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Pregabalin Is First Drug Approved for Fibromyalgia

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Pregabalin Is First Drug Approved for Fibromyalgia 50 Pain Medicine C LINICAL P SYCHIATRY N EWS • August 2007 Pregabalin Is First Drug Approved for Fibromyalgia BY ELIZABETH MECHCATIE that are not usually painful, and that pre- cording to the revised prescribing infor- The daily dose should be administered Senior Writer gabalin may reduce the degree of pain ex- mation for pregabalin. The two studies— in two divided doses per day, starting at a perienced by patients with fibromyalgia by a 14-week double-blind placebo-controlled total daily dose of 150 mg/day, which regabalin has become the first drug binding to a specific protein within study and a 6-month randomized with- may be increased to 300 mg/day, within 1 to win approval by the Food and “overexcited nerve cells.” drawal study—found that treatment was week; the maximum dose is 450 mg/day, PDrug Administration for the man- The approval “marks an important ad- associated with a reduction in pain by vi- according to the prescribing information. agement of fibromyalgia. vance, and provides a reason for optimism sual analog scale and improvements based The most common side effects in the tri- The FDA based the approval on two for the many patients on a patient global as- als were mild to moderate dizziness and double-blind, controlled trials of approxi- who will receive pain Side effects such as sessment and on the sleepiness, blurred vision, weight gain, dry mately 1,800 patients. Data from the stud- relief ” with prega- Fibromyalgia Impact mouth, and swelling of the hands and feet ies have shown that patients with fi- balin, Dr. Steven Gal- dizziness and sleepiness, Questionnaire. also were also reported. Side effects ap- bromyalgia “have decreased pain after son, the director of blurred vision, weight gain, In the 14-week peared to be dose related, according to the taking [pregabalin], but, the mechanism the FDA’s Center for study, some patients FDA. Patients should talk to their physi- by which [pregabalin] produces such an ef- Drug Evaluation and dry mouth, and swelling of experienced reduc- cians or other health care providers about fect is unknown,” according to an agency- Research said in the the hands and feet seemed tions in pain during whether pregabalin—which can impair issued statement. FDA statement. He the first week of motor function, concentration, and atten- In the clinical trials of patients with fi- added, however, that to be dose related. treatment, which tion—can affect their ability to drive, the bromyalgia, those on pregabalin (Lyrica) consumers should continued through- FDA advised. Pfizer has agreed to conduct had “rapid and sustained improvements in understand that some patients in trials out the study. Nearly 70% of those on a a study of pregabalin in children and an- pain,” compared with those on placebo, did not benefit from the drug, and that total daily dose of 300 mg of pregabalin, other in women who are breast-feeding. and “reported feeling better and improve- “we still have more progress to make for and 78% of those on a total daily dose of Pregabalin, a centrally acting drug, was ments in physical function,” according to treatment of this disorder.” 450 mg experienced any improvement on first approved in 2004 for the manage- a statement issued by Pfizer, which man- The two studies enrolled patients diag- the patient global impression of change ment of neuropathic pain associated with ufactures pregabalin. The same statement nosed with fibromyalgia using American scale, compared with 48% of those on diabetic peripheral neuropathy and post- explains that the drug’s mechanism of ac- College of Rheumatology (ACR) criteria, placebo. The total daily dose of 600 mg herpetic neuralgia, and for the adjunctive tion for fibromyalgia is not known, but which are a history of widespread pain for was not more effective than the lower dos- therapy for adult patients with partial states that patients with fibromyalgia may 3 months and pain present at 11 or more es, and there was evidence of dose-relat- onset seizures. It is taken orally in capsule be more sensitive than normal to stimuli of the 18 specific tender point sites, ac- ed side effects. form. ■ Migraine Patients May Benefit Look for Depression, PTSD in From Magnesium or CoQ10 Iraq War Vets With Migraines BY LESLIE SABBAGH The most important sup- Dr. Mauskop recommends BY MARY JO M. DALES diers’ return, indicated that nearly Contributing Writer plement, according to Dr. a combination of magne- Editorial Director 20% had migraine headaches. Mauskop, is magnesium. “It’s sium, feverfew, and riboflavin: The study results are limited by R ANCHO M IRAGE, known that up to 50% of “I find that about half of peo- B OSTON — In soldiers returning their self-reported nature, which does C ALIF. — Alternative ther- people with acute migraine ple are very happy with [this from combat in Iraq, a self-reported not establish a diagnosis and is likely apies are not a replacement have a magnesium deficien- combination]. Sometimes history of migraine headaches was as- to result in more reports of symp- for prescription drugs in mi- cy. ... It is much more effec- their headaches completely sociated with at least twice the risk of toms; they also are limited by a lack graine treatment, but they tive to treat them with a disappear so that they don’t symptoms of depression, posttrau- of information about predeployment can reduce the severity of the product they’re deficient in need prescription drugs.” matic stress disorder, and anxiety as rates of migraine. Nevertheless, the attacks and help ease symp- rather than using drugs,” he The triple combination, was seen in similar soldiers without rates are twice those seen in 20- to 40- toms, reported Dr. Alexander said. Magnesium is “very ef- available as MigreLief, costs migraines, based on a study present- year-olds in the general population Mauskop. fective for 50% of those who $18 per month, and “if mon- ed at the annual meeting of the Amer- and in men, who comprised 96% of In fact, “anyone suffering are deficient in it, but even ey is not an issue, I add ican Academy of Neurology. the study participants. from migraines can benefit prescription drugs work for CoQ10.” Patients take 300 Migraines appear to be frequently Respondents answered 15 questions from these treatments,” Dr. only 50% of migraineurs” mg/day of MigreLief for 8 associated with symptoms of psychi- about the nature and frequency of Mauskop said. The most im- (Headache 2003;43:601-10). weeks. Although one study atric conditions in soldiers returning any headaches in the last 3 months. portant point, he stressed at a Research has found that, that showed favorable results from deployment, Maj. Jay C. Erick- They also completed the four-ques- meeting sponsored by the Di- for migraine, CoQ10 at 300 in migraine patients used 100 son, MC, USA, said during a press tion Primary Care PTSD Screen (PC- amond Headache Clinic, is mg/day is effective, and that mg t.i.d., “I often recom- conference at the meeting, where the PTSD) and the Patient Health Ques- that nonpharmacologic for Parkinson’s disease 1,200 mend 300 mg once daily due study results were presented during a tionnaire (PHQ9) screen for methods can be as effective as mg/day is effective. “Ri- to adherence issues.” scientific poster session. depression and anxiety. drugs, if not more effective. boflavin has similar function Patients have a continuum Although all soldiers returning The responses indicated that 32% When instituting an alterna- in the body as CoQ10 and of responses. “Some say their from deployment undergo mental screened positive for depression, 22% tive approach, the first step is was shown to prevent mi- headaches are more respon- health screening, there is the possi- for PTSD, and 9% for anxiety. Over- to eliminate food triggers, en- graine in one double-blind sive to prescription drugs and bility that headaches and symptoms all, 39% of respondents had at least courage a proper sleep regi- study. Although the thera- some have total disappear- of a psychiatric condition could pre- one psychiatric condition. Respon- men, regular meal intake, and peutic amount of riboflavin ance of migraines, with most sent after such testing and possibly dents with migraines, compared with sufficient hydration. is very high—400 mg/day; responses somewhere in the outside the Veterans Affairs health those without migraines, had much Actual alternative thera- many multivitamins have middle,” he said. care system, he said. Mental health higher rates of depression symptoms pies to control physiologic only 2-3 mg,” he said (Neu- Butterbur has only one screening is warranted to assure that (50% vs. 27%), symptoms of PTSD response to stress include rology 1996;50:440-66). manufacturer, Dr. Mauskop psychiatric disorders are identified (39% vs. 18%), and anxiety symptoms regular aerobic exercise and Butterbur, 50 mg t.i.d, has said, “but feverfew is sold by and properly treated at that time. (17% vs. 7%). biofeedback, said Dr. also been found to help treat many companies and the Dr. Erickson of Madigan Army Migraine days per month were Mauskop, director of the migraine, most likely due to products are not always of Medical Center at Fort Lewis in Taco- linked to a higher probability of a pos- New York Headache Center. its anti-inflammatory prop- good quality. Patients need ma, Wash., reported the findings from itive screen for depression and PTSD, For migraines, the most erties, or “maybe something to buy recognized brands or a health screening questionnaire com- but not a higher rate of anxiety symp- commonly used supplements else. Herbal products contain the triple combination sup- pleted by nearly 2,200 of 3,600 soldiers toms.
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