P.1.096 Remission rates in double-blind, placebo-controlled clinical trials of duloxetine with SSRI as a comparator

Thase, M.E.; Lu, Yingjie; Joliat, Melissa J.; Detke, Michael J.

doi:10.1016/s0924-977x(03)91806-2

Cited by 8 publications

(7 citation statements)

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“…Duloxetine was most effective in the dose range of 60 -120 mg/d, as can be seen in Table 8. It produced remission rates superior to those of SSRIs in a pooled analysis [115]. It was safe and well-tolerated, with an adverse event profile similar to that of the SSRI antidepressants, good cardiac safety, and an intriguing finding strongly suggesting that it may induce less sexual dysfunction, a critical barrier to long-term compliance with SSRIs.…”

Section: Major Depressive Disordermentioning

confidence: 88%

The Dual Transporter Inhibitor Duloxetine: A Review of its Preclinical Pharmacology, Pharmacokinetic Profile, and Clinical Results in Depression

Bymaster¹,

Lee²,

Knadler³

et al. 2005

CPD

143

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Major depressive disorder (MDD) poses a significant health problem and is estimated to be the third most costly and disabling disorder in the United States. Pharmacotherapy of depression has been successful, but improvements in response rates, remission rates, side effects, compliance and faster onset of therapeutic action have become prime objectives in drug development. There is considerable support for the hypothesis that dysfunctional serotonergic or noradrenergic neurotransmission may be etiological in depressed patients. Duloxetine is a balanced and potent reuptake inhibitor of serotonin (5-HT) and norepinephrine (NE) being studied as an antidepressant medication. In this review, we highlight the preclinical pharmacology, pharmacokinetic profile, and effects of duloxetine in the pharmacotherapy of depression. Evidence for 5-HT and NE reuptake inhibition by duloxetine comes from in vitro and in vivo transporter binding and functional uptake studies. Taken together with efficacy data from in vivo microdialysis, electrophysiological and behavioral studies, it is evident that duloxetine is balanced as a dual serotonin norepinephrine uptake inhibitor in vivo. The clinical efficacy and safety of duloxetine in the treatment of MDD has been studied in 6 multicenter, randomized, double-blind, placebo-controlled trials. In these studies, duloxetine was found to be effective in the treatment of emotional/psychological and painful physical symptoms associated with depression. More importantly, duloxetine appears to have better response rates and remission from depressive symptoms, perhaps due to its ability to treat a wider range of symptoms.

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Section: Major Depressive Disordermentioning

confidence: 88%

The Dual Transporter Inhibitor Duloxetine: A Review of its Preclinical Pharmacology, Pharmacokinetic Profile, and Clinical Results in Depression

Bymaster¹,

Lee²,

Knadler³

et al. 2005

CPD

143

View full text Add to dashboard Cite

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“…This was largely replicated by Nemeroff et al in his team’s meta-analysis and also by a smaller study by Smith et al, all observing superior response rates for SNRIs [ 36 , 37 ]. A pooled analysis of another SNRI, duloxetine, utilizing less RCT data, found no statistical differences with SSRI [ 38 ] despite better response rates and higher HAM-D scale scores. It is currently unclear, therefore, whether SNRIs globally achieve a greater effect in MDD treatment or whether the effect is drug or dose dependent.…”

Section: Adt: Comparing Classes and Compoundsmentioning

confidence: 99%

Antidepressant efficacy and side-effect burden: a quick guide for clinicians

Santarsieri¹,

Schwartz²

2015

DIC

155

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Prescribing of antidepressant treatment (ADT) for major depressive disorder (MDD) has increased in quantity and popularity over the last two decades. This is likely due to the approval of safer medications, better education of clinicians and their patients, direct-to-consumer marketing practices, and less stigma associated with those taking ADT. This trend has also been met with some controversy, however, as the ongoing safety and effectiveness of these treatments have at times been called into question. This paper discusses the differing levels of evidence that support the use of ADT based on (A) Food and Drug Administration approvals, (B) data from randomized controlled trials or meta-analyses and, where these are not available, the authors discuss and apply, (C) theoretical pharmacodynamic principles to justify antidepressant choice in the treatment of MDD patients. The final section discusses standard psychopharmacology guideline approaches to better alert the reader as to which practices are commonplace compared with those which are more outside of the standard of care.

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“…Although these are the only studies comparing duloxetine with SSRI that have been published to date, other studies have been carried out. A pooled analysis of six placebo-controlled studies, 68 including two against fluoxetine 20 mg/day and one against paroxetine 20 mg/day, have been presented as a poster. Although treatment with a SSRI in 423 subjects resulted in a numerically higher remission rate than placebo (n=5O7), the difference was not significant.…”

Section: ' 57mentioning

confidence: 99%

SNRIs: The Pharmacology, Clinical Efficacy, and Tolerability in Comparison with Other Classes of Antidepressants

Stahl¹,

Grady²,

Moret³

et al. 2005

CNS spectr.

409

271

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FOCUS POINTS 1 Venlafaxine, milnacipran, and duloxetine block the reuptake of serotonin (5-HT) and norepinephrine (NE) with differing selectivity. Approximate potency ratios (5-HT:NE) are 1:1 for milnacipran, 1:10 for duloxetine, and 1:30 for venlafaxine.• When used at doses that cause inhibition of the reuptake of both 5-HT and NE, treatment with all three serotonin and norepinephrine reuptake inhibitors (SNRIs) produce higher rates of response and remission from major depression than the selective serotonin reuptake inhibitors (SSRIs). 1 SNRIs are effective in treating a variety of anxiety disorders. Efficacy of SNRIs and SSRIs in anxiety is comparable. 1 SNRIs are effective in the treatment of chronic pain, whereas SSRIs are generally not useful. ' Venlafaxine seems t o be the least well-tolerated SNRI, combining a high level of serotonergic adverse effects (nausea, sexual dysfunction, w i t h d r a w a l problems) with dose-dependent hypertension. In contrast, duloxetine and milnacipran appear better tolerated and essentially devoid of cardiovascular toxicity. ABSTRACT The class of serotonin and norepinephrine reuptake inhibitors (SNRIs) now comprises three medications: venlafaydne, milnacipran, and duloxetine. These drugs block the reuptake of both serotonin (5-HT) and norepineph-rine with differing selectivity. Whereas milnacipran blocks 5-HT and norepinephrine reuptake with equal affinity, duloxetine has a 10-fold selectivity for 5-HT and venlafaxine a 30-fold selectivity for 5-HT. M three SNRIs are efficacious in treating a variety of anxiety disorders. There is no evidence for major differences between SNRIs and SSRIs in their efficacy in treating anxiety disorders. In contrast to SSRIs, which are generally ineffective in treating chronic pain, all three SNRIs seem to be helpful in relieving chronic pain associated with and independent of depression. Tolerability of an SNRI at therapeutic doses varies within the class. Although no direct comparative data are available, venlafaxine seems to be the least well-tolerated, combining serotonergic adverse effects (nausea, sexual dysfunction, withdrawal problems) with a dose-dependent cardiovascular phenomenon, principally hypertension. Duloxetine and milnacipran appear better tolerated and essentially devoid of cardiovascular toxicity.* Positive numbers: more selective uptake inhibition and binding for NE transporter than 5-HT transporter. Negative numbers: more selective for 5-HT transporter than NE transporter. Adapted with permission from the Journal of Clinical Psychiatry. Owens MJ. Selectivity of antidepressants: from the monoamine hypothesis of depression to the SSRI revolution and beyond. * Taken from a meta-analysis comparing milnacipran 100 mg/day (n=1,871) and SSRIs. 43 * 4 t Taken from a pooled analysis of venlafaxine (IR and XR) used at variable doses from 75-225 mg/day (n=851) and SSRIs (n=748). 45p46 t Taken from a comparative study of duloxetine 40 mg/day (data not shown) and 80 mg/day (n=91) and paroxetine 20 mg/day (n=87). 47 § Response rate is...

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P.1.096 Remission rates in double-blind, placebo-controlled clinical trials of duloxetine with SSRI as a comparator

Cited by 8 publications

References 0 publications

The Dual Transporter Inhibitor Duloxetine: A Review of its Preclinical Pharmacology, Pharmacokinetic Profile, and Clinical Results in Depression

The Dual Transporter Inhibitor Duloxetine: A Review of its Preclinical Pharmacology, Pharmacokinetic Profile, and Clinical Results in Depression

Antidepressant efficacy and side-effect burden: a quick guide for clinicians

SNRIs: The Pharmacology, Clinical Efficacy, and Tolerability in Comparison with Other Classes of Antidepressants

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