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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

Mean change from baseline in VAS pain scores (LOCF).Note: No statistical comparisons were performed.Abbreviations: LOCF, last observation carried forward; VAS, visual analog scale.
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f2-jpr-6-311: Mean change from baseline in VAS pain scores (LOCF).Note: No statistical comparisons were performed.Abbreviations: LOCF, last observation carried forward; VAS, visual analog scale.

Mentions: Clinically significant improvements in global status (ie, PGIC score of 1 or 2) were found in 26/79 (32.9%) patients who were switched to milnacipran. In the small group of patients switched to placebo, 5/21 (23.8%) were improved (Table 2); however, as planned, sample sizes were not powered to evaluate between-group differences. At the week 6 and week 10 study visits, mean improvements in VAS pain score were found with milnacipran (−8.2 and −12.3, respectively, Figure 2); mean changes from baseline with placebo were minimal (+1.3 and −1.3 at weeks 6 and 10, respectively). Clinically meaningful improvements in pain (ie, ≥30% decrease from randomization in VAS pain score) were found in 27/29 (34.2%) of milnacipran-treated patients; 20/79 (25.3%) patients reported ≥50% pain improvement. In patients switched to placebo, 6/21 (28.6%) and 3/21 (14.3%) had ≥30% and ≥50% improvements in pain, respectively.


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)

Mean change from baseline in VAS pain scores (LOCF).Note: No statistical comparisons were performed.Abbreviations: LOCF, last observation carried forward; VAS, visual analog scale.
© Copyright Policy
Related In: Results  -  Collection

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

f2-jpr-6-311: Mean change from baseline in VAS pain scores (LOCF).Note: No statistical comparisons were performed.Abbreviations: LOCF, last observation carried forward; VAS, visual analog scale.
Mentions: Clinically significant improvements in global status (ie, PGIC score of 1 or 2) were found in 26/79 (32.9%) patients who were switched to milnacipran. In the small group of patients switched to placebo, 5/21 (23.8%) were improved (Table 2); however, as planned, sample sizes were not powered to evaluate between-group differences. At the week 6 and week 10 study visits, mean improvements in VAS pain score were found with milnacipran (−8.2 and −12.3, respectively, Figure 2); mean changes from baseline with placebo were minimal (+1.3 and −1.3 at weeks 6 and 10, respectively). Clinically meaningful improvements in pain (ie, ≥30% decrease from randomization in VAS pain score) were found in 27/29 (34.2%) of milnacipran-treated patients; 20/79 (25.3%) patients reported ≥50% pain improvement. In patients switched to placebo, 6/21 (28.6%) and 3/21 (14.3%) had ≥30% and ≥50% improvements in pain, respectively.

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