How well do randomized controlled trial data generalize to 'real-world' clinical practice settings? A comparison of two generalized anxiety disorder studies.

The aim of this post-hoc comparison is to compare efficacy and tolerability results from two generalized anxiety disorder (GAD) studies: a placebo-controlled, randomized controlled trial (RCT) and a study conducted in the clinical practice setting, and to evaluate the extent to which results from RCTs in GAD patients can be generalized to clinical practice. In the clinical practice study, GAD outpatients (n=578) were treated with 4 weeks of pregabalin 150-600mg/day. In the double-blind placebo-controlled RCT, GAD outpatients (n=249) were randomized to 8 weeks of pregabalin (300-600mg/day), or placebo (only the first 4 weeks are included in the current analysis).

The best next drug in the course of generalized anxiety disorders: the "PN-GAD-algorithm".

Objective: Today, there are many pharmacotherapeutic options for generalized anxiety disorder (GAD). The question is, which is the best medication for a particular patient at a particular moment? This is especially challenging because GAD is by definition a chronic disorder and new interventions should learn from earlier experiences. An algorithm which can help to use pretreatment information for drug selection is the "Pretreatment - Next Treatment (PN) - Algorithm".

Efficacy and safety of pregabalin in patients with diabetic peripheral neuropathy or postherpetic neuralgia: Open-label, non-comparative, flexible-dose study.

We assessed the efficacy and safety of a flexible-dose pregabalin regimen in patients with diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN) under clinical practice conditions. Further, the trial investigated the correlation of unspecific measures of change (patient and physician global impression of change, PGIC and CGIC) and specific measures of morbidity. The primary outcomes of this prospective, open-label, non-controlled study were the correlation between global status (PGIC and CGIC) and changes in pain, sleep, and anxiety scores as assessed on numerical or visual rating scales.