CNS‐related performance and haemodynamics of metoprolol‐Oros and propranolol after single and 3 days dosing in healthy volunteers.

Steveninck, A. L. Van; Pieters, M. S. M.; Schoemaker, Rik C.; Breimer, D. D.; Cohen, Adam F.

doi:10.1111/j.1365-2125.1993.tb05676.x

Cited by 3 publications

(2 citation statements)

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“…Physiological Data Heart rate and systolic and diastolic blood pressure were assessed using the Task Force Monitor™ [32] while the participant exercised on a bicycle ergometer. At least 1 day before drug administration, an individual workload (W) for each participant was estimated, on which a target heart rate of 150 bpm was obtained [24]. The exercise tests were conducted immediately before drug intake (pre) and 2 h after (post) drug intake.…”

Section: Methodsmentioning

confidence: 99%

“…A possible solution could be to describe them as what they are: sensations that indicate the onset of the beneficial drug effect. In our study, an active antihypertensive agent, metoprolol, was chosen to implement this paradigm as a proof of principle in healthy participants for the following reasons: antihypertensive drugs reliably induce perceptible physiological changes in healthy participants [24,25], antihypertensive intake is associated with a relatively high rate of side effects [16,26], and antihypertensive drugs induce various benign and transient side effects that can be used for the framing paradigm [27].…”

Section: Introductionmentioning

confidence: 99%

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Decreasing the Burden of Side Effects Through Positive Message Framing: an Experimental Proof-of-Concept Study

2018

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Decreasing the Burden of Side Effects Through Positive Message Framing: an Experimental Proof-of-Concept Study

2018

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Effects of a new slow release formulation of caffeine on EEG, psychomotor and cognitive functions in sleep-deprived subjects

Patat¹,

Rosenzweig²,

Enslen

et al. 2000

Hum. Psychopharmacol. Clin. Exp.

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Caffeine is a widely-consumed psychoactive substance whose stimulant effects on mood, attention and performance are largely recognised. The central nervous system pharmacodynamic profile of a single oral dose of a new slow release (SR) caffeine formulation (600 mg) was assessed in a randomised, double-blind, crossover, placebo-controlled study. Twelve young, health, male, sleep-deprived (for 36 h) subjects were studied using EEG and various measures of psychomotor and cognitive functions, including critical flicker fusion (CFF), choice reaction task (CRT), tracking, continuous performance task (CPT), Stroop test, body sway and subjective evaluation (Stanford Sleepiness Scale). Caffeine significantly ( < 0/05) antagonised the detrimental effects of sleep-deprivation on EEG (i.e. produced a significant decrease in delta and theta relative power and a significant increase in alpha and beta (12-40 Hz) relative power) and psychomotor performance (significant increase in speed of reaction on the CRT and Stroop tests, significant decrease in body sway, significant increase in accuracy of the CPT and significant reduction in subjective sedation) compared to placebo. The effect peaked 4 h after dosing and was maintained until the end of sleep deprivation (i.e. 24 h after dosing). In conclusion, the present results demonstrate that a single dose of caffeine SR possesses alerting effects which are able to reverse the deleterious effect of 36 h sleep deprivation for at least 24 h. Copyright 2000 John Wiley & Sons, Ltd.

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Novel Oral Drug Formulations

Florence

Jani

1994

Drug Safety

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The rationale for specialised oral formulations of drugs include prolongation of effect for increased patient convenience and reduction of adverse effects through lowered peak plasma concentrations. Local and systemic adverse effects due to high concentrations of drug can be minimised by the use of controlled release delivery systems. Local effects in the gastrointestinal (GI) tract from the release of irritant drug molecules can also be reduced, but the gastric damage caused by nonsteroidal anti-inflammatory drugs (NSAIDs) is only partially relieved by formulation approaches because of the involvement of systemic factors in the aetiology of GI adverse events. The advantages for each drug class must be examined. Newer dosage forms include: (i) osmotic pumps and zero order kinetics systems to control the release rate of the drug; (ii) bioadhesive systems and gastric retention devices to control GI transit; (iii) bioerodible hydrogels; (iv) molecular carrier systems (e.g. cyclodextrin-encapsulated drugs) to modulate local toxicity in the GI tract; (v) externally activated systems; and (vi) colloidal systems such as liposomes and microspheres. There is evidence for improved tolerability for a variety of drugs administered in novel delivery systems. However, the evidence for improved tolerability is complicated by the potential bias in adverse reaction reporting systems, and a lack of studies directly comparing conventional and modified release preparations. The technology now available to produce delivery systems which not only release drugs in a controlled and predetermined fashion, but which can also target to regions of the GI tract such as the colon, should allow greater control of therapy and potentially might minimise patient variables. However, the problem of variable GI transit times still eludes solution. Systems which rely on time to release drug might be more vulnerable to patient-to-patient variability than those which respond to local environments. The effect of food intake is more apparent on single-unit, nondisintegrating dosage forms, although of course none so far are immune from influence. The risk of new adverse effects resulting from such positional therapy with novel delivery devices must be considered. Understanding the mechanisms of induction of individual adverse effects can lead to advances in modes of delivery to decrease the potential for adverse reactions and events while maintaining therapeutic efficacy. Increased compliance can led to increased therapeutic control and hence safety. Each system has to be considered on its merits. No generalisations can be made, although invariably the modulation of high peak plasma concentrations diminishes adverse effects due to rapid absorption.

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CNS‐related performance and haemodynamics of metoprolol‐Oros and propranolol after single and 3 days dosing in healthy volunteers.

Cited by 3 publications

References 26 publications

Decreasing the Burden of Side Effects Through Positive Message Framing: an Experimental Proof-of-Concept Study

Decreasing the Burden of Side Effects Through Positive Message Framing: an Experimental Proof-of-Concept Study

Effects of a new slow release formulation of caffeine on EEG, psychomotor and cognitive functions in sleep-deprived subjects

Novel Oral Drug Formulations

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