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Research Article

Safety and Effectiveness of Once-Daily Hysingla Extended-Release Tablets in Patients with Baseline Depression or Anxiety

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Pages 473-488 | Received 27 Apr 2017, Accepted 03 Jul 2017, Published online: 27 Jul 2017

Figures & data

Table 1. Summary of demography and baseline characteristics of patients with and without active depression/anxiety

Table 2. Summary of medical history terms occurring in ≥10% of patients prior to enrollment by preferred term.

Table 3. Concomitant medications used to treat pain in ≥2% of patients with and without active depression/anxiety at baseline.

Table 4. Summary of patient disposition and reasons for study discontinuation among patients with and without active depression/anxiety at baseline.

Table 5. Opioid-related treatment-emergent adverse events in patients with depression/anxiety at baseline.

Figure 1. Mean ‘average pain over the last 24 h’ scores during the study in patients with and without depression/anxiety at baseline.

DT: Dose titration; HYD: Hydrocodone bitartrate; SE: Standard error.

Figure 1. Mean ‘average pain over the last 24 h’ scores during the study in patients with and without depression/anxiety at baseline.DT: Dose titration; HYD: Hydrocodone bitartrate; SE: Standard error.

Table 6. Brief pain inventory short form.

Figure 2. Mean ‘pain right now’ scores recorded daily immediately prior to dosing and at 12 h postdose and mean ‘Average Pain Over the Last 24 h’ score during the first 3 months of the maintenance period (dashed line) in patients (A) with and (B) without baseline depression/anxiety.

Error bars represent the standard deviation.

Figure 2. Mean ‘pain right now’ scores recorded daily immediately prior to dosing and at 12 h postdose and mean ‘Average Pain Over the Last 24 h’ score during the first 3 months of the maintenance period (dashed line) in patients (A) with and (B) without baseline depression/anxiety.Error bars represent the standard deviation.
Figure 3. Mean daily dose of hydrocodone bitartrate and supplemental opioid analgesics during the titration and maintenance periods in patients with and without depression/anxiety at baseline.

HYD: Hydrocodone bitartrate; SE: Standard error.

Figure 3. Mean daily dose of hydrocodone bitartrate and supplemental opioid analgesics during the titration and maintenance periods in patients with and without depression/anxiety at baseline.HYD: Hydrocodone bitartrate; SE: Standard error.
Figure 4. Hydrocodone bitartrate dose adjustments during the maintenance period in patients (A) with and (B) without depression/anxiety at baseline.

HYD: Hydrocodone bitartrate.

Figure 4. Hydrocodone bitartrate dose adjustments during the maintenance period in patients (A) with and (B) without depression/anxiety at baseline.HYD: Hydrocodone bitartrate.

Table 7. Treatment satisfaction questionnaire.