Feb 192014
 
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Rivaroxaban: A Review of Its Use in Acute Coronary Syndromes.

Drugs. 2014 Feb 18;

Authors: Plosker GL

Abstract
Rivaroxaban (Xarelto(®)) is an orally administered highly selective direct inhibitor of factor Xa that has been approved in many countries to reduce the risk of stroke in patients with atrial fibrillation and for the treatment and prevention of venous thromboembolism. More recently, rivaroxaban at a low dosage of 2.5 mg twice daily, co-administered with aspirin alone or aspirin plus either clopidogrel or ticlopidine, was approved for use in the EU for patients with a recent acute coronary syndrome (ACS). The approval of rivaroxaban in ACS was primarily based on findings of the phase III ATLAS ACS 2-TIMI 51 trial, which showed that after a median of 13.1 months of treatment with rivaroxaban 2.5 mg twice daily (combined with aspirin or aspirin plus either clopidogrel or ticlopidine) there was a statistically significant reduction in the rate of the primary composite endpoint, which was death from cardiovascular causes, myocardial infarction or stroke, compared with placebo. Rivaroxaban 2.5 mg twice daily was also associated with a reduction in all-cause and cardiovascular mortality. There was an increase in the risk of major bleeding and intracranial haemorrhage with rivaroxaban 2.5 mg twice daily compared with placebo; however, there was no increase in the risk of fatal bleeding. Aspirin plus either ticagrelor or prasugrel was not evaluated as background dual antiplatelet therapy in ATLAS ACS 2-TIMI 51 and the safety implications of rivaroxaban used in combination with such therapy are unknown. In conclusion, results of the ATLAS ACS 2-TIMI 51 trial suggest a potentially important role for rivaroxaban 2.5 mg twice daily co-administered with aspirin alone or aspirin plus either clopidogrel or ticlopidine in patients with a recent ACS.

PMID: 24535922 [PubMed - as supplied by publisher]

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Feb 182014
 
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Steroid Use in Crohn's Disease.

Drugs. 2014 Feb 15;

Authors: Vavricka SR, Schoepfer AM, Scharl M, Rogler G

Abstract
The incidence and prevalence of Crohn's disease are increasing, particularly in the Western world and Asia. Corticosteroids have been used for decades to treat active Crohn's disease and remain the mainstay in the management of moderate-to-severe relapses in Crohn's disease. The use of corticosteroids, despite their efficacy, may be associated with several drawbacks. This review article provides a comprehensive account of the role of corticosteroids in inducing remission in adult patients with Crohn's disease, including aspects such as approaches to corticosteroid sparing and to minimize the risk of corticosteroid dependency, as well as the role of newer corticosteroids such as budesonide in reducing systemic adverse effects.

PMID: 24532122 [PubMed - as supplied by publisher]

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Feb 112014
 
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Colistimethate Sodium Dry Powder for Inhalation: A Review of Its Use in the Treatment of Chronic Pseudomonas aeruginosa Infection in Patients with Cystic Fibrosis.

Drugs. 2014 Feb 8;

Authors: Conole D, Keating GM

Abstract
Historically, the polymyxin antibacterial colistin has been administered as intravenous or nebulized colistimethate sodium in patients with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa infection. More recently, colistimethate sodium has been formulated as a dry powder (Colobreathe(®)) to be administered via a hand-held Turbospin(®) inhaler. Compared with nebulized colistimethate sodium, the colistimethate sodium dry powder for inhalation (DPI) formulation reduces treatment time and improves patient convenience. Colistimethate sodium DPI is approved in the EU for the treatment of chronic P. aeruginosa infections in patients with CF aged ≥6 years. In a phase III clinical trial in this patient population, it was determined that the change in percent predicted forced expiratory volume in 1 s with colistimethate sodium DPI 1.6625 MIU (125 mg) twice daily was noninferior to that with nebulized tobramycin 300 mg/5 mL twice daily. Moreover, patients found colistimethate sodium DPI easier to use than nebulized tobramycin. Colistimethate sodium DPI was generally well tolerated, with a similar adverse event profile to that of nebulized tobramycin, except for a numerically higher incidence of cough and abnormal taste. Most adverse events diminished after 28 days in patients receiving colistimethate sodium DPI, with an occurrence similar to that in nebulized tobramycin recipients. In conclusion, colistimethate sodium DPI administered via the Turbospin® inhaler is a useful option for the treatment of chronic P. aeruginosa infection in patients with CF aged ≥6 years.

PMID: 24510624 [PubMed - as supplied by publisher]

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Jan 162014
 
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Sitagliptin: A Review of Its Use in Patients with Type 2 Diabetes Mellitus.

Drugs. 2014 Jan 10;

Authors: Plosker GL

Abstract
Sitagliptin (Januvia(®), Xelevia™, Glactiv(®), Tesavel(®)) is an orally administered, potent and highly selective inhibitor of dipeptidyl peptidase-4 (DPP-4) and was the first agent of its class to be approved for use in the management of adults with type 2 diabetes. Numerous randomized placebo- or active comparator-controlled trials have demonstrated the efficacy of sitagliptin in terms of improving glycaemic control in patients with type 2 diabetes, including its use as monotherapy, initial combination therapy (usually with fixed-dose combinations of sitagliptin/metformin), or add-on therapy to metformin or to other antihyperglycaemic drugs, with or without metformin. The primary endpoint of the clinical trials was the reduction from baseline in glycosylated haemoglobin (HbA1c), although sitagliptin also showed beneficial effects for other endpoints, such as the proportion of patients who achieved target HbA1c, and reductions from baseline in fasting plasma glucose (FPG) levels and 2-h postprandial glucose (PPG) levels. Sitagliptin was generally well tolerated in clinical trials, had a low risk of hypoglycaemia (although this depends on background therapy) and had a neutral effect on body weight. Despite concerns regarding a possible increased risk of rare pancreatic adverse events (e.g. pancreatitis) with glucagon-like peptide-1 (GLP-1)-based therapies, such as GLP-1 receptor agonists and DPP-4 inhibitors, no causal association has been found; regulators in Europe recently conducted a review of available data, concluding that there is little evidence that these drugs could cause pancreatic inflammation or pancreatic cancer. A similar review is planned in the USA and postmarketing surveillance will continue. Thus, oral sitagliptin is an effective and generally well tolerated treatment option for the management of patients with type 2 diabetes.

PMID: 24407560 [PubMed - as supplied by publisher]

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Dec 032013
 
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Linaclotide: A Review of Its Use in the Treatment of Irritable Bowel Syndrome with Constipation.

Drugs. 2013 Nov 29;

Authors: McCormack PL

Abstract
Linaclotide (Constella(®)) is a synthetic 14-amino acid peptide, structurally related to guanylin and uroguanylin, that acts as a potent guanylate cyclase C receptor agonist. It is a first-in-class agent recently approved in the EU for the treatment of adult patients with moderate to severe irritable bowel syndrome with constipation (IBS-C). Linaclotide has very low oral bioavailability and acts locally in the gastrointestinal tract to stimulate fluid secretion, increase colonic transit, and reduce abdominal pain. In phase III trials, once-daily, oral linaclotide significantly increased compared with placebo the proportions of 12-week abdominal pain/discomfort responders and 12-week degree-of-relief responders (co-primary endpoints recommended by the European Medicines Agency). Linaclotide also significantly increased the proportions of responders at 26 weeks compared with placebo, and significantly improved all abdominal symptoms and measures of bowel function at 12 weeks compared with placebo. In addition, linaclotide generally improved health-related quality of life compared with placebo. Linaclotide was generally well tolerated; the most common adverse event was diarrhoea. Thus, linaclotide is a novel and effective single agent for the treatment of IBS-C in adults.

PMID: 24293117 [PubMed - as supplied by publisher]

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Nov 202013
 
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Eculizumab: A Review of Its Use in Atypical Haemolytic Uraemic Syndrome.

Drugs. 2013 Nov 19;

Authors: Keating GM

Abstract
The recombinant humanized monoclonal antibody eculizumab (Soliris(®)) is a complement inhibitor that is indicated for use in the treatment of atypical haemolytic uraemic syndrome (aHUS). This article reviews the clinical efficacy and tolerability of eculizumab in the treatment of patients with aHUS, as well as summarizing its pharmacological properties. Intravenous eculizumab inhibited complement-mediated thrombotic microangiopathy in patients aged ≥12 years with aHUS, according to the results of two noncomparative, multinational, 26-week, phase II trials. At 26 weeks, the platelet count was significantly increased in patients with progressing thrombotic microangiopathy despite plasma exchange/infusion, and thrombotic microangiopathic event-free status was achieved in 80 % of patients with a long disease duration and chronic kidney disease who received long-term plasma exchange/infusion. Renal function and health-related quality of life also improved with eculizumab therapy in both studies. Outcomes were maintained or further improved throughout 2 years of follow-up. Eculizumab was also effective in adult and paediatric patients with aHUS, according to the results of additional prospective or retrospective trials. Intravenous eculizumab was generally well tolerated in patients with aHUS. Eculizumab is associated with an increased susceptibility to meningococcal infection, so patients should be immunized with meningococcal vaccine. In conclusion, eculizumab is a valuable new agent for use in the treatment of aHUS.

PMID: 24249647 [PubMed - as supplied by publisher]

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