DREAM shows rosiglitazone efficacy
Diabetes is a growing epidemic in the Philippines, but the last few years have seen many new advances in our understanding of diabetes and our ability to treat it effectively," said Dr. Joven Tanchuco, medical director of GlaxoSmithKline Philippines. "Clearly the best way to prevent the serious health consequence of diabetes is to prevent if from occurring."
So the question is: Is it possible to alter the course of type 2 diabetes (DM2)? Definitely, yes. In a media briefing organized by GSK Philippines in October, Tanchuco, together with noted endocrinologists Mary Ann Lim-Abrahan, Rosa Allyn Sy, and Ruby Go, presented the results of the large-scale Diabetes REduction Approaches with ramipril and rosiglitazone Medications (DREAM) trial.
DREAM evaluated the likelihood of patients considered "prediabetic" progressing to DM2 over a three-year period. It involved 5,269 participants with from 191 sites in 21 countries.
Prediabetes is a condition when the blood-sugar levels are higher than normal but not high enough to be diagnosed as diabetes. It is a cause for concern, because it significantly ups the risk of an individual developing DM2.
Patients included in DREAM were randomized to daily eight-mg rosiglitazone, daily 15-mg ramipril, and placebo. The patients were assessed every six months for a period of three to five years to determine if rosiglitazone or ramipril, an antihypertensive drug, can reduce the risks of developing DM2 in prediabetic patients. It was not designed however as a direct comparison between rosiglitazone and ramipril.
The risk of developing DM2 can now be reduced, in fact, by as much as 62 percent, with rosiglitazone. This highly significant reduction was additive to standard counseling on healthy eating and exercise.
Among those receiving rosiglitazone only, 10.6 percent progressed to DM2 compared with 25 percent in the placebo group.
In the composite primary end point of development of diabetes or death from any cause, rosiglitazone demonstrated a risk reduction of 60 percent relative to placebo. People taking rosiglitazone were about 70-percent more likely to return to normal blood-sugar levels than those on placebo. Over the three-year median follow-up period of the trial, 51 percent of the participants receiving rosiglitazone returned to normal blood-sugar levels compared with 30 percent of participants taking placebo.
Participants in the placebo group with a higher body-mass index (BMI), an indicator of obesity, were more likely to progress to diabetes than those with lower BMI. However, the risk of developing diabetes did not increase with BMI in the group randomized to rosiglitazone. M Arleen Cababa
Sutent for difficult-to-treat cancers
Sunitinib malate (Sutent) is Pfizer's breakthrough treatment for two of the most difficult-to-treat cancers-gastrointestinal stromal tumors (GISTs) and metastatic and advanced renal-cell carcinoma (RCC). Formally launched during the Philippine Society of Medical Oncology annual convention in October, Sutent and the scientific evidence behind its use were presented by Dr. Antony Chan, director of the Hong Kong Cancer Institute.
While the numbers of patients with these problems-32,000 new RCC cases and 5,000 new GIST cases every year, worldwide-may be small compared with other malignancies, it is often serious. In addition, RCC (which usually occurs in more men than women age 50 and above) in its early stages does not usually cause symptoms. Late-presenting symptoms include blood in urine, a lump in the abdomen, low-back pain, fatigue, weight loss, recurrent fever, high blood pressure, and swelling of the ankles and legs.
Meanwhile, GISTs begin in the connective tissues in the gastrointestinal tract, and include the muscle, fat, fibrous tissue, blood vessels, or other supporting tissues. Symptoms include painless lump in the abdomen, abdominal discomfort and pain, vomiting, blood in stools or vomit, fatigue, high fever, and anemia. As in RCC, the symptoms of GIST often present themselves when the disease has advanced.
"Both diseases are quite chemoresistant," said Chan. And these conditions proved to be the areas where sunitinib, a new targeted drug, can be most useful. Sutent is an oral medication that inhibits multiple receptor tyrosine kinases (RTKs) that play an important role in tumor growth, pathologic angiogenesis, and metastatic progression of cancer. It simultaneously targets vascular endothelial growth-factor and platelet-derived growth-factor receptors that have distinct roles in both tumor-cell proliferation and angiogenesis.
In clinical studies, sunitinib's efficacy was assessed by looking at time to tumor progression and an increase in survival (GIST) and objective response rates (ORR, for metastatic RCC). In advanced RCC, sunitinib's efficacy is based on partial response rates and duration of responses.
In phase-II and -III studies, sunitinib proved its efficacy consistently. GIST patients showed statistically significant high ORRs, prompting Chan to say that it might have set a new reference standard for the first-line treatment of metastatic RCC. As second-line GIST treatment, sunitinib has shown a threefold increase in the median time to tumor progression, a statistically significant high ratio (0.4) for overall survival. "Sutent treatment yielded significant improvement in survival rate versus placebo," said Chan, "with the drug well tolerated and pain relief compared favorably as well."
The United States Food and Drug Administration recently approved sunitinib (Sutent) for GIST and RCC, making it the first new oncology product approved for two indications simultaneously. It has also been reviewed and approved by the European Commission and most recently by the Bureau of Food and Drugs. M Arleen Cababa
Actonel/Calvit pack launched
The release of risedronate sodium (Actonel) as a once-weekly medication has made it possible not only to keep the ravages of osteoporosis at bay safely and effectively, but also to make intake of the medicine more convenient for patients.
Clinical studies have shown that Actonel offers significant protection against osteoporosis as early as six months after the start of treatment. This means that patients taking Actonel report significantly fewer incidents of osteoporosis-related fractures as early as six months after the start of treatment compared with patients who go without treatment. More than that, this benefit extends over the long term.
And since the drug's efficacy is boosted by the daily intake of calcium and vitamin-D supplements, Sanofi-Aventis, the manufacturer of the drug and one of the leading research-based pharmaceutical companies in the world, has announced that it will market an "osteoporosis monthly medication pack" for patients' convenience. Each pack contains four 35-mg tablets of Actonel and 32 caplets of Calvit, which contains 1,566-mg calcium (equivalent to 600-mg elemental calcium) and 200-IU vitamin D.
The World Health Organization has declared that osteoporosis is a "major public- health problem." With the global rise in the number of ageing people, osteoporosis is considered a "ticking time bomb" as it threatens to affect millions of women as well as a significant number of men.
Patients diagnosed with osteoporosis may be given Actonel, which belongs to a class of medications called bisphosphonates, considered as "first-line" drugs for the treatment of osteoporosis. Bisphosphonates work by blocking cells that break down bone, thus protecting bones at risk of fracture.
In its once-weekly formulation, Actonel addresses an important treatment issue: patient compliance. Since it only has to be taken once a week, patients will have a better chance of adhering to their treatment regimen, which in turn makes it possible for the drug to work fully. M
Bird-flu vaccine shows promise
WASHINGTON
Apreliminary trial of a bird-flu vaccine carried out on 270 healthy adults suggested it was well tolerated and could prove effective in combating several types of the H5N1 virus. "We have achieved an important step toward our goal of producing a safe and efficacious pandemic vaccine," said Noel Barrett, vice president of global research and development of Baxter International.
"These preliminary data, which must be confirmed in a larger study, suggest that the vaccine may provide wider protection for a larger number of people before and during a pandemic," Hartmut Ehrlich, vice president of global research and development for Baxter BioScience, said. "This is the first clinical demonstration that a candidate H5N1 vaccine can induce antibodies that neutralize widely divergent strains of H5N1," he added. M AFP
Some 30 different prototypes of vaccines against different types of the bird flu virus are currently in development around the world.
Baxter's clinical trial was carried out on 270 healthy adults in Austria and Singapore. M AFP
Tamiflu available for flu season
Roche announced that its antiviral medication oseltamivir (Tamiflu) is readily available for the 2006-2007 influenza season, even as it confirmed that government and corporate orders for stockpiling for an influenza pandemic are being processed.
"During the past year, Roche has been gearing up its production capacity and we will be in a position to produce 400 million treatment courses by the end of this year," said William Burns, chief executive officer, Roche Pharma. "Physicians can be confident that oseltamivir will be readily and widely available to patients who need it this season for flu treatment and postexposure prevention. The measures taken also enable us to schedule any additional orders from governments and corporations who are stockpiling oseltamivir in preparation for an influenza pandemic."
During the 2005-2006 season Roche had to restrict distribution of oseltamivir to wholesalers in many markets to ensure availability during an influenza outbreak, while the production capacity was being expanded. This led to the perception that oseltamivir was in short supply. Based on the available manufacturing capacities, there is now no supply shortage.
The broad availability of oseltamivir for both seasonal and pandemic use is due to expanded global production capacity, which will reach the rate of 400 million treatment courses annually by the end of 2006. Roche's global network for the manufacture of oseltamivir includes several Roche sites and more than 15 external contractors located in 10 different countries. Roche has also extended sublicenses to Hetero Pharmaceuticals and the HEC Group in India and Shanghai Pharmaceuticals in China. M
FDA: Don't combine triptan, SSRI/SNRI
The United States Food and Drug Administration (FDA) has alerted health-care professionals about a possible life-threatening condition that can occur when triptans are taken concomitantly with SSRIs or SNRIs.
If taken together, these drugs can produce excessively high serotonin levels, the FDA said. This can lead to serotonin syndrome, a rare but serious and sometimes fatal condition that can result in a wide variety of symptoms including changes in mental status, autonomic instability, and neuromuscular abnormalities. The risk of developing the syndrome is greatest immediately after a new serotonergic drug is started or the dose is increased.
SSRIs and SNRIs are both used to treat depression and other mood disorders, while triptans are used to treat migraines. So a patient might be regularly taking an antidepressant, and then intermittently taking a triptan to treat migraine. Data suggest that 20 percent of people prescribed a triptan might also be taking an SSRI.
The FDA advised physicians prescribing a triptan, SSRI, or SNRI to:
o Keep in mind that triptans are often used intermittently and that either the triptan, SSRI, or SNRI may be prescribed by a different physician.
o Weigh the potential risk of serotonin syndrome with the expected benefit of using a triptan with an SSRI or SNRI.
o Discuss the possibility of serotonin syndrome with patients if a triptan and an SSRI or SNRI will be used together.
o Follow patients closely if a triptan and an SSRI or SNRI are used together, particularly during treatment initiation, with dose increases, or with the addition of another serotonergic medication. M FDA News
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