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PubMed1988

Sigma 1 protein of mammalian reoviruses extends from the surfaces of viral particles.

Electron microscopy revealed structures consisting of long fibers topped with knobs extending from the surfaces of virions of mammalian reoviruses. The morphology of these structures was reminiscent of the fiber protein of adenovirus. Fibers were also seen extending from the reovirus top component and intermediate subviral particles but not from cores, suggesting that the fibers consist of either the mu 1C or sigma 1 outer capsid protein. Amino acid sequence analysis predicts that the reovirus cell attachment protein sigma 1 contains an extended fiber domain (R. Bassel-Duby, A. Jayasuriya, D. Chatterjee, N. Sonenberg, J. V. Maizell, Jr., and B. N. Fields, Nature [London] 315:421-423, 1985). When sigma 1 protein was released from viral particles with mild heat and subsequently obtained in isolation, it was found to have a morphology identical to that of the fiber structures seen extending from the viral particles. The identification of an extended form of sigma 1 has important implications for its function in cell attachment. Other evidence suggests that sigma 1 protein may occur in virions in both an extended and an unextended state.

Amino Acid Sequence↗

PubMed2004

Glycine-extended gastrin promotes the growth of lung cancer.

The less processed forms of gastrin have recently been shown to act as trophic factors for both normal and malignant colonic cells. Although incompletely processed forms of gastrin such as glycine-extended gastrin and progastrin are also expressed in human lung cancers, the clinical significance of this expression has not been addressed. Consequently, we investigated the effects of overexpression of glycine-extended gastrin in a mouse strain that is prone to developing lung cancer and also examined the expression of incompletely processed gastrins in primary human lung cancers. We found that transgenic overexpression of glycine-extended gastrin in FVB/N mice resulted in a significant increase in the prevalence and growth of bronchoalveolar carcinoma. In addition, a substantial subset of human lung cancers was found to express progastrin and/or glycine-extended gastrin. Overexpression of glycine-extended gastrin by human lung cancers was associated with a significantly decreased survival. Taken together, these results suggest that glycine-extended gastrin may play a role in the growth and progression of some human lung cancers.

Adenocarcinoma↗

PubMed1996

Metabolism and influence of glycine-extended gastrin on gastric acid secretion in man.

Glycine-extracted gastrins are the immediate precursors of the bioactive carboxyamidated gastrins. The effect on gastric acid secretion and the pharmacokinetics of glycine-extended gastrin-17 were studied in 8 normal subjects. The elimination in plasma after bolus injection was biexponential, the half-lives being 4.1 +/- 0.2 and 21.8 +/- 0.9 min, and clearance and apparent volume of distribution being 7.9 +/- 0.6 ml/kg/min and 69.5 +/- 2.7 ml/kg, respectively. Infusion of the peptide at three consecutive dose rates did not stimulate gastric acid secretion, although plasma concentrations reached supraphysiological levels. Nor did glycine-extended gastrin-17 influence submaximal acid secretion induced by amidated gastrin-17. In contrast to amidated gastrins, the concentration of glycine-extended gastrins in peripheral venous plasma did not increase significantly after a meal. The postprandial rise in amidated gastrin was unaffected by concomitant infusion of glycine-extended gastrin-17. A reduction in glycine-extended gastrin-17 concentrations in plasma during constant-rate infusion of the peptide was observed after a protein meal (p < 0.05). This reduction was reflected by an increase in glycine-extended gastrin-17 is without immediate effect on gastric output in man. The postprandial increase in clearance might be due to increased splanchnic blood flow with subsequently increased peptide elimination.

Adult↗

PubMed1993

Glucagon adsorption on polymer surfaces with alpha-helical and extended beta-strand conformations: a computational approach.

The adsorption of glucagon with alpha-helical and extended beta-strand conformations on polymer surfaces was investigated using a computer simulation approach. An X-ray crystallographic structure of glucagon was employed in the study of the alpha-helical glucagon adsorption. The X-ray structure was then modified to simulate an extended beta-strand structure in the study of the beta-strand glucagon adsorption. Totally, 1632 different adsorption orientations of glucagon with each conformation were examined on polystyrene, polypropylene, polyethylene, poly(hydroxyethyl methacrylate) and poly(vinyl alcohol) surfaces. The calculation of the average adsorption energies among different orientations did not reveal any marked difference between the two conformations. However, when the lowest-energy orientations were compared, the adsorption energy of the extended beta-strand glucagon was always much lower than that of the alpha-helical glucagon, indicating that the adsorption of extended beta-strand glucagon was more energy favorable. The lower adsorption energy for the extended beta-strand glucagon than for the alpha-helical glucagon appeared to be contributed by the lower interaction potential energy of the former conformation. A greater number of the surface atoms in the extended beta-strand glucagon than in the alpha-helical glucagon was also observed. Fourier transform infrared spectroscopic (FTIR) studies in the literature showed conformational changes in adsorption of various larger proteins. Our study appears to provide a theoretical insight for the results from the FTIR studies.

Adsorption↗

PubMed2004

Extended nortriptyline and psychological treatment for cigarette smoking.

OBJECTIVE: Accepted treatments for cigarette smoking rarely achieve abstinence rates of >35% at 1 year. Low rates may reflect failure to provide extended and multifocal treatment for this complex and chronic addiction. Using a chronic disease model of smoking, the authors undertook a study to determine the effects of long-term antidepressant and psychological treatment. METHOD: One hundred sixty smokers of > or =10 cigarettes/day were randomly assigned to one of four treatment conditions in a two-by-two (nortriptyline versus placebo by brief versus extended treatment) design. All subjects received 8 weeks of a transdermal nicotine patch, five group counseling sessions, and active or placebo treatment. Interventions for subjects in brief treatment ended at this point. Subjects in extended treatment continued taking drug or placebo to week 52 and received an additional 9 monthly counseling sessions, with checkup telephone calls midway through each session. Subjects were assessed at baseline and weeks 12, 24, 36, and 52. The principal outcome variables were repeated abstinence at each assessment after the first over a 1-year period and a point prevalence of 7 days of abstinence. RESULTS: At week 52, point-prevalence abstinence rates with missing subjects imputed as smokers were 30% for placebo brief treatment, 42% for placebo extended treatment, 18% for active brief treatment, and 50% for active extended treatment. With missing subjects omitted, these rates were 32%, 57%, 21%, and 56%, respectively. CONCLUSIONS: Comprehensive extended treatments that combine drug and psychological interventions can produce consistent abstinence rates that are substantially higher than those in the literature.

Administration, Cutaneous↗

PubMed2002

A randomized trial of divalproex sodium extended-release tablets in migraine prophylaxis.

OBJECTIVE: To evaluate the efficacy and safety of extended-release divalproex sodium compared with placebo in prophylactic monotherapy treatment of migraine headache. METHODS: This was a double-blind, randomized, placebo-controlled, parallel-group study. Subjects with more than two migraine headache attacks during a 4-week baseline were randomly assigned in a 1:1 ratio at each center to receive either extended-release divalproex sodium or matching placebo once daily for 12 weeks. Subjects initiated treatment on 500 mg once daily for 1 week, and the dose was then increased to 1,000 mg once daily with an option, if intolerance occurred, to permanently decrease the dose to 500 mg during the second week. Reduction from baseline in 4-week migraine headache rate was the primary efficacy variable. Migraine headaches separated by a < 24-hour headache-free interval were counted as single migraines in calculating migraine headache rates. Tolerance and safety were also evaluated. RESULTS: The mean reductions in 4-week migraine headache rate were 1.2 (from a baseline mean of 4.4) in the extended-release divalproex sodium group and 0.6 (from a baseline mean of 4.2) in the placebo group (p = 0.006); reductions with extended-release divalproex sodium were significantly greater than with placebo in all three 4-week segments of the treatment period. No significant differences were detected between treatment groups in either the overall incidence or in the incidence of any specific treatment-emergent adverse event; 8% of subjects treated with extended-release divalproex sodium and 9% of those treated with placebo discontinued for adverse events. CONCLUSION: Extended-release divalproex sodium is an efficacious, well-tolerated, safe, and easy-to-use once-a-day prophylactic antimigraine medication.

Adolescent↗

PubMed2006

The extended retrosigmoid approach: an alternative to radical cranial base approaches for posterior fossa lesions.

OBJECTIVE: The extended retrosigmoid approach is presented as a simple and safe modification of the traditional retrosigmoid approach, with increased exposure resulting from a limited mastoidectomy and skeletonization of the sigmoid sinus. METHODS: Patients with posterior fossa vascular lesions treated with the extended retrosigmoid approach between 1997 and 2003 were reviewed. A detailed description of the surgical approach, as well as case illustrations, is provided. We present a video narrated by the senior author in which a description of the technique is offered. RESULTS: Thirty-eight patients underwent this approach to manage 40 lesions, including 15 dural arteriovenous fistulae, 9 arteriovenous malformations, 10 cavernous malformations, and 6 aneurysms. The extended retrosigmoid approach differs from the traditional approach with its C-shaped skin incision, posterior mastoidectomy, and extensive dissection of the sigmoid sinus, craniotomy rather than craniectomy, and anterior mobilization of the sinus with the dural flap. CONCLUSION: The application of the extended retrosigmoid approach to a series of complex lesions in the posterior fossa demonstrates its applicability as an alternative to radical cranial base approaches. The extended retrosigmoid approach requires a fundamental change in the management of the sigmoid sinus. The neurosurgeon must be familiar with petrous bone anatomy, experienced dissecting through bone using a high-speed drill, and comfortable working directly over a major venous sinus. The technical modifications of the extended retrosigmoid approach can be incorporated into the neurosurgical repertoire and will enhance exposure of the cerebellopontine angle and deep vascular structures, thereby minimizing the need for brain retraction and other transpetrous approaches.

Adult↗

PubMed2006

Enhanced freezability of goat spermatozoa collected into tubes containing extender supplemented with bovine serum albumin (BSA).

The purpose of this study was to investigate the effects of semen collection into tubes containing extender supplemented with BSA on the cryosurvival of goat spermatozoa. Semen was collected from two goats into empty tubes or tubes containing 10 ml extender supplemented with 0, 0.1, 1, or 5% BSA, and the washed spermatozoa were frozen as pellets in egg yolk-trehalose extender with the addition of 0.04% SDS and 4% glycerol. Sperm motion parameters were evaluated after post-thawing and during a thermal resistance test. The acrosome status of frozen-thawed spermatozoa was also observed using FITC-PNA staining. In frozen semen that was collected into tubes containing extender supplemented with 5% BSA, the post-thawed spermatozoa exhibited a significant improvement in motion parameters and maintained high motility throughout incubation and acrosome integrity, as compared with semen collected into tubes containing extender supplemented with lower concentrations of BSA. In conclusion, semen collection into tubes with a large volume of extender containing high concentrations of BSA dramatically improves the motility and acrosome integrity of frozen-thawed spermatozoa. This suggests that the in vitro functional freezability of spermatozoa is abruptly modified by reducing contact with seminal plasma and by flash contact with BSA at ejaculation.

Acrosome↗

PubMedDate not supplied

Analysis of pharmacist and pharmacist-extender workforce in 1998--2000: assessing predictors and differences across states.

OBJECTIVE: To examine the impact of supply and demand factors on filled positions for pharmacists and pharmacist extenders (pharmacist technicians and aides) and assess differences across states through analysis of state-level pharmacist labor market data. DESIGN: Cross-sectional analysis. SETTING: United States. PARTICIPANTS: Not applicable. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: State-level counts of filled pharmacist and pharmacist-extender positions, wages, and various available demographic, health, policy, and other factors related to the pharmacist labor market. RESULTS: Across states, the total population and the number of community pharmacy prescriptions were very accurate predictors (R2 = 0.99) of the number of pharmacist and pharmacist-extender positions, and all other variables were insignificant after these two variables were controlled for. Pharmacists and pharmacist-extenders were positively correlated, and the ratio of the two was not related to observable policy-related variables. Outlying states, in terms of simple pharmacist-to-population ratios, were difficult to categorize. CONCLUSION: Future changes in prescriptions are likely to affect the pharmacist and pharmacist-extender labor markets. Across states, pharmacists and extenders relate as complements rather than substitutes. The number of pharmacist graduates and state-level regulations regarding technician-to-pharmacist ratios appears to have a small effect on filled positions across states.

Cross-Sectional Studies↗

PubMed2006

Drug utilization review in an extended care facility. 1974.

Clinical pharmacy has expanded the scope of pharmaceutical services and one of the newer areas of involvement is the extended care facility. The author discusses the need, because of a limited budget, for better financial control of drug usage in Lions Gate Hospital's new 170 bed extended care unit. A need for pharmacy involvement in geriatrics because of the rising population of elderly people in extended care facilities and nursing homes and the complexities of using drugs in the elderly is discussed. The new extended care unit was provided with traditional pharmacy services and a pharmacist to participate in a patient review committee. This pharmacist monitored the patients' drug usage and made recommendations to the committee where applicable. The lowered costs of drug therapy in the extended care unit and the more efficacious use of certain medications are discussed in terms of pharmacy involvement. The author concludes that the pharmacist can make a significant contribution to the more economical use of drugs in extended care facilities and has a potential valuable role in improving patient care in this area.

Aged↗

PubMed2000

The effect of extended family living on the mental health of three generations within two Asian communities.

BACKGROUND: A study by Shah & Sonuga-Barke (1995) identified a relationship between family structure and the mental health of Pakistani Muslim mothers and their children. Children in extended families fared better, but their mothers fared worse than their nuclear family counterparts. The present study replicates and extends this study by exploring the impact of nuclear and extended family living on the mental health of three generations (children, mothers and grandmothers) in British Hindu as well as Muslim communities. METHOD: 44 Muslim and 42 Hindu families participated in the study. The mental health of mothers and grandmothers and the behavioural problems of children (aged 5-11) were examined. Both mothers and grandmothers completed the Hospital Anxiety and Depression Scale. The children's behavioural adjustment was rated by their teachers using the Rutter Scale. Other relevant variables such as acculturation levels were also measured. RESULTS: Children and grandmothers were better adjusted in extended families than nuclear families. In contrast, mothers were better adjusted in nuclear families. This interaction between family type and generation was evident in both Muslim and Hindu families and did not appear to be mediated by other variables such as acculturation. Furthermore, mothers' and childrens' adjustment was significantly correlated with grandmothers', but not mothers', mental health in extended families (although not in nuclear families). DISCUSSION: These results provide further evidence for the link between family structure and mental health in Asian communities. They also challenge some of the assumptions about maternal mental health, its effects on child adjustment and its links to systems of social support. In extended families where social support was likely to be most available mothers were at greatest risk, while their children profited and this advantage seemed to be linked to the grandmaternal presence.

Adaptation, Psychological↗

PubMed2005

Single-dose azithromycin microspheres vs clarithromycin extended release for the treatment of mild-to-moderate community-acquired pneumonia in adults.

BACKGROUND: Community-acquired pneumonia (CAP) is a major cause of morbidity and mortality worldwide. The inability or failure of many subjects to adhere to standard antibiotic regimens, which may last up to 10 days, results in suboptimal antibiotic treatment. Treatment with a single-dose antibiotic regimen may improve compliance with prescribed therapy. A novel microsphere formulation of azithromycin provides a single-dose regimen while maintaining tolerability. STUDY OBJECTIVE: To compare the efficacy and safety of a single 2.0-g dose of azithromycin microspheres to that of an extended-release formulation of clarithromycin (1.0 g/d for 7 days) for the treatment of adults with mild-to-moderate CAP. DESIGN: A phase III, multinational, multicenter, randomized, double-blind, double-dummy study, comparing single-dose azithromycin microspheres to extended-release clarithromycin, both administered orally. METHODS: Subjects with mild-to-moderate CAP (Fine class I and II) were included. The primary end point was clinical response at the test-of-cure (TOC) visit (days 14 to 21) in the clinical per protocol (CPP) population. The bacteriologic response at the TOC visit was assessed in subjects with a baseline pathogen. RESULTS: A total of 501 subjects were randomized, and 499 were treated. Clinical cure rates at the TOC visit in the CPP population were 92.6% (187 of 202 subjects) for azithromycin microspheres and 94.7% (198 of 209 subjects) for extended-release clarithromycin. Overall pathogen eradication rates were 91.8% (123 of 134 subjects) for azithromycin microspheres and 90.5% (153 of 169 subjects) for extended-release clarithromycin. Both agents were well tolerated. The incidence of treatment-related adverse events was 26.3% with azithromycin microspheres and 24.6% with extended-release clarithromycin. Most adverse events were mild to moderate in severity. CONCLUSION: A single 2.0-g dose of azithromycin microspheres was as effective and well tolerated as a 7-day course of extended-release clarithromycin in the treatment of adults with mild-to-moderate CAP.

Adult↗

PubMed1998

Is the caudomedial shell of the nucleus accumbens part of the extended amygdala? A consideration of connections.

The conceptual origins of two forebrain functional-anatomical systems, the ventral striatopallidum and extended amygdala, are reviewed briefly, and reductionist and constructionist doctrines pertaining to descriptions of forebrain organization are generally discussed briefly. The cortical, subcortical, and intrinsic connectional relationships of the caudomedial shell of the nucleus accumbens, an anomalous component of the ventral striatopallidum, are compared with those of the extended amygdala, leading to an attempt to formulate an assessment as to the extent to which the caudomedial shell might actually be regarded as a part of extended amygdala, or a transitional structure with a capacity to bridge extended amygdaloid and striatal mechanisms. The relatively distinct intrinsic circuitries and different outputs of the two are noted. Extended amygdala projects most strongly to the posterior half of the lateral hypothalamus and brainstem autonomic effector sites. Caudomedial shell and ventromedial ventral pallidum project throughout the lateral preoptico-lateral hypothalamic continuum and are major components in a basal ganglia-thalamocortical pathway to the prefrontal cortex. It is concluded that connectional features distinguishing the caudomedial shell/ventromedial ventral pallidum and extended amygdala are of sufficient magnitude that the two should most usefully be regarded as separate, interacting functional-anatomical entities.

Afferent Pathways↗

PubMedDate not supplied

Effects of various extenders and permeating cryoprotectants on cryopreservation of cynomolgus monkey (Macaca fascicularis) spermatozoa.

The cryoprotective effects of 11 different extenders, TTE, DM, mDM, LG-DM, G-DM, TCG, TEST, TSM, Test-M, Test-H, and LM, on sperm cryopreservation of cynomolgus monkey (Macaca fascicularis) have been compared with glycerol as cryoprotectant. Sperm motility, plasma membrane, and acrosomal integrity were examined to evaluate frozen-thawed sperm function. The results showed that TTE, DM, mDM, LG-DM, G-DM, and TCG exhibited the best and similar protective efficiencies for cynomolgus monkey sperm cryopreservation in terms of sperm motility and plasma membrane integrity (P > .05). The acrosomal integrity for spermatozoa cryopreserved in TCG was statistically lower than that of TTE, DM, mDM, LG-DM, and G-DM (P < .05) but was significantly higher than that of TEST, TSM, Test-M, Test-H, and LM (P < .05). The postthaw sperm motility for 5 other extenders (TEST, TSM, Test-M, Test-H, and LM) did not exceed 30%, and the 3 sperm parameters evaluated for them were significantly lower than that of TTE, DM, mDM, LG-DM, G-DM, and TCG (P < .05). On the basis of these findings, 5 commonly used permeating cryoprotectants, glycerol, ethylene glycol, dimethyl sulfoxide, acetamide and propylene glycol have further been tested for their effectiveness on sperm cryopreservation in extenders of TTE, DM, mDM, LG-DM, G-DM, and TCG. The results showed that the sperm cryoprotective efficiencies of glycerol and ethylene glycol were similar and best among 5 permeating cryoprotectant treatments (P > .05). Dimethyl sulfoxide or acetamide resulted in average cryoprotection for cynomolgus monkey spermatozoa: poorer than glycerol or ethylene glycol but better than that of propylene glycol (P < .05). In addition, the action of permeating cryoprotectant appeared to be independent of extenders. The results in the present study demonstrate that 1) TTE, DM, mDM, LG-DM, G-DM, and TCG are excellent extenders and suitable for cynomolgus monkey sperm cryopreservation; 2) the mechanism of action of permeating cryoprotectants are not affected by extender composition; 3) ethylene glycol has a similar cryoprotective efficacy to glycerol that makes it a successful cryoprotectant for sperm cryopreservation in cynomolgus monkeys.

Acetamides↗

PubMed2006

Bioavailability of immediate- and extended-release formulations of glipizide in healthy male volunteers.

BACKGROUND AND OBJECTIVE: An extended-release glipizide formulation using a hydrophilic matrix system containing hydrophilic polymers has been developed for use in diabetes mellitus. This study compared the pharmacokinetic parameters of immediate- and extended-release formulations of glipizide 5mg in healthy male volunteers. METHODS: In a single-dose, four-period, four-treatment, Latin-square crossover study, the bioavailability of immediate-release glipizide 5mg (Glynase) [GL], extended-release glipizide 5mg (Glynase) XL [GLXL], Glucotrol XL [GTXL], and the new formulation developed in our laboratory [GLPF]) was compared. Plasma glipizide levels of the four formulations were determined at different time intervals, and pharmacokinetic parameters were analysed using a two-compartment body model. RESULTS: The mean peak plasma concentration (C(max)) of the immediate-release formulation (523+/-60 ng/mL) was significantly higher (p<0.05) than those of the three extended-release formulations (403+/-24, 349+/-37 and 426+/-55 ng/mL for GLXL, GTXL and GLPF, respectively). Mean time to reach C(max) was 1.83+/-0.3 hours for GL, 4.41+/-1.2 hours for GLXL, 3.21+/-0.8 hours for GTXL and 3.24+/-0.4 hours for GLPF. The order of magnitude of area under the plasma concentration-time curve was GTXL (5591 ng . h/mL)>GLXL (4,771 ng . h/mL)>GLPF (4,537 ng . h/mL)>GL (1,897 ng . h/mL). The mean residence time was 3.14+/-0.59 hours for GL, 8.26+/-0.81 hours for GLXL, 9.70+/-2.70 hours for GTXL and 7.87+/-1.93 hours for GLPF. Extended-release glipizide formulations maintained effective plasma drug concentrations for approximately 24 hours. Plasma levels of glipizide fluctuated less with GTXL than with the other two extended-release formulations. CONCLUSION: The newly developed formulation (GLPF) maintained effective levels of glipizide for a period of more than 20 hours, with quicker onset of action than the other two formulations. This formulation may be more economical than glipizide GITS.

Adolescent↗

PubMed1999

Extended-release dipyridamole/aspirin.

The fixed-dose combination of extended-release dipyridamole/aspirin (Aggrenox/Asasantin Retard) combines 2 antiplatelet agents with different mechanisms of action. The combination reduced thrombus formation in human and animal models. Coadministration of extended-release dipyridamole and aspirin in healthy volunteers had no significant effects on the plasma concentrations of either agent. Twice-daily oral extended-release dipyridamole/aspirin (400/50 mg/day) was twice as effective as either agent alone in the secondary prevention of stroke in a large clinical trial involving patients with prior stroke or transient ischaemic attack. The rate of the combined end-point of stroke and death tended to be lower with the combination than with other treatments. The incidence of death was not significantly reduced by any treatment. Most adverse events with extended-release dipyridamole/aspirin were mild and similar to those with either agent alone. Bleeding was more common with the combination than with extended-release dipyridamole alone, as was headache when compared with aspirin alone. Limited pharmacoeconomic analyses suggest that treatment with extended-release dipyridamole/aspirin was cost saving and was cost effective compared with aspirin monotherapy for the secondary prevention of stroke.

Animals↗

PubMed2002

Extended-release methylphenidate (Ritalin LA).

An extended-release formulation of methylphenidate (Ritalin LA), a CNS stimulant that inhibits dopamine and noradrenaline (norepinephrine) reuptake into presynaptic neurons, has been developed for use in patients with attention deficit/hyperactivity disorder (ADHD). In children with ADHD and healthy male adults, extended-release methylphenidate 20mg was rapidly absorbed and demonstrated two distinct peak plasma concentrations approximately 4 hours apart. The absorption pharmacokinetics of extended-release methylphenidate 20mg, which closely mimics those of immediate-release methylphenidate 10mg given in two doses 4 hours apart, permits once-daily administration. In a 2-week randomised, double-blind, placebo-controlled trial in 134 evaluable children aged 6 to 12 years with ADHD, symptoms improved to a significantly greater extent with extended-release methylphenidate 10 to 40mg once daily than with placebo. Extended-release methylphenidate improved both inattention and hyperactivity symptoms and was effective in children with combined- (inattentive and hyperactive/impulsive) type or predominantly inattentive-type ADHD. In clinical trials, the safety and tolerability profiles of extended-release methylphenidate were consistent with that of the immediate-release formulation.

Administration, Oral↗

PubMed2005

Extended-release carbamazepine capsules : in bipolar I disorder.

An extended-release capsule formulation of carbamazepine is approved for use in adult patients experiencing an acute manic or mixed episode associated with bipolar I disorder. A capsule of extended-release carbamazepine contains three types of bead: immediate release, extended release and enteric release, constituting 25%, 40% and 35% of the dose, respectively.black triangle Extended-release carbamazepine capsules 200--1600 mg/day demonstrated superior antimanic efficacy to placebo in two 3-week, well designed trials in adult patients with bipolar I disorder and acute manic or mixed episodes. At study end, reductions from baseline in Young Mania Rating Scale scores were significantly greater with carbamazepine than with placebo (primary endpoint). The active treatment was effective from the end of the first week of treatment (post hoc analysis).black triangle In the 3-week trials and a 6-month extension study, most treatment-emergent adverse events observed with extended-release carbamazepine were of mild or moderate severity. In the 3-week trials, although significantly greater reductions in white blood cell count occurred with extended-release carbamazepine than with placebo, only one case of leukopenia was deemed serious. There were no reports of agranulocytosis or aplastic anaemia with up to 6 months' treatment.

Anticonvulsants↗