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Article ; Online: Intra-arterial Alteplase vs Placebo After Successful Thrombectomy and Functional Outcomes in Patients With Large Vessel Occlusion Acute Ischemic Stroke-Reply.

Chamorro, Ángel / Torres, Ferrán

2022 Volume 327, Issue 24, Page(s) 2456

MeSH term(s)	Arterial Occlusive Diseases/complications ; Arterial Occlusive Diseases/drug therapy ; Arterial Occlusive Diseases/surgery ; Fibrinolytic Agents/administration & dosage ; Fibrinolytic Agents/therapeutic use ; Humans ; Infusions, Intra-Arterial ; Ischemic Stroke/drug therapy ; Ischemic Stroke/etiology ; Ischemic Stroke/surgery ; Thrombectomy ; Tissue Plasminogen Activator/administration & dosage ; Tissue Plasminogen Activator/therapeutic use ; Treatment Outcome
Chemical Substances	Fibrinolytic Agents ; Tissue Plasminogen Activator (EC 3.4.21.68)
Language	English
Publishing date	2022-06-28
Publishing country	United States
Document type	Journal Article ; Comment
ZDB-ID	2958-0
ISSN	1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
ISSN (online)	1538-3598
ISSN	0254-9077 ; 0002-9955 ; 0098-7484
DOI	10.1001/jama.2022.7430
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Article: Prevalence of use of on-label and off-label psychotropics in the Greek pediatric population.

Pesiou, Stella / Barcelo, Rafel / Papazisis, Georgios / Torres, Ferran / Pontes, Caridad

Frontiers in pharmacology

2024 Volume 15, Page(s) 1348887

Abstract: With a global increased use of psychotropics in pediatrics, their off-label use is a concern due to uncertainty and risk. Data on psychotropics use in the Greek pediatric population do not exist to date. We analyzed retrospective data from the nationwide ...

Abstract	With a global increased use of psychotropics in pediatrics, their off-label use is a concern due to uncertainty and risk. Data on psychotropics use in the Greek pediatric population do not exist to date. We analyzed retrospective data from the nationwide pharmacy claim database, to estimate the prevalence of psychotropics in pediatrics focusing on off-label use (March 2016-October 2019). In total 63,782 pediatric subjects had at least one identified psychotropic prescription. The prevalence of psychotropics use was 5.1-14.6/1,000 pediatric inhabitants. When excluding 42,508 subjects who received only short-time hydroxyzine, the prevalence was 3.1-6.5/1,000 pediatric inhabitants; adolescents and boys had higher exposures. An in-depth analysis of 21,274 subjects accounting for 222,307 psychotropic dispensations, showed antiepileptics as the most frequent psychotropics, consistently with the finding on epilepsy being the most frequent diagnosis; diazepam was the single drug with the highest exposure in almost all ages. 14% of subjects have received at least one medicine with no pediatric information in the labelling, corresponding to 5.5% of dispensed psychotropics. 7.6% of all dispensed psychotropics were used in a non-authorized age range with quetiapine being the most frequent psychotropic as off-label age range; antipsychotics and antidepressants were first as off-label for non-authorized indication. Data from Greece show that a relevant number of patients are prescribed psychotropics, with 1 in 7 being under off-label use. Due to the limitations inherent to pharmacy claims databases, further research using clinical data for a longer follow-up period could confirm and identify trends in psychotropics use in Greece.
Language	English
Publishing date	2024-03-14
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2587355-6
ISSN	1663-9812
ISSN	1663-9812
DOI	10.3389/fphar.2024.1348887
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Article ; Online: Reply to: "Carvedilol in patients with compensated cirrhosis: The ongoing benefits of definitive randomised trials over meta-analysis in patients with small varices".

Villanueva, Càndid / Torres, Ferran / Tripathi, Dhiraj / Bosch, Jaume

Journal of hepatology

2023 Volume 79, Issue 1, Page(s) e23–e24

MeSH term(s)	Humans ; Carvedilol/therapeutic use ; Liver Cirrhosis/complications ; Esophageal and Gastric Varices/etiology ; Varicose Veins ; Longitudinal Studies ; Gastrointestinal Hemorrhage ; Randomized Controlled Trials as Topic
Chemical Substances	Carvedilol (0K47UL67F2)
Language	English
Publishing date	2023-02-25
Publishing country	Netherlands
Document type	Meta-Analysis ; Letter ; Research Support, Non-U.S. Gov't ; Comment
ZDB-ID	605953-3
ISSN	1600-0641 ; 0168-8278
ISSN (online)	1600-0641
ISSN	0168-8278
DOI	10.1016/j.jhep.2023.02.025
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Article: Utilisation of drugs for the treatment of psychiatric diseases in the pediatric population: focus on off-label use.

Pesiou, Stella / Barcelo, Rafel / Fradera, Marc / Torres, Ferran / Pontes, Caridad

Frontiers in pharmacology

2023 Volume 14, Page(s) 1157135

Abstract: Psychotropics are increasingly used in pediatrics, often as off-label medicines. The guarantees of safety and efficacy are not always granted in clinical practice compared to adult authorised indications. A retrospective observational study was done to ... ...

Abstract	Psychotropics are increasingly used in pediatrics, often as off-label medicines. The guarantees of safety and efficacy are not always granted in clinical practice compared to adult authorised indications. A retrospective observational study was done to estimate the prevalence of psychotropic use in pediatric subjects of Catalonia (Spain). Anonymised data on dispensation of psychotropics to pediatric patients, demography and other related data were obtained by the local healthcare management for the period 2008-2017. Estimation of off-label use was done through description of drug dispensations with no authorised use related to age range. The prevalence of psychotropics was 40.8-64.2 per 1,000 pediatric inhabitants. Hydroxyzine-only represented two-thirds of dispensations, and when removed, the prevalence dropped to 26.4-32.2 per 1,000 pediatric inhabitants. Adolescents and boys were more likely to receive a psychotropic. Psychostimulants had the highest exposure rate, mainly due to methylphenidate. Off-label use was observed in 12% of subjects, corresponding to 4.6% of all dispensed psychotropics with boys being more exposed. The proportion of off-label use vs. labelled use was higher in younger populations. Aripiprazole had the highest off-label frequency. Our data support the frequent reality of off-label use in pediatrics, despite the potential underestimation related to the selected off-label definition. There is an urgent need to systematically ascertain effectiveness and any potential adverse events in the off-label pediatric setting, and to generate valuable information for risk-benefit assessment in these populations where extrapolation from adults is not reliable.
Language	English
Publishing date	2023-06-16
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2587355-6
ISSN	1663-9812
ISSN	1663-9812
DOI	10.3389/fphar.2023.1157135
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Article ; Online: Early treatment with inhaled budesonide to prevent clinical deterioration in patients with COVID-19.

Agusti, Alvar / Torres, Ferran / Faner, Rosa

The Lancet. Respiratory medicine

2021 Volume 9, Issue 7, Page(s) 682–683

MeSH term(s)	Administration, Inhalation ; Bronchodilator Agents/therapeutic use ; Budesonide ; COVID-19 ; Clinical Deterioration ; Humans ; SARS-CoV-2
Chemical Substances	Bronchodilator Agents ; Budesonide (51333-22-3)
Language	English
Publishing date	2021-04-09
Publishing country	England
Document type	Journal Article ; Comment
ZDB-ID	2686754-0
ISSN	2213-2619 ; 2213-2600
ISSN (online)	2213-2619
ISSN	2213-2600
DOI	10.1016/S2213-2600(21)00171-5
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Zs.A 7041: Show issues

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Article ; Online: Navigating the landscape of liver cancer management: Study designs in clinical trials and clinical practice.

Cabibbo, Giuseppe / Celsa, Ciro / Rimassa, Lorenza / Torres, Ferran / Rimola, Jordi / Kloeckner, Roman / Bruix, Jordi / Cammà, Calogero / Reig, Maria

Journal of hepatology

2024

Abstract: Hepatocellular carcinoma (HCC) is the fourth leading cause of cancer death worldwide and its prognosis is highly heterogeneous, being related not only to tumour burden but also to the severity of underlying chronic liver disease. Moreover, advances in ... ...

Abstract	Hepatocellular carcinoma (HCC) is the fourth leading cause of cancer death worldwide and its prognosis is highly heterogeneous, being related not only to tumour burden but also to the severity of underlying chronic liver disease. Moreover, advances in systemic therapies for HCC have increased the complexity of patient management. Randomised-controlled trials represent the gold standard for evidence generation across all areas of medicine and especially in the oncology field, as they allow for unbiased estimates of treatment effect without confounders. Observational studies have many problems that could reduce their internal and external validity. However, large prospective (well-conducted) observational real-world studies can detect rare adverse events or monitor the occurrence of long-term adverse events. How best to harness real world data, which refers to data generated from the routine care of patients, and real-world 'evidence', which is the evidence generated from real-world data, represents an open challenge. In this review article, we aim to provide an overview of the benefits and limitations of different study designs, particularly focusing on randomised-controlled trials and observational studies, to address important and not fully resolved questions in HCC research.
Language	English
Publishing date	2024-02-01
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	605953-3
ISSN	1600-0641 ; 0168-8278
ISSN (online)	1600-0641
ISSN	0168-8278
DOI	10.1016/j.jhep.2024.01.018
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Zs.A 2027: Show issues

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Article ; Online: Longitudinal treatment patterns in patients recently diagnosed with type 2 diabetes mellitus in Catalonia.

Ouchi, Dan / Giner-Soriano, Maria / Vilaplana-Carnerero, Carles / Monfa, Ramon / Torres, Ferran / Morros, Rosa

Diabetes research and clinical practice

2023 Volume 202, Page(s) 110777

Abstract: Aim: To investigate initial and subsequent treatments prescribed to newly diagnosed type 2 diabetes mellitus (T2DM) patients.: Methods: Data from SIDIAP (Information System for Research in Primary Care) including all recorded incident T2DM patients ... ...

Abstract	Aim: To investigate initial and subsequent treatments prescribed to newly diagnosed type 2 diabetes mellitus (T2DM) patients. Methods: Data from SIDIAP (Information System for Research in Primary Care) including all recorded incident T2DM patients in primary care between 2015 and 2020. We used descriptive statistics and different graphical techniques to describe the most frequent longitudinal patterns. Results: A total of 86,854 patients were included. 78.3 % of the patients began treatment with a single metformin medication and 21.7 % began with a combination therapy (CT). Metformin was the most frequent treatment as first and third-line therapy, while the CT of metformin with DPP4i or sulfonylurea was more prevalent as second-line. Most common first to third-line pattern was initial metformin for 15 months, adding a second antidiabetic in the second line, staying in CT for 6 months, and switching back to single metformin. Treatment patterns varied depending on HbA1c levels, with higher levels (>8 %) being associated with changes to CT and lower levels with switches to monotherapy or temporary discontinuation. Conclusion: The study described in detail the different treatment patterns in incident T2DM patients in Catalonia, its adherence to the guidelines, and how the changes are associated to the HbA1c dynamics.
MeSH term(s)	Humans ; Diabetes Mellitus, Type 2/diagnosis ; Diabetes Mellitus, Type 2/drug therapy ; Diabetes Mellitus, Type 2/epidemiology ; Glycated Hemoglobin ; Spain/epidemiology ; Drug Therapy, Combination ; Hypoglycemic Agents ; Metformin/adverse effects ; Sulfonylurea Compounds
Chemical Substances	Glycated Hemoglobin ; Hypoglycemic Agents ; Metformin (9100L32L2N) ; Sulfonylurea Compounds
Language	English
Publishing date	2023-06-14
Publishing country	Ireland
Document type	Journal Article
ZDB-ID	632523-3
ISSN	1872-8227 ; 0168-8227
ISSN (online)	1872-8227
ISSN	0168-8227
DOI	10.1016/j.diabres.2023.110777
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Zs.A 2047: Show issues

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Article ; Online: Indolent cancer and pattern of progression: Two missing parameters in trial design for hepatology.

Iavarone, Massimo / Nault, Jean-Charles / Cabibbo, Giuseppe / Torres, Ferran / Reig, Maria

Hepatology (Baltimore, Md.)

2023

Abstract: The indolent and aggressive behaviors of HCC might have a role in clinical trial (CT) results; however, the indolent HCC is less analyzed compared to others cancer. Indolent profile could be characterized as follows: (1) patients with low risk of ... ...

Abstract	The indolent and aggressive behaviors of HCC might have a role in clinical trial (CT) results; however, the indolent HCC is less analyzed compared to others cancer. Indolent profile could be characterized as follows: (1) patients with low risk of progression itself due to the HCC molecular profile and/or due to the interaction between cancer cell their microenvironment; (2) patients who achieve objective response or present spontaneous regression; and (3) patients who develop radiological progression with no consequence on either the liver function or general status, and without trigger a change in the tumor stage. Patients with "indolent HCC" generally never develop cancer-related symptoms neither die for HCC-related causes. Thus, we hypothesize that the imbalance in the proportion of "indolent" versus "aggressive HCC" between arms or the underestimation/overestimation of HCC behavior at baseline in single-arm CT could be associated with CT failure or under-overestimation of trial results. The "indolent progression" may also explain the discrepancy between radiological progression-based end points and survival. Moreover, we discuss the related causes that explain the indolent profile of HCC and propose (1) refining the progression-related end point by the pattern of progression to minimize the limitations of the current end points; (2) considering alternative statistical tools for survival analysis such as milestone survival, or restricted mean survival time to capture the value of indolent HCC. According to these considerations, we propose incorporating novel end points into the single arm of phase I/II CT as exploratory analysis or as a secondary end point in phase III CT.
Language	English
Publishing date	2023-07-03
Publishing country	United States
Document type	Journal Article
ZDB-ID	604603-4
ISSN	1527-3350 ; 0270-9139
ISSN (online)	1527-3350
ISSN	0270-9139
DOI	10.1097/HEP.0000000000000527
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Article: Are Quality of Randomized Clinical Trials and ESMO-Magnitude of Clinical Benefit Scale Two Sides of the Same Coin, to Grade Recommendations for Drug Approval?

Rodriguez, Adela / Esposito, Francis / Oliveres, Helena / Torres, Ferran / Maurel, Joan

Journal of clinical medicine

2021 Volume 10, Issue 4

Abstract: The approval of a new drug for cancer treatment by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) is based on positive, well-designed randomized phase III clinical trials (RCTs). However, not all of them are analyzed to ...

Abstract	The approval of a new drug for cancer treatment by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) is based on positive, well-designed randomized phase III clinical trials (RCTs). However, not all of them are analyzed to support the recommendations. For this reason, there are different scales to quantify and evaluate the quality of RCTs and the magnitude of the clinical benefits of new drugs for treating solid tumors. In this review, we discuss the value of the progression-free survival (PFS) as an endpoint in RCTs and the concordance between it and the overall survival (OS) as a measure of the quality of clinical trial designs. We summarize and analyze the different scales to evaluate the clinical benefits of new drugs such as the The American Society of Clinical Oncology value framework (ASCO-VF-NHB16) and European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) and the concordance between them, focusing on metastatic colorectal cancer (mCRC). We propose several definitions that would help to evaluate the quality of RCT, the magnitude of clinical benefit and the appropriate approval of new drugs in oncology.
Language	English
Publishing date	2021-02-13
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2662592-1
ISSN	2077-0383
ISSN	2077-0383
DOI	10.3390/jcm10040746
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Article: Impact of Second-Line Combination Treatment for Type 2 Diabetes Mellitus on Disease Control: A Population-Based Cohort Study.

Ouchi, Dan / Vilaplana-Carnerero, Carles / Monfà, Ramon / Giner-Soriano, Maria / Garcia-Sangenís, Ana / Torres, Ferran / Morros, Rosa

Drugs - real world outcomes

2023 Volume 10, Issue 3, Page(s) 447–457

Abstract: Background: Type 2 diabetes mellitus is a chronic disease affecting millions of people worldwide. Achieving and maintaining glycemic control is essential to prevent or delay complications and different strategies are available as second-line treatment ... ...

Abstract	Background: Type 2 diabetes mellitus is a chronic disease affecting millions of people worldwide. Achieving and maintaining glycemic control is essential to prevent or delay complications and different strategies are available as second-line treatment options for patients with type 2 diabetes who do not achieve glycemic control with metformin monotherapy. Objective: The aim of this work is to describe the impact of initiating a combination treatment to reduce glycated hemoglobin in patients with type 2 diabetes with insufficient glycemic control. Methods: We included patients with a type 2 diabetes diagnosis between 2015 and 2020 at the Information System for Research in Primary Care (SIDIAP) database in Catalonia, Spain. The primary outcome was the time to glycated hemoglobin control (≤ 7%) during the first 720 days, expressed as the restricted mean survival time. Adjusted differences of the restricted mean survival time were compared to analyze the performance of each treatment versus the combination with a sulfonylurea. Adherence was calculated as the medication possession ratio using an algorithm to model treatment exposure. Results: A total of 28,425 patients were analyzed. The most frequent combinations were those with sulfonylureas and dipeptidyl peptidase-4 inhibitors. All treatments reduced glycated hemoglobin and the restricted mean survival time for the sulfonylurea treatment was 455 (451-459) days although combinations with glucagon-like peptide-1 and insulin reached glycemic control earlier, - 126 days (- 152 to - 100, p < 0.001) and - 69 days (- 88 to - 50, p < 0.001), respectively. Adherence was high in all groups apart from the insulin combination and had a significant effect in reducing glycated hemoglobin except in sodium-glucose cotransporter type 2 inhibitors and insulin. Glucagon-like peptide-1 and sodium-glucose cotransporter type 2 inhibitors showed significant reductions in weight. Conclusions: Patients achieved the glycated hemoglobin goal with second-line treatments. Glucagon-like peptide-1 and insulin combinations achieved the goal earlier than sulfonylurea combinations. Adherence significantly reduced the time to glycated hemoglobin control except for the combination with sodium-glucose cotransporter type 2 inhibitors.
Language	English
Publishing date	2023-05-09
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2806600-5
ISSN	2198-9788 ; 2199-1154
ISSN (online)	2198-9788
ISSN	2199-1154
DOI	10.1007/s40801-023-00374-2
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