Routine aspirin not good for elderly
PARIS
Routine recommendations that people at high risk for cardiac problems should take a low dose of aspirin each day to help ward off a possible heart attack may be unsound for the aged, a study by the British Medical Journal says. Among elderly people--those most likely to come under this category--the benefit may be offset by the risk of gastrointestinal bleeding or a brain hemorrhage.
The researchers took a health database of 20,000 men and women ages 70 to 74 living in Victoria, Australia. They then ran this database through a computer into which they factored in the outcome of clinical trials that calculate the advantages and risk from daily aspirin taking. According to this simulation, 710 elderly men and women were prevented from having a heart attack and 54 were prevented from having a stroke. But 1,071 had bad gastrointestinal bleeding and 129 suffered intracranial bleeding. Life expectancy was not affected, whether the person took aspirin or not.
Current treatment guidelines recommend that people with a raised risk of cardiovascular and coronary disease take a small daily dose of aspirin (75 to 150 mg). But the study says that "the temptation to blindly implement [this treatment] ... must be resisted" where elderly people are concerned. "The potential health gains of any preventive strategy need to be carefully balanced against their potential risks."
AFP
New study reaffirms NSAID risks
PARIS
New research points an accusing finger at widely prescribed nonsteroidal antiinflammatory drugs (NSAIDs), saying it found evidence that some of these drugs fuel the risk of first-time heart attack.
In the biggest study of its kind, British researchers compared the drug regimen among 9,218 people in England and Wales who had suffered their first heart attack. They took into account the person's age, obesity, smoking habits, whether the patient was taking aspirin or had heart disease, for these are factors that could distort the picture. The researchers found that the risk of a first-time heart attack was "significantly increased" for people who had taken certain NSAIDs in the three months before the cardiac event compared with those who had not taken any NSAID in the previous three years.
The increased risk was 24 percent for the over-the-counter ibuprofen and 55 percent for diclofenac.
The figures were also bad for COX-2 inhibitors. Those prescribed celeCOXib (Celebrex) or rofeoxib (Vioxx) were at a 21- and 32-percent increased risk of a first-time heart attack compared with people who had not taken the drugs in the previous three years, the study found. Vioxx was voluntarily withdrawn from the market last September by Merck after it was linked to a higher incidence of cardiac problems among some patients. Since then, the safety of the remaining COX-2 inhibitor drugs has come under close scrutiny. The United States now requires them to carry strong labels warning of the risk of heart problems and gastrointestinal bleedings.
The study, which appears in the British Medical Journal, says patients should not stop taking the drugs involved, and adds there could be data flaws in the study. The drug naproxen did not have any increased risk. But, it said, further investigation into these drugs is needed, especially as they are widely prescribed to elderly people, a section of the population that is most at risk of heart attack.
AFP
Claritin keeps allergy patients alert
LEVERKUSEN, Germany
Bayer HealthCare Biological Products (BP) division will begin phase-I clinical trials of its longer-acting Kogenate, the first recombinant factor VIII product of its kind to be granted permission by United States Food and Drug Administration to be used in clinical trials for hemophilia. The product, which uses PEGylated liposome technology licensed from Zilip-Pharma, represents an opportunity for a major breakthrough in hemophilia treatment based on a longer time of activity, which could result in weekly, or even less frequent, infusions in prophylaxis.
Previous clinical results obtained by Zilip-Pharma outside of the US suggest a prolonged protection from bleeding episodes--one week or more--occurs when factor VIII, attached to liposomes, is administered to individuals with hemophilia A.
Bayer does not use albumin in Kogenate's purification or formulation and includes a solvent/detergent viral inactivation step, thereby further reducing the potential risk of viral transmission. Kogenate is manufactured at Bayer BP's headquarters and state-of-the-art biotechnology facility in Berkeley, California.
"Advancing the longer-acting Kogenate through clinical development is one of our highest priorities," said Joseph Akers, president of Bayer BP. "We believe this product has the potential to dramatically shift current treatment paradigms while improving treatment convenience." Currently, individuals with hemophilia on prophylaxis infuse factor VIII product as often as three times per week.
Dr. Jerry Powell from the UC Davis Medical Center in Sacramento, California, and Dr. Diane Nugent from the Children's Hospital of Orange County will be the investigators for the phase-I trial. "This is an exciting development for the hemophilia community," said Nugent. "A treatment option that would result in less frequent dosing, say, once weekly or less, represents a major advance in hemophilia care, significantly improving convenience for patients."
"This is a treatment that has the potential to revolutionize hemophilia care, providing individuals with hemophilia and their families greater freedom to live the lives they choose," commented Michael Fournel, senior vice president for research and development at Bayer BP.
Approximately 400,000 people around the world have hemophilia, an inherited bleeding disorder characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. The disease is caused by deficient or defective blood coagulation proteins known as factor VIII or IX. The most common form of the disease is hemophilia A, or classic hemophilia, in which the clotting factor VIII is either deficient or defective. Hemophilia B is characterized by deficient or defective factor IX.
Bayer Press
Xenical now available OTC
Orlistat (Xenical), the popular weight-reducing pill, may now be bought over the counter, following approval by the Bureau of Food and Drugs of Roche Philippines' petition to market the drug OTC. Announcing the approval during a relaunch dubbed as "Xenical to a New You," Roche said this makes the drug readily accessible to individuals wishing to lose weight.
A nonsystemic antiobesity treatment, Xenical has been shown in numerous clinical trials to reduce fat absorption from food by 30 percent. The undigested fat is excreted to prevent it from being absorbed and deposited, particularly in the waist, hips, and thighs.
Overweight and obese patients taking Xenical combined with proper diet and exercise can lose up to 10 pounds in about two months. It has also been shown to have beneficial effects in controlling blood pressure and cholesterol levels.
Warwick Bedwell, Roche Philippines general manager, said the breakthrough weight-loss treatment is the world's leading doctor-prescribed, evidence-based weight-loss treatment. It is backed by clinical trials involving over 30,000 patients. "We recognize that excess weight is a problem that many people are facing. Now that we have launched the brand as an over-the-counter weight-loss treatment, we are allowing [greater] access for people who need to lose weight in a way that is safe, effective, and responsible," he said.
Noting that weight is becoming a health problem in the Philippines--the National Nutrition and Health Survey showed that 38.3 percent of men and 45.6 percent of women are classified "at risk" or obese" based on body-mass index--Brian Forrester, Roche Philippines marketing director, stressed the need to promote healthy lifestyle among Filipinos.
"This upward trend [in the prevalence of overweight and obesity] could be stopped with the right knowledge in the right selecting food low in fat--toward a healthier lifestyle," he said. Making Xenical available over the counter provides "an opportunity to educate the public about healthier lifestyle …. and strengthen the fight against obesity in the Philippines," he added.
A. Mendoza
Plavix helps prevent blood clots
Heart attack, stroke, peripheral arterial disease (PAD)--these health problems comprise one condition few people realize the seriousness of. Called atherothrombosis, it is, to Dr. Francisco Dalangin, consulting cardiologist at the St. Luke's Medical Center, "the culminating effect of atherosclerosis," and to Dr. Marcelito Durante, former president of the Philippine Heart Association and the Philippine College of Physicians, "the end point of a constellation of risk factors." Either way, it deserves closer attention, if only to lower the number of deaths associated with it--70,000 every day.
In a media forum organized by Sanofi-Aventis in late May, atherothrombosis, the risks associated with it, and its prevention and treatment were discussed in detail by Dalangin and Durante. The event also served to highlight the antiplatelet agent clopidogrel (Plavix).
There are various factors that contribute to one's risk of developing atherothrombosis, including a strong family history of an atherothrombotic event, the presence of certain conditions (hypertension, diabetes, dyslipidemia, and obesity) and certain lifestyle factors, with smoking, unhealthy diet, and physical inactivity being among the most significant.
If these risk factors are present in an individual, there will be a gradual buildup of fatty deposits in his arteries. Over time the athe-rosclerotic plaques harden and narrow the arteries, limiting the flow of blood. In itself atherosclerosis could overwork one's heart and raise one's blood pressure. But when these plaques rupture or burst, they result in the formation of thrombi, preventing blood from passing through.
The end event depends on where a thrombus forms: if in an artery leading to the heart, it could result in a heart attack; if in an artery leading to the brain, a stroke; if in an artery in one's extremities, usually the legs, it could bring PAD, a culprit behind many leg amputations, and itself a big risk factor for a heart attack.
A healthy diet, smoking cessation, and exercise contribute significantly to the prevention, primary or secondary, of atherothrombosis. But for secondary prevention, drug therapy may be required on top of making lifestyle changes. Plavix helps in preventing the development of blood clots in the arteries. Two recent studies--CLARITY and COMMIT--showed that either alone or in combination with aspirin, clopidogrel lowers the risk of death and reinfarction.
J.P. de Guzman
Avastin effective v. lung cancer
Avastin (bevacizumab, rhuMAb-VEGF), the innovative and groundbreaking antiangiogenesis drug, significantly improves survival in patients with advanced nonsmall-cell lung cancer (NSCLC) results of phase-III trial announced by Roche and Genentech showed. This is in addition to the positive results on colorectal cancer reported over the last two years.
Avastin works by choking off the blood supply that is essential for the growth of the tumor and its spread throughout the body. The trial investigated the use of Avastin in patients who had not received any previous treatment. The interim analysis of the phase-III study investigating Avastin in combination with a platinum-based chemotherapy (paclitaxel and carboplatin) met its primary efficacy end point of improving overall survival, or a reduction in the risk of death, compared with chemotherapy alone. The study was stopped since it reached its efficacy end point early.
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"To observe an improvement in survival in this study is remarkable, particularly as it is the first time in years that a study has shown an increase in survival for people with NSCLC in the first-line setting," said William Burns, chief executive officer of Roche's Pharmaceutical Division. "These results are extremely important and we plan to share the data with the regulatory authorities in order to discuss the next steps for registering Avastin for first-line treatment of NSCLC."
The randomized, controlled, multicenter study enrolled 878 patients with advanced NSCLC. It was sponsored by the National Cancer Institute of the United States National Institutes of Health, and conducted by a network of researchers led by the Eastern Cooperative Oncology Group (ECOG).
Avastin was administered at 15 mg/kg every three weeks. The paclitaxel and carboplatin chemotherapies were also administered every three weeks. Treatment in both arms repeated every three weeks for up to six courses in the absence of disease progression or unacceptable toxicity.
Avastin is the first treatment that inhibits angiogenesis--the growth of a network of blood vessels that supply nutrients and oxygen to cancerous tissues. Avastin targets a naturally occurring protein called vascular endothelial growth factor (VEGF), a key mediator of angiogenesis, thus choking off the blood supply essential for the growth and metastasis of the tumor.
In Europe, Avastin is approved for first-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with the chemotherapy regimens of intravenous 5-fluorouracil/folinic acid or intravenous 5-fluorouracil/folinic acid/irinotecan. Avastin received fast-track approval by the US Food and Drug Administration and was launched in the US in February 2004.
Roche seeks new Tamiflu indication
BASEL, Switzerland
Roche has filed in Europe for a new indication for oseltamivir (Tamiflu) in the prevention of influenza (prophylaxis use) in children aged one to 12 years.
Tamiflu is already indicated for the treatment of influenza in adults and children aged one year and above and for the prevention of influenza in adults and adolescents 13 years and older. With this filing, Roche plans to make Tamiflu available to prevent flu in very young children who are particularly vulnerable during an outbreak of the disease.
Tamiflu works by blocking an enzyme on the surface of the virus that prevents it from infecting other cells in the body.
Roche is optimistic that the Committee for Medicinal Products for Human Use (CMPH) will complete their review of the application before the end of the year. An application for the same indication was submitted in the United States in April.
William M. Burns, chief executive officer of Pharma Division said the filing underscores the outstanding efficacy and safety profile of Tamiflu. Said Burns: "It is important that the protection provided by Tamiflu can be extended to include young children because not only are children more likely to suffer from the symptoms of influenza, but they are also a major cause of viral spread during a seasonal epidemic."
The application is based on results from a subset of pediatric patients in a clinical study where Tamiflu was used for the management of influenza in households. The study showed that treatment of flu patients with Tamiflu combined with postexposure prophylaxis of other household members is more effective in preventing secondary spread of influenza infection in the household than treating the patient alone. The protective efficacy of Tamiflu was the same in children aged one to 12 as in the whole population.
Prior studies have shown that Tamiflu achieves 38-percent reduction in the severity of flu symptoms; 67-percent reduction in secondary complications such as bronchitis, pneumonia, and sinusitis; and 37-percent reduction in the duration of influenza illness.
It is also shown to provide up to 89-percent overall protective efficacy against clinical influenza in adults and adolescents who had been in close contact with influenza-infected patients.
In children, treatment with Tamiflu delivers 36-percent reduction in the severity and duration of influenza symptoms and 44-percent reduced incidence of associated otitis media compared with standard care.
Doxycycline works v. elephantiasis
PARIS
British doctors say a cheap antibiotic wipes out the parasitic worms that cause elephantiasis, a disease that afflicts more than 120 million people in India, Africa, and Southeast Asia.
Elephantiasis (lymphatic filariasis) is transmitted by mosquitoes that pick up microscopic larvae from an infected human and pass it when they take a blood meal from another person. The larvae then develop into thread-like parasitic worms that infest the lymphatic system, causing acute inflammation that makes the legs, groin, breasts, vulva, or penis to swell grotesquely and painfully.
The mainstay treatment for elephantiasis is made up of two drugs, diethylcarbamazine and ivermectin, boosted by albendazole. But they are generally effective only against the worm in its earliest stages, not the adult worm that causes the symptoms.
Taking a different tack, doctors led by Dr. Mark Taylor of the Liverpool School of Tropical Medicine in northeastern England, targeted not the worm itself but a cellular bacterium that inhabits it and is essential for its survival.
They recruited 72 men with elephantiasis in a Tanzanian village, half of whom were given an eight-week course of doxycycline, while the other half were given placebo. Those who were given the doxycycline were almost completely eliminated of adult worms after 14 months of treatment-there was an 80 percent decline according to ultrasound tests that highlight characteristic movement of "worm nests" in the scrotum. There was a dramatic fall in larval offspring, too. Side effects were negligible, according to Taylor, who reported his work in The Lancet.
AFP
Recurrence lower with anastrozole
PARIS
Women diagnosed with early breast cancer who switch treatment after two years on the mainstream drug tamoxifen can greatly improve their chance of avoiding a recurrence of the disease, a study published in The Lancet says.
For more than two decades, tamoxifen has been the standard drug given to postmenopausal women after they receive surgery to remove early breast cancer. The powerful drug aims to starve breast cancer cells of estrogen, which they need in order to grow.
Austrian and German doctors looked at data from two big trials in which patients were randomly assigned just tamoxifen for their postsurgery drug, or were switched to anastrozole (Arimidex), an aromatase inhibitor, after two years on tamoxifen.
At a follow-up five years after surgery, women who made the switch to anastrozole were 40 percent less likely to have a recurrence of breast cancer. Of the 1,606 women in the tamoxifen-only group, there had been 110 cases of recurrence by the five-year mark.
Among the 1,618 in tamoxifen-then-anastrozole group, there were 67 cases of recurrence.
Interest in testing anastrazole, which is also an antiestrogen drug, stems from side effects with long-term treatment with tamoxifen, including the potential risk of uterine cancer and dangerous blood clotting.
The study was led by Raimund Jakesz, a professor at Vienna Medical University.
Breast cancer is the commonest form of female cancer, and its incidence increases with age. It is diagnosed in more than a million women worldwide each year, and accounts for at least 400,000 deaths annually.
AFP
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