Drugs & Therapy Perspectives

Blair, Hannah A.

doi: 10.1007/s40267-024-01084-7pmid: N/A

Several oral disease-modifying therapies (DMTs) have been approved for the treatment of relapsing multiple sclerosis (MS), including diroximel fumarate, ponesimod and teriflunomide. Oral DMTs are more convenient than other MS therapies that require infusions or injections. This Adis Summary of Research reports the findings of matching-adjusted indirect comparisons of diroximel fumarate versus ponesimod and diroximel fumarate versus teriflunomide in patients with relapsing MS.

France, Nicole L.; Shirley, Matt

doi: 10.1007/s40267-024-01098-1pmid: N/A

Bexagliflozin (Brenzavvy®), the fifth sodium-glucose transport 2 (SGLT2) inhibitor to be approved in the USA, is a useful option to consider for the treatment of type 2 diabetes mellitus (T2DM). Developed to be more affordable than existing SGLT2 inhibitors, bexagliflozin is indicated in the USA for use as an adjunct to diet and exercise to improve glycemic control in adults with T2DM. It is taken orally once daily in the morning, with or without food. Data from randomized, double-blind, placebo-controlled phase 3 clinical trials show that bexagliflozin significantly improves glycemic control when used as monotherapy and in combination with other antidiabetic medications in adults with inadequately controlled T2DM, including in patients with moderate kidney impairment or at increased risk of cardiovascular events. Noninferiority to sitagliptin, glimepiride (titrated up to a maximum dose of 6 mg), and dapagliflozin in improving glycemic control was also demonstrated in phase 3 trials. Bexagliflozin is generally well tolerated, with a tolerability and safety profile consistent with that of other SGLT2 inhibitors.

Fung, Simon; Syed, Yahiya Y.

doi: 10.1007/s40267-024-01094-5pmid: N/A

Sovateltide (TyvalziTM), a first-in-class selective endothelin B receptor agonist, is a valuable new therapy for the treatment of cerebral ischaemic stroke. It promotes neurovascular remodelling, increases cerebral blood flow, has anti-apoptotic activity, protects neural mitochondria, and enhances mitochondrial biogenesis. In a randomized, placebo-controlled phase 3 study in patients with cerebral ischaemic stroke, the addition of sovateltide within 24 h of symptom onset to standard of care treatment provided statistically significant and clinically meaningful improvement in neurological outcomes 90 days post-randomization. Additionally, sovateltide was generally well tolerated.

Kim, Esther S.; Fung, Simon

doi: 10.1007/s40267-024-01087-4pmid: N/A

The diagnosis and management of orofacial pain can be challenging, especially when pain of non-odontogenic origin mimics dental pain or is localised intraorally. There is a risk of misdiagnosis as well as unnecessary dental procedures of the supposedly affected tooth or area. Therefore, orofacial pain management should start with referral to an orofacial pain specialist trained to recognise and manage the vast array of disorders that fall under the umbrella of orofacial pain. The choice of pharmacological treatment (e.g. analgesics, anticonvulsants, antidepressants) can vary widely depending on the specific type of orofacial pain.

Hoy, Sheridan M.

doi: 10.1007/s40267-024-01082-9pmid: N/A

Uterine fibroids are the most common gynaecological tumour in women of reproductive age and can cause heavy menstrual bleeding, anaemia, pelvic pain, bowel and bladder dysfunction, and infertility. While treatment options can be pharmacological, procedural or surgical, an individualized management approach is recommended. The choice of treatment depends on several factors, including the woman’s age, symptoms, preferences and reproductive goals, and the location, number and size of the fibroids. Pharmacological therapies often aim to manage heavy menstrual bleeding or bulk symptoms, with the hormonal dependence of uterine fibroids the mechanism by which most of them act.

Ingurgio, Alyssa

doi: 10.1007/s40267-024-01089-2pmid: N/A

Atopic dermatitis, often referred to as eczema, is classified as a chronic inflammatory skin disorder with increasing prevalence. Topical corticosteroids (TCSs) have remained the first-line treatment for atopic dermatitis for more than 50 years. They are available in a range of potencies and are minimally invasive, generally tolerable, inexpensive, and effective for short courses of treatment (<4 weeks). However, because atopic dermatitis is chronic, patients commonly use TCSs on a near-daily basis for extended periods. This review aimed to evaluate current information regarding the safety, tolerability, efficacy, disease and treatment trajectory, adherence, and patient perspective of long-term TCS use for atopic dermatitis. One recognized the effect of long-term use, TCS tachyphylaxis, is particularly concerning. Because uncontrolled atopic dermatitis can have serious complications, tachyphylaxis often perpetuates TCS treatment escalations. Despite the use of high-potency formulas, disease control remains difficult to maintain, which presents a second alarming effect: the rebound sequelae of TCS discontinuation, frequently described as topical steroid withdrawal (TSW). This review places special attention on TSW, particularly the syndrome’s definition, prognostic factors, physical symptoms and presentations, onset location and histologic features, secondary outcomes, resolution, and patient response.

Laroche, Marie-Laure; Guillaumin, Michel; Grau, Muriel; Vettoretti, Lucie; Valnet-Rabier, Marie-Blanche

doi: 10.1007/s40267-024-01090-9pmid: N/A

IntroductionDrug regulatory agencies are particularly interested in pharmacovigilance data relating to medication errors (MEs) involving a product-related cause (problems with drug names, packaging, labels, tablet marking, modalities of drug use, or instructions for users), an educational failure, or a ‘never event’. Older adults are particularly affected by MEs but little is known about the root causes of MEs, which could be a focus for regulatory agencies.ObjectiveThe aim of this study was to describe and characterise MEs associated or not associated with adverse reactions that have occurred in older adults and fall under the scope of drug regulatory agencies.MethodA retrospective and descriptive analysis of pharmacovigilance data from the French Pharmacovigilance Network was performed. All ME reports, with or without adverse effects (AEs), which occurred from 1 September 2019 to 31 August 2020 and involved adults aged 75 years and over were analysed. We conducted a globally descriptive analysis of MEs, in particular on root causes in the scope of drug regulatory agencies (i.e. product-related cause, educational failure, ‘never events’).ResultsDuring the study period, 802 MEs were reported to the French pharmacovigilance system; 305 (38.0%) were associated with AEs (of which 171 [56.1%] were serious and 13 [4.3%] were fatal). The mean age of patients was 85.2 years and 493 (61.5%) were females. Globally, 224 (27.9%) of MEs had at least one root cause in the scope of the regulatory agencies and were more frequently observed in cases of MEs with AEs compared with those without (174 [57.1%] vs. 46 [9.2%]). The first root cause was an educational problem (159, 71%), followed by ‘never events’ (94, 42%) and product-related causes (20, 9%). MEs due to problems in the scope of regulatory agencies occurred more frequently at the administration and prescription stages and consisted of a wrong drug, wrong dose, and dosage/concentration.ConclusionsIn the older population, the proportion of MEs for which a drug regulatory agency could act is high, confirming the importance of reporting MEs to pharmacovigilance in order to implement risk reduction measures. The ignorance of medication use was the first reason for errors, and actions taken by the health authorities should focus on producing visible and understandable instructions for healthcare professionals and patients. It is also necessary to collaborate closely with the manufacturers to improve packaging, labelling and product nomenclature to completely safeguard the use of their products.