Day: 03/11/2013

Scale-Up of ART in South Africa Begins to Turn the Tide.

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Two studies from South Africa suggest that the scale-up of ART is increasing life expectancy and decreasing HIV transmission at the population level.

 

Because of the devastating HIV epidemic and the unavailability of antiretroviral therapy (ART) in government clinics and hospitals until 2004, life expectancy in South Africa declined significantly. Now, two studies suggest that this bleak picture is changing. Both were conducted in rural KwaZulu-Natal, where rates of poverty are high and >20% of adults are HIV infected. ART has been rapidly scaled up in this area — first for patients with CD4 counts <200 cells/mm3 and later for those with CD4 counts <350 cells/mm3 who either are pregnant or have tuberculosis.

Bor and colleagues examined changes in adult life expectancy in the area between 2003 — the year before public-sector provision of ART to adults began — and 2011. During this period, adult life expectancy rose from 49.2 to 60.5 years, and all-cause mortality among adults aged 25 to 44 declined by >50%. The authors estimated that approximately one third of the HIV-infected adults in the community were receiving ART. The cost of ART in this population was estimated at US$10.8 million over the study period, for a cost-effectiveness ratio of $1593 per year of life saved (considered cost effective, because it is less than <25% of South Africa’s 2011 per-capita gross national income).

Tanser and colleagues performed a population-based study to examine the effect of ART coverage in the surrounding community on HIV-uninfected individuals’ risk for HIV acquisition. Between 2004 and 2011, a total of 1413 HIV seroconversions occurred among 16,667 individuals who were HIV-uninfected on first testing, for a crude rate of 2.63 new infections per 100 person-years. After adjustment for age and sex, the risk for HIV acquisition was lowest in areas where the highest proportion of HIV-infected people were receiving ART. For example, such risk was 34% lower for a person living in an area with 30% to 40% ART coverage than for a person living in an area with <10% coverage.

Comment: These two studies provide strong evidence that the scale-up of ART in heavily affected communities in South Africa is saving lives, increasing life expectancy, and having a population-level preventive effect. The results of HPTN 052 conclusively demonstrated the efficacy of treatment as prevention in a clinical trial; Tanser and colleagues’ findings now provide evidence of effectiveness in a real-world setting. However, unlike HPTN 052, which included people with high CD4-cell counts, this population-based study was conducted in an area where ART was generally initiated at CD4 counts <200 cells/mm3, with the cutoff eventually increased to 350 cells/mm3 for pregnant women and tuberculosis patients. One can only guess how much higher the preventive effect might have been if ART had been started at higher CD4-cell counts. It is time to focus our efforts on early diagnosis, linkage and retention in care, and ART initiation at any CD4-cell count, both for individual patient health and for population-level prevention, if we are truly going to have an “AIDS-free generation.”

 

Source: Journal Watch HIV/AIDS Clinical Care

 

Changing how food aid is allocated ‘may save more lives’.

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Malawi_Food_Aid_Flickr_Peter_Casier_140x140International development agencies may be able to save the lives of a greater number ofundernourished children by changing how they allocate food aid in developing countries, suggests a study published today (4 March) inProceedings of the National Academy of Sciences.

Instead of allocating food based solely on weight-for-height measurements, as is currently recommended, making use of additional ‘height-for-age’ data reduced the effects of malnutrition by nine per cent in the study.

Also, the same end results in alleviating malnutrition were achieved with the new method as with the current one but with a 61 per cent cut in the cost of providing ready-to-use therapeutic and supplementary food, the study found.

The findings are based on mathematical modelling using data from more than 5,600 children from Bwamanda in the Democratic Republic of Congo.

The study also proposes that when making crucial food allocation decisions, aid agencies should prioritise those children most in need — even if it means that others go without.

Lawrence M. Wein, professor of management science at Stanford University, United States, and the corresponding author of the study, says one of the main results is that “relative to the currently used policies, incorporating height-for-age information into the allocation decision improves performance — that is, it saves lives”.

The other key finding is that “the optimal policy is an ‘all-or-nothing’ policy where the most at-risk children receive 500 kilocalories per day and the other children receive nothing,” he says.

But because of the limited scope of the study, the authors do not make specific policy recommendations.

They call for more data that can be used to inform such pressing allocation decisions, and also highlight the scarcity of useful data on the effect of food-based treatment.

“Without better data, policymakers will continue to make these important allocation decisions in the face of very limited information,” says Wein.

However, paediatrician Patricia Wolff, executive director of US-based food aid organisation Meds & Food for Kids, argues that height-for-age is a measure of chronic rather than acute malnutrition.

“Being stunted is not related to acute risk of death, although over a lifetime a stunted person will be less healthy than a non-stunted person,” she says.

“I don’t agree that, in resource-poor environments, this stunted group has an equivalent risk-benefit ratio to those children who are low on the weight-for-height graph,” she adds.

Although wary of the benefits of including height-for-age data in food allocation decisions, Wolff admits that the proposed ‘all-or-nothing’ approach could save more lives.

“If you mean by an ‘all-or-nothing’ policy that you give the appropriate treatment resources to the sickest children first and then look around to see if you can find more resources, then I agree. First, you save lives. Second, you optimise health,” she says.

Source: SciVx

 

Gastric banding led to improvements in HDL, particle size after 5 years.

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Bariatric surgery using gastric banding did not improve LDL cholesterol or LDL particle number or size, despite significant weight loss among patients who underwent the procedure. Results suggest, however, a beneficial HDL remodeling process based on a significant increase in HDL cholesterol and HDL particle size.

Researchers from the New York University Langone Medical Center said the HDL remodeling process persisted up to 5 years after gastric banding.

“Knowing that some studies suggest early improvements in lipids after bariatric surgery, there is a paucity of data regarding changes in the lipoprotein abnormalities characteristic of the dyslipidemia of obesity. What we sought to do was to determine both initial and long-term effects of gastric banding surgery on lipids, with attention to LDL and HDL characteristics,” researcherAmita Singh, MD, from NYU Langone Medical Center in New York, said during a presentation here.

Patients with a BMI of 30 to 40 (n=50) underwent laparoscopic gastric banding. Physical exams and blood samples for nuclear magnetic resonance spectroscopy were performed at baseline and at annual follow-up, which lasted 5 years.

At 1 and 5 years, researchers observed significant increases in HDL cholesterol (P<.001). After 5 years, mean HDL size was significantly increased (9.1 nm at baseline vs. 9.24 nm at 5 years; P<.002), and there was a trend toward increased HDL particle number (33.49 nm/L at baseline vs. 36.75 nm/L; P=.064). Conversely, early reductions in LDL particle number and size were nonsignificant after 5 years.

Metabolic syndrome and percent BMI loss had no effect on changes in particle number or size for both LDL and HDL. However, LDL particle number and LDL cholesterol were significantly correlated at 5 years (P<.001), although HDL cholesterol and HDL particle number were not, the researchers wrote. – by Samantha Costa

  • This study was interesting in the fact that we didn’t see a lot of the changes we expected. Acute weight loss lowers your cholesterol, but losing weight doesn’t lower your cholesterol, and it’s often just dietary changes. It’s interesting to see that, but it’s also limited.
  • Donna M. Polk, MD, MPH
  • Physician at Hartford Hospital (Connecticut)

 

  • Source: Endocrine Today.

 

HPS2-THRIVE: Niacin therapy not beneficial for vascular disease.

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Niacin, in combination with laropiprant, appears to provide no benefit and may have harmful effects in patients with vascular disease, researchers reported.

The 4-year HPS2-THRIVE study tested a combination of extended-release niacin 2 g plus laropiprant 40 mg (Tredaptive, Merck) compared with placebo in 25,673 patients at risk for CV events. In addition, all patients received simvastatin (Zocor, Merck), with or without ezetimibe (Zetia, Merck).

According to results presented at a late-breaking clinical trials session, the study did not meet the primary endpoint of reducing risk for a major vascular event, defined as a composite of nonfatal MI or CV-related death, stroke, or need for angioplasty or bypass surgery. Patients assigned extended-release niacin/laropiprant had a similar number of major vascular events compared with patients assigned placebo (13.2% vs. 13.7%; P=.29).

The extended-release niacin/laropiprant had increased rates of excess bleeding (2.5% vs. 1.9%) and infections (8% vs. 6.6%). In addition, serious adverse events were more prevalent with combination therapy, including new-onset diabetes (9.1% vs. 7.3%), diabetic complications (11.1% vs. 7.5%), indigestion and diarrhea (4.8% vs. 3.8%) and rashes (0.7% vs. 0.4%).

Data by the HPS2-THRIVE Collaborative Group published in European Heart Journal in early March revealed that by the end of the study 25% of patients assigned combination therapy had stopped treatment compared with 17% of patients assigned placebo.

“A striking finding from the study was a significant excess [in adverse events] among people who were allocated the niacin preparation. The excess represents a 3% absolute excess, which means 30 patients for every 1,000 treated patients had at least one side effect,” Jane Armitage, FFPH, FRCP,professor at the University of Oxford, United Kingdom, said at a press conference.

“It was a disappointing result but, nevertheless, these are clear and reliable results from a large study.”

 

PERSPECTIVE

 

Christie M. Ballantyne

  • We confirmed that using niacin in well-treated patients on statins with low LDL does not have a benefit. That was a very common use for this medicine. The other important point this study nails down is that the adverse effects of niacin in extended release were considerable. If we are going to use the drug in patients with high LDL, we have to think about the modest benefits and risks.
  • Christie M. Ballantyne, MD
  • Professor of Medicine
    Baylor College of Medicine

    • Source: Endocrine Today.

 

TERISA: Ranolazine reduced angina in patients with diabetes.

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Results from an international trial demonstrate that ranolazine was safe and effective for patients with type 2 diabetes, coronary artery disease and persistent chronic angina.

Mikhail Kosiborod, MD, from St. Luke’s Mid America Heart Institute and University of Missouri, Kansas City, presented data that showed ranolazine (Ranexa, Gilead) significantly reduced angina frequency and sublingual nitroglycerin use, and as safe and well tolerated.

Following a single blind, 4-week placebo run-in phase, 949 patients were randomly assigned to 8 weeks of ranolazine (1,000 mg twice daily) or matching placebo. The mean age of the patients’ was 64 years; 61% were men; mean diabetes duration was 7.5 years; and mean baseline HbA1c was 7.3%.

“Ranolazine has previously been shown to be effective and may have the additional property of lowering HbA1c,” Kosiborod said at a press conference.

The primary endpoint was number of self-reported angina episodes between weeks 2 and 8. Weekly episodes of angina were reported less in patients assigned ranolazine compared with placebo (3.8 vs. 4.3; P=.008). A secondary endpoint was frequency of sublingual nitroglycerin use during the same study period. Self-reported use was also lower in the ranolazine group (1.7 doses per week vs. 2.1 doses per week; P=0.003).

Data indicate no difference in the incidence of serious adverse events between groups.

The researchers also found that ranolazine was especially effective in patients with worse glucose control.

“If the glucose-lowering action of ranolazine is confirmed in future studies, patients with diabetes and angina may derive a dual benefit from this drug,” Kosiborod stated in a press release.

The TERISA trial was conducted at 104 centers in 14 countries. At baseline, 43% of patients were taking one anti-angina agent and 57 were taking two anti-angina agents. The use of guideline-recommended therapy was high: 87% taking antiplatelet agents, 83% taking statins, 88% taking ACE inhibitors/angiotensin receptor blockers and 90% taking beta-blockers.

Compliance with self-reports in an electronic diary was 98% in both groups, Kosiborod said. – by Samantha Costa

For more information:

Kosiborod M. Late-breaking clinical trials III: Chronic CAD/stable ischemic heart disease. Presented at: American College of Cardiology Scientific Sessions; March 9-11, 2013; San Francisco.

Kosiborod M. J Am Coll Cardiol. 2013;doi:10.1016/j.jacc.2013.02.011.

Disclosure: The study was funded by Gilead Sciences. Kosiborod reports consultancy fees/honoraria from Boehringer Ingelheim, CardioMEMS, Genentech, Gilead, Hoffman-La Roche, Kowa Pharmaceuticals, Medtronic Minimed and Sanofi-Aventis, and research grants from Genentech, Gilead, Glumetrics and Medtronic Minimed.

PERSPECTIVE

  • In many European countries, particularly in the countries that participated in this study, there is still more of a conservative approach to the management of patients with angina. They are stable, they use more medications and less interventions than we do in the United States.

Now, there are new criteria for revascularization and we are being encouraged to treat people medically — to treat them properly — if they respond to drugs. In the United States, we might be moving a little more in that direction.

Ranolazine already has been shown to be effective, so the question researchers were looking [to answer] was whether patients with diabetes benefit from this drug. Diabetics, as we know, have problems with reduction in coronary reserve, myocardial issues, diabetic cardiomyopathy, muscle stiffness and more.

The other interesting point is that patients with HbA1c levels greater than 7% had strikingly better effect response than those with HbA1c less than 7%. This becomes very interesting in terms of possible mechanisms exploring other areas.

  • Miguel A. Quinones, MD, MACC
  • Chairman of the ACC, 2013
    Professor of Medicine, Weill Cornell Medical College
    Chairman, Department of Cardiology, The Methodist Hospital
    Methodist DeBakey Heart & Vascular Center

Source: Endocrine Today.

 

 

 

Pesticides are Killing More Than Bees – They’re Killing Humans.

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bees-flowersThat’s just one example of how the ecological balance can be interrupted. Why is this happening? Several factors have been identified, including:

One poignant example of the pesticide problem comes with a lawsuit filed by The German Coalition against Bayer Dangers against Werner Wenning, chairman of the Bayer Board of Management, after losing thousands of hives due to poisoning by the pesticide clothianidin. Bayer was accused of marketing dangerous pesticides that allegedly caused the mass death of bees all over the world. In fact, apple orchards require at least one bee colony for every acre to be adequately pollinated. So, unless this devastating trend is reversed, the world could be in for some major food shortages.

Even more alarming may be the rate at which wild bees are dropping from sight, particularly regarding crop yields, according to a worldwide study.6 Coffee, onions, almonds, tomatoes and strawberries were among 40 fruits and vegetables in 600 fields examined by scientists to determine which would win the pollination race. The report returned that wild bees were twice as effective as honey bees in this endeavor.7

Scientists studied the pollination of more than 40 crops in 600 fields across every populated continent and found wild pollinators were twice as effective as honey bees in producing seeds and fruit on crops including oilseed rape, coffee, onions, almonds, tomatoes and strawberries. Furthermore, trucking in managed honey bee hives did not replace wild pollination when that was lost, but only added to the pollination that took place.8

One of every three bites of food you eat depends on the honey bee. They pollinate at least 130 different crops in the US alone, including fruits, vegetables and tree nuts. That bees can actually sense and respond to electrical fields emitted by flowering plants is remarkable, says bee biologist and author Mark Winston from Simon Fraser University in Burnaby, B.C. He adds:

“[B]ees perceive the world around them, and it adds another wonderful story that continues to deepen our understanding the co-evolved relationship between bees and flowers.”

Only a change in the status quo will cause a turnaround of this tragic situation that threatens not only bees all over the world, but the world’s entire, increasingly unsustainable food system.

Source: mercola.com

Multidrug-Resistant TB a Concern Along U.S.-Mexico Border.

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The Wall Street Journal tracks the increase in tuberculosis cases along the U.S.-Mexico border and highlights concerns about the possibility of a drug-resistant TB outbreak.

The MDR-TB rates are still quite low compared to other nations — Mexico had 467 MDR-TB cases in 2011, and the U.S. had 124. Nearly half of the U.S. cases were in California and Texas. In San Diego, the overall TB rate is about twice the national average. Meanwhile, Los Angeles is currently trying to control its worst TB outbreak in a decade.

The article details the challenges presented by a relatively porous border, nonadherence to treatment, reduced funding, and drug-related violence.

Source: Wall Street Journal