If you’ve been diagnosed with fibromyalgia, chances are your physician has written you a prescription to try at least one of the three drugs – Lyrica, Cymbalta or Savella – currently approved by the U.S. Food and Drug Administration to treat fibromyalgia.
And chances are you may have been disappointed when those drugs didn’t work.
Well, here’s what your doctor won’t tell you, or maybe he/she doesn’t even realize: The drugs approved to treat fibromyalgia aren’t much better than sugar pills. The results of several clinical trials support this.
In 2007, Lyrica became the first FDA-approved drug for fibro. At the time of the writing of this post, Lyrica’s website reads, “In clinical studies, many patients taking Lyrica had less fibromyalgia pain compared with patients taking a placebo (53% for Lyrica vs. 33% for placebo), so they felt better and could do more.”
But that statistic paints a somewhat distorted picture of Lyrica’s effectiveness, lumping improved patients into one group. Dig a little deeper into Pfizer’s research, and you’ll find the numbers aren’t nearly as impressive. During Pfizer’s first Lyrica trial for fibro:
- Only 20-21 percent of patients experienced at least a 50 percent reduction in pain, depending on the administered dose (dosages ranged from 300-600mg a day).
- Between 34-38 percent reported at least a 30 percent improvement in pain, depending on the dose. On the surface, this sounds ok … until you look at the number of patients who responded in the placebo (i.e. a sugar pill) group. About 27 percent of those patients reported the same 30 percent improvement in pain when taking a placebo! So, Lyrica only outperformed a sugar pill by a few percentage points.
I know Lyrica is a godsend for patients when it works, and I am in no way anti-pharmaceutical, but looking strictly at the numbers, Lyrica’s performance is hardly reliable.
Reading further down into the study, the numbers are even more dismal when you consider that 36 percent of the study’s participants didn’t even complete the trial. Many of those patients dropped out due to adverse side effects, such as dizziness, blurry vision, weight gain, sleepiness, trouble concentrating, swelling of the hands and feet, dry mouth and feeling “high.” (Let me point out that some of these side effects are the very ones we are trying to avoid by taking these medications.)
Now, let’s move on to Cymbalta. Cymbalta is probably best recognized for its “Depression Hurts” commercials. It gained FDA approval for the treatment of fibro in 2008 following two randomized trials.
Cymbalta also has a less-than-stellar success rate among fibro patients, but to its credit, it does outperform Lyrica:
- During an initial trial, only about 32-36 percent of patients reported at least a 50 percent reduction in pain, depending on the dosage administered (60mg was given once or twice a day).
- About 40-46 percent of patients saw at least a 30 percent reduction in pain.
- The numbers weren’t as good during the second trial, when patients were randomized to take dosages of 20mg, 60mg and 120mg once a day.
- Almost 35 percent of study participants dropped out of the trials – about half were due to side effects. Nausea, headache, fatigue and sleepiness were the most common side effects cited as reasons for why patients left the studies.
Eli Lilly and Co., Cymbalta’s maker, received a warning from the U.S. Department of Health & Human Services (HHS) several years ago for fudging the drug’s efficacy in advertising. According to an HHS letter addressed to Eli Lilly, the drugmaker’s website and a promotional piece on WebMD.com claimed “more than half [53 percent] of patients with fibromyalgia treated with Cymbalta had a 30 percent improvement in pain severity at study endpoint.”
From the figures above, you can tell this is a clear overstatement of Cymbalta’s effectiveness.
More than 200 U.S. residents are currently suing Eli Lilly, claiming the company didn’t properly warn patients about Cymbalta’s withdrawal symptoms. Patients say they experienced mania, suicidal thoughts, insomnia, “brain zaps” and other disturbing symptoms upon stopping Cymbalta.
Savella has the poorest performance record of all three FDA-approved drugs. During Savella’s first fibro study:
- About 18 percent of patients reported at least a 50 percent reduction in pain.
- About 27 percent had at least a 30 percent decrease in pain. But again, to put this into perspective, about 20 percent of patients taking a placebo also reported a 30 percent reduction in pain. So, here we have yet another fibro medication that’s barely outperforming the placebo.
- The numbers were similar during a second trial.
- As with Lyrica and Cymbalta, large numbers of patients didn’t complete the Savella studies due to side effects. Between 23-26 percent dropped out of studies because of adverse reactions, the most common being nausea, heart palpitations, headache, constipation, increased heart rate, excessive sweating, vomiting and dizziness.
What patients say
Of course, clinical research doesn’t tell us everything about the effectiveness of these drugs. Patient feedback can be even more enlightening.
Last year, The National Pain Foundation and NationalPainReport.com conducted a survey of 1,339 people with fibro, looking at the effectiveness of Lyrica, Cymbalta and Savella.
Here are some highlights from the report:
- Lyrica: 61 percent said Lyrica does not work at all; 29 percent said it helps a little; and 10 percent said it was very effective.
- Cymbalta: 60 percent said Cymbalta does not work at all; 32 percent said it helps a little; and only 8 percent said it was very effective.
- Savella: 68 percent said it does not work at all; 22 percent said it helps a little; and 10 percent said it was very effective.
So, what is the takeaway from all of these numbers? Well, it’s obvious that a few of us do find relief from these drugs, and for that, I am grateful.
But for those of us who are still suffering, let’s hope that one of the new fibro drugs in the works will give us a more reliable, easy-to-tolerate treatment.
Note: All statistics quoted in this post originated from the drug manufacturers’ medication guides for physicians, available for viewing on the drugmakers’ websites.