Efficacy and Safety of Duloxetine in Patients With Chronic Low Back Pain

Skljarevski, Vladimir; Desaiah, Durisala; Liu‐Seifert, Hong; Zhang, Qi; Chappell, Amy S.; Detke, Michael J.; Iyengar, Smriti; Atkinson, J. Hampton; Bačkonja, Miroslav

doi:10.1097/brs.0b013e3181d3cef6

Cited by 147 publications

(179 citation statements)

References 31 publications

(39 reference statements)

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“…Active treatment was superior to placebo in both 12-week trials when a 30% improvement in pain was defined as a positive response (Skljarevski et al, 2010a;Skljarevski et al, 2009) but only in 1 trial when a 50% improvement was defined as a positive response (Skljarevski et al, 2010a). Given modest efficacy, duloxetine may be a helpful adjunctive therapy (discussed below).…”

Section: Serotonin-norepinephrine Reuptake Inhibitorsmentioning

confidence: 99%

“…Duloxetine has shown modest efficacy in two 12-week trials (Skljarevski et al, 2010a;Skljarevski et al, 2009) and in a 41-week open-label study (Skljarevski et al, 2010b). Active treatment was superior to placebo in both 12-week trials when a 30% improvement in pain was defined as a positive response (Skljarevski et al, 2010a;Skljarevski et al, 2009) but only in 1 trial when a 50% improvement was defined as a positive response (Skljarevski et al, 2010a).…”

Section: Serotonin-norepinephrine Reuptake Inhibitorsmentioning

confidence: 99%

“…Duloxetine has only modest efficacy (Skljarevski et al, 2010a;Skljarevski et al, 2009), is associated with patients taking a product that combines a narcotic with acetaminophen and then augmenting it with additional acetaminophen (Larson et al, 2005). Overdose may also be deliberate (Camidge et al, 2003;Larson et al, 2005).…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Pharmacotherapy for Chronic Low Back Pain

Peniston¹

2012

Low Back Pain Pathogenesis and Treatment

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Section: Serotonin-norepinephrine Reuptake Inhibitorsmentioning

confidence: 99%

Section: Serotonin-norepinephrine Reuptake Inhibitorsmentioning

confidence: 99%

See 1 more Smart Citation

Pharmacotherapy for Chronic Low Back Pain

Peniston¹

2012

Low Back Pain Pathogenesis and Treatment

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“…However, no overall evidence of superior efficacy has been attributed to either of these drugs. 26 Other antiepileptic drugs may have a pain-relieving effect, but side-effects are a significant problem.…”

Section: Anticonvulsantsmentioning

confidence: 99%

The management of acute low back pain in adults: a guide for the primary care physician, Part II

Brighton

2013

South African Family Practice

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When a patient presents with acute low back pain (LBP), any red flag warnings of serious disease should first be excluded. Yellow and blue flag warnings of psychological factors should be noted. A psychological opinion of patients with substantial psychological distress could be sought. Advice may be offered on the benign nature of non-specific LBP. The person should be encouraged to be physically active and to continue with normal activities as far as possible. A structured exercise programme, that includes aerobic activity, movement instruction, muscle strengthening, postural control and stretching, should be devised. A combined exercise and psychological treatment programme that includes a cognitive behavioural approach can be considered in patients with significant disability or substantial psychological distress. A course of acupuncture may also be added. Manual therapy, including spinal manipulation, could be considered. Paracetamol should be the first medication option. If this is inadequate, a nonsteroidal anti-inflammatory drug or weak opioid, or both, can be added. Individual risks for side-effects and the patient's preference should be taken into account. Strong opioids should be considered in patients in severe pain, but for short-term use only. Antidepressants and gabapentine or pregabolin can be considered when there is a neurogenic component of the pain. Consider obtaining a surgical opinion on patients who have completed an optimal package of care and who still have persistent severe non-specific LBP. Progressive neurological fallout requires a surgical opinion.Peer reviewed.

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“…Using data from 2 clinical trials of duloxetine for the treatment of chronic pain, ie, chronic lower back pain (CLBP) (study 1), 6 and chronic pain due to osteoarthritis (OA) of the knee (study 2), 7 we investigated the underlying reasons for patient discontinuation from the trials and their roles in the BOCF approach, and propose examining modifications of the BOCF approach to take into consideration treatment-related and nontreatment-related reasons for discontinuation.…”

Section: Dovepressmentioning

confidence: 99%

A closer look at the baseline-observation-carried-forward (BOCF)

Liu‐Seifert

Zhang²,

D’Souza³

et al. 2010

PPA

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Purpose:The baseline-observation-carried-forward (BOCF) approach is one method to handle missing data from early treatment discontinuation. We examined modifications of this approach, taking into consideration treatment-related and nontreatment-related reasons for discontinuation. Methods: Two duloxetine chronic pain trials (placebo-controlled) were used to examine the impact of different analytical methods on study outcome. Reasons for discontinuation were categorized as treatment-related and nontreatment-related. Missing data in the primary efficacy outcome were handled using five statistical methods: mixed-model repeated measures (MMRM), last-observation-carried-forward (LOCF), BOCF, modified BOCF (mBOCF, discontinuation due to treatment-related reasons, ie, adverse events [AEs] or lack of efficacy), and aeBOCF (discontinuation due to AEs only). Results: Duloxetine was superior to placebo on mean change from baseline in Brief Pain Inventory average pain rating, using MMRM (study 1, P = 0.004; study 2, P  0.001), LOCF (study 1, P = 0.019; study 2, P  0.001), BOCF (study 1, P = 0.019; study 2, P = 0.013), and mBOCF (study 1, P = 0.041; study 2, P = 0.005). Using aeBOCF, duloxetine was superior to placebo in study 2 (P = 0.005) and numerically better in study 1 (P = 0.075). Conclusion: Due to the different assumptions made by various methods regarding accounting for missing data, the analytical methods chosen may influence the interpretation of study results. Consideration should be given to the effect of actual treatment outcomes from patients. Employing different statistical approaches such as sensitivity analyses may help to assess the robustness of the study results and provide a more accurate reflection of the treatment outcome.

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Efficacy and Safety of Duloxetine in Patients With Chronic Low Back Pain

Abstract: Duloxetine significantly reduced pain and improved functioning in patients with CLBP. The safety and tolerability were similar to those reported in earlier studies.

Cited by 147 publications

References 31 publications

Pharmacotherapy for Chronic Low Back Pain

Pharmacotherapy for Chronic Low Back Pain

The management of acute low back pain in adults: a guide for the primary care physician, Part II

A closer look at the baseline-observation-carried-forward (BOCF)

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