From the April issue of The Fibromyalgia Network Newsletter:
"While physicians who are less experienced with managing FM pain may eagerly prescribe Lyrica (pregabalin) because it is the first drug with large scale clinical trial daa to substantiate its use, patients concerns about side effects are valid.
When a drug is new, all the adverse effects are not always known. In addition, physicians who are not accustomed to prescribing Lyrica may follow the standard dosing regimen approved by the Food and Drug Administration (FDA), which may not be optimal for you.
What are the odds that Lyrica will improve your FM symptoms? In general , a one third reduction in symptoms is viewed as providing clinically meaningful relief (e.g., a degress of improvement that patients would clearly notice). Of course, if a drug could cut your symptoms in half, that would be even better but these results are extremely hard to achieve with a single medication. in the real world of managing FM symptoms, three or more meds are combined in hopes that each one gives a patient 15-20 percent symptom improvement. Yet , the FDA does not allow this strategy for documenting the effectiveness of a drug, so keep this in mind.
While the above statistics look impressive, 33% of the patients taking a placebo (sugar pill) also indicated a one third improvement in pain. So the chances that Lyrica alone will significantly reduce your FM symptoms are between 10 and 20 percent. Stating it another way, less than one out of five FM patients will achieve significant relief from their FM symptoms while using Lyrica as mono-therapy.
The above statistics blend the data from over 2000 FM patients who were only allowed to take Lyrica. The range in response to this drug varies substantially with some patients claiming 'I got my life back' to others stating 'It did nothing for me but produce intolerable side effects.' Given the diversity in response to Lyrica, it still may be worth a try to find out if this drug can help you, even if you have to take a lower dose to avoid side effects.
Most of Lyrica's side effects are dose-dependent, meaning that the more you take the greater your chances of getting a particular side effect.
'The most common reasons for discontinuing Lyrica are sleepiness and weight gain,' says Kenneth Miller, M.D., of Danbury, CT. 'The side effects of blurred vision occur in less than 10% of patients and usually resolves with continued use of Lyrica.' Should patients encounter this side effect, they need to notify their doctor and have routine eye exams as a precautionary measure. 'Dry mouth and constipation occur more often at the higher doses,' adds Miller. The cause of these two side effects is unknown.
While it is reassuring that the weight gain tends to plateau off after three to four months, a study investigating this side effect indicates that it is highly variable. The average weight gain per month for patients at the 300 mg/day dose could be as high as 4.5 percent of a person's body weight. 'I have seen patients gain 10-15 pounds during the first three to four months,' says Miller. 'If a patient gains more than this, I would advise them to discontinue the drug. There are no safe appetite suppressants, so patients ned to monitor their calories and try to increase physical activity if their pain improves.'
'Patients who get edema (which can also be a source of weight gain) can try taking a mild diuretic.
Patients with reduced kidney function as shown by a creatinine clearance less than 60 ml/min. should be monitored carefully. Increased incidence of neurological symptoms occur in people over 65 years (tremor, reduced coordination, muscle pain, and weakness). If Lyrica is discontinued, it should be done gradually over at least one week to decrease weighdrawal symptoms.
In the Octorber 2007 Journal, I. Jon Russell, M.D., Ph.D., of San Antonio, TX, suggested that patients take Lyrica at bedtime to minimize dizziness and use the sedating side effect to help with sleep.
'I have many patients that get an entire day of symptoms relief when they just take Lyrica at bedtime, says Kevin Hackshaw, m.D., of Ohio State University in Columbus. 'I would say there is a 50% chance that this strategy will be effective.' He adds that predominatnt nighttime dosing leads to less daytime side effects for the other problems as well. For example, blurry vision and ry mouth shouldn't bother you during sleep and peripheral edema ought to be lessened because you are not on your feet when the higher dose of Lyrica is in your system. If you take the brunt of lyrica at night, your GI system gets a rest from the drug during the daytime, making constipation problems less likely.
Even if you find nightly dosing of Lyrica helpful, Hackshaw says, 'It is more often effective as an all-day medication.' But how do you get around the daytime side effects of Lyrica? He places his patients on 25 mg in the late afternoon, and then anywhere from 100 to 150 mg at bedtime. 'You don't have to take the 150 mg dosage to get relief from Lyrica.'
Sometimes Hackshaw writes two prescriptions, one for 25 mg capsules of Lyrica to be taken twice daily, and a separate script for 150 mg capsules to be taken at bedtime. This method may be the most convenient for patients and is usually covered by insurance companies, but it requires patients to pay for two copays. Since Lyrica is not available as a generic, this method may be costly.
'A way to get around the issue of two copays is to write just one prescription for 25 mg caps,' says Hackshaw. 'For example, I write the script for one 25 mg cap in the morning, one 25 mg cap in the afternoon and six 25 mg caps at bedtime.
Insurance companies usually approve prescriptions written in this manner. The advantage of this prescription is that the patient only pays one copay because the coay is dependent on the different dosages of Lyrica and independent of the number of capsules being dispensed.'
Certainly , the above dosing strategy in which the brunt of Lyrica is taken at bedtime with small booster doses during the day, is bound to minimize side effects. It also makes plenty of sense given that several studies have shown Lyrica enhances the quality of sleep and it also is thought to reduce glutamate, an excitatory pain transmitter. So , why is this dosing method of Lyrica not generally publicized? Hackshaw says that 'Pfizer-sponsored speakers are required to adhere to the FDA-approved dosing schedules (e.g., 150 to 225 mg twice daily). However, if physicians were to ask a speaker about non-standard dosing, the speaker would be allowed by law to address the question.'
sue in ohio
"While physicians who are less experienced with managing FM pain may eagerly prescribe Lyrica (pregabalin) because it is the first drug with large scale clinical trial daa to substantiate its use, patients concerns about side effects are valid.
When a drug is new, all the adverse effects are not always known. In addition, physicians who are not accustomed to prescribing Lyrica may follow the standard dosing regimen approved by the Food and Drug Administration (FDA), which may not be optimal for you.
What are the odds that Lyrica will improve your FM symptoms? In general , a one third reduction in symptoms is viewed as providing clinically meaningful relief (e.g., a degress of improvement that patients would clearly notice). Of course, if a drug could cut your symptoms in half, that would be even better but these results are extremely hard to achieve with a single medication. in the real world of managing FM symptoms, three or more meds are combined in hopes that each one gives a patient 15-20 percent symptom improvement. Yet , the FDA does not allow this strategy for documenting the effectiveness of a drug, so keep this in mind.
While the above statistics look impressive, 33% of the patients taking a placebo (sugar pill) also indicated a one third improvement in pain. So the chances that Lyrica alone will significantly reduce your FM symptoms are between 10 and 20 percent. Stating it another way, less than one out of five FM patients will achieve significant relief from their FM symptoms while using Lyrica as mono-therapy.
The above statistics blend the data from over 2000 FM patients who were only allowed to take Lyrica. The range in response to this drug varies substantially with some patients claiming 'I got my life back' to others stating 'It did nothing for me but produce intolerable side effects.' Given the diversity in response to Lyrica, it still may be worth a try to find out if this drug can help you, even if you have to take a lower dose to avoid side effects.
Most of Lyrica's side effects are dose-dependent, meaning that the more you take the greater your chances of getting a particular side effect.
'The most common reasons for discontinuing Lyrica are sleepiness and weight gain,' says Kenneth Miller, M.D., of Danbury, CT. 'The side effects of blurred vision occur in less than 10% of patients and usually resolves with continued use of Lyrica.' Should patients encounter this side effect, they need to notify their doctor and have routine eye exams as a precautionary measure. 'Dry mouth and constipation occur more often at the higher doses,' adds Miller. The cause of these two side effects is unknown.
While it is reassuring that the weight gain tends to plateau off after three to four months, a study investigating this side effect indicates that it is highly variable. The average weight gain per month for patients at the 300 mg/day dose could be as high as 4.5 percent of a person's body weight. 'I have seen patients gain 10-15 pounds during the first three to four months,' says Miller. 'If a patient gains more than this, I would advise them to discontinue the drug. There are no safe appetite suppressants, so patients ned to monitor their calories and try to increase physical activity if their pain improves.'
'Patients who get edema (which can also be a source of weight gain) can try taking a mild diuretic.
Patients with reduced kidney function as shown by a creatinine clearance less than 60 ml/min. should be monitored carefully. Increased incidence of neurological symptoms occur in people over 65 years (tremor, reduced coordination, muscle pain, and weakness). If Lyrica is discontinued, it should be done gradually over at least one week to decrease weighdrawal symptoms.
In the Octorber 2007 Journal, I. Jon Russell, M.D., Ph.D., of San Antonio, TX, suggested that patients take Lyrica at bedtime to minimize dizziness and use the sedating side effect to help with sleep.
'I have many patients that get an entire day of symptoms relief when they just take Lyrica at bedtime, says Kevin Hackshaw, m.D., of Ohio State University in Columbus. 'I would say there is a 50% chance that this strategy will be effective.' He adds that predominatnt nighttime dosing leads to less daytime side effects for the other problems as well. For example, blurry vision and ry mouth shouldn't bother you during sleep and peripheral edema ought to be lessened because you are not on your feet when the higher dose of Lyrica is in your system. If you take the brunt of lyrica at night, your GI system gets a rest from the drug during the daytime, making constipation problems less likely.
Even if you find nightly dosing of Lyrica helpful, Hackshaw says, 'It is more often effective as an all-day medication.' But how do you get around the daytime side effects of Lyrica? He places his patients on 25 mg in the late afternoon, and then anywhere from 100 to 150 mg at bedtime. 'You don't have to take the 150 mg dosage to get relief from Lyrica.'
Sometimes Hackshaw writes two prescriptions, one for 25 mg capsules of Lyrica to be taken twice daily, and a separate script for 150 mg capsules to be taken at bedtime. This method may be the most convenient for patients and is usually covered by insurance companies, but it requires patients to pay for two copays. Since Lyrica is not available as a generic, this method may be costly.
'A way to get around the issue of two copays is to write just one prescription for 25 mg caps,' says Hackshaw. 'For example, I write the script for one 25 mg cap in the morning, one 25 mg cap in the afternoon and six 25 mg caps at bedtime.
Insurance companies usually approve prescriptions written in this manner. The advantage of this prescription is that the patient only pays one copay because the coay is dependent on the different dosages of Lyrica and independent of the number of capsules being dispensed.'
Certainly , the above dosing strategy in which the brunt of Lyrica is taken at bedtime with small booster doses during the day, is bound to minimize side effects. It also makes plenty of sense given that several studies have shown Lyrica enhances the quality of sleep and it also is thought to reduce glutamate, an excitatory pain transmitter. So , why is this dosing method of Lyrica not generally publicized? Hackshaw says that 'Pfizer-sponsored speakers are required to adhere to the FDA-approved dosing schedules (e.g., 150 to 225 mg twice daily). However, if physicians were to ask a speaker about non-standard dosing, the speaker would be allowed by law to address the question.'
sue in ohio
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