Clinical drug investigation
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Review Meta Analysis
Umeclidinium Plus Vilanterol Versus Placebo, Umeclidinium, or Vilanterol Monotherapies for Chronic Obstructive Pulmonary Disease: A Meta-Analysis of Randomized Controlled Trials.
The role of umeclidinium plus vilanterol as a combination therapy for chronic obstructive pulmonary disease (COPD) has not yet been clearly defined. ⋯ Compared with the other three groups, i.e. placebo, umeclidinium and vilanterol, umeclidinium plus vilanterol improves lung function and quality of life in patients with COPD, reduces the use of albuterol, and does not increase the incidence of adverse events and serious adverse events.
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Hydrocodone bitartrate extended-release (Hysingla® ER; referred to hereafter as hydrocodone ER) was the first single-entity hydrocodone formulation recognized by the US FDA as having abuse-deterrent properties. It is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Once-daily oral hydrocodone ER provides consistent plasma hydrocodone concentrations and sustained analgesia over the 24-h dosing interval. ⋯ Hydrocodone ER was generally well tolerated, with a safety profile consistent with that seen with other μ-opioid analgesics. However, like other opioids, it is associated with risks of addiction, abuse/misuse and serious adverse events (AEs), including respiratory depression, withdrawal, physical dependence and overdose. Although large postmarketing studies are needed to determine whether the abuse-deterrent properties of hydrocodone ER result in meaningful reductions in abuse, misuse and related adverse clinical outcomes, current evidence indicates that hydrocodone ER is a useful treatment option for patients with chronic pain.
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Randomized Controlled Trial
Exposure-Efficacy Analyses of Ombitasvir, Paritaprevir/Ritonavir with Dasabuvir ± Ribavirin in HCV Genotype 1-Infected Patients.
The three-direct-acting antiviral (DAA) combination regimen of ombitasvir, paritaprevir (coadministered with ritonavir [paritaprevir/ritonavir], and dasabuvir (the 3D regimen) ± ribavirin for treatment of HCV genotype 1-infected patients demonstrated efficacy and safety in Phase II and Phase III clinical trials. The relationships between the steady-state exposure (area under the concentration-time curve at steady state and trough concentration at steady state) of the three DAAs and ribavirin with sustained virologic response at 12 weeks after treatment (SVR12) following administration of the 3D regimen in six Phase II/III studies were examined. ⋯ The results of these analyses indicate that the doses selected for the 3D regimen were optimal, achieving high SVR12 rates across the range of exposures observed in the Phase III studies.
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Type 2 diabetes mellitus (T2DM) is a chronic progressive disease that has been spread worldwide over the past three decades and associated with increased morbidity and mortality resulting in considerable socioeconomic implications for national healthcare systems. Effective management of disease is highly needed ensuring patients receive the best possible care within the available budget. The objective of this study was to evaluate the long-term cost-effectiveness of dapagliflozin, a sodium-glucose co-transporter-2 (SGLT-2) inhibitor, compared with a sulfonylurea (SU) or a dipeptidyl-peptidase-4 inhibitor (DPP-4i), when added to metformin, in T2DM patients inadequately controlled on metformin alone in Greece. ⋯ Dapagliflozin in combination with metformin was shown to be a cost-effective treatment alternative for patients with T2DM whose metformin regimen does not provide sufficient glycemic control in a Greek healthcare setting.
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Observational Study
Cost-Effectiveness Analysis of Omalizumab for the Treatment of Severe Persistent Asthma in Real Clinical Practice in Spain.
Omalizumab is a humanized monoclonal antibody that targets circulating immunoglobulin E molecules to treat severe uncontrolled asthma. The aim of this study was to determine the cost effectiveness of omalizumab compared with standard treatment for the control of severe persistent asthma according to data from patients treated in a specialized asthma unit. ⋯ The results of this study confirm the effectiveness of the addition of omalizumab to standard therapy in patients with uncontrolled severe persistent asthma.