Search

Background/Objectives: Pasireotide (PAS) is a somatostatin receptor ligand (SRL) used to treat acromegaly, a chronic condition caused by excess growth hormone. While it offers significant benefits as a second-line treatment for uncontrolled acromegaly, its use raises major concerns due to hyperglycemic side effects and gastrointestinal issues, the latter being similar to those seen with first-generation SRLs. The aim of this study is to evaluate the real-world evidence on adverse drug reactions (ADRs) reported for PAS in the EudraVigilance database, in comparison to other established drug-based therapies for acromegaly. Methods: A descriptive analysis and a disproportionality analysis were conducted. Results: The fewest individual case safety reports (ICSRs) and adverse drug reactions (ADRs) were reported for PAS, with 698 (4%) ICSRs and 1,647 (4%) ADRs, which is even lower than for pegvisomant (PEG), which had 1765 (11%) ICSRs and 4842 (10%) ADRs. Both PAS and lanreotide (LAN) exhibited the lowest proportion of cases classified as serious. Among the total reported ADRs, those categorized as "Metabolic and nutrition disorders" were most frequent and severe for PAS (PAS—17.5% vs. OCT—4.6%, LAN—4.5%, and PEG—2.7%). Additionally, PAS demonstrated a higher likelihood of reporting endocrine disorders, which were frequently classified as serious, as well as stones affecting the hepatobiliary system compared to other drugs. Conclusions: Although PAS had the fewest ICSRs and ADRs, and less frequent serious ADRs, it had more reports frequently classified as serious in the "Metabolism and Nutrition Disorders" category (including events such as elevated blood glucose levels or diabetes) and "Endocrine Disorders" category compared to other SRLs and PEG. Furthermore, there was a higher likelihood of reporting hepatobiliary stones with PAS compared to OCT and PEG. This highlights the importance of adequately monitoring glycemic control and the biliary tract through ultrasound at the initiation and during follow-up of PAS therapy. Improved monitoring and reporting of these ADRs could enhance care for patients with acromegaly. [ABSTRACT FROM AUTHOR]

Insulin is essential for treating type 1 diabetes and insulin-requiring type 2 diabetes. Background/Objectives: Diabetes is a widespread condition that can lead to multiple and severe complications. Rapid-acting insulin analogs (RAIAs) and long-acting insulin analogs are prescribed for the effective management of diabetes. RAIAs are expected to be associated with a higher number of dosing errors because of their rapid onset, short duration of action, and the need for frequent dosing, compared to other insulin analogs. There are three approved RAIAs on the market: insulin lispro (LIS), insulin aspart (ASP), and insulin glulisine (GLU). The aim of this study is to evaluate the real-world evidence on dosing errors reported for RAIAs in EudraVigilance (EV), an established pharmacovigilance database, in comparison to other insulin analogs and human insulins. Methods: A descriptive analysis and a disproportionality analysis were conducted. Results: ASP and LIS were associated with high percentages of adverse drug reactions (ADRs) (22% and 17%, respectively), with over 70% of the reports involving serious ADRs. A higher frequency of cardiac and eye disorder ADRs was observed for LIS compared with ASP and GLU. GLU showed a higher frequency of ADRs in the skin and subcutaneous tissue disorders category. LIS dosing errors accounted for 5% of the total number of cases, while dosing errors for ASP and GLU were less than 3%. The most frequently reported dosing errors involved improper dosing (49%). Conclusions: Although there were fewer dosing errors of RAIAs in comparison to other insulins, the severity of the potential outcome highlights the importance of precise dosing and timing. Improved the monitoring and reporting of these dosing errors could enhance diabetes patient care. Additionally, smart medical devices could improve therapeutic outcomes. [ABSTRACT FROM AUTHOR]

Some glucagon-like peptide-1 receptor agonists (GLP-1 RAs), first used in the treatment of type 2 diabetes mellitus (T2DM), have been approved for the treatment of obesity in patients with or without T2DM (liraglutide—LIR, semaglutide—SEM, and tirzepatide—TIR). Social media had an important influence on the off-label use of GLP-1 RAs for obesity, especially for SEM. We analyzed the Google queries related to SEM to assess people's interest in this drug. We also investigated the occurrence of adverse drug reactions (ADRs) by searching the EudraVigilance database (EV) for Individual Case Safety Reports (ICSRs) that reported SEM as the suspected drug and performed a descriptive and a disproportionality analysis. The data obtained for SEM were compared to other GLP-1 RAs. SEM had the highest proportions of searches on Google associated with the term "weight loss" and presented the lowest number of severe ADRs, but it also had the highest number of ICSRs reported in EV. Even though no unexpected safety issues have been reported for it until now, SEM has a hi3gh tendency for overdose reports. The most frequent off-label use was reported for SEM and TIR. In order to lower the risks of ADRs, the off-label use should be reduced and carefully monitored. [ABSTRACT FROM AUTHOR]

Trastuzumab (T) and tyrosine kinase inhibitors (TKIs) are among the first-line treatments recommended for HER2-positive breast cancer. More recently, antibody-drug conjugates (ADCs) such as trastuzumab deruxtecan (T-DXd) and trastuzumab emtansine (T-DM1) have been authorized, and they represent the second-line therapy in this type of cancer. The present study aimed to evaluate adverse drug reactions (ADRs) associated with T-based ADCs that were spontaneously reported in EudraVigilance—the European pharmacovigilance database. Out of 42,272 ADRs reported for currently approved ADCs on the market, 24% of ADRs were related to T-DM1, while 12% of ADRs were related to T-DXd. T-DM1 had a higher probability of reporting eye, ear and labyrinth, and cardiac and hepatobiliary ADRs, while T-DXd had a higher probability of reporting respiratory, thoracic and mediastinal, blood and lymphatic system, metabolism and nutrition, and gastrointestinal ADRs. The present research found that in terms of hematological disorders, T-DM1 and T-DXd had a higher probability of reporting ADRs than TKIs. Moreover, the data showed that T-DM1 seemed to have a higher risk of cardiotoxicity than T-DXd, while T-DXd had a higher probability of reporting metabolism and nutrition disorders than T-DM1. [ABSTRACT FROM AUTHOR]

Introduction Diabetes is increasing worldwide at an alarming rate. The prevalence of type 2 diabetes is increasing, and diabetes is a strong adverse prognostic factor among patients with cardiovascular (CV) [...], Diabetes is a chronic metabolic disease with a high prevalence worldwide. Diabetes and insulin resistance are associated with the development of cardiovascular and nervous diseases. The development of these disorders reflects complex pathological processes in which the oxidative stress caused by reactive oxygen species (ROS) and reactive nitrogen species (RNS) plays a pivotal role. It is widely accepted that diabetes impairs endothelial nitric oxide synthase (eNOS) activity and increases the production of ROS, thus resulting in diminished NO bioavailability and increased oxidative stress. Alpha-lipoic acid (LA) possesses beneficial effects both in the prevention and in the treatment of diabetes. LA is a potent antioxidant with insulin-mimetic and anti-inflammatory activity. LA in the diet is quickly absorbed, transported to the intracellular compartments, and reduced to dihydrolipoic acid (DHLA) under the action of enzymes. LA, which plays an essential role in mitochondrial bioenergetic reactions, has drawn considerable attention as an antioxidant for use in managing diabetic complications such as retinopathy, neuropathy and other vascular diseases. Key words: lipoic acid, antioxidant, diabetes, metabolism, prevention, treatment. Le diabete est un desordre metabolique chronique avec une prevalence elevee a travers le monde. Cette pathologie et la resistance a l'insuline sont associees au developpement d'atteintes cardiovasculaires et nerveuses. Le developpement de ces atteintes reflete des processus pathologiques complexes mettant en jeu un stress oxydatif qui joue un role majeur en impliquant les especes radicalaires oxygenees (ERO) et nitro-oxygenees (ERN). Il est generalement admis que le diabete modifie l'activite des oxyde nitrique synthases endotheliales (eNOS), conduisant a une diminution de la biodisponibilite du NO et une augmentation du stress oxydatif. L'acide alpha-lipoique (AL) possede des effets benefiques dans la prevention et le traitement du diabete. AL est un antioxydant puissant pourvu d'activites insulino-mimetiques et anti-inflammatoires. AL present dans la nourriture est rapidement absorbe, transporte dans les compartiments intracellulaires et reduit en acide dihydrolipoique (ADHL) sous l'effet d'enzymes. AL qui joue un role essentiel dans les reactions bioenergetiques mitochondriales, suscite beaucoup d'attention comme antioxydant dans la prise en charge des complications liees au diabete telles que les retinopathies, les neuropathies et les autres atteintes vasculaires. Mots-cles : acide lipoique, antioxydant, diabetes, metabolisme, prevention, traitement.

Copyright of Farmacia is the property of Societatea de Stiinte Farmaceutice Romania and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Canadian Journal of Physiology & Pharmacology is the property of Canadian Science Publishing and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

During 2004-2006 anti-diabetic drug delivery was done through centralized procedure, national auction just through hospital pharmacies. Starting with October 1st, 2006, their delivery has decentralized through community pharmacies. The present study was carried out through 100 questionnaires in pharmacies in 6 counties from the North-Western part of Romania. The study shows that both urban and rural pharmacies delivery both oral anti-diabetic drugs and insulin's. Aspects such as: preferred distributors, time of delivery, the most requested products, collaboration between physicians and pharmacists, pharmacists' grievances, communication with patients etc have been identified. [ABSTRACT FROM AUTHOR]

The increased prevalence of diabetes mellitus, mainly of the non-insulin dependent has brought about more sales of oral anti-diabetic drugs. Starting from the sales in the interval 2004-2007, we tried to make a medium term estimate of sales for the period 2008-2010. The software Statgraphics Plus and the index method have been used. Results show that the best sold medicines for the interval in question were Siofor (Berlin Chemie), Amaryl (Sanofi-Aventis), Diaprel (Servier) and Glibomet (Berlin Chemie), and the same products are supposed to increase in sales in the interval 2008-2010. [ABSTRACT FROM AUTHOR]

Hypoxialischemia and reperfusion is associated to increased production of reactive oxygen species, hence the attempts to use antioxidants compounds in order to combat their deleterious effects. The aim of this study was to evaluate the antioxidant effects of a red grape seed extract in experimental hypobaric hypoxia. Rats were divided in 4 groups: 1 control group and 3 groups exposed for 24 hours to hypobaric hypoxia 5500 m simulated altitude. One of these groups was given grape seed extract before exposure and one group was given immediately after exposure. Oxidative stress parameters and antioxidant enzymes were measured in both plasma and brain homogenate. We found that hypobaric hypoxia exposure inhibits the activity of superoxide dismutase and catalase in brain and increases oxidative stress parameters. Polyphenols do not seem to influence the activity of antioxidant enzymes in the brain. [ABSTRACT FROM AUTHOR]

Diabetes mellitus is a pathology with multiple and severe implications. Its prevalence has been continuously increasing during the last years, as well as the number of drugs introduced in its therapy. The value of the antidiabetics global market was evaluated at over 18 billion USD in 2005. The following five international producers hold the biggest share: NovoNordisk, Takeda, Sanofi-Aventis, GlaxoSmithkline and Eli Lilly. The two bestselling drugs in the USA in 2008 were Actos and Lantus, two products of latest generation, which, however, seems to be a global tendency. As far as the OAD (Oral Antidiabetic Drug) category is concerned, the products to be prescribed in the following years will be those of latest generation, such as thiazolidinedione, GLP-1 analogues, DPP-4 inhibitors, as well as their fixed combinations with metformine. Rapid or slow acting Insulin analogues and their combinations with isophane insulins replace the classic insulins which seem to be outdated. [ABSTRACT FROM AUTHOR]