Thalidomide (Thalomid®, Celgene), a drug that was blamed for birth defects years ago, is finding a new respectability as an experimental therapy for various malignancies, including multiple myeloma, gliomas, Kaposi’s sarcoma, and advanced breast cancer. The treatment, however, appears to be dogged by a complication: the more frequent occurrence of venous thromboembolism (VTE). A study of 70 men with advanced andro-gen-independent prostate cancer bears this out.

The men, aged 50 to 80, were given intravenous docetaxel (Taxotere®, Aven-tis) or docetaxel with thalidomide. None of the 23 who received docetaxel alone developed VTE, compared with nine of 47 (19%) who received the combination treatment.
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The researchers could not determine why thalidomide might have a pro-thrombotic effect. The only measured factor that declined appreciably after the initiation of thalidomide/docetaxel therapy—which was not seen in the men taking docetaxel alone—was protein C.

Although the change was statistically significant, it wasn’t great enough to raise the risk of thrombosis; however, it was noted that thalidomide might cause endothelial damage. Agents used in combination with thalidomide that are toxic to the endothelium might be exposing the subendothelial tissue to the pro­thrombotic effect of the anti-angiogenic agent. The authors suggest that thalido-mide and docetaxel, which has anti-angiogenic effects in vitro, might have a synergistic harmful effect.

The Food and Drug Administration (FDA) has announced the accelerated approval of enfuvirtide (Fuzeon^TM, Roche) for use with other anti-HIV medications in adults and children ages six years and older with advanced human immunodeficiency virus (HIV) infection. Enfuvirtide is the first in a new class of medications called fusion inhibitors, which interfere with the fusion of viral and cellular membranes, thus hindering the entry of HIV-1 into cells.

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Neurologists at Thomas Jefferson University Hospital in Philadelphia, Pennsylvania, may have found a long-acting drug to stop monthly migraines that occur in some women around the time of their menstrual periods—before the headaches start.

Frovatriptan succinate (Frova®, Elan), was found in a nationwide study to prevent migraines associated with menstruation in as many as 50% of the women evaluated. Frovatriptan is in a class of drugs called triptans, which reduce inflammation of certain blood vessels in the brain that are thought to cause pain.

Participants had an average 12-year history of migraine, which affects more than five million American women. In the U.S. alone, approximately nine million women suffer from migraines; about 60% of them, or 5.4 million, report an increased number of headaches in association with their menstrual periods.

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Liver-function tests might not be all that helpful in determining which patients with sarcoidosis should discontinue tak­ing methotrexate. Researchers from the University of Cincinnati performed 100 liver biopsies in 68 patients with chronic sarcoidosis who had been treated for up to eight years with methotrexate. (To their knowledge, this study represented the largest series of liver-biopsy results in this patient population.)

Toxic drug effects were observed in 14 cases. After examining all the abnormal liver-function test results during the year before the biopsy, however, the researchers found no pattern that might predict toxicity. Patients with hepatic sarcoidosis already had higher levels of various liver enzymes, which meant that the predictive value of the liver-function tests was lost; in addition, more than half of the patients in the methotrexate toxicity group did not have elevated aspartate transami-nase levels in the year before biopsy.
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Methotrexate has become a standard second-line agent for the treatment of sarcoidosis, and hepatotoxicity is a well-known side effect of the drug. Using a liver biopsy to look for a toxic reaction to methotrexate has been controversial, the researchers note, and they point out that rheumatologists have relied on serial liver-function tests to identify at-risk patients with rheumatoid arthritis, based on the relatively low rate of metho-trexate-related liver damage. For patients with sarcoidosis, the policy at the researchers’ institution is to perform a liver biopsy in patients who receive metho-trexate for more than two years.

The doctrine of double effect—that a harmful effect of treatment is permissible if it occurs unintentionally as a side effect of a beneficial action—is “almost completely irrelevant” in the case of sedatives given in palliative end-of-life care, according to a case study from St. Christopher’s Hospice in London.

After reviewing information about 237 patients who died in the 62-bed hospice, the researchers concluded that most episodes of sedative use were brief, with no evidence that they had precipitated death. Instead, the episodes were a response to features of a dying process that had already begun. The sedatives were intended not to produce unconsciousness but to relieve symptoms such as agitation and restlessness that were associated with the final stages of terminal illness.

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Cephalon, Inc., has received approval to market modafinil (Provigil®) tablets to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome and “shift work sleep disorder.”

In 1998, modafinil became the first in a new class of wake-promoting agents for patients with narcolepsy.
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In preclinical studies, the drug promoted wakefulness without causing generalized stimulation in the brain. It seems to work selectively through the sleep-wake centers to activate the brain cortex. Activation of the cortex is essential for wakefulness.

The safety of modafinil was shown in clinical trials that enrolled more than 3,500 patients. The drug does not affect the ability to sleep when sleep is desired.

Two recent studies have linked a lack of exposure to vitamin D, which is created naturally by sunshine or artificial ultra­violet (UV) light, to the development of multiple sclerosis (MS), an often debili­tating disease that affects 250,000 to 350,000 Americans.

The body makes vitamin D through exposure to sunlight’s UV-B ultraviolet rays. The exact causes of MS remain un­known, but MS becomes more prevalent in people living farther away from the Equator. It is thought that a minimum level of UV exposure throughout the year might be important in conferring protec­tion by influencing the immune system response, possibly through changes in the production of vitamin D and melanin, the substance involved in acquiring a tan.
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A major hindrance to generating suffi­cient vitamin D is living at high latitudes, where exposure to natural sunlight may be insufficient. Some research, including these two new studies, has shown a cor­relation between high latitudes and increases in diseases linked to vitamin D deficiency.

In the National Institutes of Health study of more than 185,000 women, MS was 40% less likely to develop in women who maintained recommended levels of vitamin D than in women who were oth­erwise deficient in vitamin D.