Azilect For Parkinsons Disease
Azilect is approved by the Food and Drug Administration to treat Parkinsons disease. For this purpose, Azilect can be taken by itself or in combination with other drugs that also treat Parkinsons disease.
Parkinsons disease explained
Parkinsons disease is a condition that affects the nervous system. The most noticeable symptoms of Parkinsons disease are usually movement-related, such as tremors . People with this condition also usually have non-movement related symptoms, including:
- trouble sleeping
The symptoms of Parkinsons disease develop gradually. In most people, symptoms appear at age 60 years or later. They often start on one side of the body, such as a tremor in one hand. Symptoms spread to both sides of the body and usually worsen over time. Some people with Parkinsons disease also develop dementia, which is a general decline in intellectual abilities, such as memory and communication.
Effectiveness for Parkinsons disease
Azilect contains the active drug rasagiline, which has been shown to be effective in clinical trials for treating Parkinsons disease symptoms. The trials measured how well people taking Azilect improved in mental and physical activity .
If youd like to read more about how this drug performed in studies, see the prescribing information for Azilect.
Azilect In Clinical Trials
It has received full approval by the U.S. Food and Drug Administration for the treatment of Parkinsons disease on May 17, 2006. The FDA revised the prescribing information for Azilect on December 14, 2009, to remove the tyramine dietary restriction, based on clinical studies carried out by Teva Pharmaceuticals. The initial approval of Azilect was based on four key clinical trials.
The first study assessed Azilect as the sole treatment for Parkinsons disease and showed a significant improvement in patients treated with 1 mg or 2 mg of Azilect compared to a placebo using the Unified Parkinsons Disease Rating Scale . The UPDRS assesses how the motor and non-motor symptoms of Parkinsons disease affect daily activities, the overall motor ability of the patient, and whether there are any complications associated with the use of medication. There was no difference between 1 mg or 2 mg. The trial demonstrated that taking Azilect resulted in an improvement in UPDRS scores and a reduction in the duration of off time patients experience between levodopa doses by over an hour.
The other three trials all assessed Azilect as an adjunct therapy to levodopa treatment. In these studies, the participants were randomly assigned to either receive Azilect or a placebo whilst also taking levodopa.
Parkinson’s Patients Slow In Disease Progression At 1 Mg Rasagiline
Patients in the delayed start group receiving 1 mg per day of rasagiline showed a greater level of disability than their counterparts who received 1 mg per day of rasagiline early, according to a report published yesterday in the New England Journal of Medicine.
The study was funded by Teva Pharmaceutical Industries, the company that manufactures rasagiline.
If rasagiline only had an effect on symptoms, the level of disability between the early and late treatment group would have been the same, Olanow said. But since the early treatment group showed a significantly lower level of disability, then the rate of disease was modified and may have been inhibited.
“If it’s slowing the disease, the deficit should persist, and that’s what happened,” said Olanow, who also consults for Teva.
Woods, who participated in the ADAGIO study, said he had an overall positive experience taking rasagiline and credits his continued good health to proper medication, exercise, and a positive attitude.
“I can’t say it hasn’t slowed me down at all,” said Woods, noting his right hand is still stiff. “It hasn’t gotten better, certainly, but it hasn’t gotten significantly worse.”
Some Caution Ambiguous Study Results
But the investigators cautioned that the results were somewhat ambiguous, as no disease-modifying effect was seen with a higher rasagiline dose of 2 mg per day.
But some experts were not inclined to accept the study’s results.
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What Other Information Should I Know
Keep all appointments with your doctor.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
How Does It Compare
Rasagiline efficacy as monotherapy has not been directly compared with any other Parkinson’s disease drugs. As adjunctive therapy rasagiline has only been directly compared with entacapone.6 Therefore it is not clear how rasagiline compares with other therapies in terms of benefit and adverse events.
Efficacy of rasagiline monotherapy compared with placebo has been assessed in people with early Parkinson’s disease in two randomised trials .
As levodopa adjunctive therapy rasagiline has been compared with levodopa therapy alone in two randomised trials of people with advanced Parkinson’s disease .47 The LARGO study also included a group receiving entacapone adjunctive therapy .6
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Blinding May Be Broken Before The Final Scoring
Although delayed-start trials are labeled as double-blind, this is true for only the first half of the study, with the last half, open-label. With transition to known symptomatic drug therapy, clinical responses to the open-label active drug may also disclose the randomization status of the initial double-blind phase; e.g., initial placebo treatment, then a clinical response to the active drug in phase 2 may retrospectively unblind these subjects. Since clinical scoring at study end is crucial, unblinding in phase 2 could compromise the findings.
Can Progression Of Parkinson Disease Be Slowed
Deep brain stimulation implanted in early-stage Parkinson disease was found to decrease the risk of disease progression. If findings are replicated in a larger trial recently approved by the FDA, DBS would be the first therapy proven to slow the progression of any element in PD.
Deep brain stimulation implanted in early stage Parkinson disease was found to decrease the risk of disease progression and lessen the need for multiple, simultaneous prescription drugs, according to study findings published in Neurology.
PD serves as the fastest growing neurological disorder worldwide, with as many as 60,000 US cases diagnosed each year. Innovations within the treatment of PD have led to better, noninvasive outcomes for common symptoms such as tremor and OFF periods. However, as the disease progresses, these therapies may not prove as effective and can contribute to significant economic burden for both patients and caregivers.
When it comes to managing PD, senior author David Charles, MD, professor and vice chair of neurology at Vanderbilt University Medical Center , noted the relentless nature of the disease, which currently has no therapies approved to slow its progression.
After the 5-year follow-up, the study found that those with early-stage PD who received early DBS with ODT had a more than 5 times lesser odds of of experiencing worsening of their rest tremor compared with those given only ODT .
Practical Problems With Prescribing Rasagiline In Clinical Practice
One might argue that rasagiline should be prescribed to all patients with PD on the chance that it might be neuroprotective . However, balanced against this are considerations of potential drug interactions and expense.
The package insert lists numerous drugs that are contraindicated with rasagiline, including most antidepressants. Many of the listed drugs are likely to be considered in patients with PD. At the very least, this has medicallegal implications, whereby the drug combination might well be blamed for a variety of coincidental problems. A second issue is the considerable expense of rasagiline. Retail price is approximately $10 per tablet, not inconsequential even with pharmaceutical plans requiring copayments.
Some Experts Don’t Agree With Adagio Study
“I would be reluctant to accept the conclusion that this provides compelling evidence of slowed Parkinson’s disease progression,” said Dr. J. Eric Ahlskog, a neurologist at the Mayo Clinic in Rochester, Minn.
Dr. William Weiner, chairman of neurology at the University of Maryland and one of the trial investigators, said he disagreed with the NEJM report’s emphasis on the possible disease-modifying effect.
“I would not have agreed to stressing the neuroprotection angle so strongly,” he said. ” may be statistically significant but it is surely not clinically meaningful.”
But while medical data on the potential neuroprotective effects of some Parkinson’s drugs is sparse, doctors have been aware that they may have such an effect for several years and prescribe them as such to patients.
Evan Henry, 54, from Newport Beach, Calif., said he was prescribed medications for symptom management and to slow disease progression when he was diagnosed with Parkinson’s disease in 2003.
“It was both right from the get go,” Henry said. ” thought it was better to try it and see what happens than to squander an opportunity to help stave something off.”
The study did not allow researchers to differentiate whether rasagiline was having a neuroprotective effect or whether it only treated symptoms while the brain compensated for any cognitive losses by dialing up the activity in other areas.
Study Could Signal Paradigm Shift
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What Special Dietary Instructions Should I Follow
You will need to avoid eating foods that contain very high amounts of tyramine, such as aged cheeses during your treatment with rasagiline. Talk to your doctor or dietitian about which foods you should avoid during your treatment or if you do not feel well after eating or drinking certain foods while taking rasagiline.
Effect Of Rasagiline On Cognitive And Behavioral Symptoms In Pd
PD treatment has largely involved strategies to correct the underlying dopamine deficit. However, management of patients with long standing disease is often complicated by development of cognitive and behavioral symptoms, resulting from medication side effects and/or development of extranigral disease, which may involve other neurotransmitter systems than dopamine . Neuropsychiatric symptoms that have been associated with PD therapy include hallucinations, depression, confusion, impulse control disorders, sleep disorders, daytime somnolence, and sleep attacks. Adverse events reported with administration of selegiline include confusion, hallucinations, and insomnia .
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About Rasagiline For Parkinson’s Disease
|Type of medicine
The cause of Parkinson’s disease is still unknown but the symptoms of tremor, stiffness and slow movement are due to there being less of a chemical called dopamine in your brain. Rasagiline increases the amount of dopamine in the brain and so helps to relieve these symptoms.
You may be prescribed rasagiline on its own as a treatment for Parkinson’s disease. It is also used alongside other treatments which contain a medicine called levodopa. When a dose of levodopa starts to wear off, the symptoms of Parkinson’s disease can return. This is known as an ‘end-of-dose fluctuation’. Taking rasagiline helps to prevent this problem.
How Long Does It Take To Work
In a clinical study, people reported that their Parkinsons symptoms eased after 1 week of taking Azilect daily.
If youve been using Azilect for more than a couple of weeks and havent noticed any symptoms relief, talk with your doctor. They may suggest making adjustments to your treatment plan.
Here are answers to some frequently asked questions about Azilect.
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When Levodopa Wears Off
One new study addressed the wearing off effect of levodopa, the most common drug treatment for Parkinsons. The effect occurs in patients who have been taking the drug for several years and involves a period between dosessometimes up to six hoursduring which the drug is ineffective.
As each dose wears off, people experience longer periods of time where the motor symptoms do not respond to levodopa, researchers said in a press release.
Researchers supplemented levodopa treatments with a new trial drug called tozadenant. Half of the 420 patients in the study were given two doses of tozadenant with levodopa, while others were given levodopa and a placebo.
After 12 weeks, those taking levodopa and tozadenant experienced slightly more than one hour of decreased wear-off time, along with fewer involuntary muscle movements.
The drug, licensed by Biotie Therapies, will now move into the third phase of development, and patient enrollment in studies is expected to begin in early 2015, according to the company website.
Monotherapy: Adverse Events Similar To Those With Placebo
In rasagiline monotherapy trials, incidence of adverse events was not significantly increased with rasagiline compared with placebo. In the TEMPO trial , headache was reported as a very common adverse event with incidence increased with rasagiline over placebo .4,7
Other common adverse events reported with increased incidence compared with placebo include those reported in Box 1.3,4,723
Safety data for the ADAGIO trial are limited to events reported in > 5% of trial participants. Of these only fatigue was increased in rasagiline-treated compared with placebo-treated subjects. However, incidence was not significantly increased compared with placebo.7
Dosage For Parkinsons Disease
If Azilect is the only Parkinsons disease medication that your doctor prescribes for you, youll likely take one 1-mg tablet once daily.
If Azilect is prescribed for you along with a medication that contains levodopa , youll likely take one 0.5-mg tablet daily to start. Your doctor will see whether you have any side effects and how well the drug is working for you. Based on these factors, they may increase your dosage of Azilect to one 1-mg tablet daily.
If you take certain medications that interact with Azilect, such as ciprofloxacin , or if you have mild liver disease, your doctor may adjust your dosage.
Make sure to take the dosage your doctor prescribes for you. They can determine the best dosage to fit your needs.
Azilect And Herbs And Supplements
If you take Azilect, you shouldnt use St. Johns wort. This includes teas, tablets, and capsules that contain the herb.
Taking Azilect and St. Johns wort could raise your risk for serotonin syndrome .* This interaction could also prevent Azilect from working effectively to treat your Parkinsons symptoms.
* For more information on serotonin syndrome, see the Azilect side effects section above.
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Who Is It For
Rasagiline is indicated for treating the symptoms of Parkinson’s disease, either as monotherapy or as adjunctive therapy with levodopa.3 Participants in monotherapy trials had been diagnosed for approximately 4 months and 1 year and did not have severe symptoms. Participants in adjunctive therapy trials had been diagnosed for about 10 years on average and experienced more severe motor symptoms as well as off-time and dyskinesia.47
Rasagiline is contraindicated for people with hepatic impairment .3 For further information on ChildPugh classification of liver disease see the NPS web extra on this topic or the Australian Prescriber article ‘Prescribing in liver disease’.8
Rasagiline may not be suitable for people already taking antidepressants; some classes and specific drugs are contraindicated and specialist advice should always be obtained . Use of antidepressants in combination with dopamine agonists is less restricted.9 The suitability of rasagiline for people with severe depression, clinically significant or unstable vascular disease, congestive heart failure or cognitive impairment has not been investigated.47
Rasagiline May Cause Side Effects Tell Your Doctor If Any Of These Symptoms Are Severe Or Do Not Go Away:
- mild headache
- red, swollen, and/or itchy eyes
- dry mouth
- unsteadiness, wobbliness, or lack of coordination
- involuntary, repeated body movements
- weakness or numbness of an arm or leg
- extreme restlessness
- difficulty thinking clearly or understanding reality
Rasagiline may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
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Important Information About All Medicines
Never take more than the prescribed dose. If you suspect that you or someone else might have taken an overdose of this medicine, go to the accident and emergency department of your local hospital at once. Take the container with you, even if it is empty.
This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.
Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you.
If you have any questions about this medicine ask your pharmacist.
Further reading and references
Rasagiline Adjunctive Therapy May Increase Dyskinesia
As with other levodopa adjunctive therapies, rasagiline may increase dyskinesia. There was a significant mean increase in dyskinesia compared with levodopa therapy alone in the PRESTO but not the LARGO trial ||.5,6
The reason for the disparity between the two trials is not known, although combinations of rasagiline and entacapone were permitted in the PRESTO trial but not the LARGO trial. In both trials levodopa dose adjustment was precluded after the first 6 weeks. During this first 6 weeks a small decrease in required levodopa was reported.5,6
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Can Rasagiline Cause Problems
Along with their useful effects, all medicines can cause unwanted side-effects although not everyone experiences them. These usually improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following side-effects continue or become troublesome.
|Very common rasagiline side-effects – these affect more than 1 in 10 people who take this medicine
|What can I do if I experience this?
|Drink plenty of water and ask a pharmacist to recommend a suitable painkiller. If the headaches continue, let your doctor know
|Try chewing sugar-free gum or sucking sugar-free sweets
|Chest pains, skin problems
|Let your doctor know about this straightaway
|Flu-like symptoms, feeling unwell, aches and pains, loss of appetite, feeling depressed, increased urgency to pass urine, conjunctivitis, unusual dreams and thoughts
|Let your doctor know if any of these become troublesome
Rarely, rasagiline may cause people to have impulsive thoughts or cravings which are difficult to resist. This could include excessive shopping or spending, gambling or an increased sex drive. Let your doctor know if you or your family/carer notice any new behaviours which cause concern.
If you experience any other symptoms which you think may be due to this medicine, speak with your doctor or pharmacist.