Brexpiprazole for schizophrenia Background: Brexpiprazole (proposed proprietary name “Rexulti”) is a new molecular entity atypical antipsychotic co-developed by Otsuka Pharmaceutical Co, Ltd (Otsuka) and H. Lundbeck A/S (Lundbeck). The mechanism of action is unknown. Methods: The FDA site was searched to locate relevant documents.  If these were not sufficient then EPARs from the European Medicines Agency were to be used.  Relevant data was extracted and … Continue reading Example rapid review: Brexpiprazole for schizophrenia v2

Over the past week I’ve been working on a new method of rapid reviews, one based on FDA regulatory documents [1, 2, 3].  In pursuing the reviews and their development I had a conversation with Kamal Mahtani (Deputy Director of the Centre for Evidence-Based Medicine) who asked if the FDA documents contained the data to undertake a meta-analysis.  Great question!  But I had no idea as I’ve … Continue reading Another piece in the puzzle

Inspired by Erick Turner I wrote these two rapid reviews based on FDA reports: Brexpiprazole for schizophrenia Empagliflozin in Type 2 Diabetes I produced these reviews, not to claim perfection but to familiarise myself with the type of content and to try to see what a report might look like.  After I’d finished them I sent the links to Erick who, very generously, supplied some … Continue reading Example rapid review: Feedback from Erick Turner

The second rapid review produced using regulatory data, the first being Brexpiprazole for schizophrenia. Empagliflozin in Type 2 Diabetes Background: Empagliflozin is a reversible, potent and selective competitive inhibitor of sodium-glucose co-transporter 2 (SGLT2). SGLT2 is highly expressed in the kidney (proximal tubules) where it is responsible for 90% of glucose reabsorption from the glomerular filtrate back into the circulation. Inhibition of SGLT2 reduces renal … Continue reading Example rapid review: Empagliflozin in Type 2 Diabetes

After a great conversation with Erick Turner yesterday I thought I would make an attempt at a rapid review.  Erick wrote the seminal paper Selective publication of antidepressant trials and its influence on apparent efficacy.  In this paper Erick used FDA regulatory documents to highlight significant discrepancies between reviews based on published journal articles and regulator data.  Nothing I’ve seen makes me think that reviews … Continue reading Example rapid review: Brexpiprazole for schizophrenia