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Novel drug helped in Fibromyalgia

Sunday 1 July 2012


From MedPage Today:


TabletsNovel Drug Helped in Fibromyalgia

This report is part of a 12-month Clinical Context series.

By Nancy Walsh, Staff Writer, MedPage Today
Published: June 29, 2012

Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston

Treatment with a novel selective norepinephrine reuptake inhibitor led to decreases in pain among patients with fibromyalgia and lessened the impact of the disease on their daily lives, a large multicenter clinical trial found.

Among patients receiving 4 mg per day of esreboxetine for 14 weeks, mean change in pain score from baseline was −0.74 (95% CI −1.10 to −0.37, P<0.001), according to Lesley M. Arnold, MD, of the University of Cincinnati, and colleagues.

And in patients receiving 8 mg per day, the change in pain score was −0.76 (95% CI −1.13 to −0.04, P<0.001), the researchers reported in the July Arthritis & Rheumatism.

Action Points

Explain that esreboxetine, a selective norepinephrine reuptake inhibitor, decreased pain and improved fibromyalgia status compared with placebo over a 14-week trial.

Note that the drug, which was removed from development, also had a good safety profile.

Nonetheless, clinical development of esreboxetine was discontinued by the manufacturer "as part of an overall portfolio review," not because of concerns about efficacy or safety, according to the investigators.

"The findings from this study suggest that other selective norepinephrine reuptake inhibitors may be useful therapeutic agents for the management of fibromyalgia," wrote Arnold and colleagues.

The rationale for using norepinephrine reuptake inhibitors in pain conditions derives from the belief that this neurotransmitter can inhibit pain signaling in a pathway involving analgesia and also can reduce pain sensitivity.

Because a proof-of-concept study suggested that esreboxetine eased pain and fatigue in patients with fibromyalgia, the investigators enrolled 1,122 patients from more than 130 centers in North America, randomizing them to placebo or 4 mg, 8 mg, or 10 mg of esreboxetine per day.

Most patients were white women about 50 years of age who had fibromyalgia for about 7 years.

After 14 weeks of treatment, a decrease in pain of 30% or more was reported in the 4 mg and 8 mg groups:

  • 4 mg, 37% (OR 1.51, 95% CI 1.06 to 2.17, P=0.024)
  • 8 mg, 39.4% (OR 1.68, 95% CI 1.18 to 2.40, P=0.004)

Overall symptoms and the effects of the disease on factors such as physical functioning, difficulty with work, and depression were assessed on the Fibromyalgia Impact Questionnaire, showing significant differences from baseline:

  • 4 mg, −7.12 (95% CI −10.47 to −3.76, P<0.001)
  • 8 mg, −6.67 (95% CI −10.02 to −3.33, P<0.001)
  • 10 mg, −3.88 (95% CI −7.21 to −0.54, P=0.023)

Statistically significant changes also were seen for the 4 mg and 8 mg doses on the Patient Global Impression of Change scale and the Global Fatigue Index, though not on the Short Form-36 measure of health-related quality of life.

Most adverse effects were mild to moderate, and were typical of drugs with noradrenergic effects, such as insomnia, dry mouth, constipation, and nausea.

However, moderate-to-severe insomnia was reported by 10.7%, constipation by 7.8%, dry mouth by 5.6%, and nausea by 4.8% of patients receiving the active treatment compared with 2.6%, 0.4%, 0.4%, and 1.1% of those on placebo.

Cardiovascular changes seen in patients receiving esreboxetine included standing pulse rates of 100 beats per minute or more in 16.5%, 17%, and 17.4% of patients receiving the 4 mg, 8 mg, and 10 mg doses, respectively, compared with 3% of those receiving placebo.

Palpitations also were reported by 4.1% of the esreboxetine patients compared with 2.5% of the placebo patients.

Increases in supine systolic blood pressure of 0.9 mm Hg and 2.4 mm Hg over baseline were observed in the 4 mg and 8 mg groups, while increases in diastolic pressures were 2.8 mm Hg and 4.3 mm Hg, respectively.

"The clinical relevance of such increases is unknown and requires further study," Arnold and colleagues wrote.

"Overall, these findings demonstrated a significant and clinically meaningful effect of esreboxetine in the management of pain and fatigue and in the overall impact of fibromyalgia," they stated.

They noted that the study had limitations, including its short duration and the requirement that participants stop other fibromyalgia medications, which could have resulted in the exclusion of patients with worse disease.

The study was supported by Pfizer.

Arnold has received consulting fees and research grants from various companies, including Pfizer, Eli Lilly Takeda, AstraZeneca, Boehringer Ingelheim, and Novartis.

Her co-authors were employees of Pfizer Global Research and Development.

Primary source: Arthritis & Rheumatism
Source reference:
Arnold L, et al "Safety and efficacy of esreboxetine in patients with fibromyalgia: a 14-week, randomized, double-blind, placebo-controlled, multicenter clinical trial" Arthritis Rheum 2012; 64: 2387-2397.


The above originally appeared here.


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