New HIV strain came from gorillas

Medical Tribune September 2009 P3

French scientists have identified a new strain of HIV, which appears to have evolved in gorillas before crossing the species divide.

The virus has a distinct lineage from other HIV strains – notably the one chiefly responsible for the current AIDS pandemic, which is thought to have reached humans from chimpanzees. The researchers, who found the virus in a 62-year-old Cameroonian woman living in Paris, propose calling the new strain HIV-1 group P.

“The discovery of this novel HIV-1 lineage highlights the continuing need to watch closely for the emergence of new HIV variants, particularly in western central Africa, the origin of all existing HIV-1 groups,” they wrote.

[Nat Med 2009 Aug;15(8):871-2]

New fears raised over hormone therapy cancer risk

Medical Tribune September 2009 P3

A new study of almost a million people has strengthened the link between postmenopausal hormone therapy and the risk of developing ovarian cancer.

Danish researchers reviewed registry data from 909,946 women aged 50 to 79, over an average of 8 years of follow up. They found that hormone therapy users had an incidence rate ratio of 1.38 (95 percent CI 1.26 – 1.51) for all ovarian cancers, compared to women who had never used therapy. Cancer risk was increased “regardless of the duration of use, the formulation, estrogen dose, regimen, progestin type and route of administration,” the authors wrote.

“Thus the risk of ovarian cancer is one of several factors to take into account when assessing the risks and benefits of hormone use,” they concluded.

[JAMA 2009 Jul 15;302(3):298-305]

Study flaws hinder review of TCM for stroke

Medical Tribune September 2009 P3

The poor quality of published data prevents a proper assessment of the efficacy of traditional Chinese medicine (TCM) remedies for stroke, a study suggests.

Despite finding 11,234 journal articles on TCM post-stroke therapies, the researchers from Italy and China were unable to conduct a meta-analysis as intended. Thirty four randomized controlled trials (RCTs) were found, but wide variation in the studies prevented them from being pooled. Moreover, all but one RCT reported results in favor of TCM, prompting the authors to suggest a “strong publication bias.”

“The key to lead to evidence-based practices is establishing a consensus on standardized relevant outcome measures and then designing and conducting appropriate RCTs that adopt those standards,” they wrote.

[Stroke 2009 Aug;40(8):2797-804]

Famotidine protects against aspirin GI damage

Medical Tribune September 2009 P6
David Brill

Histamine H2-receptor antagonists can limit the gastrointestinal side effects of low-dose aspirin and could offer a viable alternative to proton-pump inhibitors (PPIs), a recent study suggests.

The randomized, phase III FAMOUS* trial found that 12 weeks of treatment with famotidine significantly reduced the incidence of gastric ulcers, duodenal ulcers and erosive esophagitis compared to placebo.

The study, published in The Lancet, included 404 adults who were taking low-dose aspirin and had no ulcers or esophagitis at baseline. [2009;374:119-25]

Aspirin use continues to soar worldwide, yet there are few options for prevention of associated gastrointestinal complications. PPIs are known to be effective but have faced safety concerns – particularly over the risk of adverse interactions with clopidogrel.

“There is little doubt that aspirin and other anti-clotting drugs are very useful in the prevention of heart, brain, and other vascular diseases, hence their increasing use worldwide. Patients on such drugs should continue using them as advised by their family doctors or hospital specialists,” said the study’s lead author Dr. Ali Taha, of the University of Glasgow, UK.

“However, everybody should be aware that aspirin use can also be associated with a variety of gastrointestinal or digestive system problems, which sometimes can be serious. The results of this research widen the options for the prevention of such problems, particularly when more than one clotting drug is required,” he said.

Twelve weeks after randomization, 7 of 204 patients on famotidine had developed gastric ulcers, compared to 30 of 200 taking placebo (3.4 percent versus 15 percent; odds ratio 0.2; P=0.0002).

Just one patient developed a duodenal ulcer on famotidine, compared to 17 on placebo (0.5 percent versus 8.5 percent; OR 0.05; P=0.0045). Nine and 38 patients developed erosive esophagitis in the famotidine and placebo groups, respectively (4.4 percent versus 19 percent; OR 0.2; P<0.0001).>

Diabetic children often oblivious to hypoglycemia

Medical Tribune September 2009 P7

David Brill

Almost one in three children with type 1 diabetes cannot tell when their blood sugar dips low, and could face serious consequences from slipping into hypoglycemia, a study suggests.

A survey of 656 Australian children found that 29 percent had impaired awareness of hypoglycemia – a deficit in the adrenergic symptoms that ordinarily serve as a warning sign.

Children with impaired awareness were over twice as likely to have experienced a severe hypoglycemic episode in the previous year, involving loss of consciousness or seizure.

The effect was even more pronounced in the very young: children under 6 with impaired awareness were almost six times as likely to have had a serious episode.

Senior author Dr. Tim Jones said that hypoglycemia unawareness has traditionally been considered to be an adult problem, but urged physicians to step up screening among younger patients in light of the new findings.

“Ask the child: ‘do you get your usual symptoms? Do you still feel shaky when you go low? Or is the first thing you notice about being low that you find a low reading when you test yourself?’ It only takes a minute if you know what to ask,” he said.

Hypoglycemia unawareness appears to be caused by hypoglycemia itself, with repeated episodes successively dampening the adrenergic response, added Jones, head of the department of endocrinology and diabetes at Princess Margaret Hospital for Children, Perth, Australia.

The good news, however, is that the problem seems to some extent to be reversible, he said. Once impaired awareness is identified, the patient should meticulously ensure that they avoid hypoglycemia for around a month, and the warning symptoms may begin to return.

Further testing can also be carried out – particularly using continuous glucose monitoring systems to track a child’s blood sugar over time. This can help to identify and avoid episodes of hypoglycemia, regardless of whether the child is aware of it.

The study involved type 1 diabetic children aged from 6 months to 19 years. All were taking insulin – ranging from twice-daily injections to four times a day with insulin analogs and subcutaneous infusion therapy. [Diabetes Care 2009 Jul 8; Epub ahead of print]

A total of 161 hypoglycemic episodes had occurred in the year leading up to the study. The rate of episodes among children with impaired awareness was 37.1 episodes per 100 patient-years, compared to 19.3 per 100 patient-years in children with normal awareness.

Patients with impaired hypoglycemia awareness tended to be younger, had an earlier onset of diabetes, and had lower mean HbA1C levels since diabetes onset.

MIMS.com hailed for excellence in technology

Medical Tribune September 2009 P7
David Brill

Asia’s leading online drug database has been lauded for its innovative approach to digital technology at the recent Asian Multimedia Publishing Awards (AMPA).

MIMS.com – used by over 250,000 doctors and pharmacists in Asia – was named a runner-up in the ‘Use of Digital Technology’ category at the AMPA ceremony in Manila.

The award marks the 40th year of the directory, which is now used in 15 countries across the Asia-Pacific region and receives over 300,000 unique visitors each month. It was chosen out of 74 entries from 9 different countries.

Mr. Ben Yeo, Chief Executive Officer at CMPMedica Asia, publishers of MIMS and Medical Tribune, said: “This award commemorates the achievement that MIMS has attained in Asia at its 40th anniversary, further underscoring CMPMedica’s leading position in delivering drug information and scientific publishing in Asia. Our teams are keeping up their momentum in achieving the highest standards in the industry.”

The award makes CMPMedica the most highly decorated healthcare publisher at the Asian Publishing Convention, having previously picked up an award in 2007.

MIMS.com is used by doctors, pharmacists and healthcare professionals to access comprehensive drug information such as dosage, indications, safety and interactions. It is accessible online, and integrated within some hospital formularies.

Aspirin trial seeks to tackle colorectal cancer in Asia

Medical Tribune September 2009 P8
David Brill

A major new trial is set to launch in Asia to establish whether aspirin can prevent recurrence of colorectal cancer.

The ASCOLT study will involve over 2,000 patients from centers across Southeast Asia, China and India, and will be led jointly by the National Cancer Centre Singapore (NCCS) and the University of Oxford, UK.

Patients will be randomized to aspirin (200mg/day) or placebo for 3 years, following surgery and adjuvant chemotherapy for high-risk stage II and III colorectal cancer. The primary endpoint will be disease-free survival over 5 years of follow-up.

A growing body of evidence suggests that aspirin is effective for primary prevention of colorectal cancer, but ASCOLT is thought to be the first prospective clinical study to investigate the drug in the adjuvant setting after chemotherapy.

If positive, the results could have a huge impact on the treatment of colorectal cancer in Asia and worldwide, according to Dr. Toh Han Chong, head of the department of medical oncology at NCCS and one of the ASCOLT lead investigators.

“It’s incredible how many people you could save from relapse with the addition of aspirin if this study is positive. If you go to a village in India you can’t really give costly [monoclonal antibodies], so there is compelling power of social responsibility here,” he told Medical Tribune.

“We have undervalued the power of simple drugs. It’s time to redress the balance – change the paradigm and go cheap.”

Recruitment for ASCOLT is already underway, with centers confirmed in Singapore, Hong Kong, Jakarta and several cities in India.

More study centers are still needed in order to reach the target of 2,000 patients however said Toh, who extended the invite to all Asian delegates at the recent ‘Best of ASCO’ conference in Singapore.

“It’s a drug trial that cannot be done in the West. Many people over the age of 50 in the US are popping aspirin over the counter for heart conditions or stroke prevention,” he said. “Fewer people are on aspirin in Asia. That’s why it’s a perfect study to do here.”

Colorectal cancer is the second leading cause of cancer death in North America, Europe and Australasia according to a 2007 global report from the American Cancer Society. In Southeast Asia, it is the third biggest killer (behind liver and lung cancer) – responsible for 7.9 percent of cancer deaths.

In Singapore, colorectal cancer is the leading cancer among men and the second most common among women, data from the national cancer registry show.

A recent study found that regular use of aspirin after a diagnosis of colorectal cancer was associated with lower overall mortality (hazard ratio [HR] 0.79; 95% CI 0.53 – 0.95) and cancer-specific mortality (HR 0.71; 0.53 – 0.95), after a median of 11.8 years of follow-up. [JAMA 2009;302(6):649-58]

A 2007 paper, meanwhile, reported that taking 300 mg/day or more of aspirin for 5 years was effective for primary prevention of colorectal cancer, according to pooled data from two large randomized trials (HR 0.74; 95% CI 0.56 – 0.97; P=0.02). [Lancet 2007;369(9573):1603-13] Earlier trials have also shown that aspirin can prevent colorectal adenomas – the precursors to cancer – both in patients with, and without, a prior history of cancer. [N Engl J Med 2003;348(10):883-90; N Engl J Med 2003;348(10):891-9]

“Why should oncologists do an aspirin trial? Because the epidemiological data is strong, the data on polyp reduction is very convincing, the retrospective observational studies are very compelling and remarkable in terms of hazard ratios, and the data preclinically is scientifically robust,” added Toh.