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PubMedDate not supplied

Off-label prescribing of drugs in specialty headache practice.

OBJECTIVE: To assess the extent of off-label prescribing in specialty headache practice. METHODS: A prospective record was kept of all prescriptions written during a 30-day period in a tertiary care headache program affiliated with two teaching hospitals. Each drug was categorized as "on-label," defined as approved by the FDA for a headache or general pain indication, and used in accordance with label instructions, or "off-label," defined as any use of a drug not covered in the FDA-approved package insert. RESULTS: A total of 379 prescriptions were written during a 30-day period. One hundred and seventy-eight prescriptions (47%) met the criteria for off-label use. In all, 23 categories of off-label treatment were prescribed during the study, but just 4 accounted for over half of all off-label prescriptions: newer antiepileptic drugs such as topiramate and lamotrigine (each accounted for n = 26, 15% of off-label prescriptions), newer antidepressants, especially venlafaxine (n = 27; 15% of off-label prescriptions), and botulinum toxin type A (n = 13; 7% of off-label prescriptions). Two hundred and one prescriptions met criteria for on-label use. The largest percentages of prescriptions written for approved, on-label indications were for triptans (n = 74; 37% of on-label prescriptions), and nonsteroidal anti-inflammatory drugs (n = 64; 32% of on-label prescriptions). CONCLUSIONS: Off-label prescribing is common in the specialty management of headache conditions. We conclude that it is within the current standard of care, and an integral part of practice, to use off-label medications in the treatment of complex headache conditions.

Adult↗
PubMed2005

The efficacy and safety of venlafaxine in the prophylaxis of migraine.

OBJECTIVE: To evaluate the efficacy and safety of venlafaxine in the prophylaxis of migraine. BACKGROUND: The efficacy of venlafaxine, which is selectively effective on the serotonergic and noradrenergic mechanisms, on various headaches and chronic pain syndromes has been demonstrated. To our knowledge, this is the first placebo-controlled, double-blind, randomized study of two different doses of venlafaxine for migraine treatment. METHODS: In this prospective study, 60 migraine patients without aura were randomly assigned to venlafaxine XR 75 mg, venlafaxine XR 150 mg, or placebo. The frequency of headache attacks, the severity and the duration of attacks, and analgesic use were monitored every 2 weeks for 2 months. Adverse events and patient satisfaction were also evaluated during these visits. At the end of the 2 months, global efficacy and tolerance were investigated. RESULTS: A significant difference was observed between the venlafaxine 150 mg and placebo groups in the number of headache attacks (P= .006). According to patient satisfaction comparisons, the active drug groups were significantly different when compared with placebo (P= .001 at visit 2 and visit 6). When the global efficacy was considered, 80% of patients in the 75-mg group and 88.2% of the patients in the 150-mg group evaluated treatment benefits as either good or very good. CONCLUSIONS: Venlafaxine was more effective than placebo and is safe and well tolerated as migraine prophylaxis.

Adolescent↗
PubMed2002

Mycosporine-2-glycine is the major mycosporine-like amino acid in a unicellular cyanobacterium (Euhalothece sp.) isolated from a gypsum crust in a hypersaline saltern pond.

Mycosporine-like amino acids (MAAs) were extracted from a unicellular cyanobacterium (Euhalothece sp.) isolated from a gypsum crust on the bottom of a hypersaline saltern pond in Eilat, Israel. When grown at high light intensities, this isolate contained high concentrations of two MAAs, one showing maximum optical density at 331 nm and one at 362 nm. The compound absorbing at 331 nm was purified by preparative high performance liquid chromatography, and its structure was elucidated by one-dimensional ((1)H and (13)C) and two-dimensional nuclear magnetic resonance, mass spectrometry and amino acid analysis, and identified as mycosporine-2-glycine. This is the first report of mycosporine-2-glycine in cyanobacteria.

Amino Acids↗
PubMed2006

A broadly applicable method for extraction and characterization of mycosporines and mycosporine-like amino acids of terrestrial, marine and freshwater origin.

A universal method allowing simultaneous extraction and analysis of diverse ultraviolet-B-absorbing compounds belonging to mycosporines and mycosporine-like amino acids (MAAs) is presented. Mycosporines and MAAs are found both in prokaryotes and eukaryotes and possess photoprotective properties. Our method was successfully tested by screening 31 cyanobacterial, 11 actinomycete and 45 fungal strains for their mycosporine and MAA content. The majority of the isolates tested originated from subaerial rock surfaces and were inherently protected from excessive sun irradiation. The new method includes a solid-liquid extraction procedure, followed by a reversed phase liquid chromatography/mass spectrometry. Eight different mycosporines and five MAAs were efficiently separated and identified by their retention times, absorption maxima and fragmentation patterns. Mycosporines were found both in rock-inhabiting fungi and cyanobacteria and consequently may render an ecological marker of these peculiar terrestrial environments.

Actinobacteria↗
PubMed2006

Structure of euhalothece-362, a novel red-shifted mycosporine-like amino acid, from a halophilic cyanobacterium (Euhalothece sp.).

The unicellular cyanobacterium Euhalothece sp. strain LK-1, isolated from a gypsum crust on the bottom of a hypersaline saltern pond in Eilat, Israel, contains high concentrations of two mycosporine-like amino acids with maximum absorbance at 331 and 362 nm when grown at high light intensities. The 331 nm-absorbing compound has previously been identified as mycosporine-2-glycine. Here, we confirm this identification and document the elucidation of the structure of the 362 nm absorbing compound ('euhalothece-362'), using liquid chromatography/mass spectrometry combined with other techniques, as a novel compound, 2-(E)-3-(E)-2,3-dihydroxyprop-1-enylimino-mycosporine-alanine.

Alanine↗
PubMed1997

Designing a new generation of antidepressant drugs.

Although longer-term adaptive changes in receptor sensitivity may better explain the delayed onset of action of antidepressants, the mechanism based on acutely elevated noradrenaline (NA) and serotonin (5-HT) synaptic levels remains the basis for new drug design. The dual action concept, which postulates that effects on both NA and 5-HT are more advantageous than a selective action on serotonin reuptake (SSRI), has been used to design new antidepressants such as venlafaxine and mirtazapine. Both drugs enhance NA and 5-HT neurotransmission with little affinity for receptors mediating tricyclic-like side effects. Mirtazapine, the prototype noradrenergic and specific serotonergic antidepressant (NaSSA), specifically enhances 5-HT1 neurotransmission and blocks 5-HT2 and 5-HT3 receptors, and in contrast to venlafaxine lacks SSRI-like and adverse cardiovascular side effects. The unique pharmacological action of mirtazapine is a result of implementation of two concepts: dual action as a basis of efficacy combined with receptor-specific action as a basis of tolerability.

Adrenergic Uptake Inhibitors↗
PubMed1997

Efficacy of venlafaxine in depressive illness in general practice.

A double-blind, placebo-controlled study of 229 patients with a Research Diagnostic Criteria diagnosis of major, minor or intermittent depression was used to compare the clinical profiles of venlafaxine and imipramine in general practice. Venlafaxine produced a significant improvement compared to placebo in symptoms of depression and anxiety as rated by the total MADRS and percentage of responders, the CGI improvement, the CGI severity of illness, the BSA psychic anxiety item and the HSCL. On a number of these measures, venlafaxine was also significantly more effective than imipramine. Venlafaxine was significantly superior to both imipramine and placebo for the SARS total score and the items 'social/leisure' and 'extended family.' A similar proportion of patients discontinued treatment in each group, but fewer patients on venlafaxine discontinued treatment because of an unsatisfactory response.

Adult↗
PubMed1994

Effects of odorants on pigment aggregation and cAMP in fish melanophores.

Odor perception within olfactory neuroepithelium and pigment translocation within melanophores both seem to rely on a cAMP-based second messenger system. From studies on cultured frog melanophores, Lerner et al. (Proc. Natl. Acad. Sci. USA 85:261-264, 1988) suggested that some aspect of odor perception may be mediated by a nonspecific mechanism whose signal is transduced by a cAMP-based second messenger system. In the present study, odorants (beta-ionone, benzylaldehyde, cineole, cinnamaldehyde, and octanol), which previously have been shown to stimulate formation of cAMP in the olfactory neuroepithelium, were investigated for possible pigment dispersing and cAMP-increasing effects. Pretreatment of fish melanophores with the adenylate cyclase activator forskolin (1 microM) resulted in an approximately 300% increase in cAMP and an almost complete blockage of noradrenaline-induced pigment aggregation. However, none of the tested odorants were able to increase the cAMP level and only cinnaldehyde and beta-ionone were found to have any pigment dispersing activity.

1-Octanol↗
PubMed2005

Open-field behavioural alterations in liver-impaired and sham-operated rats after acute exposure to the antidepressant venlafaxine.

Patients with chronic liver impairment often display symptoms of affective psychiatric nature where the choice for antidepressant treatment is rational. Since caution is recommended when these drugs are used in such patients, a dose reduction is usually performed. We have previously reported that a dose reduction to liver-impaired portacaval shunted rats has resulted in similar brain concentrations of venlafaxine as compared to sham-operated control rats that received a two times higher dose. The main aim of the present study was therefore to investigate if this "normalisation" in pharmacokinetics of the portacaval-shunted rats also was true for the pharmacodynamic response in terms of drug effect on spontaneous open-field behaviour. Thus, portacaval-shunted rats received a single reduced dose (5 mg/kg) of venlafaxine or saline, whereas sham-operated rats received either 10 mg/kg or saline. Thereafter, central and peripheral arena locomotor and rearing activities were recorded during 60 min. The venlafaxine-treated portacaval-shunted and sham rats displayed reduced and unchanged overall behavioural activities compared with corresponding controls, respectively. However, the ratios between centrally and peripherally performed behavioural activities were higher in the venlafaxine-treated sham rats, indicating an increase in central arena activity as compared to the sham-saline and portacaval-shunted rats. The present study indicates that, despite a 50% dose reduction, caution still is necessary when antidepressants are used in liver insufficient subjects. This study also shows the importance of detailed open-field behavioural studies in which both central and peripheral activities are recorded for measurement of open-field behavioural drug effects.

Animals↗
PubMed1989

An in vitro comparison of the single cone and lateral condensation techniques using 'friction-fitted' and 'solvent dip-fitted' primary gutta-percha cones.

Extracted teeth, root-filled by single cone and lateral condensation techniques, using friction fitted and solvent (chloroform and eucalyptol) dip-fitted primary gutta-percha cones, were compared with respect to apical sealing as measured by length of dye penetration and frequency of no dye penetration. Overall, the single cone techniques were significantly more effective than lateral condensation techniques regarding length of dye penetration. The single cone techniques were not significantly different from the lateral condensation technique which employed chloroform dip-fitted primary gutta-percha cones regarding length of dye penetration. The single cone and lateral condensation techniques which utilized chloroform dip-fitted cones ranked first and second with respect to frequency of no dye penetration.

Chloroform↗