One of the challenges with initiating long-acting injectable (LAI) antipsychotic regimens is achieving relevant drug levels quickly. After first injection of the LAI antipsychotic aripiprazole lauroxil (AL), the lag to reaching relevant plasma aripiprazole levels was initially addressed using supplemental oral aripiprazole for 21 days. A 1-day AL initiation regimen using a NanoCrystal® Dispersion formulation of AL (ALNCD; Aristada Initio®) combined with a single 30 mg dose of oral aripiprazole has been developed as an alternative approach. We compared the 1-day AL initiation regimen (ALNCD + 30 mg oral aripiprazole for 1 day) with the 21-day AL initiation regimen (AL + 15 mg/day of oral aripiprazole for 21 days) using kinetic modeling. Observed and modeled data demonstrate that the 1-day AL initiation regimen provides continuous aripiprazole exposure comparable to the 21-day AL initiation regimen. Each component of the 1-day AL initiation regimen (30 mg oral aripiprazole, ALNCD, and AL) contributes to aripiprazole plasma levels at different times, with oral aripiprazole predominating in the first week, then ALNCD and AL over time. In a double-blind, placebo-controlled, phase 1 study in patients with schizophrenia, the 1-day initiation regimen resulted in rapid achievement of relevant plasma aripiprazole levels comparable to those from the 21-day initiation regimen. Safety and tolerability of the 1-day regimen were consistent with the known profile of aripiprazole. Each part of the 1-day initiation regimen, together with AL, is necessary for continuous aripiprazole exposure from treatment initiation until the next regularly scheduled AL injection is administered.

Despite a marked increase in the prescription of oral nutritional supplements (ONS) in the community (Department of Health, 1991–7), there is still uncertainty about the value of their use in patients with different diseases. To answer questions about the effects on ONS on body weight and structure, spontaneous food intake and body function, a critical systematic review was undertaken (Stratton & Elia, 1999a). Eighty-four trials were reviewed (forty-five randomized, thirty-nine non-randomized; 2570 patients; diagnoses including chronic obstructive pulmonary disease, Crohn’s disease, cystic fibrosis, human immunodeficiency virus and acquired immune deficiency syndrome and cancer). Most studies (83 %) were conducted in patients living at home. The supplements were typically mixed macronutrients in liquid form, providing < 0.42–10.5 MJ/d for 1 week–2 years. The studies reviewed in patients with predominantly chronic conditions living in the community suggested that: (1) ONS produce demonstrable clinical (including functional) benefits, but the nature and extent of these benefits varies with the underlying chronic condition; (2) ONS increase total energy intake with > 50 % of the energy from ONS typically additional to that from habitual food intake; (3) improvements in body weight, total energy intake and body function following ONS appear to occur more frequently in individuals with a BMI < 20 kg/m2 than in those with a BMI > 20 kg/m2.