Linked Life Data

8626361

Source:http://linkedlifedata.com/resource/pubmed/id/8626361

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:dateCreated
1996-6-25
pubmed:abstractText
Comprehensive review of safety data from approximately 3500 patients who received nefazodone in premarketing clinical trials demonstrates the drug to be very well tolerated, with a favorable side effect profile compared with other antidepressant drugs. Nefazodone treatment was associated with fewer side effects than were the control drugs. The incidence of side effects was generally low, and treatment discontinuations for adverse effects were less frequent with nefazodone than with imipramine and comparable with fluoxetine. No late-appearing side effects or toxicity emerged during the long-term treatment (1 year or longer) of several hundred patients. There were no drug-related fatalities and no evidence that nefazodone caused specific organ toxicity, although some cardiovascular side effects were noted (e.g., asymptomatic reduced systolic blood pressure, asymptomatic sinus bradycardia). Experience in 488 elderly patients treated with nefazodone yielded no evidence of increased susceptibility of older patients to nefazodone-associated adverse experiences, including those pertaining to the cardiovascular system. However, treatment should be initiated at a reduced dose in elderly patients because of reduced hepatic clearance of nefazodone in this age group. Final dose range may be similar in healthy younger and older patients. Although nefazodone may interact with some other medications (e.g., increases at steady state in AUC: alprazolam, twofold; triazolam, fourfold), drug-drug interactions involving patients have been clinically minor. On the basis of the inhibition of cytochrome P450 3A4 isoenzyme by nefazodone in vitro, coadministration of terfenadine or astemizole with nefazodone is contraindicated because nefazodone can increase the plasma levels of these two drugs. Extensive clinical experience provides substantial evidence that nefazodone is an extremely safe and effective treatment for depression, with important advantages over existing therapies. Therapeutic benefits include a low incidence of clinically troublesome side effects and lack of unwanted psychic activation, sexual dysfunction, weight change, and the cardiotoxicity of other antidepressants.
pubmed:commentsCorrections
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:issn
0160-6689
pubmed:author
pubmed:issnType
Print
pubmed:volume
57 Suppl 2
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
31-8
pubmed:dateRevised
2010-11-18
pubmed:meshHeading
pubmed-meshheading:8626361-Adolescent, pubmed-meshheading:8626361-Adult, pubmed-meshheading:8626361-Age Factors, pubmed-meshheading:8626361-Aged, pubmed-meshheading:8626361-Antidepressive Agents, Second-Generation, pubmed-meshheading:8626361-Antidepressive Agents, Tricyclic, pubmed-meshheading:8626361-Clinical Trials as Topic, pubmed-meshheading:8626361-Cytochrome P-450 CYP3A, pubmed-meshheading:8626361-Cytochrome P-450 Enzyme System, pubmed-meshheading:8626361-Depressive Disorder, pubmed-meshheading:8626361-Double-Blind Method, pubmed-meshheading:8626361-Drug Interactions, pubmed-meshheading:8626361-Female, pubmed-meshheading:8626361-Fluoxetine, pubmed-meshheading:8626361-Humans, pubmed-meshheading:8626361-Imipramine, pubmed-meshheading:8626361-Male, pubmed-meshheading:8626361-Middle Aged, pubmed-meshheading:8626361-Mixed Function Oxygenases, pubmed-meshheading:8626361-Placebos, pubmed-meshheading:8626361-Sexual Dysfunctions, Psychological, pubmed-meshheading:8626361-Treatment Outcome, pubmed-meshheading:8626361-Triazoles, pubmed-meshheading:8626361-Weight Gain
pubmed:year
1996
pubmed:articleTitle
The safety profile of nefazodone.
pubmed:affiliation
Bristol-Myers Squibb Pharmaceutical Research Institute, Wallingford, CT 06492, USA.
pubmed:publicationType
Journal Article, Review