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Full-length recombinant human parathyroid hormone [rhPTH (1–84); Natpara®] is approved in the USA as an adjunct to calcium and vitamin D therapy for control of hypocalcaemia in patients with hypoparathyroidism. This article reviews the clinical efficacy and tolerability of rhPTH (1–84) in hypoparathyroidism and summarizes its pharmacological properties. In a pivotal phase III trial, subcutaneous rhPTH (1–84)...
Intravenous dalbavancin (Dalvance™; Xydalba™) is approved for use in adult patients with acute bacterial skin and skin structure infections (ABSSSI), with the recommended regimen being a 1000 mg dose followed 1 week later by a 500 mg dose. In the multinational DISCOVER 1 and 2 trials in adult patients with ABSSSI, dalbavancin treatment was noninferior to vancomycin (for ≥3 days with an option to switch...
Eluxadoline (Viberzi™), developed by Actavis (now Allergan), is an orally administered, first-in-class compound that functions as both a µ-opioid receptor agonist and a δ-opioid receptor antagonist, and is indicated for the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D) in adults. The agent was originally developed by Janssen Pharmaceutica. Eluxadoline has been approved in the...
Recently, a significant number of additional key medications have become licensed in Europe for the treatment of patients with cystic fibrosis (CF), including a number of inhaled antibiotics, such as nebulised aztreonam and dry powder versions of colistin and tobramycin for inhalation; dry powder inhaled mannitol, an agent to improve airway hydration and aid airway clearance; and ivacaftor, an oral...
Aflibercept is a recombinant fusion protein that acts as a soluble decoy receptor for vascular endothelial growth factor (VEGF), a key regulator of angiogenesis. It binds to all isoforms of VEGF-A as well as VEGF-B and placental growth factor, and, thus, prevents them from binding to and activating their cognate receptors. In the USA and EU, intravenously administered aflibercept in combination with...
The prevalence of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) is increasing world-wide in parallel to the increase of the obesity epidemic. Insulin resistance (IR) and the accumulation of triglyceride-derived toxic lipid metabolites play a key role in its pathogenesis. Multiple biomarkers are being evaluated for the non-invasive diagnosis of NASH. However, a...
Nebivolol is a highly selective β1-adrenergic receptor antagonist with a pharmacologic profile that differs from those of other drugs in its class. In addition to cardioselectivity mediated via β1 receptor blockade, nebivolol induces nitric oxide-mediated vasodilation by stimulating endothelial nitric oxide synthase via β3 agonism. This vasodilatory mechanism is distinct from those of other vasodilatory...
Apremilast (Otezla®) is an oral phosphodiesterase 4 inhibitor indicated for the twice-daily treatment of adults with psoriasis and psoriatic arthritis (PsA). Its use in these patient populations has been assessed in two phase III clinical trial programmes (ESTEEM and PALACE). At 16 weeks in the two ESTEEM trials, apremilast reduced the severity and extent of moderate to severe plaque psoriasis, including...
Imatinib is strongly positioned as the recommended first-line agent for most patients with advanced gastrointestinal stromal tumor (GIST) due to its good efficacy and tolerability. Imatinib-resistant advanced GIST continues to pose a therapeutic challenge, likely due to the frequent presence of multiple mutations that confer drug resistance. Sunitinib and regorafenib are approved as second- and third-line...
Collagenase Clostridium Histolyticum (CCH) (Xiaflex®, Xiapex®) intralesional injection is a mixture of class I (AUX-I) and class II (AUX-II) clostridial collagenases. It is indicated for the treatment of adult men with Peyronie’s disease with a palpable plaque and curvature deformity of ≥30° at the start of therapy. This article reviews the efficacy and tolerability of CCH in this indication and briefly...
Cangrelor (Kengrexal®, Kengreal™) is an intravenously administered P2Y12 receptor inhibitor. It is direct-acting and reversible, with a very rapid onset and offset of action. The randomized, double-blind, multinational, phase III CHAMPION PHOENIX trial compared the efficacy of intravenous cangrelor with that of oral clopidogrel in patients requiring percutaneous coronary intervention (PCI) for stable...
Endocrine therapy is a key component of adjuvant treatment for premenopausal patients with endocrine-responsive tumors. It is commonly well tolerated, although side effects are a main concern in the selection of treatment options. Tamoxifen is still considered an adequate endocrine therapy in a large group of premenopausal patients (e.g. lower-risk patient, presence of co-morbidities, patient preference)...
Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) such as gefitinib, erlotinib, and afatinib are standard-of-care for first-line treatment of EGFR-mutant advanced non-small cell lung cancer (NSCLC). These drugs have a proven benefit in terms of higher response rate, delaying progression and improvement of quality of life over palliative platinum-based chemotherapy. The most...
An improved understanding of cancer genetics and immune regulatory pathways, including those associated with evasion of immune surveillance by tumours, has culminated in the development of several targeted therapies. One such strategy that acts to negate evasion of immune surveillance by tumours is inhibition of the programmed cell death receptor-1 (PD-1) checkpoint pathway. Intravenous nivolumab...
Radiation-induced hemorrhagic cystitis (HC) is a complication of pelvic radiotherapy, mainly for prostate and uterine cancers. In the acute phase, patients feel urinary urgency and bladder pain. This phase is reversible after radiotherapy. In the chronic stage, an irritative syndrome is coupled with hematuria during the 2–10 years following radiotherapy. Cystoscopy shows white and frosted mucosa with...
Status epilepticus (SE) represents the most severe form of epilepsy. It is one of the most common neurologic emergencies, with an incidence of up to 61 per 100,000 per year and an estimated mortality of 20 %. Clinically, tonic-clonic convulsive SE is divided into four subsequent stages: early, established, refractory, and super-refractory. Pharmacotherapy of status epilepticus, especially of its later...
Empagliflozin/linagliptin (Glyxambi®) is a once-daily sodium glucose co-transporter type 2 (SGLT2) inhibitor and dipeptidyl peptidase (DPP)-4 inhibitor fixed-dose combination product that is approved in the USA as an adjunct to diet and exercise in adults with type 2 diabetes (T2D) when treatment with both empagliflozin and linagliptin is appropriate. This article reviews the clinical efficacy and...
Resistance to antiretroviral drugs is an increasingly prevalent challenge affecting both the adult and pediatric HIV-infected populations. Though data on the safety, pharmacokinetics, and efficacy of newer antiretroviral agents in children typically lags behind adult data, newer agents are becoming available for use in HIV-infected children who are failing to respond to or are experiencing toxicities...
Evolocumab (Repatha™) is a fully human monoclonal antibody developed by Amgen that has been approved as a treatment for hypercholesterolaemia in the EU, and is awaiting approval in the USA and Japan. It specifically binds proprotein convertase subtilisin/kexin type 9 (PCSK9)—a negative regulator of low-density lipoprotein (LDL)-receptors—thereby improving the ability of the liver to bind LDL-cholesterol...
Despite effective antiretroviral therapy (ART) and undetectable HIV RNA in the plasma, latent replication-competent HIV persists indefinitely in long-lived cells. Cessation of ART results in rebound of HIV from these persistent reservoirs. While this was thought to be an insurmountable obstacle to viral eradication, recent cases suggest otherwise. To date one patient has been “cured” of HIV and several...
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