jeudi 28 juillet 2016

DNC: Win or Lose, GOP Will Act on Obamacare

PHILADELPHIA -- No matter which way the election turns out, it will force the Republicans to do something about the Affordable Care Act (ACA), a political strategist said here.

Take, for example, the case in which Trump wins the presidency, Jennings explained at a briefing Wednesday sponsored by Americans United for Change, a liberal lobbying group, in conjunction with the Democratic National Convention.

"When you feel as a Republican that you've been running on 'repeal and replace the Affordable Care Act' for like 6 or 8 years, and your only criticism was, 'I didn't have the person in White House to sign it,' and then you don't do it [when a Republican is elected]? You know, people tell me it's not a big deal -- this is a big deal," said Chris Jennings, former healthcare adviser to presidents Bill Clinton and Barack Obama.

If, on the other hand, Hillary Clinton is elected president, the Republicans will probably decide to drop their efforts to repeal it, figuring that they won't want to fight it for another 4 years while a Democrat remains in the White House, he told MedPage Today.

As for how these same Republicans feel about cutting Medicare and Medicaid, one is different from the other, continued Jennings, who is now a private healthcare consultant.

"They're scared of Medicare. Why? It's all the old white people who are their base, and without Democratic cover they'll be scared ... They don't think that about Medicaid program. We're at a fork in the road, and they're going to say, 'I need to cut this program big time; I need to have big savings.' I'm not just saying that -- they just passed legislation in the reconciliation bill to do just that, a trillion dollars in Medicaid cuts."

Of the 19 states who haven't expanded Medicaid -- "the vast majority of those governors want to expand it; do you know why they can't? They have state legislators controlled by Republicans who will not provide the authority," he continued. "This [election] is not just about the presidency; it's about the House, the Senate, the state legislatures, the governors. This is huge for the Medicaid program."

Ron Pollack, executive director of Families USA, said when it comes to the ACA, its benefits need to be communicated more clearly. He pointed to a June survey by the Kaiser Family Foundation showing that 42% of those polled felt generally favorable toward the ACA while 44% did not. "That doesn't mean the public wants it repealed; the vast majority do not," he said. Indeed, when pollsters asked about whether it should be repealed, 58% said no while 33% said yes -- and of the 58%, half wanted to see it strengthened.

"There is a lesson here for all of us," he said to the ACA supporters in the room. "Leading by [talking about] Obamacare of the ACA doesn't get you very far, but if you start by talking about the things in it -- like its ban on discrimination against patients with preexisting conditions and its provision allowing children to stay on their parents' insurance until age 26 -- "you go off the chart with support."

As with panelists at a different healthcare briefing on Wednesday, speakers at the Americans United for Change event expressed concern about the rising cost of deductibles in private insurance plans. The Department of Health and Human Services "is experimenting with standardized plans that would provide more services [on a] pre-deductible [basis]," Pollack said. "I think this concept is really worth exploring further."

"We do need to ensure that healthcare cost reductions benefit consumers" who enroll in private plans through the ACA's health insurance exchanges, said Neera Tanden, president and CEO of the Center for American Progress, a left-leaning think tank in Washington. "That should be a first goal ... we had a huge amount of savings vis-a-vis the Affordable Care Act if you look at the [Congressional Budget Office's] projections; if you just take a little bit of those savings and put it back into subsidies, you could save a lot of the exchanges and make them far more affordable for people."

In addition, "There are a lot of people concerned about healthcare costs who have no connection to ACA," she continued. "They're in employer-based plans and seeing rising deductions, rising out-of-pocket costs .. There's real concern there. [And] pharmaceutical costs have risen at double-digit inflation rates, and that's where consumers really feel a lot of out-of-pocket costs."

Former Senate Majority Leader and retired senator Tom Daschle (D-S.D.) said maintaining the viability of the ACA's health insurance exchanges was also a concern. "We need to be realistic about marketplace viability," said Daschle, the co-founder of the Bipartisan Policy Center, in Washington. "We have to find ways to bring healthy people into the marketplace."

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DNC: Win or Lose, GOP Will Act on Obamacare

Doc's Dilemma: Lucentis or Avastin?

I sometimes worry that my wife Paula won't be able to see me grow old. Not that I expect to outlive her. She is 4 years my junior and has the blood pressure of a 17-year-old track star. It's her eyesight I'm worried about, because she is at risk for a form of blindness called macular degeneration. Paula is the youngest in a long line of redheads, several of whom have been diagnosed with this illness. Her fair-haired grandmother developed macular degeneration and was eventually unable to see her bridge hand and had to give up her golf game, just when she was threatening to score below her age. Fortunately, Paula should be able to avoid her grandmother's fate, because we now have outstanding treatments for this disease.

Too bad these treatments are costing us billions more than they should. The price of some macular degeneration treatments is staggeringly high, and both doctors and the pharmaceutical company making the treatments are motivated to keep it that way. If we as a country want to forestall blindness in people like my wife, without going bankrupt in the process, we need to pressure our government to do some hardball negotiating.

By way of background, my grandmother-in-law suffered from what ophthalmologists call "wet" macular degeneration. Frail little blood vessels began proliferating in the back of her retina. It's not unusual to have lots of blood vessels back in the retina. It's that red blood, after all, that causes so many of us to look possessed in family photos, with red eyes staring demonically into the lens. But in wet macular degeneration, there's even more blood vessels than normal in the back of the eye, and they are more inclined to leak than typical blood vessels. This leaking fluid damages the nerve cells we depend upon to see light and darkness. For years, there was little doctors could do to slow these leaks.

Then along came Avastin (bevacizumab).

Some of you may recognize Avastin as being a cancer drug. That's true. Avastin works by disrupting a chemical our body makes to promote blood vessel growth. Tumors that depend on new blood vessels to grow are thereby thwarted by the drug. So, too, is macular degeneration. No new frail blood vessels means no blood vessel leakage!

Many ophthalmologists treat wet macular degeneration by injecting Avastin directly into the back of patient's eyeballs. (Under local anesthesia, of course!) And the drug isn't even terribly expensive. By one estimate, Medicare pays about $50 a pop for monthly Avastin injections. There is a problem with this effective and affordable treatment, however. Avastin has never been approved by the FDA to treat macular degeneration. Physicians are allowed to use it as an off-label treatment, but because it is off label, it needs to be reformulated by pharmacies into an injectable form, and before standards for such reformulation were bolstered, some patients experienced eye infections from contaminated vials.

Fortunately, there is a second drug to treat macular degeneration, one very similar in its chemical composition, another blood vessel-blocking drug called Lucentis (ranibizumab). Unlike Avastin, Lucentis is FDA-approved to treat the disease. That means it is made by the manufacturer in a ready-to-inject formulation, and there is no need for pharmacies to do any additional prepping. Lucentis is just as good as slowing the progression of macular degeneration as Avastin. There's just one little problem with Lucentis, however. Instead of costing Medicare $50 per pop, it costs up to $2,000.

$2,000?! With Avastin's contamination issue largely resolved, surely ophthalmologists aren't prescribing Lucentis. Right?

Wrong. Lucentis holds about one-third of the market share for macular degeneration treatments. Medicare alone could save $18 billion over the next 10 years if physicians switched to Avastin.

Why don't all doctors switch to Avastin? Some no doubt have had patients who experienced infections. Fool me once, they probably think. But such infections were quite rare, and few ophthalmologists believe Avastin is a risky treatment now. Some ophthalmologists continue to use Lucentis because they have close connections to the manufacturer, and by close connections I mean -- they make lots of money "consulting" for Genentech. According to the New York Times, physicians consulting for Genentech disproportionately prescribe Lucentis over Avastin.

Once again, however, such consultants make up but a small proportion of practicing ophthalmologists, and can't explain why Lucentis accounts for one-third of macular degeneration treatments. To explain that figure, we must turn to the bizarre way that Medicare reimburses physicians for the medications they inject or infuse into their patients. To be able to treat macular degeneration, ophthalmologists must first purchase and store either Avastin or Lucentis. This contrasts with, say, a primary care physician like me prescribing a blood pressure pill, which the patient picks up at their local pharmacy. When eye doctors treat macular degeneration, they act like a pharmacy. Same is true when cancer doctors, oncologists, provide I.V. chemotherapy in their clinics. They purchase, store and handle the drugs before giving them to patients. Such efforts cost the doctors and clinics money. So Medicare gives extra money to clinicians, beyond the purchase price of the drugs, to reimburse them for this effort.

How much money? A 6% markup from the purchase price. Do you see the problem here? Inject $50 of Avastin into a patient, and the eye clinic will receive an extra $3 from Medicare. Inject $2,000 of Lucentis, however, and it will receive an extra $120.

Imagine you are an ophthalmologist in private practice. You've noticed that Medicare reimbursement for cataract procedures has been getting stingier lately. In addition, many patients are cutting back on routine eye visits, in the aftermath of the great recession. As a result, the 6 percent markup is becoming a critical part of your bottom line, of being able to maintain your take-home income without laying off available office staff. On top of that, you believe that the risk of injection from Avastin will never be 0. Wouldn't you be tempted to use Lucentis? It's pretty impressive, in fact, that ophthalmologists are only using Lucentis one-third of the time.

As for that injection risk, it could be avoided if the manufacturer made a version of Avastin already formulated for ophthalmology use. But the company making Avastin doesn't plan to do this. Probably because that company is Genentech, the same one making Lucentis. What sane company, appropriately motivated to maximize returns to its shareholders, would purposely undercut its more lucrative product?

In short, two powerful interest groups -- eye doctors and a leading pharmaceutical company -- have very good reason to hope Lucentis will stay expensive and popular. As a result, the rest of the American population suffers. We spend billions of tax dollars that we shouldn't have to spend. And many Medicare recipients, who pay out-of-pocket for a portion of their medical care, suffer financial distress from the unnecessarily high cost of their macular degeneration treatment.

Here are a few simple ways we can fix this problem.

1. Replace the 6% markup with a flat fee. We should not incentivize doctors and medical clinics to use expensive drugs over less expensive ones. A study of oncology treatments showed that when choosing between two equally effective chemotherapies, many oncologists prescribed the more expensive one and then, when it went generic (and their 6% markup plummeted), they shifted to an alternative treatment, which was now relatively expensive. Medicare should jettison the 6 percent markup and consider offering healthcare providers a flat payment to cover administrative costs. Then no matter what chemotherapy or macular degeneration drug they use, they would get the same amount of extra money.

2. Bundled payments for macular degeneration treatment. Medicare should consider giving ophthalmologists a fixed amount of money per month to treat macular degeneration, and let physicians decide how to care for their patients. This policy would basically limit the use of Lucentis to patients, or insurance companies, willing to pay the difference in price.

3. Reference pricing for macular degeneration treatment. In reference pricing, insurance companies tell patients the maximum amount of money they will give them for specific health care services, and patients shop around for providers with the understanding that they will pay any of the cost above and beyond the maximum price. Reference pricing works a lot like bundling, by giving people a price up front that's supposed to cover the cost of all her services. But under bundling, it is health care providers who are in charge of trying to control expenditures. With reference pricing, the onus is on patients to control how much they spend.

4. Negotiate prices with Genentech. If Lucentis really is better than Avastin, Medicare could negotiate prices with Genentech, and then either agree to pay the negotiated price for Lucentis or make Avastin the standard of care for macular degeneration. It would be up to the company to convince Medicare that Lucentis was worth more than Avastin, and price it at a figure commensurate with its added value.

5. Just say no to Lucentis. Finally, Medicare could simply decide Avastin is an excellent and affordable treatment, and tell providers it won't pay for Lucentis.

Administratively speaking, all these approaches are relatively simple. But politically? Not so easy. Nevertheless, with billions of tax dollars at stake, we need to overcome these political barriers. One way to do this perhaps would be to throw a bone to physicians. Medicare could raise the fees it pays for ophthalmologists to make up for some of the revenue they lose from the macular degeneration treatments. I don't think Medicare should throw a bone to Genentech. I don't think they're going to approve any policy that shifts people from Lucentis to Avastin. But Medicare is not a welfare program for pharmaceutical companies. As a country, we need to scrutinize medical spending, or we will be bankrupted by health care costs.

I am ecstatic that Genentech has developed two drugs likely to help people like my wife maintain their eyesight into old age. And the company deserves to make decent profits on its wonderful treatments. And Medicare ought to cover the expense of these treatments for patients with macular degeneration. But that doesn't mean it should give Genentech a blank check.

Peter Ubel is a physician and behavioral scientist who blogs at his self-titled site, Peter Ubel and can be reached on Twitter @PeterUbel. He is the author of Critical Decisions: How You and Your Doctor Can Make the Right Medical Choices Together. This article originally appeared in Forbes and on KevinMD.com.

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Doc's Dilemma: Lucentis or Avastin?

No Dementia Prevention With Vascular Care (CME/CE)

Action Points

  • Note that this randomized trial in The Netherlands demonstrated no protective effect of a multi-modality cardiovascular intervention to reduce the incidence of dementia.
  • Be aware that the "standard of care" arm received very good care, given the nature of the Dutch healthcare system.

TORONTO -- Intense vascular risk management failed to prevent dementia in a large pragmatic trial in The Netherlands, researchers reported here.

In the open-label, cluster-randomized controlled PreDIVA trial, there was no significant difference in the proportion of patients who developed dementia over about 6 years whether they received intensive management or standard of care (6.5% and 7%), respectively, according to Edo Richard, MD, of Radboud University Medical Center in The Netherlands, and colleagues.

They reported their findings here at the Alzheimer's Association International Conference and simultaneously online in The Lancet.

"The contrast between our groups was relatively small, probably because the level of healthcare in The Netherlands is very good already, so it's difficult to improve on an already high level of healthcare," Richard said during an oral presentation at the meeting. "Potentially this intervention is more effective in countries with less developed healthcare systems or in middle-income countries."

Cardiovascular risk factors are associated with an increased risk of dementia, so Richard and colleagues decided to test whether an intensive intervention targeting several of these risk factors can prevent dementia in a general primary care population.

Overall, a total of 3,526 patients ages 70 to 78 at 26 healthcare practices were randomized to either a nurse-led, multi-domain cardiovascular intervention or to usual care. The intervention targeted blood pressure, smoking, exercise, overweight, cholesterol, and glucose levels.

Patients were followed for a median of 6.7 years, and the primary outcome was the development of dementia. Secondary outcomes included stroke, MI, cognitive decline, dementia subtype, and mortality.

Richard said that many patients did end up dropping the intervention, but since this was a pragmatic trial, his team made every effort to follow up on all cases, and ultimately had outcomes for 98% of the population.

"The importance of a pragmatic outcome in a pragmatic trial in older people is that it hugely facilitates the interpretation of the results," Richard said.

Overall, they saw no difference in the primary endpoint, with 7% of those in the standard care developing dementia compared with 6.5% of those in the intensive vascular intervention group (hazard ratio 0.92, 95% CI 0.71 to 1.19).

They did see a mean 2 mm Hg reduction in blood pressure for those in the intervention, which is "very modest, but on a population level this could be relevant," Richard said, adding that those with the highest blood pressure at baseline garnered the most benefit.

There was no treatment effect on any of the other vascular risk factors.

In sensitivity analyses, there was a trend toward a benefit for the intervention in the per-protocol analysis, but it was of borderline significance (HR 0.78, 95% CI 0.58 to 1.04).

For the secondary outcome of dementia subtype, they saw a reduction in the risk of non-Alzheimer's dementia (HR 0.37, 95% CI 0.18 to 0.76) but this was based on a small number of cases, Richard warned.

There was also a trend toward a benefit of the intervention for those with untreated hypertension, and when they looked specifically at untreated patients who remained adherent, there was a significant reduction in dementia risk (HR 0.54, 95% CI 0.32 to 0.92) -- but again Richard noted that this was based on a small number of cases.

He concluded that their work shows that intensive vascular care in older patients "is safe. People were afraid it would be dangerous but we did not see any excess mortality or any excess hospitalizations in the intervention group compared with the control group."

"There was no significant effect on all-cause dementia, but we did see some interesting signals in the direction of a potential effect in adherent patients and in those with untreated hypertension, which could be used to guide development of future trials to prevent dementia," he said. "And it suggests and effect on non-Alzheimer's dementia, but we must interpret this with care."

Maria Carrillo, PhD, chief science officer of the Alzheimer's Association, said that despite the fact the study was negative on its primary outcome, its additional findings "suggest once again the benefits – for the head and the heart – of assessing, treating and managing heart health risk factors as we age."

The study was supported by the Dutch Ministry of Health.

Richard disclosed no financial relationships with industry.

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No Dementia Prevention With Vascular Care (CME/CE)

Stop Collecting, FDA Tells Florida Blood Banks

The FDA is urging blood banks in two Florida counties to stop collections until they can test donations for Zika virus.

The recommendation comes as Florida health officials are investigating four cases of Zika infection, reported in Miami-Dade and Broward counties, that might have been transmitted locally.

Those cases might represent the first cases of local Zika transmission by mosquitoes in the continental U.S., according to Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research.

As of Wednesday, the CDC said 1,658 cases of Zika have been reported in the U.S., the vast majority of them related to travel to Central and South America and the Caribbean, where the Zika outbreak is raging.

But the possibility of local transmission suggests it is "prudent" for blood banks in the two counties -- as well as those nearby -- to stop collections until they can test each donation for Zika, Marks said in a statement.

Marks said the establishments can use an investigational test for Zika RNA that is now available or they can wait until they can use a technology, either investigational or approved, that will inactivate the pathogen.

One Blood, a non-profit blood collection agency that serves much of Florida, said on its website that it will begin using the investigational RNA test Monday.

The agency plans to test blood donations for Zika, so that hospitals can get screened blood products "from unaffected areas to use with their high risk patients, such as pregnant women," the website said.

The molecular test has been in use in Puerto Rico since June.

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Stop Collecting, FDA Tells Florida Blood Banks

A Call Worth Making

Could something this simple really work?

At a recent meeting about practice management, while discussing ways to improve access, we dove once again into our usually high, very troublesome no-show rate -- the fact that many of our patients break appointments.

Everything we've been trying to do to try and get patients urgent and same-day access, like sick visits or those being sent home from the emergency room or the inpatient services, has been frustrated by the lack of available appointment times.

We've created bump lists, added people to work on shuffling and reshuffling the schedules, created "frozen" appointments that "thaw" 24 and 48 hours in advance, and built other reserved appointments for same-day, rapid discharge, and walk-in patients.

Overbooking -- we've tried that. Usually this just leads to three patients showing up at the same time, and then everyone's upset.

But still, our no-show rate has remained incredibly high, ranging upwards of 40% at times.

Of course, we get pressure from the powers that be, insisting that we make access for the emergency department and inpatient discharges that need to be seen, and our own established patients continue to complain that they're unable to get in to see us.

And that high no-show rate leads to decreased volume, which leads to decreased billing, which leads to decreased revenue, which makes those same people (and many others) unhappy.

As we were going through the problem, trying to analyze how we could improve things, we kept noticing that our highest no-show rate was for initial visits -- new patients who schedule appointments to come to establish care here. This includes new patients being referred from the hospital, as well as those who just found us through the Internet or referrals from friends or family.

In our practice model, there's no skin off anyone's teeth if you don't show up for an appointment, beyond the fact that you are not getting healthcare that you probably need.

In the old days, and in the present day for some practitioners, if you don't show up for an appointment, you got charged for that appointment. It's not a bad business model, and many doctors and other businesses still work this way, out of necessity.

However, most of our insurance contracts do not allow for any punitive charges for no-shows.

When we have tried to talk about this with patients, they say they schedule an appointment to come here for care, but then decide to see another doctor, and getting in touch with us was a challenge. Or else their schedules changed and they were unable to keep that appointment. Or else their dog ate their homework.

Quickly pulling up our schedule and running through the appointments for the previous few weeks, we saw we were seeing several hundred patients a day, and averaging somewhere between 40 and 50 initial visits per day. Our no-show rate for these initial visits was hovering between 30% and 40% just over this time course.

So we decided to try something. Why not invest in a simple phone call the night before to new patients, to remind them that they had an appointment with us to establish primary care, and ask them if they're going to keep the appointment or wished to reschedule?

Yesterday we had 40 initial visits scheduled -- 19 with attendings and 21 with residents. Those phone calls allowed us to confirm 17 appointments, for 13 people we left messages on their voicemail, five had either a full voicemail or an inactive phone number, but interestingly five patients canceled on the basis of that phone call.

So what happened yesterday, of those 35 patients that were left on the schedule, there were only seven who did not show up. This dropped our no-show rate from approximately 35% to 21%. With nothing more than a simple phone call the night before.

And if we consider the 17 reached and 13 messaged (total 30) leading to 28 kept appointments (best case scenario), then this could be viewed as a 93% effective intervention.

But best of all, most importantly, this freed up time, space on the schedule, places for registrars to put a walk-in patient or patient who'd been told a few days earlier that there were no available appointment slots.

Suddenly were able to take care of a few more of our patients that really needed to be seen. Each of those initial visits that were removed from the schedule in advance opened up at minimum two subsequent visit appointment slots.

We've tried sending out postcards in advance, we have a Robo-caller that 48 hours before asks patients to push a button selecting number 1 if they want to keep their appointment or number 2 if they want to cancel or number 3 if they want to reschedule, but in reality we've seen that these things really weren't moving the dial all that much.

This simple phone call, that simple request, to do us the courtesy of telling us whether you're coming, seems to have done more than we could have imagined.

Now, it's probably too onerous to do this for all of the 200 to 300 patients on our schedule every day, but since these initial visits are more of a problem, are longer, and getting them cleaned up frees up a lot of available time slots, it may be worth the ongoing investment.

We're going to continue this project, this mini-pilot, and then drill even deeper, looking to see who and what types of appointments are being canceled, who is not showing up, and who is keeping their appointments. Are there characteristics that we can identify that might help us predict which are the best appointments to try and confirm? Are those appointments made less than 48 hours before the scheduled time more likely to be kept, or more likely to be broken? If the patient is traveling from far away are they more likely to come, or more likely to break the appointment?

But at least for now, seems like a phone call from us getting you to commit to whether you're coming or not seems to really make a difference. Maybe it's the personal touch, maybe they think, "Wow, this practice really cares about me," and maybe that makes it all worthwhile.

Worth the call.

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A Call Worth Making

Amplatzer LAA Occluder Thombosis Reported

The early experience in Europe with the next-generation Amplatzer Amulet has shown signs of device thrombosis in 16.7% of cases after implantation for left atrial appendage (LAA) closure.

That proportion of atrial fibrillation (Afib) patients exhibited signs of device thrombosis on transesophageal echocardiography after 11 weeks on average -- despite continued dual antiplatelet therapy in 95.6% of cases, according to results published online in JACC: Clinical Electrophysiology by Cristoph Hammerstingl, MD, PhD, of University of Bonn in Germany, and colleagues.

"All thrombi were observed within the untrabeculated region of the LAA ostium between the left upper pulmonary vein ridge and the occluder-disc, indicating suboptimal LAA occlusion," the investigators suggested, emphasizing "the need for an optimized post-LAA occlusion anticoagulation regimen, a revised implantation strategy and possibly modified patient selection criteria."

Hammerstingl's team studied the outcomes of 24 Afib patients who were treated with the Amplatzer Amulet system for stroke prevention, which was cleared for use in Europe in 2013 but is not on the U.S. market.

Clots on the Amplatzer Amulet were more likely for those with numerically higher degrees of spontaneous echo contrast grades within the LAA (3.0 versus 1.3), lower LAA peak emptying velocities (17.5 cm/s versus 48.3 cm/s), decreased left ventricular function (39% versus 50%), and a history of LAA thrombi (75.0% versus 19.2%).

Direct-acting oral anticoagulants resolved device thrombi; no strokes or bleeding events were observed at 6 weeks.

Even so, "given the limited patient number included in this analysis, large scale randomized studies are needed to further address this topic and general recommendations cannot be given at this point," commented Hammerstingl and colleagues.

Hammerstingl reported no relevant conflicts of interest.

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Flu Shot Drops CV Risk in Type 2 Diabetes (CME/CE)

Action Points

  • In adults with type 2 diabetes, influenza vaccine reduced the risk of hospitalization for stroke, heart failure, influenza or pneumonia, and the risk of death from any cause, according to this retrospective U.K. study.
  • Note that most flu deaths every year occur in people with pre-existing health conditions such as type 2 diabetes, and this study suggests the vaccine may have substantial benefits for patients with chronic conditions.

Getting a flu shot could help protect against cardiovascular disease in adults with type 2 diabetes, according to a U.K. retrospective cohort study.

Compared with unvaccinated adults with type 2 diabetes, those who got the influenza vaccine were 30% less likely to be hospitalized for stroke (incidence rate ratio [IRR] 0.70; 95% CI 0.53 to 0.91) and 22% less likely to be hospitalized for heart failure (IRR 0.78; 95% CI 0.65 to 0.92), reported a research team led by Eszter Vamos, MD, PhD, of the Imperial College London.

Vaccinated adults with type 2 diabetes were also 15% less likely to be hospitalized for pneumonia or influenza (IRR 0.85; 95% CI 0.74 to 0.99) and 24% less likely to die from any cause (IRR 0.76; 95% CI 0.65 to 0.83), Vamos and colleagues reported in the Canadian Medical Association Journal.

The study also found a non-significant trend toward reduced hospitalizations for acute myocardial infarction in vaccinated adults with type 2 diabetes (IRR 0.81; 95% CI 0.62 to 1.04).

"The health burden caused by seasonal influenza in the general population is substantial and explains much of the excess winter mortality," the researchers wrote. "Influenza infection may accelerate acute thrombotic vascular events, particularly in patients with ischemic heart disease and cerebrovascular disease."

In a statement, Vamos noted that most flu deaths every year occur in people with pre-existing health conditions such as type 2 diabetes. "This study suggests the vaccine may have substantial benefits for patients with long-term conditions. Not only might it help reduce serious illness such as stroke -- and possibly heart attack -- in high-risk individuals, but it may also reduce the risk of death in the flu season."

Co-senior study author Azeem Majeed, MD, also of the Imperial College London, added: "There are few studies looking at the effectiveness of the influenza vaccine in people with diabetes. Although there have been questions surrounding the effectiveness of the flu vaccine in recent years, this research demonstrates a clear advantage for people with diabetes."

"The flu vaccine is available free to these patients from general practitioners and pharmacists, and patients with diabetes should ensure that they receive the vaccine every year."

The retrospective cohort study included 124,503 adults age 18 or older with type 2 diabetes and medical records in the Clinical Practice Research Datalink, a database of primary care medical records in England. The investigators analyzed the data for a 7-year period, from 2003-2004 to 2009-2010.

The study's main outcome measures were hospital admissions for acute myocardial infarction, stroke, heart failure, and pneumonia or influenza, as well as all-cause mortality.

Seasonal vaccine uptake in the cohort ranged from 63% in the 2008-2009 season to 69% in the 2006-2007 season. Vaccine recipients tended to be older, generally more ill, and have more coexisting conditions; however, they also tended to have lower glycated hemoglobin and cholesterol levels.

The investigators adjusted for covariates including age, sex, duration of diabetes, number of comorbid conditions, smoking status, medications, blood pressure, body-mass index, glycated hemoglobin levels, and serum cholesterol levels.

"Additional adjustment for residual confounding did not qualitatively alter the results of the conventional analyses, but attenuated the associations for acute myocardial infarction, pneumonia or influenza, and death, and strengthened the associations for stroke and heart failure," Vamos and colleagues wrote.

A limitation of the study was that it did not evaluate whether medical records on outcomes and comorbidities might be inaccurate or incomplete, the team said.

"This study has shown that people with type 2 diabetes may derive substantial benefits from current vaccines, including protection against hospital admission for some major cardiovascular outcomes. These findings underline the importance of influenza vaccination as part of comprehensive secondary prevention in this high-risk population."

The study was funded by the National Institute of Health Research. None of the researchers reported any financial relationships with industry.

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Flu Shot Drops CV Risk in Type 2 Diabetes (CME/CE)