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Results of switching to milnacipran in fibromyalgia patients with an inadequate response to duloxetine: a phase IV pilot study.

Bateman L, Palmer RH, Trugman JM, Lin Y - J Pain Res (2013)

Bottom Line: The small placebo group was included solely to blind the study and minimize expectation bias among patients and investigators, and there was no preplanned statistical comparison between treatment groups.The primary efficacy parameter was the percentage of patients rating themselves as "much improved" or "very much improved" on the Patient Global Impression of Change (PGIC) at the final visit.Nausea and dizziness were the most common treatment-emergent adverse events in patients switched to milnacipran, reported in 21% and 15%, respectively, of patients in this group.

View Article: PubMed Central - PubMed

Affiliation: Fatigue Consultation Clinic, Salt Lake City, UT.

ABSTRACT

Background: The purpose of this study was to evaluate the safety, tolerability, and efficacy of milnacipran following a direct switch from duloxetine in fibromyalgia patients experiencing inadequate clinical response to duloxetine after receiving treatment for 6 weeks or longer.

Methods: This exploratory study included 107 patients with fibromyalgia who had been treated with duloxetine 60 mg/day for at least 4 weeks prior to enrollment. Following a 2-week open-label period on duloxetine, patients who had visual analog scale pain scores ≥ 40 and were dissatisfied with current treatment were randomized 4:1 to milnacipran 100 mg/day (n = 86) or placebo (n = 21) for 10 weeks of double-blind treatment. The small placebo group was included solely to blind the study and minimize expectation bias among patients and investigators, and there was no preplanned statistical comparison between treatment groups. The primary efficacy parameter was the percentage of patients rating themselves as "much improved" or "very much improved" on the Patient Global Impression of Change (PGIC) at the final visit. Other efficacy parameters included changes in one-week recall visual analog scale pain, Fibromyalgia Impact Questionnaire Revised (FIQR), and Multiple Ability Self-Report Questionnaire (MASQ).

Results: Of patients switched to milnacipran, 32.9% were classified as PGIC responders, and they also demonstrated improvement in visual analog scale pain, FIQR total, and MASQ total scores (mean changes from baseline were -12.3, -7.77, and -2.39, respectively). Nausea and dizziness were the most common treatment-emergent adverse events in patients switched to milnacipran, reported in 21% and 15%, respectively, of patients in this group.

Conclusion: Results from this exploratory study suggest that switching from duloxetine to milnacipran may be beneficial in some patients with fibromyalgia who have an inadequate response to duloxetine. Further research investigating the efficacy and safety of switching fibromyalgia therapies is warranted.

No MeSH data available.


Related in: MedlinePlus

Study flow.Note: *Placebo group included for blinding purposes only.Abbreviation: ITT, intent to treat.
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f1-jpr-6-311: Study flow.Note: *Placebo group included for blinding purposes only.Abbreviation: ITT, intent to treat.

Mentions: Of the 115 patients who received at least one dose of open-label duloxetine during the 2-week run-in period, 107 met the criteria for inadequate response to duloxetine and were randomized to double-blind treatment (Figure 1). In the group switched to milnacipran, 51/86 (59.3%) patients completed the study. The most common reasons for discontinuation were adverse events for milnacipran (15/86 [17.4%]) and insufficient therapeutic response for placebo (6/21 [28.6%]). In the milnacipran group, one patient who did not receive double-blind treatment was excluded from safety and intent-to-treat efficacy analyses; five patients without post-baseline efficacy assessments were excluded from the intent-to-treat population. All randomized patients in the placebo group were included in the safety and efficacy analyses.


Results of switching to milnacipran in fibromyalgia patients with an inadequate response to duloxetine: a phase IV pilot study.

Bateman L, Palmer RH, Trugman JM, Lin Y - J Pain Res (2013)

Study flow.Note: *Placebo group included for blinding purposes only.Abbreviation: ITT, intent to treat.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3643187&req=5

f1-jpr-6-311: Study flow.Note: *Placebo group included for blinding purposes only.Abbreviation: ITT, intent to treat.
Mentions: Of the 115 patients who received at least one dose of open-label duloxetine during the 2-week run-in period, 107 met the criteria for inadequate response to duloxetine and were randomized to double-blind treatment (Figure 1). In the group switched to milnacipran, 51/86 (59.3%) patients completed the study. The most common reasons for discontinuation were adverse events for milnacipran (15/86 [17.4%]) and insufficient therapeutic response for placebo (6/21 [28.6%]). In the milnacipran group, one patient who did not receive double-blind treatment was excluded from safety and intent-to-treat efficacy analyses; five patients without post-baseline efficacy assessments were excluded from the intent-to-treat population. All randomized patients in the placebo group were included in the safety and efficacy analyses.

Bottom Line: The small placebo group was included solely to blind the study and minimize expectation bias among patients and investigators, and there was no preplanned statistical comparison between treatment groups.The primary efficacy parameter was the percentage of patients rating themselves as "much improved" or "very much improved" on the Patient Global Impression of Change (PGIC) at the final visit.Nausea and dizziness were the most common treatment-emergent adverse events in patients switched to milnacipran, reported in 21% and 15%, respectively, of patients in this group.

View Article: PubMed Central - PubMed

Affiliation: Fatigue Consultation Clinic, Salt Lake City, UT.

ABSTRACT

Background: The purpose of this study was to evaluate the safety, tolerability, and efficacy of milnacipran following a direct switch from duloxetine in fibromyalgia patients experiencing inadequate clinical response to duloxetine after receiving treatment for 6 weeks or longer.

Methods: This exploratory study included 107 patients with fibromyalgia who had been treated with duloxetine 60 mg/day for at least 4 weeks prior to enrollment. Following a 2-week open-label period on duloxetine, patients who had visual analog scale pain scores ≥ 40 and were dissatisfied with current treatment were randomized 4:1 to milnacipran 100 mg/day (n = 86) or placebo (n = 21) for 10 weeks of double-blind treatment. The small placebo group was included solely to blind the study and minimize expectation bias among patients and investigators, and there was no preplanned statistical comparison between treatment groups. The primary efficacy parameter was the percentage of patients rating themselves as "much improved" or "very much improved" on the Patient Global Impression of Change (PGIC) at the final visit. Other efficacy parameters included changes in one-week recall visual analog scale pain, Fibromyalgia Impact Questionnaire Revised (FIQR), and Multiple Ability Self-Report Questionnaire (MASQ).

Results: Of patients switched to milnacipran, 32.9% were classified as PGIC responders, and they also demonstrated improvement in visual analog scale pain, FIQR total, and MASQ total scores (mean changes from baseline were -12.3, -7.77, and -2.39, respectively). Nausea and dizziness were the most common treatment-emergent adverse events in patients switched to milnacipran, reported in 21% and 15%, respectively, of patients in this group.

Conclusion: Results from this exploratory study suggest that switching from duloxetine to milnacipran may be beneficial in some patients with fibromyalgia who have an inadequate response to duloxetine. Further research investigating the efficacy and safety of switching fibromyalgia therapies is warranted.

No MeSH data available.


Related in: MedlinePlus