Savella for fibromyalgia – impact on FIQ score

Savella - milnaciran label
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Quick Look

Does Savella reduce the FIQ score?

Science: Yes, Savella use for 12-weeks resulted in a small but statistically significant reduction in total FIQ score.

Conclusion: On average, those using Savella for 12 weeks will reduce their FIQ score by about 5 points.

 

A 12 week trial of Savella in the treatment of fibromyalgia.

Approximately 500 patients received Savella, 50 mg twice a day, for 12 weeks. Prior to the 12 week period, patients had their dose of Savella gradually increased over 4 to 6 weeks in preparation for the 12 week stable dose phase of the study.

Outcome in terms of FIQ score reduction

Savella - milnaciran labelThe Fibromyalgia Impact Questionnaire (FIQ) was utilized as one of several secondary outcome measures.

The average initial FIQ score of those receiving Savella was 56.7. After 12 weeks of stable dose Savella treatment the average FIQ score decreased by a placebo-adjusted 5.22 points (active drug decrease was 12.34 while those receiving placebo had a 7.12 decrease.)

The placebo-adjusted decrease in total FIQ score after 12 weeks of Savella treatment was 9.2%.

Among those receiving Savella, the average initial score on the physical function sub-scale of the FIQ was 4.33 (adjusted, this score ranges from 0-10.) After 12 weeks of stable dose treatment with Savella this score decreased by a placebo-adjusted 0.33 points.

The placebo-adjusted decrease in the physical function sub-scale of the FIQ after 12 weeks of Savella treatment was 7.7%.

Pain relief

On the basis of 24-hour pain recall, treatment with Savella at a stable dose of 100 mg per day for 12 weeks provided significant pain relief.

Among patients receiving Savella, the average initial 24-hour pain recall was 63.1 (out of a possible 100.)

After 12 weeks of treatment with Savella, the average placebo-adjusted 24-hour pain recall decreased by just under 7 points, or about 10%.

Other Outcomes

Depression, assessed by the Beck Depression Inventory (BDI.)

It’s important to note that anyone with a BDI score of greater than 25 was excluded from this clinical trial, so it’s uncertain to what extent the results can be generalized to fibromyalgia patients in general, many of whom are significantly depressed.

On the Beck Depression Inventory:

  • 0-13 = minimal depression
  • 14-19 = mild depression
  • 20-28 = moderate depression
  • 29-63 = severe depression

The initial average BDI score among those receiving Savella was 9.1 (so the average patient was minimally depressed.)

After 12 weeks of treatment with Savella, the average placebo-adjusted BDI score decreased by 0.89. (Average total decrease with Savella = 2.12 points; average placebo decrease = 1.24 points.)

So it seems that those who are minimally depressed might see, on average, a slight reduction (just under 10%) in their depression after 12 weeks of Savella treatment.

Fatigue, assessed by the Multidimensional Fatigue Inventory (MFI.)

Among patients receiving Savella, the average initial fatigue as rated by the MFI was 67.4 (out of a possible 100 points.)

After 12 weeks of treatment with Savella, the average placebo-adjusted MFI score decreased by 1.69, or 2.5%. (Average total decrease with Savella = 4.31 points; average placebo decrease = 2.61 points.)

Anxiety, assessed by the Beck Anxiety Index (BAI.)

Among patients receiving Savella, the average initial anxiety as rated by the BAI was 12.7 (out of a possible 63 points.)

After 12 weeks of treatment with Savella, the average placebo-adjusted BAI score increased by 0.99, or 7.8%. (Average total decrease with Savella = 0.74 points; average placebo decrease = 1.73 points.)

 

September 2010

Efficacy and safety of milnacipran (Savella) 100 mg/day in patients with fibromyalgia: results of a randomized, double-blind, placebo-controlled trial.

Summary of the Abstract

A randomized controlled trial of milnacipran (Savella) in the treatment of fibromyalgia enrolled 1,025 patients who used Savella for 12 weeks after an initial 4 to 6 weeks of dose escalation. Approximately half the participants received Savella at 50 mg twice a day, while the other half were administered placebo (‘sugar pill’) Neither the researchers conducting the trial nor the patients were intended to know which patients received placebo and which received Savella. That is, the trial was “double blinded”.

The effect of Savella on the Fibromyalgia Impact Questionnaire (FIQ) score was evaluated as one of several secondary endpoints. Primary endpoints included improvement in pain score and Patient Global Impression of Change (PGIC.)

After 12 weeks of treatment, those receiving milnacipran had significant improvement in multiple secondary outcome measures, including pain recall, PGIC score, FIQ score, and Multidimensional Fatigue Inventory.

Nausea was the the most commonly reported side effect and was reported by 36.6% of those using milnacipran vs 20.8% of those receiving placebo (placebo-adjusted rate of nausea with Savella treatment = 15.8%.) Constipation, dizziness, and hot flush were also common with Savella use, having been reported by over 10% of users at a rate more than double that for the placebo.

The most serious common side effect was hypertension (high blood pressure) and tachycardia (rapid heart rate,) each reported by just over 5% of those receiving Savella vs 1% of those receiving placebo.


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