Current medical research and opinion
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Randomized Controlled Trial
An anchored simulated treatment comparison of uptitration of amlodipine compared with a low-dose combination treatment with amlodipine 5 mg/bisoprolol 5 mg for patients with hypertension suboptimally controlled by amlodipine 5 mg monotherapy.
To compare changes in systolic and diastolic blood pressures (SBP, DBP) from baseline to following 8 weeks of treatment with a low dose combination of amlodipine 5 mg plus bisoprolol 5 mg versus up titration to the maximum daily dose of amlodipine 10 mg, in hypertensive patients uncontrolled by amlodipine 5 mg. ⋯ In this indirect comparison, a more important decrease was observed in DBP with the low-dose combination as compared to the alternative therapeutic approach of up-titration from amlodipine 5 mg to amlodipine 10 mg. No meaningful difference was seen for SBP.
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Randomized Controlled Trial
Relationship between baseline clinical characteristics and efficacy of lusutrombopag in thrombocytopenic patients with chronic liver disease: post hoc analysis of two placebo-controlled Phase 3 trials.
Lusutrombopag is a thrombopoietin receptor agonist approved to treat thrombocytopenia in patients with chronic liver disease (CLD). This post hoc analysis of the Japanese L-PLUS 1 and global L-PLUS 2 trials aimed to clarify factors related to platelet count increase after lusutrombopag treatment. ⋯ This post hoc analysis revealed a possible association between baseline WBC count and platelet count increase after lusutrombopag treatment. WBC count could be a relevant factor for lusutrombopag efficacy.
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Randomized Controlled Trial Multicenter Study
Efficacy and safety of valsartan in children aged 1-5 years with hypertension, with or without chronic kidney disease: a randomized, double-blind study followed by open-label phase.
To assess the dose-response relationship for reduction in mean systolic blood pressure (MSBP) with valsartan solution, in young children with hypertension with or without chronic kidney disease (CKD). ⋯ Valsartan was efficacious and well tolerated in children 1 to 5 years of age with hypertension, with or without CKD. Clinical trial registration: The study has been registered at ClinicalTrials.gov (Identifier: NCT01617681).
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Randomized Controlled Trial
Duration and onset of effect of incobotulinumtoxina for the treatment of blepharospasm in botulinum toxin-naïve subjects.
Blepharospasm is a focal dystonia whereby excessive eyelid muscle contractions cause involuntary eye closure. Botulinum neurotoxin type A (BoNT-A) injections are an approved treatment. This randomized placebo-controlled trial (NCT01896895; EudraCT number 2012-004821-26) assessed the efficacy, safety, and treatment effect duration of incobotulinumtoxinA (Xeomin, Merz Pharmaceuticals GmbH), a BoNT-A formulation without complexing proteins, in BoNT-A-naïve adults with blepharospasm. ⋯ Subjects reported an effect onset from 5 days after injection lasting up to 20 weeks (maximum observation period). Data indicate that incobotulinumtoxinA re-treatment of blepharospasm may not be required at fixed 12-week intervals and provide evidence for a patient-tailored approach.
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Randomized Controlled Trial Observational Study
Effectiveness and tolerability of the thyme/ivy herbal fluid extract BNO 1200 for the treatment of acute cough: an observational pharmacy-based study.
Efficacy and safety of an oral thyme/ivy syrup for the treatment of acute cough was previously demonstrated in a randomized clinical trial. Here, we present real-life data from a pharmacy-based, observational study on the effectiveness and tolerability of another thyme/ivy combination (BNO 1200, Bronchipret drops). ⋯ Patients with acute cough taking BNO 1200 had a significant reduction in BSS, cough severity and improvement in HRQoL confirming RCT data with the syrup formulation. BNO 1200 was well tolerated.