Desvenlafaxine for the Acute Treatment of Depression: A Systematic Review and Meta-analysis

Laoutidis, Zacharias G.; Kioulos, Kanellos T.

doi:10.1055/s-0035-1555879

Cited by 16 publications

(12 citation statements)

References 33 publications

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“…The US Food and Drug Administration (FDA) approved all 4 target drugs 5 to 11 years before the study period, and all have generic alternatives in their class. 24 There is limited, mixed, or contrary evidence about the superiority of these 4 drugs over generic alternatives, [25][26][27][28] and all 4 are excluded from the national formulary for the US Department of Veterans Affairs medical sytem. 29…”

Section: Selection Of Target Drugsmentioning

confidence: 99%

Pharmaceutical Industry–Sponsored Meals and Physician Prescribing Patterns for Medicare Beneficiaries

et al. 2016

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IMPORTANCE The association between industry payments to physicians and prescribing rates of the brand-name medications that are being promoted is controversial. In the United States, industry payment data and Medicare prescribing records recently became publicly available. OBJECTIVE To study the association between physicians' receipt of industry-sponsored meals, which account for roughly 80% of the total number of industry payments, and rates of prescribing the promoted drug to Medicare beneficiaries. DESIGN, SETTING, AND PARTICIPANTS Cross-sectional analysis of industry payment data from the federal Open Payments Program for August 1 through December 31, 2013, and prescribing data for individual physicians from Medicare Part D, for all of 2013. Participants were physicians who wrote Medicare prescriptions in any of 4 drug classes: statins, cardioselective β-blockers, angiotensin-converting enzyme inhibitors and angiotensin-receptor blockers (ACE inhibitors and ARBs), and selective serotonin and serotonin-norepinephrine reuptake inhibitors (SSRIs and SNRIs). We identified physicians who received industry-sponsored meals promoting the most-prescribed brand-name drug in each class (rosuvastatin, nebivolol, olmesartan, and desvenlafaxine, respectively). Data analysis was performed from August 20, 2015, to December 15, 2015. EXPOSURES Receipt of an industry-sponsored meal promoting the drug of interest. MAIN OUTCOMES AND MEASURES Prescribing rates of promoted drugs compared with alternatives in the same class, after adjustment for physician prescribing volume, demographic characteristics, specialty, and practice setting. RESULTS A total of 279 669 physicians received 63 524 payments associated with the 4 target drugs. Ninety-five percent of payments were meals, with a mean value of less than $20. Rosuvastatin represented 8.8% (SD, 9.9%) of statin prescriptions; nebivolol represented 3.3% (7.4%) of cardioselective β-blocker prescriptions; olmesartan represented 1.6% (3.9%) of ACE inhibitor and ARB prescriptions; and desvenlafaxine represented 0.6% (2.6%) of SSRI and SNRI prescriptions. Physicians who received a single meal promoting the drug of interest had higher rates of prescribing rosuvastatin over other statins (odds ratio [OR], 1.18; 95% CI, 1.17-1.18), nebivolol over other β-blockers (OR, 1.70; 95% CI, 1.69-1.72), olmesartan over other ACE inhibitors and ARBs (OR, 1.52; 95% CI, 1.51-1.53), and desvenlafaxine over other SSRIs and SNRIs (OR, 2.18; 95% CI, 2.13-2.23). Receipt of additional meals and receipt of meals costing more than $20 were associated with higher relative prescribing rates. CONCLUSIONS AND RELEVANCE Receipt of industry-sponsored meals was associated with an increased rate of prescribing the brand-name medication that was being promoted. The findings represent an association, not a cause-and-effect relationship.

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Section: Selection Of Target Drugsmentioning

confidence: 99%

Pharmaceutical Industry–Sponsored Meals and Physician Prescribing Patterns for Medicare Beneficiaries

et al. 2016

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“…Several meta-analyses have previously assessed the efficacy of desvenlafaxine at the population level based on HAM-D 17 total score or remission rates (Carrasco et al, 2016; Laoutidis and Kioulos, 2015; Thase et al, 2009). Overall, desvenlafaxine is associated with significant improvement on efficacy measures.…”

Section: Discussionmentioning

confidence: 99%

Effects of desvenlafaxine versus placebo on MDD symptom clusters: A pooled analysis

et al. 2020

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Background: Major depressive disorder is characterized by the presence of at least five of nine specific symptoms that contribute to clinically significant functional impairment. This analysis examined the effect of desvenlafaxine (50 or 100 mg) versus placebo on symptom cluster scores and the association between early improvement in symptom clusters and symptomatic or functional remission at week 8. Methods: Using data from nine double-blind, placebo-controlled studies of desvenlafaxine for the treatment of major depressive disorder ( N=4317), the effect of desvenlafaxine 50 or 100 mg versus placebo on scores for symptom clusters based on 17-item Hamilton Rating Scale for Depression items was assessed using analysis of covariance. Association between early improvement in symptom clusters (⩾20% improvement from baseline at week 2) and symptomatic and functional remission (17-item Hamilton Rating Scale for Depression total score ⩽7; Sheehan Disability Scale score <7) at week 8 was analyzed using logistic regression. Symptom clusters based on Montgomery–Åsberg Depression Rating Scale were also examined. Results: Desvenlafaxine 50 or 100 mg was associated with significant improvement from baseline compared to placebo for all symptom clusters ( p<0.001), except a sleep cluster for desvenlafaxine 100 mg. For all symptom clusters, early improvement was significantly associated with achievement of symptomatic and functional remission at week 8 for all treatment groups ( p⩽0.0254). Conclusion: Early improvement in symptom clusters significantly predicts symptomatic or functional remission at week 8 in patients with depression receiving desvenlafaxine (50 or 100 mg) or placebo. Importantly, patients without early improvement were less likely to remit.

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“…The current prescribing guidelines for ODV recommend a dose of 50 mg/day, although doses of 50–400 mg/day were shown to be effective, no additional benefit was demonstrated at the higher doses with side effects being more prevalent (Boyer et al, ; Laoutidis & Kioulos, ; Liebowitz et al, ; Montgomery, Fava, Tourian, Padmanabhan, & Guico‐Pabia, ). This study demonstrates that at a dose of 50 mg/day ODV SERT occupancy is, on average, ∼80%, consistent with previous studies of antidepressants showing > 80% occupancy of the SERT is required for antidepressant effectiveness (Meyer et al, ; Meyer, Wilson, et al, ; Suhara et al, ).…”

Section: Discussionmentioning

confidence: 99%

An open‐label positron emission tomography study to evaluate serotonin transporter occupancy following escalating dosing regimens of (R)‐(–)‐O‐desmethylvenlafaxine and racemic O‐desmethylvenlafaxine

Frankle

Robertson

Maier³

et al. 2017

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SEP-227162 [R(-)-O-desmethylvenlafaxine] is an enantiomer of the venlafaxine metabolite O-desmethylvenlafaxine (ODV, Pristiq™, Wyeth). This study compared the serotonin transporter (SERT) occupancy achieved by SEP-227162 and ODV, at daily doses of 25, 50, 100, and 150 mg using [ C]DASB positron emission tomography (PET). Sixteen healthy male subjects participated in one of four dose groups (N = 4 per group) during which they were administered two doses of the study drug (SEP-227162 or ODV). For each study drug, total daily doses of 25, 50, 100, and150 mg were studied. Subjects underwent three PET scans with [ C]DASB. A baseline, off-medication, scan was performed prior to dosing and a [ C]DASB PET scan was performed after 72 hr at each dose level. [ C]DASB binding potential (BP ) was calculated using the simplified reference tissue method. SERT occupancy was calculated as the change in BP (ΔBP ) from baseline scan to the on-medication scan relative to the baseline BP value. SEP-227162 and ODV significantly reduced regional distribution volumes and region BP values in a dose-dependent manner. Across all doses ODV produced significantly greater SERT occupancy than SEP-227162 (ANOVA F = 21.8, df = 1,23, p < .001). The total daily dose required to provide 50% SERT occupancy was 24.8 mg for SEP-227162 and 14.4 mg for ODV. In vitro data suggests a ratio of 3.3:1 for binding at human SERT for SEP-227162 relative to ODV. Our study suggests a ratio of 1.7:1, highlighting the value of in vivo imaging in the drug development process.

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Desvenlafaxine for the Acute Treatment of Depression: A Systematic Review and Meta-analysis

Cited by 16 publications

References 33 publications

Pharmaceutical Industry–Sponsored Meals and Physician Prescribing Patterns for Medicare Beneficiaries

Pharmaceutical Industry–Sponsored Meals and Physician Prescribing Patterns for Medicare Beneficiaries

Effects of desvenlafaxine versus placebo on MDD symptom clusters: A pooled analysis

An open‐label positron emission tomography study to evaluate serotonin transporter occupancy following escalating dosing regimens of (R)‐(–)‐O‐desmethylvenlafaxine and racemic O‐desmethylvenlafaxine

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