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Update From the Medical Journals: December 2008
December 31, 2008  By Mary Pickett, M.D.
Harvard Medical School What's the latest news in the medical journals this month? Find out what your doctor is reading. Some Asthma Inhalers No Longer Recommended In 2005, the U.S. Food and Drug Administration (FDA) issued a Public Health Advisory to alert health care professionals and patients about long-acting beta agonist (LABA) drugs. They are a commonly-used family of inhaled medications for asthma. The warning said that LABA medicines may increase the chance of severe asthma episodes and death when the episodes occur. Nevertheless, lung specialists have continued to recommend these medicines to many patients because they provide valuable symptom relief and problems seemed rare. LABA medications include salmeterol (Serevent), formoterol (Foradil, Perforomist), arformoterol (Brovana), and two inhalers that combine a LABA medication with a corticosteroid (Advair diskus, Symbicort). LABA medications are airway-opening drugs that wear off very gradually. They are commonly used once or twice daily to help control symptoms, especially nighttime symptoms. Even though these medicines reduce daily symptoms and usually reduce the frequency of flare-ups, when they do occur, flare-ups can be surprisingly difficult to "turn around." They can even be fatal. Experts are not sure why this happens to some people. It may be that the medicines cause the lungs to adapt and adjust over time, limiting their power to treat severe symptoms. On November 18, the FDA notified consumers in its "FDA Safety Update: Asthma Medications" that it would take a new look at the safety of LABA drugs based on recent studies and drug-event reporting. This month the FDA made good on its promise when it held a series of public advisory committee meetings December 10 and 11. The committee now recommends that people with asthma only use a LABA medicine if it is combined with an inhaled corticosteroid (anti-inflammatory) medicine. This shortens the list of recommended LABA medicines for asthma to just Advair diskus and Symbicort. FDA officials have not yet announced whether they will place restrictions on the LABA medicines that are no longer recommended for asthma (Serevent, Foradil, Perforomist, Brovana). However, experts anticipate that the FDA will follow the recommendations of the committee. The committee recommendations do not affect the use of any of these inhalers for bronchitis and emphysema, also called chronic obstructive pulmonary disease (COPD). The committee arrived at it's decision by reviewing data from 110 asthma studies involving nearly 61,000 patients. Again the committee noted the higher rates of unexpectedly severe attacks and deaths. However, these events only occurred in people who used the pure LABA inhalers, but not the inhalers that combined LABA medicines with corticosteroid (anti-inflammatory) drugs. Back to top Movements During REM Sleep May Be First Sign of Disabling Neurologic Diseases The online December 24 issue of Neurology includes a report about 93 people who were diagnosed with REM sleep behavior disorder, but otherwise had normal brain function. Researchers monitored the health of these individuals over time. The found that many of the subjects began to show signs of either Parkinson's disease, Alzheimer's dementia, Lewy body dementia (dementia with features that are similar to Parkinson's, and hallucinations), or — in the case of one subject — a rarer progressive brain disorder. Within five years of the onset of REM sleep behavior disorder, 18% of the people had a diagnosis of one of these more disabling neurologic illnesses. Within 12 years, 52% of the individuals were affected. This study suggests that sudden or wild movements during dreams predict that a person is at high risk for developing one of several possible degenerative neurologic diseases. This connection may eventually allow us to understand neurologic diseases better. People with REM sleep disorder may also benefit from any preventive therapies that are developed for dementia. Back to top More News in Brief - Diuretic Might Not Be Best Option When Blood Pressure Control Needs Two Drugs. Diuretics and "ace inhibitors" (lisinopril and benazepril, for example) are at the top of the list of medications to treat high blood pressure. In large studies these drugs provide the best health and survival advantage when they are used alone. But most people with hypertension need to take two or more drugs. It is usual practice for doctors to prescribe a diuretic, such as hydrochlorothiazide, as one of the drugs. The December 4 issue of the New England Journal of Medicine has published a study that compared a combination of a diuretic (hydrochlorothiazide) and an ace inhibitor (benazepril) with a drug combination of benazepril and a "calcium channel blockers" (amlodipine). The study randomly assigned 11,500 older adults who had risk factors for heart attack to one of the two drug combinations. After three years, benazepril plus amlodipine resulted in the best survival and the lowest risk for stroke and heart attack, although both treatment groups had good results. This study demonstrates that doctors have numerous good medications to choose from for high blood pressure treatment, and need not be rigid about including a diuretic when two drugs are needed to control blood pressure.
- Seizure (and Pain) Medicines May Trigger Suicidal Thoughts. On December 16, the FDA issued an online public health advisory that 20 popular medications used to prevent seizures, reduce nerve pain, manage chronic pain, and in some cases treat bipolar depression can trigger suicidal thoughts and double the risk for suicide. Most of the drugs on the list are categorized as "anti-epileptic" (anti-seizure) medicines or "mood stabilizers." The risk applies to all people who are using the medications, even people who did not have depression before beginning the drugs. Compared with people who are not on one of these medicines, for every 530 people who are taking a drug there seems to be one extra case of suicidal thoughts or actions. Some of the more commonly used medications that were listed include gabapentin (Neurontin), pregabalin (Lyrica), lamotrigine (Lamictal), carbamazepine (Tegretol), clonazepam (Klonopin) and topiramate (Topamax). These medications can be very useful, and the risk for suicide is low in people without depression symptoms. It is important for doctors and patients to be aware of this potential side effect, and to watch for unexpected symptoms of depression or worsening of pre-existing depression.
- Radiation Plus Flutamide Is New Standard of Care for Treating Locally Advanced Prostate Cancer. A report published online by The Lancet on December 15 shows that radiation plus hormone therapy (using the medication flutamide) doubled long-term survival in patients with locally advanced prostate cancer compared with radiation alone. Locally advanced prostate cancer has spread far enough into the prostate capsule or the adjacent seminal vesicles to make surgery an unreliable treatment if it is used alone. The study included 875 men who were randomly assigned to one of the two treatments. Eighty-eight percent of the men in the radiation-plus-hormone group survived for 10 years or longer compared with 76% of the men who received radiation alone. As a result of this study, combination treatment is the new standard of care for locally advanced prostate cancer.
Back to top Mary Pickett, M.D. is an Associate professor at Oregon Health & Science University where she is a primary care doctor for adults. She supervises and educates residents in the field of Internal Medicine, for outpatient and hospital care. She is a Lecturer for Harvard Medical School and a Senior Medical Editor for Harvard Health Publications.
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