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PubMed1996

Relatively low doses of cisapride in the treatment of nausea in patients treated with venlafaxine for treatment-refractory depression.

Low doses of cisapride (5-10 mg twice daily) produced relatively rapid relief from nausea elicited by venlafaxine in six patients with treatment-refractory recurrent major depression. This further suggests that the nausea associated with serotonergic reuptake inhibition may be a result of 5-hydroxytryptamine (5-HT3) agonist action. No adverse cardiac experiences were encountered in spite of the potential interaction of cisapride with selective serotonin reuptake inhibitors at the cytochrome P4503A4 enzyme system.

Adult↗
PubMed1996

Antidepressant options: venlafaxine in perspective.

Depression is often related to disturbances of norepinephrine and serotonin neurochemical systems within the brain that affect functional neurobehavioral systems. Classes of antidepressant agents have been developed that directly affect proposed brain neurochemical alterations. Many of the differences among antidepressant agents, particularly in safety and tolerability, can be attributed to their differing effects on receptor blockade and neurotransmitter reuptake. The overall goal of antidepressant treatment is complete recovery, and three phases of treatment have been delineated. Because of the recurrent and potentially chronic nature of depression, safety and tolerability of available treatments are especially important. An overview of antidepressant options is presented, with a particular focus on venlafaxine.

Antidepressive Agents, Second-Generation↗
PubMed1996

Dose-response relationship with venlafaxine.

Considerations when selecting a first-line antidepressant agent include the potential for achieving greater response with increasing dosages, thereby allowing greater flexibility in dosing. The efficacy and dose-response of venlafaxine, a novel serotonin and norepinephrine reuptake inhibitor, was evaluated in two placebo-controlled studies. Both studies demonstrated that venlafaxine was efficacious (as determined by the Hamilton Rating Scale for Depression, the Montgomery-Asberg Depression Rating Scale, and the Clinical Global Impressions scale scores), as well as safe and tolerable when administered either twice or three times daily in the treatment of outpatients who had major depression. In addition, evidence of a dose-response relationship was shown in both studies.

Adolescent↗
PubMed1996

Clinical evaluation of venlafaxine.

Recent studies have shown venlafaxine to be an effective first-line agent for patients who have depression of varying severity. Two representative clinical trials to assess the efficacy of venlafaxine were reviewed: one in severely ill hospitalized patients and the other in outpatients. Efficacy was assessed using scores on several rating scales for 93 inpatients in the placebo-controlled trial and 224 outpatients in the active-control trial. Demographics and baseline scores were similar among study patients in each trial. In both trials, venlafaxine was significantly more effective than placebo. The study of inpatients demonstrated a rapid onset of antidepressant efficacy of venlafaxine and a reduction in comorbid symptoms of anxiety. In the study of outpatients, anticholinergic side effects commonly associated with tricyclic antidepressants such as imipramine were not found to be associated with venlafaxine, although some nausea occurred. Results of these clinical studies confirm those of previous studies that have shown venlafaxine to be an effective first-line agent for the management of depression in both hospitalized patients and outpatients.

Adult↗
PubMed1996

Drug-drug interactions involving antidepressants: focus on venlafaxine.

Selection of an antidepressant is influenced by many factors, including the patient's current drug regimen and the drug's potential for drug-drug interactions. Many psychotropic agents are known to be involved in drug-drug interactions because they are metabolized by various cytochrome pigment 450 (CYP) isoenzymes. In vitro testing with human hepatic microsomal preparations and monoclonal antibody techniques has allowed for the identification and investigation of many of these isoenzymes. Also, screening of substrates (both drug and probe) at the level of the various enzymes expressed in the human liver has allowed for the development of models that predict the risk for drug-drug interactions in vivo. Antidepressants are metabolized by and are competitive inhibitors of several isoenzymes: CYP1A2, CYP2D6, CYP3A3/4, CYP2C8/9, CYP2C19, and others. Of these, CYP2D6 has been the most thoroughly investigated and is the most extensively characterized, whereas CYP3A3/4 are more abundant and play a major role in the metabolism of many commonly used drugs. CYP2D6, but not CYP3A3/4, is subject to genetic polymorphism, which has been identified through the administration of a probe drug (sparteine, debrisoquin, or dextromethorphan). This analysis allows for the determination of an individual's "metabolizer status." This article discusses the CYP isoenzyme system in general terms and presents selected in vitro information that has been used to determine the likelihood of in vivo drug-drug interactions with various antidepressants. Of the marketed antidepressants, venlafaxine seems to have one of the most favorable drug-interaction profiles, and data specific to it are highlighted. In vitro and in vivo data indicate that venlafaxine either does not significantly inhibit or weakly inhibits the activity of isoenzymes CYP2C9, CYP2D6, CYP1A2, or CYP3A3/4.

Animals↗
PubMed1996

The safety and tolerability of venlafaxine hydrochloride: analysis of the clinical trials database.

The tolerability and safety of venlafaxine hydrochloride, a new serotonin and norepinephrine reuptake inhibitor, are reviewed in this article. The data presented here are based on a pool of 3,082 patients who were treated with this agent during clinical trials. Of these patients, 2,897 received venlafaxine for depression; 455 of these patients were treated for more than 360 days. The tolerability and safety profiles of venlafaxine were similar to those previously reported for selective serotonin reuptake inhibitors. Patients receiving venlafaxine experienced nausea, insomnia, dizziness, somnolence, constipation, and sweating more often than did patients receiving placebo but reported anticholinergic events less frequently than did patients receiving tricyclics. This is accounted for by the fact that, unlike the tricyclics, venlafaxine lacks significant affinity for muscarinic cholinergic receptors. Resolution of venlafaxine-associated nausea occurred rapidly in the vast majority of the patients who reported it at the start of therapy. Serious adverse events were rare among venlafaxine-treated patients. A small percentage of the patients given venlafaxine experienced modest but significant increases in blood-pressure readings, similar to those observed among imipramine-treated patients. At mean daily venlafaxine dosages of up to 300 mg, the percentage of venlafaxine-treated patients who had sustained elevations in supine diastolic blood pressure during treatment ranged from 2% to 6%, compared with 2% and 5% among the placebo- and imipramine-treated patients, respectively. All of the 14 patients who took an overdose of venlafaxine recovered without sequelae. Tolerability and safety in the elderly did not differ significantly from that observed in younger patients.

Adult↗
PubMed1997

Channeling of three newly introduced antidepressants to patients not responding satisfactorily to previous treatment.

The demand for knowledge about differences in effectiveness, tolerability, safety, and economic outcomes between and within groups of antidepressant drugs when used in routine daily clinical practice is growing. For gaining this knowledge, observational pharmacoepidemiologic studies are often the most feasible option. However, the results of such studies can only be valid if either patient baseline characteristics associated with the outcome under study are similar or if differences can be adjusted for in the analysis. The aim of this study was to evaluate to what extent and for what type of patients three antidepressant drugs recently introduced in The Netherlands (mirtazapine, sertraline, and venlafaxine) were prescribed during the first year after their introduction and whether there were differences compared with longer-available antidepressant drugs. For this purpose, prescription drugs histories from 20 pharmacies serving a population of approximately 200,000 persons were analyzed. One year after their introduction, the newly introduced antidepressant t drugs accounted for approximately 6% of new uses of all antidepressant drugs. In comparison to longer-available antidepressant, the newly introduced antidepressant drugs were more often prescribed for patients with prior prescriptions of another antidepressant drug (rate ratio [RR] 2.7 [95% confidence interval [CI], 2.3-3.0]), for patients with prior prescriptions of other psychotropic medicines (RR 1.3 [95% CI, 1.1-1.4), and by psychiatrists (RR 1.9 [95% CI, 1.6-2.2]). In addition, the newly introduced antidepressant drugs seemed to be more often, although not significantly, prescribed for patients who had been hospitalized on a psychiatric ward (RR 1.5 [95% CI, 0.9-2.5]). No differences were observed with regard to age and gender distribution, the total number of medicines prescribed, and prescriptions of any cardiovascular or gastrointestinal medicine. These finding suggest that a significant proportion of the patients receiving one of the newly introduced antidepressant drugs did not respond satisfactorily to previous pharmacologic treatment. This channeling phenomenon may have important consequences for the interpretation of observational comparisons between different antidepressant drugs after their introduction.

1-Naphthylamine↗
PubMed1998

The use of venlafaxine in the treatment of major depression and major depression associated with anxiety: a dose-response study. Venlafaxine Investigator Study Group.

This 12-week, double-blind, placebo-controlled study evaluated the efficacy and safety of venlafaxine as first-line therapy for the treatment of major depression and major depression associated with anxiety in 384 adult outpatients. Fixed total daily dosages of 75, 150, and 200 mg of venlafaxine were administered in a twice-a-day regimen. Primary efficacy parameters were the Hamilton Rating Scale for Depression (HAM-D) total score, the HAM-D Depressed Mood Item, the Montgomery-Asberg Depression Rating Scale total score, and the Clinical Global Impressions Scale. Overall, a higher percentage of patients responded to venlafaxine than to placebo. Efficacy data indicated a dose-related response, most evident in the onset of clinical improvement; statistically significant improvements in some primary parameters were seen as early as 1 to 2 weeks after initiation of treatment, especially in the 150-and 200-mg/day groups. These dose-related clinical improvements continued through week 12. Venlafaxine-treated patients who had depression associated with anxiety showed significant dose-related improvements compared with placebo-treated patients; improvement was noted by scores on the HAM-D Anxiety-Psychic Item and Anxiety-Somatization Factor. Few clinically significant changes were observed in laboratory values, vital signs, or electrocardiogram tracings. Venlafaxine was generally well tolerated at all dosages. The most common study events included nausea, dizziness, somnolence, insomnia, dry mouth, and asthenia, which are consistent with findings of previous studies. The current study demonstrated that 75 to 200 mg/day of venlafaxine twice daily produced a dose-related improvement in the primary efficacy parameters and in the onset of significant antidepressant effects, which was noted at weeks 1 to 2 with the highest dosage tested (200 mg/day). The study also demonstrated that these dosages of venlafaxine were safe and effective as first-line therapy for major depression and depression associated with anxiety.

Adult↗