Patients with essential thrombo-cythemia have a high risk of thrombosis, particularly in the arteries. Hydroxyurea, often with low-dose aspirin, is widely used to control platelet counts in these patients. However, anagrelide (Agrylin®, Shire), which inhibits platelet aggregation, is also used in first-line therapy, despite drawbacks such as greater expense and concerns about efficacy.

A trial from the United Kingdom compared hydroxyurea plus aspirin with anagrelide plus aspirin in 809 high-risk patients for 12 to 72 months. The results give hydroxyurea/aspirin a distinct edge.
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The anagrelide/aspirin combination was associated with higher rates of arterial thrombosis, hemorrhage, transformation to myelofibrosis, and withdrawal from treatment. Although this therapy also carried a significantly lower rate of venous thromboembolism, the investigators were unsure whether anagrelide reduced the incidence or whether hydroxyurea raised it. They suggest that the optimal treatment of patients with previous venous thrombosis will depend on individual circumstances, but they note that arterial thrombosis is more than three times more common than venous thrombosis in essential thrombo-cythemia.

Both groups of patients maintained control of platelet counts.

Nearly half of emergency physicians are reluctant—even resistant—to use recombinant tissue-plasminogen activator (rt-PA) (e.g., alteplase [Activase®, Genentech]) to treat acute ischemic stroke, even in patients at risk, according to a survey by researchers from the University of Michigan Health System and the American College of Emergency Physicians in Dallas. And that’s likely to be an underestimate, they add.

Stroke is the primary cause of adult disability in the U.S and third most common cause of death. Yet only one FDA-approved drug—rt-PA—has been shown to improve stroke recovery. In general, the researchers say, only 1% to 2% of ischemic stroke patients are treated with this therapy. Even in academic medical centers, only 20% of those eligible are treated with intravenous (IV) rt-PA.

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The experimental drug ranibizumab (Lucentis™, Genentech) has improved vision in patients with the “wet” form of age-related macular degeneration (AMD), a serious eye disease of the elderly. In a one-year trial, vision improved on an eye chart in 25% to 34% of patients; only 5% of patients receiving a placebo improved by the same amount.

Lucentis™ appears to be the first drug that can improve vision in patients with AMD; until now, other treatments have been able to only slow or stabilize the condition.

In May, Genentech reported preliminary data but did not state the percentage of improvement. Some researchers also questioned whether the studied patients were representative of AMD patients in general. In one trial, the drug was associated with an elevated risk of uveitis.
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Lucentis™ is a modified form of the company’s cancer drug bevacizumab (Avastin), which blocks protein factors that promote the growth of blood vessels. Bevacizumab is not readily absorbed into the retina; thus, Lucen-tis™ was developed as a separate drug. Genentech and some doctors say that risks associated with the drug should be minimal, because Lucentis™ is injected directly into the eye instead of being administered systemically, like bevacizumab.

Genentech plans to ask the FDA to grant “fast-track” status to win an earlier approval based on the one-year data, although Lucentis™ is unlikely to win regulatory approval until at least mid-2006.

On August 19, a Texas jury found Merck liable for the death of Robert C. Ernst. Mr. Ernst died in 2001 after taking the painkiller rofecoxib (Vioxx®) for eight months. The jury awarded $253.5 million to his widow. The huge award will probably be reduced to $26.1 million because of a Texas law capping punitive damages.

During the six-week trial, jurors were reported to have concluded, from the testimony and documents presented, that Merck had been aware of the drug’s potential heart risks but had hidden those risks from patients. However, according to a Wall Street Journal editorial, the jury might have been duped by a questionable scientific theory introduced by the plaintiff’s attorney.

The theoretical sequence of events that he “concocted” (in an effort to link the drug to the death, namely a blood clot leading to a heart attack and then to a fatal arrhythmia) was contrary to the autopsy findings. The pathologist found no blood clot and no heart muscle damage from a heart attack when Mr. Ernst died: she had attributed the death to arrhythmia. No studies have linked this drug to arrhythmia.

Some experts are calling for experienced medical court judges to help juries understand the technical issues and reach a fair verdict, and they have stated that blaming the death on this drug is “far-fetched.” Juries do not understand medical information up to 80% of the time, according to the Harvard Medical Practice Study of Litigation in New York state.

Time will tell whether the COX-2s can bounce back. Sales of generic celecoxib (Celebrex canadian, Pfizer), the only COX-2 remaining in the U.S. market, have already rebounded. Some physicians still consider these agents to be safer anti-inflammatories for the stomach than conventional painkillers such as aspirin.

A zoster vaccine that reduces the incidence of herpes zoster by 51% and decreases pain and discomfort by 61% is certainly big news. But even bigger, perhaps, is the fact that fewer older people would need to fear one of the most devastating types of pain—postherpetic neuralgia (PHN). The zoster vaccine reduced the incidence of PHN by 66%.

The Shingles Prevention Study Group, which conducted the Veterans Affairs Cooperative Study No. 403, studied a live attenuated vaccine in 38,546 adults 60 years of age or older. Although the effect of zoster vaccine on the incidence of herpes zoster was lower among older subjects, the effect on the severity of illness was greater.
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Cell-mediated immunity is the key to the protective effect of the vaccine. The minimum potency of the zoster vaccine was at least 14 times greater than that of Varivax, the vaccine currently licensed to prevent the varicella-zoster virus (VZV). A preliminary study indicates that potencies of that magnitude are required to elicit a significant increase in the cell-mediated immunity to VZV among older adults, the study group says.

A combination vaccine (Proquad®, Oka/Merck) has been approved to protect children 12 months to 12 years of age against measles, mumps, rubella (German measles), and varicella (chickenpox).

This is the first U.S.-approved vaccine approved to offer protection against these four diseases in a single injection.
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Proquad® combines two Merck vaccines: M-M-R®II (Measles, Mumps and Rubella Virus Vaccine Live) and Varivax® (Varicella Virus Vaccine Live).

Mylan Pharmaceuticals, Inc., has received final approval from the FDA for its Abbreviated New Drug Applications (ANDAs) for generic metformin HCl extended-release tablets, 500 and 750 mg. These tablets are the generic version of Bristol-Myers Squibb’s Canadian Glucophage XR Tablets. Metformin, a biguanide, is indicated for improvement of glucose control in patients with type-2 diabetes.