Could Those Creepy-Crawly Nighttime Leg Sensations Be A Treatable Medical Condition? One Woman’s Search For Relief

Could Those Creepy-Crawly Nighttime Leg Sensations Be A Treatable Medical Condition? One Woman’s Search For Relief

For more than 10 years, Beth McFadden, a 44-year- old mother of three, lived with strange leg sensations that were not only difficult to describe, but were also uncomfortable and disruptive.

“At night, I would be lying in bed, just on the verge of going to sleep, and I would get these feelings in my legs that I needed to make go away. It was a tingling sensation-my legs would feel like something was crawling deep inside them. I felt like I had to move my legs and then would start tossing and turning. Sometimes, I had to get out of bed and walk to relieve the feelings. This would usually go on for quite some time, preventing me from falling asleep.”

Beth knew that what she was experiencing wasn’t normal, so she started talking to others about her symptoms. At the time, her doctors did not know how to help her. Beth even thought the symptoms might be related to her diet or exercise habits.

“I was frustrated. Night after night, I would feel the same creepy-crawly sensations in my legs, and getting up to relieve the feelings would keep me from falling asleep. Sometimes, I would get these sensations during the day if I was sitting for a long time: I couldn’t really sit and read, watch TV, go to the movies. Travel became difficult because I couldn’t sit for long periods of time on airplanes or in the car.”

Recently, Beth saw an article about Restless Legs Syndrome (RLS) in a local newspaper. It described RLS as a common and disruptive neurological condition that is characterized by a compelling urge to move the legs and by uncomfortable or sometimes painful sensations in the legs. These sensations are frequently described as creeping-crawling, tingling, pulling or tightening in the legs.

Beth wondered if this could be the same condition she had lived with for all these years.

She brought the article to her doctor to help her describe what she was experiencing. After an examination, Beth’s physician diagnosed her with RLS, a recognized-and now treatable-medical condition.

“I’m relieved to know that what I’ve been experiencing is a recognized medical condition. For me, my RLS diagnosis was an important step forward in my quest for relief from the disruptive creepy-crawly feelings that I had lived with for so long.”

In May 2005, the U.S. Food and Drug Administration approved Requip® (ropinirole HCl) Tablets for the treatment of moderate-to-severe primary RLS, making Requip the first and only treatment for RLS of any type or severity.

In a recently published study in Mayo Clinic Proceedings, researchers found that patients taking Requip reported significant improvement in RLS symptoms when compared with placebo, and onset of symptom improvement was observed after two nights of treatment.

Important Safety Information About Requip®

Prescription Requip Tablets are not for everyone. Requip may cause you to fall asleep or feel very sleepy while doing normal activities such as driving; or to faint or feel dizzy, nauseated or sweaty when you stand up from sitting or lying down. If you experience these problems, talk with your doctor. Tell your doctor if you drink alcohol or are taking other medicines that make you drowsy. Side effects include nausea, drowsiness, vomiting and dizziness. Most patients were not bothered enough to stop taking Requip.

Requip should be taken once daily one to three hours before bedtime.

In the study published in Mayo Clinic Proceedings and entitled “Therapy with Ropinirole, Efficacy And Tolerability in Restless Legs Syndrome” (TREAT RLS US), the most common adverse events reported in the ropinirole group (n=187) versus placebo (n=193) were nausea (43 percent versus 8 percent), headache (17 percent versus 19 percent), somnolence (13 percent versus 7 percent) and nasopharyngitis (11 percent versus 12 percent). The withdrawal rate due to adverse events was similar between the two groups (ropinirole 3 percent versus placebo 4 percent).

Recognizing Changing Symptoms In Parkinson’s Disease May Help Patients To Better Manage Their Condition

Recognizing Changing Symptoms In Parkinson’s Disease May Help Patients To Better Manage Their Condition

Parkinson’s disease (PD) affects about 1 million people in the United States and 50,000 new cases are diagnosed each year. As researchers learn more about the disease, improved treatment options are possible.

That’s good news for people like Paul Ramirez, a World War II veteran and avid dancer. He was first diagnosed with Parkinson’s disease in 1999, after his wife saw him shuffling his feet during their daily neighborhood walks. Like many people with PD, Ramirez was treated with a traditional levodopa medication to manage his symptoms.

Levodopa is the most widely used symptomatic PD treatment and has remained the “gold standard” of care for nearly 40 years. The majority of people with PD eventually need levodopa treatment to control their symptoms, even if they begin their therapy with other medications. After several years of treatment with levodopa, however, people with PD may see changes in the way their medication controls their symptoms. Symptoms may return before it is time for the next dose of medication.

For Ramirez, the change in duration of his symptom control became increasingly noticeable after the first two to three years of levodopa treatment. Not only did he find that the onset of daily symptoms was becoming less predictable, he also found that his “off” time was increasing, meaning his motor symptoms, like freezing and slowness of movement, lasted for longer periods of time during each day.

Since Ramirez’s PD symptoms were not controlled as long as they could be, he needed to use a walker in order to maintain his balance, which severely limited his ability to participate in the activities that he enjoyed.

“I love to dance, but within a few years of being diagnosed with Parkinson’s disease, I found that I not only couldn’t dance, but many times I was even too weak to walk. It was very frustrating,” says Ramirez.

The change in symptom control that he experienced is called “wearing off.” Symptoms associated with levodopa therapy “wearing off” can include both motor and nonmotor symptoms. Motor symptoms may include trembling or shaking and nonmotor symptoms may include anxiety or feeling restless. When levodopa medication “wears off,” it can make even basic daily activities, such as walking and dressing, difficult for the person with Parkinson’s disease.

Ramirez’s doctor, Kevin Callerame, M.D., staff Adult Neurologist at the NeuroMedical Center in Baton Rouge, La., says, “The good news is that the motor symptoms of ‘wearing off’ can be treated with newer levodopa medications that can help increase the time levodopa controls the symptoms of Parkinson’s disease.”

When Dr. Callerame saw him in the summer of 2004, the physician noticed that he would have frequent freezing episodes.

Dr. Callerame began treating Ramirez with a Parkinson’s disease medication called Stalevo® (carbidopa, levodopa and entacapone). Stalevo is an enhanced levodopa medication that combines levodopa with two other components to reduce its side effects and extend its benefits. Stalevo tablets are indicated for certain PD patients who have levodopa-related “wearing off” motor complications.

In the year since Ramirez’s medication has changed, Dr. Callerame says, “Ramirez’s symptoms have been controlled for four to five hours, versus one to two hours, following each dose of Stalevo.” For Ramirez, longer symptom control has enabled him to walk more easily, and that has given him the confidence to try other activities that he once enjoyed.

Dr. Callerame urges people with Parkinson’s disease to communicate openly with their doctors because different treatment options may be available. However, in order to treat “wearing off,” it must first be identified.

A new, free-of-charge information and resource kit is available for people with Parkinson’s disease that can help to identify the signs and symptoms of “wearing off.” The kit contains a diary card to track when symptoms come back between doses of medication.

To order a free StEP Kit, call 1-866-STEP-KIT (1-866-783-7548) toll-free or visit www.stepkit.net.

Ramirez’s story represents the successful treatment with Stalevo (carbidopa, levodopa and entacapone) of an actual patient with Parkinson’s disease and experiencing “wearing off.” Because every patient responds differently, results may vary. In a clinical trial, Stalevo provided, on average, 1.4 more hours a day of symptom relief than standard levodopa.

Recognizing the signs and symptoms of “wearing off” can help you manage your Parkinson’s disease symptoms.

Important Information for Patients Regarding Stalevo®: Stalevo® (carbidopa, levodopa and entacapone) tablets are indicated for patients with Parkinson’s disease (PD). Stalevo is a medicine that can be used instead of carbidopa/levodopa and Comtan® (entacapone) by patients taking those medicines as separate tablets. Depending on levodopa dose and side effects, Stalevo can also be used to replace carbidopa/levodopa when the benefits of levodopa are wearing off. Please ask your health care professional if Stalevo is appropriate for you. Stalevo is supplied as tablets in three strengths: Stalevo 50, containing 12.5 mg carbidopa, 50 mg levodopa and 200 mg entacapone; Stalevo 100, containing 25 mg carbidopa, 100 mg levodopa and 200 mg entacapone; and Stalevo 150, containing 37.5 mg carbidopa, 150 mg levodopa and 200 mg entacapone. The most common side effects of Stalevo are unwanted or uncontrollable movements (known as dyskinesia); nausea; diarrhea; excessive muscle movements (known as hyperkinesia); harmless discoloration of urine, sweat and/or saliva; diminished or slow movements (known as hypokinesia); abdominal pain; dizziness; constipation; fatigue; pain; and hallucinations. Some of the more serious side effects may include severe diarrhea, severe dyskinesia, hallucinations, other mental disturbances, orthostatic hypotension (low blood pressure), rhabdomyolysis (a muscle disease), and symptoms resembling neuroleptic malignant syndrome (a condition characterized by fever and muscle stiffness). Tell your health care professional if you have bothersome side effects. He or she can make adjustments that may reduce these effects. You should not quickly lower your Stalevo dose or suddenly stop it altogether. Drugs broken down by the COMT enzyme (e.g., isoproterenol, epinephrine) should be used with caution when taking Stalevo. If you take a nonselective monoamine oxidase (MAO) inhibitor, you should not take Stalevo. Stalevo should not be taken with selegiline at doses higher than 10 mg/day. Because Stalevo contains entacapone, it should not be taken together with Comtan. Be careful using Stalevo if you have severe heart or lung disease; asthma; renal, hepatic or endocrine disease; or a history of heart attacks or ulcers. Do not take Stalevo if you have glaucoma, melanoma or other related medical disorders. Before you take Stalevo, talk to your doctor about any health problems you might have.