make the best choice for each patient by conducting risk/benefit assessment.

scholarly journals Focus on Clozapine Withdrawal- and Misuse-Related Cases as Reported to the European Medicines Agency (EMA) Pharmacovigilance Database

2020 ◽  
Vol 10 (2) ◽  
pp. 105 ◽  
Author(s):  
Stefania Chiappini ◽  
Fabrizio Schifano ◽  
John Martin Corkery ◽  
Amira Guirguis
Keyword(s):  
Descriptive Analysis ◽  
Drug Misuse ◽  
European Medicines Agency ◽  
Drug Reactions ◽  
Treatment Resistant ◽  
Polydrug Abuse ◽  
Pharmacovigilance Database ◽  
History Of ◽  
Recreational Use ◽  
Clozapine Withdrawal

Background: Clozapine is of high clinical relevance for the management of both treatment-resistant schizophrenia and psychotic disturbances with concurrent drug misuse. Although the molecule presents with a range of well-known side-effects, its discontinuation/withdrawal syndrome has been only anecdotally described. Aims: the 2005–2018 European Medicines Agency (EMA) dataset of Adverse Drug Reactions (ADRs) was analyzed to identify and describe possible clozapine withdrawal- and misuse-/abuse-/dependence-related issues. Method: A descriptive analysis of clozapine-related ADRs was performed when available, data on ADRs’ outcome, dosage, and possible concomitant drug(s) were considered. Results: Out of 11,847 clozapine-related ADRs, some 599 (5.05%) were related to misuse/abuse/dependence/withdrawal issues, including 258 withdrawal-related (43.1%); 241 abuse-related (40.2%); and 80 intentional product misuse-related (13.3%) ADRs. A small number of overdose- and suicide-related ADRs were reported as well. Clozapine was typically (69.2%) identified alone, and most (84.7%) fatalities/high-dosage intake instances were reported in association with a history of substance abuse. Conclusions: Previous suggestions about the possibility of a clozapine discontinuation/withdrawal occurrence are here supported, but further studies are needed. However, the misuse/abuse cases here identified might be difficult to interpret, given the lack of studies highlighting the possible recreational use of clozapine. The high-dosage intake, fatal outcomes and clozapine/polydrug abuse issues reported here may, however, be a reason for concern.

β-adrenoceptor antagonists and nightmares: A pharmacoepidemiological–pharmacodynamic study

2021 ◽  
pp. 026988112110348
Author(s):  
Philippe Garcia ◽  
Jean-Louis Montastruc ◽  
Vanessa Rousseau ◽  
Jacques Hamard ◽  
Agnès Sommet ◽  
...  
Keyword(s):  
Individual Case ◽  
World Health ◽  
Lipid Solubility ◽  
Multivariate Logistic Regression ◽  
Individual Case Safety Report ◽  
High Lipid ◽  
Increased Risk ◽  
Pharmacodynamic Analysis ◽  
Health Organization ◽  
High Lipid Solubility

Aim: To compare different β-adrenoceptor antagonists for the risk of reporting nightmare. Methods: The study involved two approaches: first, we investigated in VigiBase®, the World Health Organization Individual Case Safety Report (ICSR) database, the disproportionality between exposure to each β-adrenoceptor antagonists and reports of nightmares between 1967 and 2019. Second, in a pharmacoepidemiological–pharmacodynamic analysis, we assessed whether use of β-adrenoceptor antagonists with moderate and high lipid solubility or strong 5-HT1A affinity were associated with an increased risk of reporting nightmares. We conducted multivariate logistic regression to estimate reporting odds ratios (RORs) of nightmares compared to all other adverse drug reactions. Results: Of the 126,964 reports recorded with β-adrenoceptor antagonists, 1138 (0.9%) were nightmares. The highest risk of reporting a nightmare was found with exposure of pindolol (adjusted ROR 2.82, 95%CI, 2.19–3.61), metoprolol (1.89, 1.66–2.16), and alprenolol (1.77, 1.06–2.97). Compared to use of low lipid solubility β-adrenoceptor antagonists, use of moderate or high lipid solubility β-adrenoceptor antagonists were significantly more associated with nightmare reports (aROR moderate vs. low 1.72, 95%CI 1.47–2.00 and aROR high vs. low 1.84, 95%CI 1.53–2.22). Use of moderate or high 5-HT1A affinity of β-adrenoceptor antagonists was associated with an increased ROR of nightmares compared with low 5-HT1A affinity of β-adrenoceptor antagonists (aROR moderate vs. low 1.22, 95%CI 1.04–1.43 and aROR high vs. low 2.46, 95%CI 1.93–3.13). Conclusion: In our large pharmacovigilance study, nightmares are more frequently reported for pindolol and metoprolol, and among β-adrenoceptor antagonists with high lipid solubility and high 5-HT1A receptor affinity.

Research and Standard of Care: Lung Cancer in Romania

2012 ◽  
pp. 437-441
Author(s):  
Tudor E. Ciuleanu
Keyword(s):  
Lung Cancer ◽  
Kinase Inhibitors ◽  
Standard Of Care ◽  
Recruitment Rate ◽  
New Drugs ◽  
Cytotoxic Agents ◽  
World Health ◽  
European Medicines Agency ◽  
Incidence And Mortality ◽  
Health Organization

Overview: In Romania, lung cancer is the most frequent cancer in men and fourth most frequent in women, and its incidence and mortality continue to rise. Recently, firm antitobacco policies were implemented, in agreement with the MPOWER strategies recommended by the World Health Organization (WHO). As of January 2012, the recognized “official” standard of care in lung cancer is still represented by the 2009 edition of the European Society for Medical Oncology (ESMO) guidelines. Cancer treatment is free, as the National Program of Oncology covers the budget for all cytotoxic agents and targeted therapy. However, reimbursement for several expensive drugs such as pemetrexed, erlotinib, and bevacizumab is individually approved by a centralized commission. All new drugs registered in Europe by the European Medicines Agency are concomitantly registered in Romania. However, no new drugs (such as gefitinib) or new indications (such as first-line tyrosine-kinase inhibitors or maintenance treatment) have been accepted for reimbursement since 2008. Clinical research is rapidly growing, and Romanian centers demonstrate a high recruitment rate in pivotal trials, despite initial delays because of a slow approval of the studies by authorities.

Sign in / Sign up

Export Citation Format

Share Document