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PubMedDate not supplied

A multinational pharmacoeconomic evaluation of acute major depressive disorder (MDD): a comparison of cost-effectiveness between venlafaxine, SSRIs and TCAs.

METHODS: We conducted a multinational pharmacoeconomic evaluation comparing the immediate release form of a new class of serotonin norepinephrine reuptake inhibitor (SNRI), venlafaxine IR to the selective serotonin reuptake inhibitors (SSRIs) and the tricyclic antidepressants (TCAs) in the treatment of acute major depressive disorder (MDD) in 10 countries (Germany, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom, United States, and Venezuela). We designed a decision analytic model assessing the acute phase of MDD treatment within a 6-month time horizon. Six decision tree models were customized with country-specific estimates from a clinical management analysis, meta-analytic rates from two published meta-analyses, and a resource valuation of treatment costs representing the inpatient and outpatient settings within each country. The meta-analyses provided the clinical rates of success defined as a 50% reduction in depression scores on the Hamilton Depression Scale (HAM-D) or the Montgomery-Asberg Depression Rating Scale (MADRS). Treatment regimen costs were determined from standard lists, fee schedules, and communication with local health economists in each country. The meta-analytic rates were applied to the decision analytic model to calculate the expected cost and expected outcomes for each antidepressant comparator. Cost-effectiveness was determined using the expected values for both a successful outcome, and a composite measure of outcome termed symptom-free days. A policy analysis was conducted to examine the health system budget impact in each country of increasing the utilization of the most effective antidepressant found in our study. RESULTS: Initiating treatment of MDD with venlafaxine IR yielded a lower expected cost compared to the SSRIs and TCAs in all countries except Poland in the inpatient setting, and Italy and Poland within the outpatient settings. The weighted average expected cost per patient varied from US$632 (Poland) to US$5647 (US) in the six-month acute phase treatment of MDD. The estimated total budgetary impact for each 1% of venlafaxine utilization, assuming a population of one million MDD patients, ranged from US$1600 (Italy) to US$29,049 (US). CONCLUSIONS: Within the inpatient and outpatient treatment settings, venlafaxine IR was a more cost-effective treatment of MDD compared to the SSRIs and TCAs. Additionally, the results of this investigation indicate that increased utilization of venlafaxine in most settings across Europe and the Americas will have favorable impact on health care payer budgets. ADR, adverse drug reaction; CMA, clinical management analysis; ECT, electroconvulsive therapy; HAM-D, Hamilton Depression Scale; MADRS, Montgomery-Asberg depression rating scale; MDD, major depressive disorder; SFD, symptom-free day; SNRI, serotonin-norepinephrine reuptake inhibitor; SSRI, selective serotonin reuptake inhibitor; TCA, tricyclic antidepressant; WHO, world health organization.

Antidepressive Agents, Second-Generation↗
PubMedDate not supplied

Venlafaxine extended release (XR) for the prophylaxis of migraine and tension-type headache: A retrospective study in a clinical setting.

OBJECTIVE: To assess the efficacy of extended-release venlafaxine in the prophylaxis of migraine and chronic tension-type headache. BACKGROUND: Venlafaxine, a structurally novel antidepressant, is a selective serotonin-norepinephrine reuptake inhibitor. This study is the first to test the effects of extended-release venlafaxine on headaches. METHODS: Patients were evaluated on a retrospective basis. Fifty-six patients with chronic tension-type headache and 114 patients with migraine were prescribed extended-release venlafaxine. Nearly all the study subjects had been resistant to several previous preventive medications. Patients took venlafaxine for an average of 6 months with a median dose of 150 mg (range, 37.5 to 300 mg). RESULTS: The mean frequency of headaches in the group with chronic tension-type headache fell from 24.0 to 15.2 per month (P <.0001). The group with migraine showed a reduction from 16.1 to 11.1 headaches per month (P <.0001). The medicine was well tolerated. CONCLUSIONS: This trial indicates that extended-release venlafaxine has potential in headache prophylaxis based on its efficacy and safety profile. We recommend a double-blind, placebo-controlled study to further assess the role of extended-release venlafaxine in headache prevention.

Adolescent↗
PubMed2002

Venlafaxine ER as a treatment for generalized anxiety disorder in older adults: pooled analysis of five randomized placebo-controlled clinical trials.

OBJECTIVES: Concerns about the safety of benzodiazepines in older adults may have led investigators and clinicians to underestimate the importance of adequately treating generalized anxiety disorder (GAD) in later life. To evaluate the safety and efficacy profile of an alternative treatment in older patients, we conducted a secondary analysis of five randomized, placebo-controlled clinical trials of extended release venlafaxine (venlafaxine ER, Effexor XR) for adult patients with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of GAD. DESIGN: The five multicenter, parallel-group, double-blind, prospectively randomized, placebo-controlled clinical trials used similar designs to evaluate short-term efficacy after 8 weeks. In addition, two studies evaluated efficacy and safety over 24 weeks under double-blind conditions. SETTING: Outpatients from both primary care and specialty mental healthcare settings were included. Three studies were conducted in the United States and two in Europe. PARTICIPANTS: Intention-to-treat analyses included 1,839 adult outpatients with a DSM-IV diagnosis of GAD and total scores of > or =18 on the Hamilton Rating Scale for Anxiety (HAMA). Ten percent of the patients were aged 60 and older and 5.0% were aged 65 and older. INTERVENTION: Fixed or flexible doses of venlafaxine ER in the dose range of 37.5 to 225 mg/day or matched placebo were used for 8 weeks in all studies and for 24 weeks in two studies. MEASUREMENTS: Primary efficacy variables included the HAMA total score and psychic anxiety factor, the anxiety subscale of the Hospital Anxiety and Depression (HAD) Scale, and the Clinical Global Impression of Improvement (CGI-I). Secondary efficacy variables included the HAMA somatic anxiety factor, the depression subscale of the HAD, CGI-3 severity, the Covi Scale for Anxiety, and the Raskin Scale for Depression. RESULTS: On the CGI, 66% of older patients (> or =60 years) responded to venlafaxine ER, compared with 41% for placebo (P <.01 by logistic regression). For younger patients (<60 years), comparable figures were 67% and 44%, respectively (P <.001). Analysis of variance showed no main effects for age and no age-by-treatment interactions for any of the primary or secondary efficacy outcome measures for either the 8- or 24-week analyses. Within the older adults subgroup, increasing age did not influence responses. In this cohort of GAD patients, higher levels of depression were associated with decreased responses of anxiety symptoms. In older adults, 23% of venlafaxine ER patients discontinued treatment prematurely versus 31% of those who received placebo; comparable figures for younger adult patients were 27% and 28%, respectively. Discontinuations due to adverse events were 15% versus 14% for venlafaxine ER and placebo, respectively, in older adults compared with 15% versus 8%, respectively, for younger adults. CONCLUSION: Venlafaxine ER is equally safe and well tolerated by and shows similar efficacy in younger and older patients in the treatment of GAD.

Adult↗
PubMed2001

Psychopharmacologic treatment of adolescent depression.

Child and adolescent depression is one of the greatest health concerns in our society today. This article critically reviews the literature on the psychopharmacologic treatment of adolescent depression. Although double-blind studies have failed to show the efficacy of tricyclic antidepressants, more recent evidence has emerged for the use of selective serotonin reuptake inhibitors in this population. However, placebo-controlled, double-blind studies are limited, and many of the other newer antidepressants have yet to be investigated in treating adolescent depression. Nonetheless, antidepressants are widely prescribed to these populations, and psychiatric nurses are actively involved in assessing and monitoring the need for these medications in adolescents.

Adolescent↗
PubMed2002

Venlafaxine in neuropathic pain following treatment of breast cancer.

Amitriptyline effectively relieves neuropathic pain following treatment of breast cancer. However, adverse effects are a major problem. Venlafaxine has no anticholinergic effects and could have a better compliance. The aim of the study was to evaluate the effectiveness of venlafaxine in neuropathic pain. The study was a randomized, double-blind, crossover comparison of venlafaxine and inactive placebo. The study lasted 10 weeks. The number of tablets (18.75 mg) taken daily was increased by one at a 1 week interval. Pain intensity and pain relief were registered daily by a diary and by a questionnaire and a computer program (Painscreen) on each visit. Adverse effects were evaluated with the diaries and a 10-item list on each visit. Also, anxiety and depression were measured on each visit. Venous blood samples were collected before the treatment and at 4 weeks for the determination of the serum levels of venlafaxine and its three metabolites. Thirteen patients were analysed. The average daily pain intensity as reported in the diary (primary outcome) was not significantly reduced by venlafaxine compared with placebo. However, the average pain relief (diary) and the maximum pain intensity (retrospective assessment by the computer program) were significantly lower with venlafaxine compared with placebo. Anxiety and depression were not affected. Adverse effects did not show significant differences between treatments. The two poor responders had low venlafaxine concentrations whereas the two slow hydroxylizers had high venlafaxine concentrations and excellent pain relief. Thus, higher doses could be used in order to improve pain relief.

Analgesics↗
PubMed2003

Effects of venlafaxine, buspirone, and placebo on colonic sensorimotor functions in healthy humans.

BACKGROUND & AIMS: We have shown that venlafaxine-XR, a serotonin (5-HT) and norepinephrine reuptake inhibitor, enhanced gastric accommodation, whereas buspirone, a 5-HT(1A) receptor agonist, reduced postprandial symptoms after a fully satiating meal. Our aim was to compare the effects of venlafaxine, buspirone, and placebo on colonic sensorimotor functions in healthy adults. METHODS: In this randomized, double-blind, parallel-group, placebo-controlled trial of 60 healthy adults, we assessed the effects of oral venlafaxine, 150 mg; buspirone, 20 mg; and placebo on colonic sensorimotor functions. RESULTS: Venlafaxine increased colonic compliance relative to placebo; thus it decreased the intracolonic balloon pressure at half-maximum volume (P = 0.001) and altered the overall shape of the compliance curve, beta (P = 0.01). Venlafaxine also decreased fasting colonic tone (P = 0.02) and the tonic response to a meal (P = 0.003) compared with placebo; no differences in high amplitude phasic contractile events were observed. Pressure thresholds for first sensation (P = 0.1) and gas (P = 0.07) were not statistically significant with venlafaxine. The increase in pain scores per unit pressure during phasic distentions were affected by treatment (P = 0.02), with smallest changes on venlafaxine and highest on placebo. Buspirone did not significantly alter colonic compliance, tone, or sensation relative to placebo. CONCLUSIONS: Venlafaxine alters colonic compliance and tone, and tends to reduce sensation during colonic distention in healthy humans. These data support the need for further clinical and physiologic studies of venlafaxine in colonic disorders affecting motor and possibly sensory functions.

Adult↗
PubMed2003

Anti-inflammatory activity of 1.8-cineol (eucalyptol) in bronchial asthma: a double-blind placebo-controlled trial.

Airway hypersecretion is mediated by increased release of inflammatory mediators and can be improved by inhibition of mediator production. We have recently reported that 1.8-cineol (eucalyptol) which is known as the major monoterpene of eucalyptus oil suppressed arachidonic acid metabolism and cytokine production in human monocytes. Therefore, the aim of this study was to evaluate the anti-inflammatory efficacy of 1.8-cineol by determining its prednisolone equivalent potency in patients with severe asthma. Thirty-two patients with steroid-dependent bronchial asthma were enrolled in a double-blind, placebo-controlled trial. After determining the effective oral steroid dosage during a 2 month run-in phase, subjects were randomly allocated to receive either 200 mg 1.8-cineol t. i.d. or placebo in small gut soluble capsules for 12 weeks. Oral glucocorticosteroids were reduced by 2.5 mg increments every 3 weeks. The primary end point of this investigation was to establish the oral glucocorticosteroid-sparing capacity of 1.8-cineol in severe asthma. Reductions in daily prednisolone dosage of 36% with active treatment (range 2.5-10 mg, mean: 3.75 mg) vs. a decrease of only 7% (2.5-5 mg, mean: 0.91 mg) in the placebo group (P = 0.006) were tolerated. Twelve of 16 cineol vs. four out of 16 placebo patients achieved a reduction of oral steroids (P = 0.012). Long-term systemic therapy with 1.8-cineol has asignificant steroid-saving effect in steroid-depending asthma. This is the first evidence suggesting an anti-inflammatory activity of the monoterpene 1.8-cineol in asthma and a new rational for its use as mucolytic agent in upper and lower airway diseases.

Adult↗
PubMed2001

Prefrontal changes and treatment response prediction in depression.

A continuing challenge in the treatment of depression is how to determine whether an effective drug has been selected for a particular patient, given that individuals will respond to some antidepressants but not others. The factors that contribute to response for each person have been examined from a variety of perspectives, both psychological and physiological. Advances in neuroimaging and in quantitative electroencephalography (QEEG) have made it possible to examine features of brain activity that are associated with response. A new QEEG measure, cordance, is correlated with regional cortical perfusion, and has been used with retrospective and prospective studies to evaluate specific findings that are predictive of clinical response in major depression. We present here a series of depressed subjects treated with antidepressants of different classes; decreases in prefrontal activity were seen as early as 48 hours into treatment in responders and were absent in nonresponders. These findings suggest a role for the prefrontal region in mediating response to medications with different mechanisms of action and raise the possibility of using new QEEG measures to identify changes in brain activity that are predictive of clinical outcome from antidepressant treatment.

Adult↗
PubMed2005

Antidepressant and memory affecting influence of estrogen and venlafaxine in ovariectomized rats.

The experiments presented in this paper aimed to investigate whether estrogen level changes in oviariectomized rats (OVX) may lead to depression and memory disorders, and whether the effects of such changes may be reversible following administration of a new antidepressant, venlafaxine (CAS 9930-78-4, VEN, Efectin). The Porsolt forced swimming test and Morris water maze test were carried out on female Wistar rats after ovariectomy and in sham-ovariectomized rats. VEN 20 mg/kg was administered orally 30 min before the tests for the period of 14 days. Estradiol (17beta-estradiol benzoate, CAS 50-28-2, E2) administration (5 microg E2/0.2 ml sesame oil s.c.) was started 24 h after ovariectomy and was continued for 14 days--each dose was administered 180 min before the test. In the immobility test, which reflects antidepressant drug activity, it was found that VEN shortened immobility time (IT) after the 1st, 7th and 14th administration (days 1, 7, 14, respectively) in ovariectomized rats, whereas in the control group (sham-ovariectomized rats) VEN exerted antidepressant action only after single administration (day 1) and after 7 days of administration. E2 significantly reduced immobility behaviour both after single and chronic treatment in ovariectomized rats. After joint administration of VEN and E2 potentiation of the antidepressant activity of VEN could be observed in both groups except for concurrent administration of VEN and E2 after 14 days in sham-ovariectomized rats. VEN improved the spatial memory in the Morris water maze test, whereas E2 did not affect the memory of the tested animals. Joint administration of VEN and E2 maintained the memory improving effect induced by VEN. The regulatory role of the steroid hormone and the new antidepressant drug (VEN) in antidepressant activity and memory function could be related to the interactions between noradrenergic and serotoninergic systems.

Animals↗
PubMed2003

Comparison of behavioural effects of venlafaxine and imipramine in rats.

The experiments outlined in this paper examined the effects of the novel antidepressant venlafaxine (VEN) (CAS 9930-78-4) in several behavioural and memory tests in comparison with the classic antidepressant imipramine (IMI) (CAS 113-52-0). The tests were carried out on male Wistar rats of about 200 g. The drugs were administered orally 30 min before the tests during 14 days. The aim of the locomotor activity test was to select the doses without influence on the motility of the animals and active at least in two behavioural tests. Such dose was 20 mg/kg b.w. for both drugs--VEN and IMI. In the immobility test, which reflects antidepressant drug activity, the following differences were found: VEN shortened immobility time (IT) on days 1 and 7 (no activity on day 14), whereas IMI shortened IT on days 7 and 14 and displayed no activity on day 1. In the two-compartment exploratory test both drugs displayed distinct anxiolytic effect on days 1 and 7, yet on day 14 only IMI was still active. In the maze test only VEN shortened food finding time on day 1, on day 7 and on day 14 during chronic treatment. IMI was inactive in the maze test. The authors conclude that the general pattern of VEN activity is similar to that of IMI, but in some tests, especially in the memory test, the new drug is superior to IMI.

Animals↗
PubMed2000

Marked increase of venlafaxine enantiomer concentrations as a consequence of metabolic interactions: a case report.

On three occasions, unusually high trough plasma concentrations of venlafaxine were measured in a patient phenotyped and genotyped as being an extensive CYP2D6 metabolizer and receiving 450 mg/day of venlafaxine and multiple comedications. Values of 1.54 and of 0.60 mg/l of venlafaxine and O-desmethylvenlafaxine, respectively, were determined in the first blood sample, giving an unusually high venlafaxine to O-desmethylvenlafaxine ratio. This suggests an impaired metabolism of venlafaxine to O-desmethylvenlafaxine, and is most likely due to metabolic interactions with mianserin (240 mg/day) and propranolol (40 mg/day). Concentration of (S)-venlafaxine measured in this blood sample was almost twice as high as (R)-venlafaxine ((S)/(R) ratio: 1.94). At the second blood sampling, after addition of thioridazine (260 mg/day), which is a strong CYP2D6 inhibitor, concentrations of venlafaxine were further increased (2.76 mg/l), and concentrations of O-desmethylvenlafaxine decreased (0.22 mg/l). A decrease of the (S)/(R)-venlafaxine ratio (-20%) suggests a possible stereoselectivity towards the (R)-enantiomer of the enzyme(s) involved in venlafaxine O-demethylation at these high venlafaxine concentrations. At the third blood sampling, after interruption of thioridazine, concentrations of venlafaxine and O-desmethylvenlafaxine were similar to those measured in the first blood sample. This case report shows the importance of performing studies on the effects of either genetically determined or acquired deficiency of metabolism on the kinetics of venlafaxine.

Adult↗
PubMed2000

Achyrocline satureioides essential oils from southern Brazil and Uruguay.

The essential oils of the aerial parts of Achyrocline satureioides (D.C.) Lam., a regional medicinal plant, from different collection locations in the South of Brazil and Uruguay were examined by GC and GC-MS. Monoterpene and sesquiterpene hydrocarbons were the main fractions of both the oils from Brazil and Uruguay. The oxygenated monoterpenes and sequiterpenes were at much lower percentage in both samples. The Uruguayan samples have 1,8-cineole which is not present in the Brazilian samples and has not been reported in other samples from Brazil. The results indicated a high biodiversity of the native populations of A. satureioides.

Asteraceae↗
PubMed2001

Composition of the essential oil of two Nepeta species and in vitro evaluation of their activity against Helicobacter pylori.

The chemical composition of the essential oils obtained from the aerial parts of Nepeta camphorata and Nepeta argolica ssp. dirphya were analysed by GC-MS. A total of 52 components were identified and significant differences (qualitative and quantitative) were observed between the two samples. 1,8-Cineol and two nepetalactones were found to be the major components of the oil of N. camphorata and N. argolica ssp. dirphya respectively. The in vitro activity, of the two oils and the three above mentioned isolated compounds, against 25 clinically isolated and commercial strains of Helicobacter pylori was investigated and some activity was found.

Cyclohexanols↗
PubMed2002

Body weight, the tumor necrosis factor system, and leptin production during treatment with mirtazapine or venlafaxine.

Weight gain is a frequent and important side effect of psychopharmacotherapy. Recent studies suggest that the fat-cell-derived hormone leptin and the tumor necrosis factor-alpha (TNF-alpha) cytokine system are pathophysiologically involved. No information is available concerning the influence of the antidepressants mirtazapine and venlafaxine on these immunoendocrine variables. An open-labeled study was performed in 20 patients suffering from major depression treated with either mirtazapine (N = 11) or venlafaxine (N = 9). During 4 weeks, the patients' weight, body mass index (BMI), and plasma levels of leptin, TNF-alpha, sTNF-R p55, and sTNF-R p75 were assessed. Mirtazapine induced a significant increase in weight (mean weight gain: 2.4 kg) that was evident after the first week of treatment. In parallel, the plasma levels of TNF-alpha and both soluble TNF receptors increased. In addition, a slight rise in leptin levels, which occurred slowly and was significant only at the end of the 4 th week of treatment, was observed. Weight decreased slightly but significantly in patients treated with venlafaxine (mean weight loss: 0.4 kg), whereas plasma levels of leptin, TNF-alpha, or soluble TNF receptors did not change significantly. The present results further support the notion that the activation of the TNF-alpha cytokine system is an early, sensitive, and specific marker of weight gain induced by psychotropic agents. In contrast, the effects of such drugs on leptin production seem to be less sensitive with respect to weight gain and more variable.

Adult↗
PubMed2003

Melperone is an inhibitor of the CYP2D6 catalyzed O-demethylation of venlafaxine.

INTRODUCTION: Melperone, a butyrophenone neuroleptic, is frequently used for its sleep-inducing properties. Despite its common use for more than 30 years, it is not yet characterized regarding its effects on cytochrome P450 s (CYPs). In an open pilot study, effects of melperone on the steady-state blood levels of venlafaxine, a recently introduced serotonin- and noradrenaline reuptake inhibiting antidepressant, were assessed. METHODS: The dose-corrected serum concentrations of venlafaxine and O-desmethylvenlafaxine were analyzed retrospectively in a therapeutic drug-monitoring (TDM) database comprising 94 patients. In addition, three patients received venlafaxine and melperone concomitantly and the serum concentrations of venlafaxine and O-desmethylvenlafaxine were analyzed before, during, and after melperone co-medication. The effect of melperone on CYP2D6 was further assessed in seven patients by means of the dextromethorphan O-demethylation, which serves as a CYP2D6 probe reaction. RESULTS: Patients treated concomitantly with venlafaxine and melperone had significantly higher (mean +/- SD) venlafaxine (3.27 +/- 2.9 vs. 0.97 +/- 0.99 ng/ml per mg/d; p < 0.05) and lower O-desmethylvenlafaxine serum concentrations (0.69 +/- 0.35 vs. 1.51 +/- 0.9 ng/ml per mg/d; p < 0.01) compared to patients without melperone comedication. In the three patients, venlafaxine serum concentrations increased, on average by 52 % during melperone co-medication, whereas O-desmethylvenlafaxine was decreased, on average by 29 %. Administration of melperone over three days elevated the ratio of dextromethorphan to dextrorphan from 0.044 +/- 0.04 to 0.09 +/- 0.083 (p < 0.05). DISCUSSION: This study pointed to an inhibitory effect of melperone on the O-demethylation of venlafaxine. Because the O-demethylation of venlafaxine is almost exclusively catalyzed by CYP2D6 it is concluded that melperone is an inhibitor of CYP2D6. The hypothesis was further corroborated by the inhibitory effect of melperone on the dextromethorphan O-demethylation.

Adult↗
PubMed2003

Dosage finding and outcome of venlafaxine treatment in psychiatric outpatients and inpatients: results of a drug utilization observation study.

BACKGROUND: Venlafaxine is an antidepressive drug with the special characteristic of inhibiting both synaptic serotonin and norepinephrine reuptake. This double action is dosage dependent, with the relatively weaker inhibition of norepinephrine becoming clinically relevant only at higher dosages. This allows treatment to be tailored towards the needs of individual patients through differential dosing. It is unknown, however, how physicians use this unique feature in prescribing venlafaxine in routine treatment. METHOD: Data from a drug utilization observation (DUO) study, including 6706 patients, are used to investigate which patient and setting variables predict dosage of venlafaxine as prescribed by psychiatrists in inpatient and outpatient settings. Treatment outcome and adverse drug reactions (ADR) were analyzed for different dosage groups. RESULTS: Treatment setting is the most important factor in predicting high (> 75 mg/day) or low (up to 75 mg/day) dosage of venlafaxine, with inpatients receiving higher dosages. Severity of illness and a history of previous treatment with major antidepressives are also related to higher dosages. Although the total rate of ADR did not increase with increased dosage, the profile of drug reactions changed. Response to therapy was better in cases of non-chronic, major depression with no treatment history of antidepressives. Additionally, increased dosage increased the likelihood of response in outpatients. In both settings, very high dosages predicted better response to venlafaxine among severely ill patients. CONCLUSION: Venlafaxine at a dosage of 75 mg/day is sufficient for the majority of cases. In extremely ill patients, higher dosages are associated with additional benefits. Therefore, a stepwise dosage regimen is suggested, with an increase of dosage to upper limits in cases of non-response before discontinuation of treatment with venlafaxine.

Adolescent↗