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September 2005

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Drug Updates

 

 

Clarithromycin versus CAP

 

Community-acquired pneumonia (CAP) remains a serious problem in the country, especially in children. It is one of the

most common reasons for pediatric consultations.

    In a symposium organized by Westmont Pharmaceuticals on September 22, Dr. May Montellano, pediatric-infectious-disease expert, spoke about the detection, diagnosis, and management of typical and atypical pneumonia. Held at the Crowne Plaza Galleria in Pasig City, the event also featured the launch of Westmont's clarithromycin, Klaz.

    Atypical pneumonia, said Montellano, accounts for about 20 to 30 percent of pediatric CAP cases. However, distinguishing between atypical and typical pneumonia could prove to be challenging. A study in Italy in 2000 showed that using clinical, laboratory, and radiologic parameters may only have a limited role in differentiating one from the other.

    Said Montellano: "These following items will tell you that it might be you're dealing with atypical pneumonia--when

there is a delay in the resolution of symptoms, when there is diffuse bilateral infiltrates, and [when] the pneumonia is refractory to the standard treatment."

    Montellano recalled that the 2004 Philippine consensus on the identification and management of pediatric CAP recommends amoxicillin as the "drug of choice for the treatment of CAP, otitis media, [and] sinusitis in children." But she added: "If the patient does not respond to the current antimicrobial therapy within 72 hours, one should consider to change the initial antibiotic." Often, the drug used is a beta-lactam or an oral macrolide.

    She stressed that beta-lactams may be "inappropriate" for atypical CAP. So in treating atypical CAP when initial antibiotic therapy fails, Montellano recommends the use of a macrolide, particularly clarithromycin. Clarithromycin is quickly and completely absorbed from the gastrointestinal tract after being taken orally, and reaches peak concentrations after about two hours. In a number of studies, it is associated with high success rates in treating atypical pneumonia. Lastly, clarithromycin is associated with a relatively low risk for the development of resistant strains.

    "For those pneumonias not responsive to the standard treatment, macrolides play a role," concluded Montellano.

 



Early ramipril v. diabetes

 

Although treating hypertension late is much better than not treating it at all, starting treatment early is still better than starting it late.

    The old adage, "The earlier, the better," was what Dr. Luis Go, consulting cardiologist at the Philippine Heart Center, emphasized in a speakers' meeting organized by Sanofi-Aventis on September 29. He informed various specialists about the results of the Heart Outcomes Evaluation-The Ongoing Evaluation (HOPE-TOO) published August in Circulation. The extension study of the landmark HOPE trial, HOPE-TOO gathered the participants of the HOPE trial to find out whether the timing of initiating therapy with ramipril, an angiotensin-converting-enzyme inhibitor, would result in significant clinical results.

    The HOPE study, a randomized, placebo-controlled, multicenter trial that followed up more than 9,000 patients for 4.5 years, investigated the effects of daily 10-mg ramipril in hypertensive patients. The study showed that compared with placebo, ramipril led to reductions in major vascular events (stroke and myocardial infarction), cardiovascular deaths, and new-onset diabetes.

    In HOPE-TOO, 4,500 patients were followed up for 2.6 more years. Those who had been on ramipril during the HOPE trial continued to take ramipril; those who had been on placebo started taking ramipril. The following end points were set in HOPE-TOO--MI, stroke, CV death, revascularization, and new-onset diabetes.

    HOPE had shown a significant reduction in blood-pressure levels (about 136/76 mm Hg) with ramipril compared with placebo. In HOPE-TOO ramipril still showed the same blood-pressure levels (136/74 mm Hg), whether the patient took the drug early or late.

    With regard to combined end points (MI, stroke, and CV death), taking ramipril early showed a relative-risk reduction of 17 percent compared with starting ramipril late. A relatively lower risk for MI alone was also seen with early ramipril (19 percent).

    When it comes to preventing strokes and CV deaths, there seemed to be little difference in either the early-ramipril or late-ramipril groups. This, Go explained, seemed to point to "a catching-up phenomenon." This, however, does not change the fact that ramipril can lower the risk for stroke and CV death.

    The most important finding was how early ramipril significantly lowers the risk for revascularization and new-onset diabetes compared with late ramipril. Patients on early ramipril who had to submit to revascularization were fewer by 16 percent. More significantly, those on early ramipril who were diagnosed with new-onset diabetes were fewer by 34 percent than those on late ramipril. J.P. de Guzman

 



Wyeth launches Prevenar

 

Every year, as many as a million kids under five die of invasive pneumococcal disease (IPD). Caused by Streptococcus pneumoniae, it is one of the most common causes of hospitalizations, regardless of a person's age.

    IPD manifests in a wide rage of serious, if not potentially fatal, diseases. These include bacteremic pneumonia, bacteremia, septicemia, meningitis, acute otitis media, and sinusitis. Very young children are particularly vulnerable to IPD, since most of them have immune systems that have yet to develop antibodies against S. pneumoniae.

    Although treatment is available--antibiotics, primarily--parents can always do better by getting their children vaccinated with the first and only pneumococcal conjugate vaccine, 7-valent (Prevenar). Marketed by Wyeth Philippines, Prevenar was launched in the country via a press conference held on October 18 at the Holiday Inn Galleria.

    Dr. Lulu Bravo, head of the infectious diseases section of the Philippine General Hospital-Department of Pediatrics, stressed that pneumonia is the top killer of children in the Philippines, or even the rest of the world, making efforts at preventing the disease even

more necessary. "The burden of the disease in the very young cannot be overemphasized," she said.

    Meanwhile, Dr. Mark Fletcher, director for international scientific and clinical affairs of Wyeth Vaccine Research based in Paris, discussed the efficacy of Prevenar, which is backed up by "a 15-year research and development program … [and] dozens and dozens of studies." This vaccine has been safely given to over 19,000 infants worldwide. It can be given together with other vaccines for children.

    Prevenar is given as three doses every other month over a six-month period. By the baby's second birthday, a booster dose is recommended.

    Dr. Nerissa Calimon, Wyeth Philippines medical director, affirmed the company's commitment to protecting lives. "Wyeth believes … life is so precious that we must protect it as early as after birth," she said. "We heed this call for preventive health care with the first and only conjugate vaccine to help prevent IPD, the traitor disease."

 



Dengue medicine nine years away

SINGAPORE

Scientists are seven to nine years away from developing a medicine to treat dengue fever, which has survived into the modern age because of urban population growth and neglect.

    Experts said research into a cure for the mosquito-borne disease, which is common in the tropics, was still in its infancy and starting from scratch due to years of neglect as governments shifted funding to illnesses such as cancer.

    Paul Herrling, head of corporate research at Novartis International AG, said research only started at the Novartis Institute for Tropical Diseases in Singapore two years ago.

    The earliest tiame that an antidengue drug can be released from the laboratory for testing on humans is 2008 or 2009, he said at a recent international conference on dengue in Singapore. It would take another four to five years to complete the tests before the drug is finally made available to patients. Under this timetable a drug could only be available on a mass scale between 2012 and 2014.

    Research is being carried out by around 50 chemists and biologists at the Novartis facility in Singapore and it is believed to be the only effort being conducted by a nonacademic institution, Herrling said. "We are at the very beginning. We have started the activities two years ago," he said. "On average we would say we could not expect anything in human testing, the beginning of human studies, not before 2008 to 2009. And then you will need another four to five years to complete the human studies so that you know enough that you can release it (the drug) for the general patient population."

    Herrling said it could cost US$500 million to US$1 billion to come up with a drug.

    Dengue, caused by the Aedes mosquito, has killed 11 people and infected more than 12,000 others Singapore, and is resurgent in many parts of Asia despite rapid progress in standards of living.

    "I don't see it going away. I don't see anything to reverse the trend right now," said Duane Gubler, director of the Hawaii-based Asia-Pacific Institute for Tropical Medicine and Infectious Diseases.

    Gubler said complacency set in after efforts to control the spread of dengue as well as yellow fever and malaria succeeded after World War II. "As we went into the 1970s, we were highly complacent and all of the money that we used to control these diseases were redirected," he said, noting that in 1972 the United States diverted funding to a 'war' on cancer.

    "Dengue is one of these neglected diseases ... ignored for many, many years and it's gotten progressively worse.… Nothing has really been done about it until recently," said Gubler, who has been studying dengue for 35 years.

    Novartis is not involved in research to find a vaccine to prevent dengue because its focus is discovering a cure, but Gubler said it could take the same number of years for scientists to come up with a vaccine. M. Abbugao, AFP

 

 

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