Thursday, June 20, 2013

Meningitis Vaccination Needed Before Gay Pride Week



Norra MacReady
Jun 18, 2013
 


Officials at the New York City Department of Health and Mental Hygiene (NYC DOHMH) are urging men who have sex with men (MSM) to be vaccinated against meningitis, especially if they plan on participating in the city's Gay Pride events, say the authors of an article published online June 17 in the Annals of Internal Medicine.
Outbreaks of invasive meningococcal disease (IMD) among MSM are occurring in NYC and Los Angeles, California, lead author Matthew S. Simon, MD, from the Department of Public Health, Weill Cornell Medical College, New York City, and coauthors write. The situation in NYC is particularly urgent, as up to a million people are expected to gather there to celebrate Gay Pride Week, which begins June 28.
The NYC DOHMH has been aggressively promoting vaccination since October 2012. Health departments in other cities, including Toronto, Ontario, Canada, and San Francisco, California, also are recommending that gay men traveling to New York be vaccinated.
Overall, IMD in the United States is at an all-time low, with an incidence of 0.3 to 0.6 cases per 100,000 persons. However, since August 2010, 22 cases of IMD in MSM have been reported to the NYC DOHMH, putting the incidence of IMD among MSM at 50-fold greater than in the general population. Half these patients were black, and 55% were infected with HIV. They had a mean age of 34 years. Seven of those patients died. In Los Angeles, 4 cases of IMD have been reported in MSM since December 2012.
Thanks to the NYC DOHMH vaccination campaign, more than 11,000 people have been vaccinated, and no new cases of IMD have been reported since February 2013. Some community-based organizations in Los Angeles are now trying a similar approach. "However, vaccine coverage may be suboptimal because of challenges in reaching the populations most at risk, particularly African American MSM who may not self-identify as gay or be engaged in medical care," the authors write.
Primary care providers face multiple delivery barriers, including high procurement costs, limited reimbursement, and inconsistent insurance requirements. This experience "highlights the logistic challenges in effectively implementing new vaccine recommendations for adults."
"Risk factors for acquiring Neisseria meningitidis include smoking, close living quarters, bar patronage, and kissing," the authors write. "Death within 24 hours of onset of symptoms is common, and the case-fatality ratio for IMD in the United States is 10% to 15% and is 3-fold greater in outbreaks."
Recent epidemiologic studies of MSM have revealed rates of N meningitidis carriage as high as 43%, with rectal and urethral colonization rates of 2% and 1%, respectively, although the reason why the illness is concentrated among gay men remains unclear. Also unclear is whether HIV infection is a risk factor, although the authors point out that people with HIV have an increased susceptibility toPneumococcus, which, similar to N meningitidis, is an encapsulated bacterium.
"Providers should be aware of the recent meningococcal cases in NYC and Los Angeles, assess their patients' risk, and discuss the outbreak with their MSM patients," the authors conclude. "Suspected meningococcal cases should be reported promptly to local health departments, where patients should have an epidemiologic investigation that accounts for sexual history and determines HIV status."
The authors have disclosed no relevant financial relationships.
Ann Intern Med. Published online June 17, 2013. Abstract

Tea and Coffee Lower Blood Pressure in Large French Registry


Michael O'Riordan
Jun 18, 2013
 
MILAN, Italy — A large French retrospective analysis provides good news for caffeine lovers: investigators showed that drinking tea or coffee was associated with a small but statistically significant reduction in systolic and diastolic blood pressure. In addition, drinking tea and coffee was also associated with a significant reduction in pulse pressure and heart rate, although the heart-rate reductions were greater with tea.
Presenting the results at the European Society of Hypertension (ESH) 2013 Scientific SessionsDr Bruno Pannier (Centre d'Investigations Préventives et Cliniques, Paris, France) said that other studies have suggested a relationship between coffee and tea consumption and blood pressure, but these analyses haven't been conclusive. Some have suggested a benefit, while others found no relationship between tea/coffee consumption and blood pressure.
Presenting the data on 176 437 subjects aged 16 to 95 years of age who had a checkup at their center between 2001 and 2011, Pannier explained that the analysis was simply based on a questionnaire asking participants how much coffee or tea they drank per day. Individuals were classified into three groups: those who drank no coffee/tea, those who drank one to four cups, and those who drank more than four cups.
Overall, coffee is consumed more frequently than tea, although there were differences between the sexes, said Pannier. Men were more likely to drink coffee, while women were more commonly tea drinkers. Coffee consumption was also significantly associated with tobacco consumption, higher cholesterol levels, and higher scores on stress and depression indexes. Tea consumption, on the other hand, was associated with lower cholesterol levels but similarly high scores on the stress and depression measurements.
After adjustments that included these and other potential confounding variables, both coffee and tea consumption was associated with a significant reduction in systolic and diastolic blood pressure, as well as other variables.
Speaking during the session, Pannier explained that the group did not differentiate between green, black, or herbal tea consumption, which is one of the limitations of the analysis. In addition, the questionnaire is not sophisticated enough to address estimates in the caffeine content of the coffee consumed in France.
That said, Pannier believes that tea is a major source of flavonoids in the diet, and these compounds can improve vasodilation. "The vasorelaxing compounds included in these beverages might be involved in these results, something that has been suggested by the experimental data," he said.

Monday, June 17, 2013

NSAID Prescriptions for Pain 'Out of Control'



Alice Goodman
Jun 15, 2013


MADRID — An alarming number of patients with ischemic heart disease or cardiovascular risk factors are being inappropriately prescribed nonsteroidal anti-inflammatory drugs (NSAIDs) for rheumatoid arthritis, musculoskeletal diseases, and other chronic pain-related conditions, a new study suggests.
These prescriptions are being made despite the well-known cardiovascular risks associated with NSAIDs  "The landscape has changed, and we know that NSAIDs increase the risk of death and myocardial infarction with both long- and short-term use," said lead investigator Carl Orr, MD, from the Royal College of Surgeons in Ireland, located in Dublin. "We have instituted new guidelines at our hospital, and we have substituted paracetamol for NSAIDs — especially diclofenac — for patients with underlying inflammatory conditions."
Speaking here at the European League Against Rheumatism (EULAR) Congress 2013, Dr. Orr said that NSAID prescriptions are out of control. For patients with arthritis, it is preferable to target the underlying disease with disease-modifying antirheumatic drugs (DMARDs) than to prescribe NSAIDs, he said.
The cardiovascular risks of long-term NSAID use have been well described, but it is less well known that even short-term use increases the risk for recurrent myocardial infarction and death, Dr. Orr explained ( Circulation, 2011;123:2226-2235).
The new study includes more than 10,000 patients from a large primary care practice facility attached to a major university in Dublin. The study includes all patients older than 50 years prescribed diclofenac, ibuprofen, mefenamic acid, naproxen, etoricoxib, and celecoxib. Investigators analyzed patient records for risk factors for ischemic heart disease, including hypertension, diabetes mellitus, previous myocardial infarction, and revascularization with stenting or surgery.
The search identified 108 patients prescribed NSAIDs. A total of 36% of patients had established ischemic heart disease or risk factors for cardiovascular disease. Indications for the prescriptions included osteoarthritis, rheumatoid arthritis, acute musculoskeletal pain, and back pain as well as nonspecified pain and other miscellaneous conditions.
Among patients with ischemic heart disease or risk factors, more than half, 56%, were prescribed NSAIDs for a month or longer, and 15% were prescribed them for a year or longer.
Diclofenac was the most widely prescribed pain reliever in this group and is the most widely prescribed NSAID in Ireland, Dr. Orr reported.
"This is important," Maya Buch, MD, from the University of Leeds in the United Kingdom, told Medscape Medical News. "Rheumatologists should be mindful of the harmful long- and short-term effects of NSAIDs, particularly in patients with heart disease and risk factors for heart disease."
Dr. Buch said, "The relevant strategy is to control the underlying disease and obviate the need for anti-inflammatory drugs to treat pain associated with rheumatic disease."
Dr. Orr and Dr. Buch have disclosed no relevant financial relationships.
European League Against Rheumatism (EULAR) Congress 2013. Abstract OP0203-PC. Presented June 14, 2013.

Widely Used Diclofenac Associated With Increased Risk for Cardiovascular Events



Michael O’Riordan
Feb 13, 2013


 
TORONTO — The nonsteroidal anti-inflammatory drug (NSAID) diclofenac, a drug that is frequently used for the treatment of pain and inflammation caused by arthritis, is associated with a significantly increased risk of cardiovascular complications and should be removed from essential-medicines lists (EML), according to a new review [1].
Diclofenac, which is listed on the EML of 74 countries, increased the risk of cardiovascular events between 38% and 63% in different studies. The increased risk with diclofenac was similar to the COX-2 inhibitor rofecoxib (Vioxx, Merck), a drug withdrawn from worldwide markets because of cardiovascular toxicity.
Speaking with heartwire Dr David Henry (Institute for Clinical Evaluative Sciences, Toronto, ON), who conducted the review along with Dr Patricia McGettigan (London School of Medicine and Dentistry, UK), said that while use of diclofenac in North America is low--the drug has about 5% or 6% of the NSAID market in the US and 17% of the market in Canada--its use is much more common in other non-Western countries.
"The exposure in the North American community is quite low," said Henry, "but the real issue is that it has 30% to 40% of the market share in countries like Vietnam, Pakistan, parts of China, and other countries. These countries are experiencing a real epidemic of cardiovascular disease at the same time these rates are coming down in the West. They are really heavy users of these drugs, in particular diclofenac."
 
The thing with diclofenac is that even in small doses it increases the risk of cardiovascular events.Dr David Henry
 
In the review, published online February 12, 2013 in PLoS Medicine, Henry and McGettigan showed that in 15 countries, a list comprising high-, medium-, and low-income countries, diclofenac was the most widely used NSAID. It has a market share roughly equal to the combined market share ofibuprofen,naproxen, and mefenamic acid. The high-risk NSAIDs, diclofenac and etoricoxib, had one-third of the market share across the 15 countries.
Diclofenac, Even in Small Doses, Can Cause Problems
The meta-analysis by McGettigan and Henry also reviewed the relative cardiovascular risks of NSAIDs in observational and randomized studies. Rofecoxib, etoricoxib, and diclofenac were the three agents that were consistently associated with a significantly increased risk when compared with nonuse. Rofecoxib increased the risk of serious cardiovascular events between 27% and 45%, and etoricoxib increased the risk more than twofold compared with nonuse. In two observational studies, diclofenac increased risk of acute MI approximately 38% and 39%, respectively, and increased the risk of cardiovascular events 40%. In one randomized trial, diclofenac was associated with a 63% increased risk of cardiovascular events compared with nonuse.
To heartwire , Henry said the NSAIDs are familiar drugs for physicians and because of such familiarity might be casually prescribed. While the drugs are available over the counter, the cardiovascular risks are associated with the prescription strengths of NSAIDs. For diclofenac, the prescription dose ranges from 100 to 150 mg per day, and this dose is high enough to cause a risk of cardiovascular events, with higher doses associated with even greater risks. With diclofenac, as well as with rofecoxib, there does not appear to be a dose associated with no risk.
"We could find no-risk doses with some of the other drugs, like ibuprofen, naproxen, and celecoxib[Celebrex, Pfizer]," he said. "We could find a dose low enough that didn't increase the risk of heart attacks. The thing with diclofenac is that even in small doses it increases the risk of cardiovascular events. The average dose that is used and marketed is quite high."
Indometacin and meloxicam had a moderately increased risk of cardiovascular events, slightly higher than naproxen, while celecoxib and ibuprofen were associated with an increased risk of cardiovascular toxicity when used at high doses in clinical trials but not in lower doses available over the counter.
An Underappreciated Problem
Dr Gabriel Steg (Centre Hospitalier Bichaut-Claude Bernard, Paris, France), who was not affiliated with the analysis, told heartwire that the cardiovascular risks associated with NSAIDs are an underappreciated problem. He said that most NSAIDs, with the possible exception of naproxen, have some degree of cardiovascular risk associated with them. "I think the converging data from multiple sources indicates that, particularly in patients who are known to have cardiac disease, we should refrain from the chronic use of NSAIDs, if possible," said Steg. "It is conceivable that diclofenac might have a slightly higher risk than the others, but really the issue is the whole class rather than singling out a [particular] agent.
 
Steg noted that a study published last year in Circulation, reported byheartwire , showed that the use of NSAIDs was associated with apersistently increased risk of coronary events in patients with a previous MI. In more than 43 000 MI patients treated with NSAIDs, their use was associated with a 59% increased risk of death after one year and a 63% increased risk of death after five years of use. In addition, the use of the NSAIDs was associated with an increased risk of coronary death and recurrent MI.
"I think this is a completely underappreciated problem," said Steg. "Most physicians would not be alert to the long-term use of these agents. Many of these agents are over the counter, so physicians are not necessarily aware of their use. Also, they may be used fairly frequently by patients and for very long periods of time. In the elderly, because of bone and joint issues, their use is very common."
To heartwire , Henry said he has written to the World Health Organization (WHO) and has recommended that they advise the EML committees worldwide to preferentially recommend naproxen as the NSAID of choice. He said he does not expect drug regulatory committees, such as the Food and Drug AdministrationHealth Canada, or theEuropean Medicines Agency (EMA), to withdraw the drugs. In October 2012, the EMA finalized a review that concluded there was a small increase in the risk of cardiovascular side effects with diclofenac compared with other NSAIDs.
"I don't think there is any real new information that would lead them to act, rather than information showing that diclofenac is the most popular drug and it has the same risks as Vioxx," said Henry. "I'm not expecting that change in attitude to suddenly occur. What we'd like to get across to prescribers is to not use diclofenac and to use naproxen. Also, these are not disease-modifying drugs, they're symptom-relieving drugs. We typically tell patients not to stop a medication and to talk to their doctor, but if you have heart disease and are taking diclofenac, do stop the medication and then go talk to your doctor about an alternative."


EMA Committee Concludes Diclofenac Poses Similar Risks as COX-2 Inhibitors



Michael O'Riordan
Jun 14, 2013LONDON, UK — The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency(EMA) has completed its review of diclofenac and concluded that the drug poses similar risks as selective COX-2 inhibitors, particularly when used in high doses (150 mg) or when used long term.
Still, committee says the benefits of diclofenac exceed the risks and that physicians should take the same precautions to minimize thromboembolic events as they do with patients treated with selective COX-2 inhibitors.
"Patients who have serious underlying heart or circulatory conditions, such as heart failure, heart disease, circulatory problems, or a previous heart attack or stroke, should not use diclofenac," according to PRAC. "Patients with certain cardiovascular risk factors (such as high blood pressure, raised blood cholesterol, diabetes, or smoking) should only use diclofenac after careful consideration. Healthcare professionals will also be advised to periodically reassess the need for patients to continue taking the medicine."
The review conducted by PRAC was launched in October 2012 after the EMA completed a report on published information assessing the cardiovascular safety of nonsteroidal anti-inflammatory drugs (NSAIDs). Like PRAC, the EMA concluded that there was a consistent but small increase in the risk of cardiovascular side effects with diclofenac compared with other NSAIDs and that this risk was on par with that observed with COX-2 inhibitors.
The current PRAC conclusions are based on all published and unpublished data. Its recommendations will now be forwarded to the Coordination Group for Mutual Recognition and Decentralized Procedures--Human (CMDh), a regulatory body representing member European Union states, which will adopt a final position.