Showing posts with label MEDICAL NEWS. Show all posts
Showing posts with label MEDICAL NEWS. Show all posts

ICS/LABA exacerbation benefit outweighs pneumonia

By Dr Deepu

The benefit of a fixed-dose inhaled corticosteroid (ICS) and long-acting beta-agonist (LABA) combination in reducing exacerbations of chronic obstructive pulmonary disease (COPD) far outweighed any risk for pneumonia in a post hoc analysis of the 48-week FORWARD study.

Although there were 13 extra pneumonia events when a fixed-dose combination of beclometasone diproprionate and formoterol fumarate (Foster, Chiesi Farmaceutici SpA) was used as compared to formoterol fumarate alone, there were 123 fewer moderate to severe COPD exacerbations over a 342-day analysis period.
The FORWARD study was a two-arm trial designed to compare the efficacy and safety of fixed-dose treatment with beclometasone diproprionate and formoterol fumarate versus formoterol fumarate alone in 1,199 patients with severe COPD.

For inclusion in the study, patients had to have a post-bronchodilator forced expiratory volume in 1 second below 50% of predicted and a forced vital capacity ratio of less than 0.7. They also had to have a smoking history of 10 pack-years or more, and a history of at least one COPD exacerbation in the previous 12 months that had required treatment or hospitalization (Eur RespirJ. 2013;41[1]:12-7).

After a 2-week run-in period, where all patients received a 24-mcg dose of formoterol fumarate, patients were randomized to continue treatment with formoterol fumarate or to receive the fixed-dose combination of beclometasone diproprionate 400 mcg and beclometasone diproprionate 24 mcg for 48 weeks.

A total of 1,186 patients, most of whom were male (69%) with a mean age of 64 years, formed the intention-to-treat population.

Published results (Respir Med. 2014;108[8]:1153-62) showed that the combination of the ICS beclometasone diproprionate and the LABA formoterol fumarate (Chiesi Farmaceutici SpA) was associated with a 28% reduction in the annual rate of moderate to severe exacerbations versus the LABA alone.

The adjusted rate of exacerbations per patient per year was 0.80 in patients treated with the ICS/LABA combination versus 1.12 for those treated with just the LABA, with an adjusted rate ratio of 0.72 (P less than .001).

The published data also showed that pneumonia was reported by 23 patients (3.8%) treated with the ICS/LABA and by 11 (1.8%) treated with the LABA only.

For the new analysis,  pneumonia and COPD exacerbations were looked in more detail, plotting out the cumulative number of events over time and also characterizing the types of pneumonia in more detail.

All patients had a chest x-ray to confirm the presence of pneumonia, he said, there were 35 cases of pneumonia, 24 occurring in patients treated with the fixed-dose beclometasone diproprionate and formoterol fumarate combination and 11 in patients treated only with formoterol fumarate.

Of these cases, 25 required in-hospital treatment – 16 patients in the ICS/LABA arm and 9 in the LABA-only arm. There were three instances of patients acquiring pneumonia in hospital – two in the ICS/LABA and one in the LABA-only arm.

There were also two fatal cases of pneumonia – one in each treatment group. Neither were thought to be related to either of the treatments.

These findings are in line with a recent review of the use of ICS for COPD by the European Medicines Agency (EMA/488280/2016), which noted that “overall the benefits of inhaled corticosteroid medicines in treating COPD continue to outweigh their risks and there should be no change to the way in which these medicines are used.”

The European Medicines Agency advised that patients and clinicians need to “be alert for signs and symptoms of pneumonia, bearing in mind that the clinical features of pneumonia overlap with those of a worsening (exacerbation) of the underlying disease.”

Top FDA Official Says Regulators Should Consider Potential Benefits Of E-Cigarettes

By Dr Deepu

The Congressional Quarterly (10/22, Siddons, Subscription Publication) reports that Mitch Zeller, head of the Food and Drug Administration’s Center for Tobacco Products, said Wednesday that regulators have to consider the possible health benefits for smokers who transition to e-cigarettes. “If there is an opportunity to shift those unable or unwilling to quit from the most harmful form of nicotine delivery, to the least harmful form,” Zeller said, “then I think that we as regulators have an opportunity to explore what those options are. “

Fauci Optimistic About The Development Of A Universal Flu Vaccine Within Next 5 To 10 Years

By Dr Deepu

In a 1,500-word article, NBC News (10/20) reports on its website on this year’s flu vaccine, the market environment, and the push for vaccination. The piece also reports on the “holy grail for flu: A universal vaccine,” which is currently being pursued at the National Institutes of Health. National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci “said he’s optimistic a universal vaccine is five to 10 years away.” In an interview, Fauci said, “I think that we are making extraordinary progress and we can sort of see that light at the end of the tunnel.” He added, “If we can successfully induce a response against that stem part of that protein, we’re going to be very close to developing a universal flu vaccine.” In the meantime, public health researchers “emphasized the best thing the public can do to avoid spread of the flu is to wash hands, cover coughs and sneezes…and get vaccinated.”

Sleep Apnea May Be More Dangerous For Women Than For Men

By Dr Deepu

The New York Times (10/20, D6, Bakalar) “Well” blog reports that research published in Circulation suggests that “sleep apnea may be even more dangerous for women than for men.” Investigators found that “obstructive sleep apnea was independently associated with increased troponin T, heart failure and death in women, but not in men.” The researchers also found that “in women, but not men, sleep apnea was associated with an enlarged heart, another risk factor for cardiovascular disease.”

CDC: Teen Smoking Rates Declining, Marijuana Use On The Rise

By Dr Deepu

HealthDay (10/16, Reinberg) reports that according to today’s MMWR, the CDC says that smoking among teenagers has dropped 64 percent in recent years, but marijuana use has more than doubled. Investigators “tracked teen smoking rates from 1997 to 2013.” The researchers found that “overall, the number of teens who smoked cigarettes or cigars dropped from 20.5 percent to slightly more than 7 percent, while marijuana use went from 4 percent to 10 percent.”

EV-D68 No More Deadly Than Common Cold Germs, Study Finds

By Dr Deepu

HealthDay (10/16, Thompson) reports that a new study conducted at McMaster University in Ontario, Canada suggests that enterovirus D68, which made headlines in 2014 after sickening children across North America, is “no more deadly than other common cold germs.” For the study, the researchers compared “87 kids treated for EV-D68 at McMaster Children’s Hospital with 87 kids who caught a rhinovirus or some other enterovirus at the same time.” The findings were published in the Canadian Medical Association Journal. Medscape (10/16) also covers the story.

Sleep Apnea May Increase A Woman’s Risk For Heart Problems

By Dr Deepu

HealthDay (10/15, Preidt) reports that research indicated that “sleep apnea can boost a woman’s risk for heart problems and even death, but there was no such effect for men.” The study also indicated that, “compared to women without sleep apnea, women with the disorder had higher blood levels of troponin, a chemical signal of early heart damage.” The study was published in Circulation.

Experts question the evidence underpinning e-cigarette recommendations

By Dr Deepu
Concern over Public Health England's recent support for e-cigarettes
Public Health England (PHE) recently endorsed the use of electronic cigarettes as an aid to quitting smoking. But in The BMJ this week, experts question the evidence on safety and effectiveness underpinning the recommendations.
Professor Martin McKee at the London School of Hygiene The BMJ Tropical Medicine and Professor Simon Capewell at the University of Liverpool, argue that the available evidence about e-cigarettes "suggests that the debate is far from over and questions remain about their benefits and harms."
The PHE report concludes that e-cigarettes are much safer than conventional cigarettes. It also says there is no evidence that e-cigarettes give children a "gateway" into smoking.
Some of the findings have been welcomed by Action on Smoking and Health (ASH) and the Royal College of Physicians of London. But other leading health bodies - including the British Medical Association, the US Centers for Disease Control and Prevention, and the World Health Organization - have expressed caution.
So does the available evidence show clearly that e-cigarettes are as effective as established quitting aids, ask McKee and Capewell.
Unfortunately not. For example, a recent Cochrane review, widely cited in the PHE report, concluded the available evidence was of "low or very low quality" by recognised standards.
And a recent systematic review, which the PHE report surprisingly fails to cite, also found serious methodological problems in many of the studies it reviewed, and noted that one third of the studies (34%) it reviewed were published by authors with conflicts of interest.
The headline message from the PHE report is that "best estimates show e-cigarettes are 95% less harmful to your health than normal cigarettes." Yet McKee and Capewell point out that this figure comes from a single meeting of 12 people, involving several known e-cigarette champions and sponsored by companies with links to the tobacco industry.
The PHE report also asserts that the available evidence suggests that e-cigarettes are not currently re-normalising smoking among children and young people in the UK. But McKee and Capewell point out that experimentation with e-cigarettes among young people in England is "worryingly high" and "this remains a major concern for health professionals and parents."
They describe the report's dismissal of the possibility that e-cigarettes may be a gateway to smoking as "premature." And they argue that the report has many other omissions, such as concerns about product safety, and the lack of evidence of risks from long term dual use with conventional cigarettes.
Finally, the PHE summary states, "The accuracy of nicotine content labelling currently raises no major concerns." Surely, England's leading public health agency cannot be indifferent to a situation in which consumer product information is known to be wildly inaccurate, they ask.
In 2017, the European Union Tobacco Products Directive will come into force, with substantial restrictions on e-cigarettes. "These restrictions will hopefully limit the negative effect of this flawed PHE report," say TheBMJ article's authors.
"Meanwhile, directors of public health and the wider community desperately need advice on e-cigarettes that is evidence based and free from any suspicion of influence by vested interests," they conclude.
Link to full article

Banning trans fats in England could prevent 7,000 heart deaths over next five years

By Dr Deepu
A total ban is technically feasible and decisive action is now needed, say experts
A total ban on trans fatty acids (trans fats) in processed foods in England could potentially prevent or postpone about 7,200 deaths from coronary heart disease over the next five years, suggest experts in TheBMJ this week.
They say a total ban in England is "technically feasible" and they call for "decisive action" to prioritise the most effective and cost effective policy options.
Industrial trans fatty acids are produced from plant oils (a process known as hydrogenation) and are commonly added to processed foods to cheaply improve shelf life and palatability.
Higher intake of these fats is associated with increased risk of coronary heart disease and death, and consumption is generally higher in lower socioeconomic groups. Their elimination from the UK diet is part of the Department of Health's responsibility deal.
So a team of researchers decided to evaluate three policy options to reduce consumption of trans fats in England: a total ban on trans fatty acids in processed foods; improved food labelling; and bans on trans fatty acids in restaurants and takeaway outlets.
They calculated health and equity benefits and cost effectiveness of each policy compared with consumption remaining at most recent levels. Influential factors such as age, sex, and socioeconomic status were taken into account.
Guidelines currently recommend that trans fats are limited to less than 1% of energy intake. The researchers calculated that average consumption of trans fatty acids among UK adults in 2001-09 to 2011-12 was around 0.7% of energy intake. For the most disadvantaged groups, consumption was higher, around 1.3%.
The researchers found that a total ban on industrial trans fatty acids in processed foods in England might potentially prevent or postpone about 7,200 deaths (2.6%) from coronary heart disease from 2015-20 and reduce inequality in mortality from coronary heart disease by about 3,000 deaths (15%).
This inequality stems from the fact that early death from coronary heart disease is substantially higher among the most disadvantaged socioeconomic groups compared with the most affluent.
Policies to improve labelling or simply remove trans fatty acids from restaurants and takeaways could save between 1,800 (0.7%) and 3,500 (1.3%) deaths from coronary heart disease and reduce inequalities by 600 (3%) to 1,500 (7%) deaths, thus making them at best half as effective.
A total ban would also have the greatest net cost savings of The BMJ264m excluding product reformulation costs, or The BMJ64m if substantial reformulation costs are incurred.
"Elimination of trans fatty acids from processed foods is an achievable target for public health policy," say the authors. Such a ban "would lead to health benefits at least twice as large as other policy options, both in terms of total population benefit and reduction in inequality."
They suggest that continuing to rely on industry cooperation via the responsibility deal "might be insufficient" and call for "decisive action" to prioritise the most effective and cost effective policy options.
There's nothing good about industrial trans fats and a total ban would be best for public health, argues Lennert Veerman from the University of Queensland's School of Public Health, in an accompanying editorial.
"Given the clear evidence on the health impact of trans fats and what we know about consumption patterns, rates of heart disease, and related economic costs in England, we can safely conclude that these actions to accelerate the removal of industrial trans fat from the food supply are good for health, cost saving, and equitable," he writes.
Link to full study
Link to editorial

Increasing calcium intake unlikely to boost bone health or prevent fractures, say experts

By Dr Deepu
Increasing intake through diet or supplements should not be recommended for fracture prevention
Increasing calcium intake through dietary sources or supplements is unlikely to improve bone health or prevent fractures in older people, conclude two studies published in The BMJ this week. Collectively, these results suggest that increasing calcium intake, through supplements or dietary sources, should not be recommended for fracture prevention.
Guidelines advise older men and women to take at least 1000-1200 mg/day of calcium to improve bone density and prevent fractures, and many people take calcium supplements to meet these recommendations. Recent concerns about the safety of calcium supplements have led experts to recommend increasing calcium intake through food rather than by taking supplements, but the effect on bone health is unknown.
So a team of researchers in New Zealand set out to examine the evidence underpinning recommendations to increase calcium intake from dietary sources or supplements to improve bone health and prevent fractures.
They analysed the available evidence from randomised controlled trials and observational studies of extra dietary or supplemental calcium in women and men aged over 50. Study design and quality were taken into account to minimise bias.
In the first study, they found that increasing calcium intake from dietary sources or by taking supplements produces small 1-2% increases in bone mineral density, which "are unlikely to lead to a clinically meaningful reduction in risk of fracture."
In the second study, they found that dietary calcium intake is not associated with risk of fracture, and there is no clinical trial evidence that increasing calcium intake from dietary sources prevents fractures.
It is time to revisit recommendations to increase calcium intake beyond a normal balanced diet, argues Professor Karl Michaëlsson from Uppsala University in Sweden, in an accompanying editorial.
He points out that ever increasing intakes of calcium and vitamin D recommended by some guidelines defines virtually the whole population aged over 50 at risk. Yet most will not benefit from increasing their intakes, he warns, and will be exposed instead to a higher risk of adverse events.
"The weight of evidence against such mass medication of older people is now compelling, and it is surely time to reconsider these controversial recommendations," he concludes.

Calcium intake, bone mineral density, and risk of fracture

By Dr Deepu

Increasing calcium intake through supplementation or diet should not be recommended for preventing fractures, according to two studies from New Zealand. A systematic review found no association between dietary calcium intake and risk of fracture, and a meta-analysis showed that although dietary calcium led to small increases in bone mineral density, these were unlikely to reduce fracture risk to a clinically significant degree. The accompanying editorial cargues in favour of revisiting recommendations to increase intake beyond a normal balanced diet.

USFDA approves New drug KEYTRUDA ( used in Melanoma) for NSCLC.

By Dr Deepu
  • The U.S. Food and Drug Administration approved Merck & Co.’s Keytruda for the treatment of the most common form of lung cancer, the second of a costly new wave of immune-boosting drugs to be cleared for one of the deadliest cancer types.
  • The FDA cleared Keytruda for use in patients with non-small-cell lung cancer whose tumors contain a certain level of a protein known as PD-L1.
  • In early 2015, Merck & Co.'s drug Keytruda has been approved to treat melanoma, a type of skin cancer. Keytruda's FDA approval as a lung cancer treatment was announced on Oct. 2, 2015.
  • Also known as 'pembrolizumab', Keytruda is designed for patients with advanced non-small cell lung cancer (NSCLC). Patients who suffer from the illness have tumors with a specific protein called 'programmed cell death protein 1' or PD-L1.
  •  Keytruda contains an antibody which targets another protein called PD-1. When PD-L1 and PD-1 bind together, PD-1 lowers T lymphocytes or T-cells in the immune system. 
  • Normal levels of T-cells help the body fight cancer cells. Evidently low levels of T-cells are prominent in HIV/AIDS patients.
  • By blocking the interaction between proteins PD-L1 and PD-1 in the molecular pathway, Keytruda could help the immune system to fight off cancer cells.
  • An accompanying diagnostic, the PD-L1 IHC 22C3 pharmDx test, has also been approved by the FDA. This is the first diagnostic test to detect PD-L1 proteins in lung cancer patients.

Hospitals Considering Adding More Copper Surfaces That Can Help Kill Bacteria

By Dr Deepu

The Washington Post (9/20, Sun) reported at least 15 hospitals across the country have installed, or are considering installing, copper components on surfaces like light switches and door handles that are easily contaminated with microbes because of copper’s ability to “kill or inactivate a variety of pathogens by interacting with oxygen and modifying oxygen molecules.” Lynch, medical director of infection control at Harborview Medical Center in Seattle, said, “We’ve known for a long time that copper and other metals are effective in killing microbes, so it wasn’t a great leap to incorporate copper surfaces into hospitals.” The only published clinical trial showing how copper reduces infections in hospitals suggested copper surfaces reduced infection by 58 percent. The CDC is now seeking more research on the subject.

Energy-Efficient Homes May Lead To Higher UK Asthma Rates, Report Warns

By Dr Deepu

The Guardian (UK) (9/20) reported that “the number of Britons with asthma” may nearly “double by 2050 because the air inside homes is becoming more polluted as they become more energy-efficient, a new report warns.” The Guardian adds that “airborne pollutants created by cooking, cleaning and using aerosols such as hairsprays will increasingly stay indoors and affect people’s health as homes are made ever more leak-proof to help meet carbon reduction targets, a report by Professor Hazim Awbi” contends. The Daily Mail (UK) (9/21, Mailonline) also covers the story.

Pirfenidone May Extend Lives

By Dr Deepu

Bloomberg News (9/20, Bennett) reported that Roche Holding AG announced that Esbriet (pirfenidone)” reduces the risk of death by 38 percent after two years of treatment for patients with idiopathic pulmonary fibrosis,” according to clinical data to be presented at a medical conference in Amsterdam.

Study: Teens More Likely To Try Cigarettes If Their Parents Smoke

By Dr Deepu

HealthDay (9/19, Dallas) reported a study found that teens are three times likely to smoke at least one cigarettes if one of their parents are dependent are nicotine. The study, led by Denise Kandel, a professor at Columbia University Medical Center and the Mailman School of Public Health in New York City, found that among teens whose parents never smoked, 13 smoked at least one cigarette in their lifetime. In contrast, 38 percent of teens who had a parent that used nicotine said they smoked at least once. Teenage daughters of women who smoke were also four times as likely to be dependent on nicotine. Girls, however, did not appear to be more likely to become dependent if their father smoked. The study was published online Sept. 17 in the American Journal of Public Health.

FDA Approves Asthma Indication For COPD Drug.

Food and Drug Administration has approved “the long-acting muscarinic antagonist tiotropium bromide (Spiriva Respimat, Boehringer Ingelheim) for long-term maintenance treatment of asthma in people aged 12 years and older.” The drug has already been approved for treating chronic obstructive pulmonary disease (COPD).
  • U.S. FDA latest regulatory authority to approve tiotropium in asthma following authorities in the EU, Japan and other countries
  • Recent GINA 2015 Global Strategy recommends tiotropium by soft mist inhaler as add-on asthma therapy
Ingelheim, Germany, 16. September, 2015 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) approved SPIRIVA® Respimat®(tiotropium bromide) Inhalation Spray for use in the treatment of asthma. It is approved by the FDA for the long-term, once-daily, maintenance treatment of asthma in patients 12 years of age and older. Following previous regulatory approvals, tiotropium by soft-mist inhaler has been included in the recently updated Global Initiative for Asthma report (GINA) 2015 Global Strategy for Asthma Management and Prevention.
Almost one in two patients with asthma still experience symptoms while receiving maintenance therapy, putting them at increased risk of potentially life-threatening asthma exacerbations. Pivotal, Phase III study results show that Spiriva® Respimat® as an add-on treatment to ICS/LABA maintenance therapy:
  • Significantly improves asthma symptoms 
    • patients are 68% more likely to improve asthma control7
  • Significantly reduces the risk of patients having a severe asthma exacerbation by a fifth (21%)
    • reducing the number of patients who experienced a severe asthma exacerbation
The Phase III study results also showed that the safety of SPIRIVA® Respimat® is balanced as compared to placebo.

Pulmonary Specialists Pan Europe To Participate In Project To Develop New Treatments For Cystic Fibrosis, Bronchiectasis

By Dr Deepu
Healio (9/12) reported that “lung specialists across Europe have been recruited to participate in a €50 million project that will develop new treatments for cystic fibrosis and bronchiectasis, according to a press release.” According to Healio, “the inhaled Antibiotics in Bronchiectasis and Cystic Fibrosis consortium...will address the demand for new forms of inhaled antibiotics and the ongoing issue of antimicrobial resistance.”

Reliever Salbutamol Use Appears Linked To Risk Of COPD Exacerbation

By Dr Deepu
Healio (9/12) reported that research indicated that “short-term and long-term use of short-acting beta 2-agonist salbutamol 90 μg appeared associated with increased short- and long-term exacerbation of chronic obstructive pulmonary disease.” The findings were published in BMC Pulmonary Medicine.

FDA Approves Rolapitant to Prevent Nausea and Vomiting from Chemotherapy

By Dr Deepu
On September 1, the Food and Drug Administration (FDA) approvedrolapitant (Varubi®) to prevent delayed phase chemotherapy-induced nausea and vomiting in adult cancer patients. The approval is for the use of rolapitant in combination with two other antiemetic drugs given during initial or repeated courses of vomit-inducing chemotherapy.
Delayed phase nausea and vomiting—generally defined as nausea or vomiting that occurs from 24 to 120 hours or more after a course of chemotherapy—tends to be under-reported and thus underestimated, explained Ann O’Mara, Ph.D., head of Palliative Care Research in NCI’sDivision of Cancer Prevention.
“Patients generally experience delayed nausea and vomiting at home. They may forget to report this experience at their next doctor’s appointment or clinicians may forget to ask about it,” Dr. O’Mara said.
Rolapitant, which is taken as a pill, works by blocking the activation of neurokinin-1 receptors, which are particularly abundant in the area of the brain that is involved in nausea and vomiting.
The FDA approved rolapitant based on results from three large randomized clinical trials. In the trials, patients treated with highly or moderately  emetogenic chemotherapy who received rolapitant in combination with the antiemetic drugs granisetron and dexamethasone had greater reductions in delayed phase vomiting and nausea compared with patients treated with a placebo in combination with granisetron and dexamethasone.
The most common adverse reactions among patients receiving rolapitant were loss of appetite and low white blood cell count, or neutropenia, which increases the risk of infection. Other common adverse reactions included hiccups and dizziness.
“Although considerable progress has been made in the management of acute chemotherapy-induced nausea and vomiting, many patients receiving chemotherapy still experience delayed nausea,” Dr. O’Mara noted. Although the symptoms can persist for up to 7 days, she continued, they tend to peak 48 to 72 hours after chemotherapy.
Currently approved antiemetic agents generally target the acute phase of nausea and vomiting in the first 24 hours after the start of chemotherapy. “Rolapitant, because of its longer duration of action, has the ability to affect the delayed nausea and vomiting,” Dr. O’Mara concluded.
The FDA cautioned that rolapitant should not be taken with the antipsychotic drug thioridazine because this combination of drugs can cause a serious type of irregular heartbeat.
Source : National cancer institute