For Which Neuropathies Is Lyrica Really Suitable

Today's post is a Pfizer Press release (see link below) concerning Lyrica being prescribed for a specific form of neuropathy. The American FDA has approved its use for neuropathy associated with spinal cord injuries (for which there was no approved treatment before). It's a Pfizer press release, so it positively glows with pride at the achievement, yet they have withdrawn the drug for treatment of HIV-related and other neuropathies. It doesn't make sense. The pain receptors that Lyrica targets are much the same for most forms of neuropathy, yet some are considered suitable for Lyrica treatment and others not. It is still widely prescribed for HIV-related neuropathy across the world, as different medical authorities try to decide what to do about it and what the truth is. Considering the court cases Pfizer have had to face concerning the side effects of Lyrica, it would be advisable to talk carefully with your doctor before starting a course of this drug - the possible side effects shouldn't be underestimated (more articles about this subject in the list on the right of the blog). Maybe Pfizer should consider explaining the situation in simple terms to the patients themselves?

FDA Approves Lyrica For The Management Of Neuropathic Pain Associated With Spinal Cord Injury Based On Priority Review

June 21, 2012

First and Only Treatment Option Approved in the U.S. for Pain Condition Affecting 40 Percent of Spinal Cord Injury Patients

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) approved the use of Lyrica^® (pregabalin) capsules CV for the management of neuropathic pain associated with spinal cord injury. Lyrica received a priority review designation for this new indication from the FDA. More than 100,000 patients – approximately 40 percent of the 270,000 patients with spinal cord injury in the United States - suffer from this chronic, complex pain condition. Neuropathic pain associated with spinal cord injury can be severely debilitating and may significantly hinder rehabilitation and the ability to regain function.
  
“This milestone represents an important opportunity for physicians to more effectively manage the debilitating neuropathic pain that often accompanies spinal cord injury,” said clinical study investigator Diana Cardenas, MD, MHA, professor and chair, department of rehabilitation medicine, University of Miami Miller School of Medicine and chief of service for rehabilitation medicine and medical director of Jackson Rehabilitation Hospital, Miami, Florida. “Given the clinical challenges of investigating neuropathic pain in this patient population, any advancements in treatment are welcome by physicians and patients alike.”
  
An estimated 12,000 new spinal cord injury patients are diagnosed in the U.S. each year. There are a wide variety of causes for spinal cord injury, including traumatic and non-traumatic causes. Traumatic causes may include motor vehicle accidents, violence, falls and sports injuries. In these instances, a spinal cord injury typically begins with a sudden, traumatic blow to the spine that fractures or dislocates vertebrae. The damage begins at the moment of injury when displaced bone fragments, disc material, or ligaments bruise or tear into spinal cord tissue. Non-traumatic causes may involve congenital and developmental abnormalities, genetics and metabolism, infections and inflammation, removal of a benign spinal tumor and spinal cord ischemic stroke.
  
Neuropathic pain can be experienced above, at or below the level of the spinal cord injury, and is typically not confined to one area in the body. Approximately one-third of spinal cord injury patients report below-level neuropathic pain that is severe or excruciating. Patients may experience neuropathic pain associated with spinal cord injury as early as two weeks after injury and it may persist for up to 25 years.
  
“Until now, no FDA approved treatment options were available in the U.S. for people with neuropathic pain associated with spinal cord injury, a condition which can be extremely disabling,” said Steven J. Romano, MD, senior vice president and head, medicines development group, Global Primary Care Business Unit, Pfizer. “The approval of Lyrica for this indication is a significant milestone, exemplifying Pfizer’s commitment to pursue scientific advancements that address unmet medical needs.”
  
About Lyrica Phase 3 Clinical Studies
The FDA approval is based on two randomized, double-blind, flexibly dosed (150–600 mg/day), placebo-controlled Phase 3 trials, which enrolled 357 patients. Among other medications, patients were allowed to continue taking other pain medications, including NSAIDs, opioids and non-opioids. The population of one study consisted of traumatic spinal cord injury patients. The population of the other study consisted of traumatic spinal cord injury patients and patients who had injury to the spinal cord from non-traumatic causes: e.g., removal of a benign spinal tumor or spinal cord ischemic stroke (five percent of patients).
  
The primary finding in these studies was that Lyrica significantly reduced neuropathic pain associated with spinal cord injury from baseline throughout the duration of the studies (12 weeks and 16 weeks, respectively), compared to placebo. In addition, more patients receiving Lyrica showed a 30 percent and 50 percent reduction in pain than did patients receiving placebo. In some patients, the reduction in pain with Lyrica was significant as early as week one and continued throughout the duration of the trials.
  
The most common adverse events in these trials in patients receiving Lyrica were somnolence, dizziness, dry mouth, fatigue and peripheral edema.
  
About Lyrica
Lyrica is currently approved for various indications in 120 countries and regions globally. In the United States, Lyrica is indicated for diabetic nerve pain, post herpetic neuralgia (pain after shingles), fibromyalgia, neuropathic pain associated with spinal cord injury and partial onset seizures in adults with epilepsy who take one or more drugs for seizures. Antiepileptic drugs (AEDs) including Lyrica increase the risk of suicidal thoughts or behavior in patients taking AEDs for any indication.
There have been post-marketing reports of angioedema and hypersensitivity with Lyrica. Treatment with Lyrica may cause dizziness, somnolence, dry mouth, edema and blurred vision. Other most common adverse reactions include weight gain, constipation, euphoric mood, balance disorder, increased appetite and thinking abnormal (primarily difficulty with concentration/attention).
For Lyrica prescribing information, please visit www.lyrica.com.
  
Pfizer Inc.: Working together for a healthier world^®
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com.

http://www.pfizer.com/news/press_releases/pfizer_press_release.jsp?guid=20120621005572en

Which Fitness Tracker For Neuropathy

Today's post from womenshealthmag.com (see link below) may be extremely valuable if you, as neuropathy patient, are considering using one of the many fitness trackers that are available on the market at the moment. It's a bit of a minefield, especially if you are a little older and not as digitally savvy as you'd like to be but you've been convinced that exercise will help with the neuropathy symptoms so you want to get started. These gadgets give you an overview of how you're doing and whether you're making progress but which one do you need and which one is best for you as an individual? This useful article does some of the work for you and supplies the pros and cons of the currently most popular trackers although, the opinions of course belong to the article author. After that, it's up to you and you may even decide that this sort of thing isn't necessary in your case but at least you have a better idea of how and what. Worth a read even as a general interest post.

I Tested 7 Different Fitness Trackers—at the Same Time By Robin Hilmantel September 28, 2015 
 
See how the products compared to each other.
Photo by Matthew Kusel

Search for "fitness trackers" on Amazon.com, and you'll get, oh, 22,845 results. Picking the one you want to spend your hard-earned cash on can seem like a pretty daunting task.

Take a deep breath. In the name of helping you avoid fitness-tracker-buyers' remorse, I chose seven popular options and reviewed every aspect of them I could: I read the instruction manuals, sure, but I also wore the different models side-by-side to see what each clocked 100 steps at and how far each recorded a mile as being. I paid close attention to how user-friendly each one was, checked how accurate the heart-rate monitors were, and also tested the sleep functionality of the bands that promise to log your Zs. Here's what I found.

The Trackers
For the purposes of this story, I tried to stick to true fitness trackers (as opposed to running watches or other fitness-related devices you can wear on your wrist) with two big exceptions: the Apple watch and the Moto 360, one of several Android Wear options on the market. (I had to see if all the buzz is deserved because...journalism.) All of the options have the capability to track steps, distance, and calories burned—and some came with other features, too. Here’s a quick rundown of what you can expect from each watch:

Illustration by Alyssa Zolna

Setup was pretty seamless with most of the devices with one big exception: I couldn’t get the Withings Acrtivité POP to sync with the phone. Granted, the watch has great reviews on Amazon.com (four out of five stars, on average, from 271 customer reviews) so my experience may be an anomaly. But while I had one false alarm when the hands on the watch started moving and I’d thought I succeeded, I couldn’t ever manage to sync successfully. An interesting thing about this watch, though, is that you’re instructed to keep your smartphone nearby at all times—it seems like your phone is what actually does all of the tracking and it just communicates that information to your watch to control where the hands are. So I decided to keep the watch (and coinciding app) in the test.

Counting Steps
Pedometer technology has been around for a while, so I wasn’t surprised to find that all of the watches were pretty accurate when it came to logging the 100 steps I took during my test run.

Each Fitness Tracker Logged 100 Steps As…

Pivotal Living 95 steps
Misfit Shine 100 steps
Withings Activité POP 101 steps
Apple Watch POP 102 steps
Jawbone Up 3 102 steps
Fitbit Charge HR 103 steps
Moto 360 107 steps

If steps are your main priority, you’d be pretty good with any of these options.

Logging Distance
Here’s where things got interesting. None of these bands have the built-in GPS technology I’d recommend looking for if you’re training for a race and want to rely on a watch during your runs. Still, they all offer estimates of how far you’ve gone—so I hit the track to do four laps and see what each of the devices measured a mile as being.
Photo by Matthew Kusel

Mind Over Matter EXP Core Graphic Tank ($16.90, express.com); Blurred Print EXP Core Compression Crop Legging ($59.90, express.com); Adidas by Stella McCartney Ultra Boost Shoes ($260, adidas.com)

This wasn’t as easy as it might seem. Since you can’t zero out your distance for the day on any of these trackers to conduct a test like this, I had to drag my boyfriend out to the track with me, read off all of the starting distances to him to write down in a notebook, run a mile, then (without moving at all), read off all of the ending distances to him (thanks, Matt!).

I also tested the Apple Watch and the Moto 360 twice: once without keeping my phone nearby to see how they did without any help from a 4G connection and once with my iPhone in-hand. Here’s how the fitness trackers did:

Each Fitness Tracker Logged a Mile As…

Withings Activité POP 0.02 miles*
Moto 360 0.74 miles
Fitbit 0.83 miles
Apple Watch 0.97 miles
Pivotal Living 0.99 miles
Jawbone Up 3 1.1 miles
Misfit Shine 1.1 miles

*This corroborates my theory that the watch's app uses your smartphone's built-in technology since I ran without my phone during this mile.

Turns out, the Apple Watch and the Moto 360 don’t actually appear to use your phone’s GPS unless you turn on an app specifically designed to track your run. (Womp womp.) Since the Moto 360 doesn’t have a built-in app to do this (although this will change when the Moto 360 Sport is introduced with GPS technology), its reading came out virtually identical during my second mile: 0.73. When I used the Apple Watch’s “Workout” app, its reading actually came out slightly less accurate than the first time around: 1.06. *Shrugs*

Sleep Tracking and Other Functions
You didn’t think I stopped with the steps and distance, did you? Nope. I also wore these babies to bed (or at least the ones that promised sleep tracking, anyway).
Photo by Matthew Kusel


The Misfit, Fitbit, and Jawbone all are supposed to track your sleep automatically (meaning you don’t have to push any buttons to put the device in “sleep mode”). They said I slept between nine hours, 14 minutes and nine hours, 49 minutes (sometimes I like to bank shuteye on Sunday nights, okay…?). They also said I woke up between zero and two times during the night. But since I can’t say for sure exactly when I fell asleep or how restful or restless my night was...there’s no way to know which device was the most accurate on this front. (Sorry, guys!)

The Pivotal Living band has a sleep-tracking mode that you can activate by double-clicking the button on it until you see a moon icon on the screen. But even though I did this, the band didn't seem to record my Zs; I didn’t see any relevant data on the app after I synced my tracker the next morning.

I also performed one other test: counting my actual heart rate and then using the devices that measure it to see how close they got. I’m happy to report that all of the trackers do a great job on this: The Fitbit was dead-on, the Apple Watch gave a reading 1.89 percent above my actual heart rate, and the Android 360 came in 9.43 percent above it (although my heart rate was 53, so a reading of 58 isn’t so far off).

You may have noticed that the Jawbone has heart-rate functionality but that I didn’t include it in this test. That’s because you can’t check your heart rate on demand with this device—but it’s constantly monitoring you to provide data on your resting and active heart rate. The app also provides lots of guidance on what all of the numbers mean, which is a definite plus (while the 10,000 step benchmark is easy enough to grasp, the other numbers can be tough to glean meaning from).

So...Which One Should You Buy?
Not to pull a Sarah Koenig on "Serial" on you, but...there’s no one clear-cut answer here. I didn’t want to leave you hanging, though, so I decided to give some guidance on who I think each tracker is perfect for.
Photo by Robin Hilmantel



If you’re on a budget: Even with the app renewal fees after your first year of membership, the $12 Pivotal Living band (pivotalliving.com) is the most affordable option out there. And for basic step counting, it definitely gets the job done.

If you’re more concerned with how it looks than anything else: Although I couldn’t get the Withings Activité POP (withings.com) to work myself, as I mentioned, the online reviews don’t reflect that other people had this issue—and I loved the coral-pink color.

If you never want to charge it: The Misfit Shine (store.misfit.com) comes with a replaceable coin cell battery that lasts for up to six months, so you don't have to worry about plugging it in once every few days—and can wear it to track your every movement.

If you want advanced tracking features...and to be able to see your exact step count on your wrist: While other devices have various symbols that indicate roughly how close you are to hitting your step goal, the Fitbit Charge HR (fitbit.com) has a screen that lets you check in on your precise progress throughout the day.

If you want more context for the numbers to really improve your health: The "Up" app that works with your Jawbone Up 3 provides personalized tips like “Your REM sleep is most likely to be disrupted in the morning, so it may be a good idea to put in ear plugs before you hit the hay."

If you want a smartwatch...and one that doubles as a conversation starter: People will come up to you and ask you what you think of the Apple Watch (apple.com/watch) all the time when you wear one. There’s no way around it. And I also liked that the watch buzzes to remind you to stand for at least one minute of each hour.

If you want a smartwatch...but don't want to look like you’re an extra on Star Trek: Everyone who saw me in the Moto 360 (motorola.com) commented on how impressed they were that it looked like a real watch. And now that Android Wear works with iOS, anyone with a smartphone can use it.

Still Can't Decide?
Lumoid (lumoid.com) lets you rent fitness trackers before buying them—and “Wearable Boxes” lend you up to five devices (including the Apple Watch and the Moto 360) for two weeks. There’s no fee if you buy a tracker through the site—and $25 for the box if you decide to return all of them.

Keep in mind: Anything that gets you moving more has done the job that a fitness tracker is supposed to do—and since all of these will have you walking laps in your living room to try to hit 10,000 steps, the one that appeals the most to you (and that you'll therefore be most likely to wear) is your best bet.

http://www.womenshealthmag.com/fitness/fitness-tracker-reviews