Expert review of clinical pharmacology
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The role of psychosocial context around patient and therapy can be studied through randomized clinical trials. The analysis of the results of clinical trials, and considering the adverse events (AEs) in the placebo groups, provides an important perspective of study for this phenomenon. In double-blind, randomized clinical trials, the side effects reported in placebo-treated groups are not associated with pharmacological treatment, but other factors should be taken into account to explain these symptoms. ⋯ The authors depicted nocebo effects in antidepressant placebos similar to the AE profiles of the real drugs, which they were matched with. These key findings contrast with the belief that nocebo effects were simply nonspecific. Moreover, they emphasize the need to develop standardized procedures for collecting information about AEs in randomized, double-blind, placebo-controlled trials determining drug efficacy.
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Expert Rev Clin Pharmacol · Jan 2015
EditorialPrediction of treatment outcomes in major depressive disorder.
Improving the treatment of major depressive disorder will require identification of moderators that predict differential outcomes across treatments at the level of the individual patient, referred to as precision medicine. Currently, there are no biological measures demonstrated to enhance treatment selection accuracy although there are some clinical variables that have prognostic value. ⋯ Genetic combination tests, systemic inflammation, electroencephalography and neuroimaging, in particular, show significant potential for near-term development as clinically meaningful moderators for use in treatment selection. Ultimately, combinations of moderators may provide the greatest level of precision in selecting optimal treatment approaches for individual depressed patients.
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Expert Rev Clin Pharmacol · Jan 2015
ReviewFentanyl buccal tablet for the treatment of cancer-related breakthrough pain.
Fentanyl buccal tablet (FBT) (FENTORA) is indicated for the management of breakthrough pain (BTP) in patients with cancer pain and who are tolerant to ≥60 mg of oral morphine equivalents, at least with the current availability of the minimal strength of 100 μg. FBT uses the OraVescent technology to further increase the rate and extent of absorption of fentanyl. ⋯ It has been recommended that administration should be tailored to the patient's individual requirement, through dose titration starting from the lowest dose to find the effective dose. However, recent studies have demonstrated that predictable doses calculated from the basal opioid regimen are safe and more effective than doses achieved after dose titration.
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Expert Rev Clin Pharmacol · Jan 2015
ReviewUsing real-world healthcare data for pharmacovigilance signal detection - the experience of the EU-ADR project.
A prospective pharmacovigilance signal detection study, comparing the real-world healthcare data (EU-ADR) and two spontaneous reporting system (SRS) databases, US FDA's Adverse Event Reporting System and WHO's Vigibase is reported. The study compared drug safety signals found in the EU-ADR and SRS databases. ⋯ The EU-ADR system may have a greater potential for detecting signals for events occurring at higher frequency in general population and those that are commonly not considered as potentially a drug-induced event. Factors influencing various differences between the datasets are discussed along with potential limitations and applications to pharmacovigilance practice.
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Expert Rev Clin Pharmacol · Jan 2015
ReviewDabrafenib in combination with trametinib for the treatment of metastatic melanoma.
Oncogenic BRAF mutations are present in approximately 40-50% of patients with metastatic melanoma. Targeting BRAF mutations with either small molecule inhibitors of BRAF or one of the downstream mediators of oncogenic BRAF - MEK - is associated with improved outcomes compared with chemotherapy and has led to the US FDA approval of two BRAF inhibitors - vemurafenib and dabrafenib - and the MEK inhibitor trametinib. Further, the combination of dabrafenib and trametinib is well tolerated and associated with higher responses and improved survival compared with single-agent BRAF inhibitors.