FROM OUR EXPERTS
Recently I wrote about the anti-seizure medication, Topamax, for chronic headache pain. Today, I would like to discuss another medication which has also been used to treat seizures: Lyrica. This has been on the market for less than a year, but I have found it a very helpful drug in patients with chronic pain syndromes, such as fibromyalgia. Fibromyalgia occurs predominantly in women of child-bearing age, and is seen commonly in the offices of most rheumatologists in the United States. Afflicted patients usually complain of diffuse musculoskeletal pain, poor sleep, and fatigue. Often, the amount of pain is related to the amount of sleep—the less sleep, the more pain. Many patients feel their pain is worsened by stress, cold weather, or overexertion. Conversely, patients will feel better in warm weather, while on vacation and away from the usual worries of day to day living, and with improved sleep hygiene. Patients will often suffer from chronic headaches and an irritable bowel.
The FDA has completed its analysis of reports of suicidality (suicidal behavior or ideation [thoughts]) from placebo-controlled clinical trials of neuronal stabilizing agents (anticonvulsants) used to treat epilepsy, Migraine disease, psychiatric disorders, and other conditions. Based on the outcome of this review, FDA is requiring that all manufacturers of drugs in this class include a Warning in their labeling and develop a Medication Guide to be provided to patients prescribed these drugs to inform them of the risks of suicidal thoughts or actions. In the FDA's analysis of 199 clinical trials, patients receiving neuronal stabilizing agents had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the neuronal stabilizing agent and continued through 24 weeks. The results were generally consisten...
T he study called ACCORD (Action to Control Cardiovascular Risk in Diabetes) is back in the news. The study, which included 10,251 patients with type 2 diabetes mellitus and who were at especially high risk of cardiovascular events (such as heart attacks, stroke, or death from cardiovascular disease). The study should not be extrapolated to patients with type 2 diabetes "who are younger, whose diagnosis is more recent, or who have a lower risk of CVD than participants studied in the ACCORD trials. It is not known what effect more intensive therapy might have on CVD in younger people with type 2 diabetes or in patients with a lower risk of CVD than were studied in ACCORD" (per a NIH Q&A about the study).
I have previously written (several times!) about earlier results from the ACCORD trial, which surprised experts when it was announced that patients in the tight-glucose-control part of the study (aiming for A1C below 6.0) had more deaths than patients in the standard-glucose...
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