Just as the federal government is introducing several new programs to promote the recruitment, training, and placement of more primary-care providers, other efforts are being threatened with funding decreases or elimination.

One, the Children’s Hospitals Graduate Medical Education program, distributed $268 million in pediatric training funds to 55 freestanding children’s teaching hospitals in fiscal-year 2012. The program, however, was zeroed out in President Obama’s initial budget proposal last year, and the president’s fiscal-year 2013 budget proposal recommends slashing the program’s annual funding by two-thirds to $88 million.

Kathleen Klink, MD, director of the Division of Medicine and Dentistry in the federal Health Resources and Services Administration, also points to the Title VII Area Health Education Center program as an example of government-funded assistance. The competitive grant process supports innovation and access to care for vulnerable populations, in part by improving the primary-care workforce’s geographic and ethnic distribution. Some of the grantees introduce high school students to medical careers, while others recruit and train minorities or place providers in underserved communities, effectively targeting both ends of the pipeline.

Robert Phillips, MD, MSPH, director of the Washington, D.C.-based Robert Graham Center, a primary-care research center, has high regard for the Title VII program. But making an impact requires a long-term investment, he cautions. “In the states that do this well, like Arkansas and North Carolina, it pays off,” he says. “But they can’t prove it sufficiently to save their budget.” The federal program received $233 million in fiscal-year 2012. Under the president’s fiscal-year 2013 budget proposal, however, the funding is likewise eliminated.

Other programs have debuted in recent legislation. One program, introduced under the Affordable Care Act, provides $230 million over five years to expand residency training slots within ambulatory primary-care settings. Dr. Klink says the Teaching Health Center Graduate Medical Education program, as it is known, has so far supported 22 health centers and 150 enrolled residents. “It’s just the beginning,” she adds.

Another program, the Primary Care Residency Expansion, likewise initiated under the Affordable Care Act, will distribute $167 million to train an estimated 700 primary-care physicians (PCPs), 900 physician assistants, and 600 nurse practitioners and nurse midwives over five years. Glen Stream, president of the American Academy of Family Physicians, recently told The Washington Post, “It’s good, but it’s also a drop in the bucket.”

Bryn Nelson is a freelance medical writer in Seattle.

Just as the federal government is introducing several new programs to promote the recruitment, training, and placement of more primary-care providers, other efforts are being threatened with funding decreases or elimination.

One, the Children’s Hospitals Graduate Medical Education program, distributed $268 million in pediatric training funds to 55 freestanding children’s teaching hospitals in fiscal-year 2012. The program, however, was zeroed out in President Obama’s initial budget proposal last year, and the president’s fiscal-year 2013 budget proposal recommends slashing the program’s annual funding by two-thirds to $88 million.

Kathleen Klink, MD, director of the Division of Medicine and Dentistry in the federal Health Resources and Services Administration, also points to the Title VII Area Health Education Center program as an example of government-funded assistance. The competitive grant process supports innovation and access to care for vulnerable populations, in part by improving the primary-care workforce’s geographic and ethnic distribution. Some of the grantees introduce high school students to medical careers, while others recruit and train minorities or place providers in underserved communities, effectively targeting both ends of the pipeline.

Robert Phillips, MD, MSPH, director of the Washington, D.C.-based Robert Graham Center, a primary-care research center, has high regard for the Title VII program. But making an impact requires a long-term investment, he cautions. “In the states that do this well, like Arkansas and North Carolina, it pays off,” he says. “But they can’t prove it sufficiently to save their budget.” The federal program received $233 million in fiscal-year 2012. Under the president’s fiscal-year 2013 budget proposal, however, the funding is likewise eliminated.

Other programs have debuted in recent legislation. One program, introduced under the Affordable Care Act, provides $230 million over five years to expand residency training slots within ambulatory primary-care settings. Dr. Klink says the Teaching Health Center Graduate Medical Education program, as it is known, has so far supported 22 health centers and 150 enrolled residents. “It’s just the beginning,” she adds.

Another program, the Primary Care Residency Expansion, likewise initiated under the Affordable Care Act, will distribute $167 million to train an estimated 700 primary-care physicians (PCPs), 900 physician assistants, and 600 nurse practitioners and nurse midwives over five years. Glen Stream, president of the American Academy of Family Physicians, recently told The Washington Post, “It’s good, but it’s also a drop in the bucket.”

Bryn Nelson is a freelance medical writer in Seattle.

Just as the federal government is introducing several new programs to promote the recruitment, training, and placement of more primary-care providers, other efforts are being threatened with funding decreases or elimination.

One, the Children’s Hospitals Graduate Medical Education program, distributed $268 million in pediatric training funds to 55 freestanding children’s teaching hospitals in fiscal-year 2012. The program, however, was zeroed out in President Obama’s initial budget proposal last year, and the president’s fiscal-year 2013 budget proposal recommends slashing the program’s annual funding by two-thirds to $88 million.

Kathleen Klink, MD, director of the Division of Medicine and Dentistry in the federal Health Resources and Services Administration, also points to the Title VII Area Health Education Center program as an example of government-funded assistance. The competitive grant process supports innovation and access to care for vulnerable populations, in part by improving the primary-care workforce’s geographic and ethnic distribution. Some of the grantees introduce high school students to medical careers, while others recruit and train minorities or place providers in underserved communities, effectively targeting both ends of the pipeline.

Robert Phillips, MD, MSPH, director of the Washington, D.C.-based Robert Graham Center, a primary-care research center, has high regard for the Title VII program. But making an impact requires a long-term investment, he cautions. “In the states that do this well, like Arkansas and North Carolina, it pays off,” he says. “But they can’t prove it sufficiently to save their budget.” The federal program received $233 million in fiscal-year 2012. Under the president’s fiscal-year 2013 budget proposal, however, the funding is likewise eliminated.

Other programs have debuted in recent legislation. One program, introduced under the Affordable Care Act, provides $230 million over five years to expand residency training slots within ambulatory primary-care settings. Dr. Klink says the Teaching Health Center Graduate Medical Education program, as it is known, has so far supported 22 health centers and 150 enrolled residents. “It’s just the beginning,” she adds.

Another program, the Primary Care Residency Expansion, likewise initiated under the Affordable Care Act, will distribute $167 million to train an estimated 700 primary-care physicians (PCPs), 900 physician assistants, and 600 nurse practitioners and nurse midwives over five years. Glen Stream, president of the American Academy of Family Physicians, recently told The Washington Post, “It’s good, but it’s also a drop in the bucket.”

Bryn Nelson is a freelance medical writer in Seattle.

The permanent implantable cardiac heart pump was developed in the mid-20th century as an outgrowth of the success of heart-lung machines –which provided systemic support during cardiac arrest – required for valve replacement and later coronary bypass surgery.

The challenge to build a totally implantable heart has been the "holy grail" for almost half a century and occurred long before heart failure therapy was high on the agenda of cardiologists. It emerged as a result of the experimental perseverance and genius of Dr. Willem Kolff, who in 1957 was able to totally support dogs using an artificial heart device. Other surgeons, working in separate laboratories – including Dr. Adrian Kantrowitz, Dr. Denton Cooley, and Dr. Robert Jarvik – provided additional research support for the ultimate creation of the artificial heart. However, it wasn’t until 15 years later, in 1982, that Dr. Kolff captured the attention of the medical and lay press by supporting a Seattle dentist suffering from severe heart failure, Dr. Barney Clark, for 112 days with the heart that he and Dr. Jarvik had developed.

Since then, research on the totally implantable heart led to the approval in 2004 the SynCardia temporary Total Artificial Heart as a bridge to transplantation in patients with biventricular failure. In 2001, the first AbioCor totally implantable pump with an external power source was implanted. Initially approved by the FDA as a bridge to transplant for patients with biventricular failure, more recently it has been approved for patients with end stage heart failure as destination therapy.

As work went forward on the totally implantable heart, left ventricular assist devices (LVAD) were also being developed. The pharmacologic support of end stage left ventricular failure with vasodilators and inotropic agents has provided modest temporary benefit; but it has become obvious that we have reached a therapeutic wall with very few new medical options on the horizon. LVADs appeared to be our current best hope of providing additional short- and long-term support for the failing left ventricle.

Dr. E. Stanley Crawford and Dr. Domingo Liotta performed the first LVAD implant in 1966 in a patient who had cardiac arrest after surgery. Since then, there have been a variety of LVADs developed that were initially pulsatile, but now are more commonly continuous flow. Both types of devices are externally powered via drive lines and able to achieve flows up to 10 L/min and are interposed between a left ventricular apical conduit and an ascending aorta conduit. The initial LVADs were pulsatile devices based on the presumption that pulsatile flow was important for systemic perfusion and normal physiology. However, continuous-flow LVAD has proven to be quite compatible with normal organ function and perfusion, and shown better durability and lower mortality and morbidity compared to the pulsatile flow devices. (J. Am. Coll. Cardiol. 2011;57:1890-8).

In addition, as noted in "The Lead," LVADs have shown superiority over medical therapy in patients with advanced heart failure as destination therapy, and the 1-year mortality with continuous flow LVADs now approximates the experience with the 1-year mortality of patients receiving a heart transplant.

The expanded use of LVADs from creating a bridge for transplantation to destination therapy has opened an entirely new opportunity for the use of LVADs in the treatment of acute, but most importantly, chronic heart failure. The limitation of heart transplantation as a function of donor availability together with the limitation of medical therapy for heart failure patients has generated increased interest in LVADs for chronic therapy in patients with end-stage heart failure. The observation that in some patients, particularly those with reversible heart failure like myocarditis, the heart may actually recover during LVAD therapy and allow for its removal, provides a window into future clinical applications (N. Engl. J. Med. 2006:355;1873-84)

The potential for further miniaturization of these devices and the potential for total implantability also open new horizons for LVAD therapy. Total implantability hinges on the ability to apply technology of transcutaneous power source that is already available in a number of electronic implantable devices, including the total heart implant. The resolution of these technical issues will allow for further expansion of the clinical indications for LVAD therapy.

Dr. Goldstein, medical editor of Cardiology News, is a professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

The permanent implantable cardiac heart pump was developed in the mid-20th century as an outgrowth of the success of heart-lung machines –which provided systemic support during cardiac arrest – required for valve replacement and later coronary bypass surgery.

The challenge to build a totally implantable heart has been the "holy grail" for almost half a century and occurred long before heart failure therapy was high on the agenda of cardiologists. It emerged as a result of the experimental perseverance and genius of Dr. Willem Kolff, who in 1957 was able to totally support dogs using an artificial heart device. Other surgeons, working in separate laboratories – including Dr. Adrian Kantrowitz, Dr. Denton Cooley, and Dr. Robert Jarvik – provided additional research support for the ultimate creation of the artificial heart. However, it wasn’t until 15 years later, in 1982, that Dr. Kolff captured the attention of the medical and lay press by supporting a Seattle dentist suffering from severe heart failure, Dr. Barney Clark, for 112 days with the heart that he and Dr. Jarvik had developed.

Since then, research on the totally implantable heart led to the approval in 2004 the SynCardia temporary Total Artificial Heart as a bridge to transplantation in patients with biventricular failure. In 2001, the first AbioCor totally implantable pump with an external power source was implanted. Initially approved by the FDA as a bridge to transplant for patients with biventricular failure, more recently it has been approved for patients with end stage heart failure as destination therapy.

As work went forward on the totally implantable heart, left ventricular assist devices (LVAD) were also being developed. The pharmacologic support of end stage left ventricular failure with vasodilators and inotropic agents has provided modest temporary benefit; but it has become obvious that we have reached a therapeutic wall with very few new medical options on the horizon. LVADs appeared to be our current best hope of providing additional short- and long-term support for the failing left ventricle.

Dr. E. Stanley Crawford and Dr. Domingo Liotta performed the first LVAD implant in 1966 in a patient who had cardiac arrest after surgery. Since then, there have been a variety of LVADs developed that were initially pulsatile, but now are more commonly continuous flow. Both types of devices are externally powered via drive lines and able to achieve flows up to 10 L/min and are interposed between a left ventricular apical conduit and an ascending aorta conduit. The initial LVADs were pulsatile devices based on the presumption that pulsatile flow was important for systemic perfusion and normal physiology. However, continuous-flow LVAD has proven to be quite compatible with normal organ function and perfusion, and shown better durability and lower mortality and morbidity compared to the pulsatile flow devices. (J. Am. Coll. Cardiol. 2011;57:1890-8).

In addition, as noted in "The Lead," LVADs have shown superiority over medical therapy in patients with advanced heart failure as destination therapy, and the 1-year mortality with continuous flow LVADs now approximates the experience with the 1-year mortality of patients receiving a heart transplant.

The expanded use of LVADs from creating a bridge for transplantation to destination therapy has opened an entirely new opportunity for the use of LVADs in the treatment of acute, but most importantly, chronic heart failure. The limitation of heart transplantation as a function of donor availability together with the limitation of medical therapy for heart failure patients has generated increased interest in LVADs for chronic therapy in patients with end-stage heart failure. The observation that in some patients, particularly those with reversible heart failure like myocarditis, the heart may actually recover during LVAD therapy and allow for its removal, provides a window into future clinical applications (N. Engl. J. Med. 2006:355;1873-84)

The potential for further miniaturization of these devices and the potential for total implantability also open new horizons for LVAD therapy. Total implantability hinges on the ability to apply technology of transcutaneous power source that is already available in a number of electronic implantable devices, including the total heart implant. The resolution of these technical issues will allow for further expansion of the clinical indications for LVAD therapy.

Dr. Goldstein, medical editor of Cardiology News, is a professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

The permanent implantable cardiac heart pump was developed in the mid-20th century as an outgrowth of the success of heart-lung machines –which provided systemic support during cardiac arrest – required for valve replacement and later coronary bypass surgery.

The challenge to build a totally implantable heart has been the "holy grail" for almost half a century and occurred long before heart failure therapy was high on the agenda of cardiologists. It emerged as a result of the experimental perseverance and genius of Dr. Willem Kolff, who in 1957 was able to totally support dogs using an artificial heart device. Other surgeons, working in separate laboratories – including Dr. Adrian Kantrowitz, Dr. Denton Cooley, and Dr. Robert Jarvik – provided additional research support for the ultimate creation of the artificial heart. However, it wasn’t until 15 years later, in 1982, that Dr. Kolff captured the attention of the medical and lay press by supporting a Seattle dentist suffering from severe heart failure, Dr. Barney Clark, for 112 days with the heart that he and Dr. Jarvik had developed.

Since then, research on the totally implantable heart led to the approval in 2004 the SynCardia temporary Total Artificial Heart as a bridge to transplantation in patients with biventricular failure. In 2001, the first AbioCor totally implantable pump with an external power source was implanted. Initially approved by the FDA as a bridge to transplant for patients with biventricular failure, more recently it has been approved for patients with end stage heart failure as destination therapy.

As work went forward on the totally implantable heart, left ventricular assist devices (LVAD) were also being developed. The pharmacologic support of end stage left ventricular failure with vasodilators and inotropic agents has provided modest temporary benefit; but it has become obvious that we have reached a therapeutic wall with very few new medical options on the horizon. LVADs appeared to be our current best hope of providing additional short- and long-term support for the failing left ventricle.

Dr. E. Stanley Crawford and Dr. Domingo Liotta performed the first LVAD implant in 1966 in a patient who had cardiac arrest after surgery. Since then, there have been a variety of LVADs developed that were initially pulsatile, but now are more commonly continuous flow. Both types of devices are externally powered via drive lines and able to achieve flows up to 10 L/min and are interposed between a left ventricular apical conduit and an ascending aorta conduit. The initial LVADs were pulsatile devices based on the presumption that pulsatile flow was important for systemic perfusion and normal physiology. However, continuous-flow LVAD has proven to be quite compatible with normal organ function and perfusion, and shown better durability and lower mortality and morbidity compared to the pulsatile flow devices. (J. Am. Coll. Cardiol. 2011;57:1890-8).

In addition, as noted in "The Lead," LVADs have shown superiority over medical therapy in patients with advanced heart failure as destination therapy, and the 1-year mortality with continuous flow LVADs now approximates the experience with the 1-year mortality of patients receiving a heart transplant.

The expanded use of LVADs from creating a bridge for transplantation to destination therapy has opened an entirely new opportunity for the use of LVADs in the treatment of acute, but most importantly, chronic heart failure. The limitation of heart transplantation as a function of donor availability together with the limitation of medical therapy for heart failure patients has generated increased interest in LVADs for chronic therapy in patients with end-stage heart failure. The observation that in some patients, particularly those with reversible heart failure like myocarditis, the heart may actually recover during LVAD therapy and allow for its removal, provides a window into future clinical applications (N. Engl. J. Med. 2006:355;1873-84)

The potential for further miniaturization of these devices and the potential for total implantability also open new horizons for LVAD therapy. Total implantability hinges on the ability to apply technology of transcutaneous power source that is already available in a number of electronic implantable devices, including the total heart implant. The resolution of these technical issues will allow for further expansion of the clinical indications for LVAD therapy.

Dr. Goldstein, medical editor of Cardiology News, is a professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

The recent International AIDS Conference held in Washington highlighted new paradigms in HIV prevention. The biennial meeting brought more than 20,000 attendees together to focus on the political and social – as well as the clinical – aspects of the HIV/AIDS epidemic.

A major discussion topic was the new approach to HIV prevention. Back in the early 1980s, "safe sex" via condoms and abstinence was the focus of prevention strategies. In 2006, the Centers for Disease Control and Prevention recommended routine testing for everyone, in order to broaden the potential for both treatment and prevention (MMWR 2006;55(RR-14);1-17). But in the past 3-4 years, we’ve expanded the concept of prevention in the following three ways:

• Verbal consent. In July, Massachusetts became the 49th state to stop requiring written consent for HIV testing. Other states have done the same over the last 18-24 months. Now the test is explained to the patient, and the patient can simply agree verbally to be tested for HIV, without having to sign a form. We believe that’s a significant step forward, because the requirement for a signature made HIV testing different from any other medical test, which often scared patients and resulted in their reluctance to be tested.

• Treatment as prevention. In August 2011, the landmark HIV Prevention Trial 052 (HPTN 052) showed that early antiviral therapy in HIV-infected individuals who were in serodiscordant sexual relationships reduced transmission to their uninfected partners by 96% (N. Engl. J. Med. 2011;365:493-505). This means that now, part of the clinical decision about starting treatment involves consideration of the patient’s sexual contacts and their protection as well.

There is still concern about the side effects (such as insomnia, gastrointestinal problems, and bone demineralization) of antiretrovirals, as well as uncertainty about long-term adherence when treatment is started early. However, the new data on transmission have shifted the risk/benefit equation in favor of treating more people. In HPTN 052, treatment was started at CD4 counts of 350-550 cells per mcL. Now, many experts advocate starting HIV-infected individuals at T cell counts of 500 or greater, for both improved outcome in the individual and reduction in the risk of HIV transmission.

• Prophylaxis as prevention. With the approval of the combination emtricitabine and tenofovir disoproxil fumarate (Truvada) for pre-exposure prophylaxis, we now have the option of not only treating the HIV-infected partner in serodiscordant couples, but also prophylaxing the uninfected partner in order to prevent transmission.

To do this, the individual must be tested and prove to be HIV negative prior to starting on pre-exposure prophylaxis. Regular testing must also be done every 3-6 months thereafter for as long as the person is taking Truvada. Such testing is necessary because Truvada (which comprises two reverse transcriptase inhibitors) does not sufficiently suppress viral replication by itself, and must be used in combination with antiretrovirals of other classes in the treatment of HIV-infected individuals. If a person were to become HIV infected while taking only Truvada without other classes of antiretrovirals, there is a high risk for the development of resistance as a result of mutations in the replicating virus.

Of course, it could be argued that it is more ethical to treat the person who actually has the disease than to subject an uninfected person to potential antiretroviral toxicity. However, consider the following case I saw recently: A pregnant woman said that her HIV-infected partner was taking his medication, but the partner’s physician said he hadn\'t seen the patient in many months and didn’t know if he was still taking the antiretrovirals. The woman was in labor, and said she’d had sex with the man recently. If there had been time, we would have started her on nevirapine and AZT (zidovudine) prior to delivery. But in this case, she delivered too quickly. So we put the infant on antiretrovirals and tested the mother a month later. She was negative, so we were able to take the infant off the drugs.

There are many examples like this, in which the real world doesn’t quite line up with what we try to achieve through research and guidelines.

Of course, cost is a consideration as well. Insurance will typically cover some or all of the cost ($800-$1,000 per month) for antiretroviral treatment, but it’s too early to know whether that coverage will extend to prophylaxis. I think the cost will limit its use in that capacity, at least until reasonable clinical guidelines are developed to determine which patients would be best targeted with this approach. And just to note: Although Truvada is approved for treating those as young as age 12 years, thus far its use as prophylaxis is restricted to adults aged 18 years and older.

Dr. Pelton is chief of pediatric infectious disease and coordinator of the maternal-child HIV program at Boston Medical Center. He said he had no relevant financial disclosures.

The recent International AIDS Conference held in Washington highlighted new paradigms in HIV prevention. The biennial meeting brought more than 20,000 attendees together to focus on the political and social – as well as the clinical – aspects of the HIV/AIDS epidemic.

A major discussion topic was the new approach to HIV prevention. Back in the early 1980s, "safe sex" via condoms and abstinence was the focus of prevention strategies. In 2006, the Centers for Disease Control and Prevention recommended routine testing for everyone, in order to broaden the potential for both treatment and prevention (MMWR 2006;55(RR-14);1-17). But in the past 3-4 years, we’ve expanded the concept of prevention in the following three ways:

• Verbal consent. In July, Massachusetts became the 49th state to stop requiring written consent for HIV testing. Other states have done the same over the last 18-24 months. Now the test is explained to the patient, and the patient can simply agree verbally to be tested for HIV, without having to sign a form. We believe that’s a significant step forward, because the requirement for a signature made HIV testing different from any other medical test, which often scared patients and resulted in their reluctance to be tested.

• Treatment as prevention. In August 2011, the landmark HIV Prevention Trial 052 (HPTN 052) showed that early antiviral therapy in HIV-infected individuals who were in serodiscordant sexual relationships reduced transmission to their uninfected partners by 96% (N. Engl. J. Med. 2011;365:493-505). This means that now, part of the clinical decision about starting treatment involves consideration of the patient’s sexual contacts and their protection as well.

There is still concern about the side effects (such as insomnia, gastrointestinal problems, and bone demineralization) of antiretrovirals, as well as uncertainty about long-term adherence when treatment is started early. However, the new data on transmission have shifted the risk/benefit equation in favor of treating more people. In HPTN 052, treatment was started at CD4 counts of 350-550 cells per mcL. Now, many experts advocate starting HIV-infected individuals at T cell counts of 500 or greater, for both improved outcome in the individual and reduction in the risk of HIV transmission.

• Prophylaxis as prevention. With the approval of the combination emtricitabine and tenofovir disoproxil fumarate (Truvada) for pre-exposure prophylaxis, we now have the option of not only treating the HIV-infected partner in serodiscordant couples, but also prophylaxing the uninfected partner in order to prevent transmission.

To do this, the individual must be tested and prove to be HIV negative prior to starting on pre-exposure prophylaxis. Regular testing must also be done every 3-6 months thereafter for as long as the person is taking Truvada. Such testing is necessary because Truvada (which comprises two reverse transcriptase inhibitors) does not sufficiently suppress viral replication by itself, and must be used in combination with antiretrovirals of other classes in the treatment of HIV-infected individuals. If a person were to become HIV infected while taking only Truvada without other classes of antiretrovirals, there is a high risk for the development of resistance as a result of mutations in the replicating virus.

Of course, it could be argued that it is more ethical to treat the person who actually has the disease than to subject an uninfected person to potential antiretroviral toxicity. However, consider the following case I saw recently: A pregnant woman said that her HIV-infected partner was taking his medication, but the partner’s physician said he hadn\'t seen the patient in many months and didn’t know if he was still taking the antiretrovirals. The woman was in labor, and said she’d had sex with the man recently. If there had been time, we would have started her on nevirapine and AZT (zidovudine) prior to delivery. But in this case, she delivered too quickly. So we put the infant on antiretrovirals and tested the mother a month later. She was negative, so we were able to take the infant off the drugs.

There are many examples like this, in which the real world doesn’t quite line up with what we try to achieve through research and guidelines.

Of course, cost is a consideration as well. Insurance will typically cover some or all of the cost ($800-$1,000 per month) for antiretroviral treatment, but it’s too early to know whether that coverage will extend to prophylaxis. I think the cost will limit its use in that capacity, at least until reasonable clinical guidelines are developed to determine which patients would be best targeted with this approach. And just to note: Although Truvada is approved for treating those as young as age 12 years, thus far its use as prophylaxis is restricted to adults aged 18 years and older.

Dr. Pelton is chief of pediatric infectious disease and coordinator of the maternal-child HIV program at Boston Medical Center. He said he had no relevant financial disclosures.

The recent International AIDS Conference held in Washington highlighted new paradigms in HIV prevention. The biennial meeting brought more than 20,000 attendees together to focus on the political and social – as well as the clinical – aspects of the HIV/AIDS epidemic.

A major discussion topic was the new approach to HIV prevention. Back in the early 1980s, "safe sex" via condoms and abstinence was the focus of prevention strategies. In 2006, the Centers for Disease Control and Prevention recommended routine testing for everyone, in order to broaden the potential for both treatment and prevention (MMWR 2006;55(RR-14);1-17). But in the past 3-4 years, we’ve expanded the concept of prevention in the following three ways:

• Verbal consent. In July, Massachusetts became the 49th state to stop requiring written consent for HIV testing. Other states have done the same over the last 18-24 months. Now the test is explained to the patient, and the patient can simply agree verbally to be tested for HIV, without having to sign a form. We believe that’s a significant step forward, because the requirement for a signature made HIV testing different from any other medical test, which often scared patients and resulted in their reluctance to be tested.

• Treatment as prevention. In August 2011, the landmark HIV Prevention Trial 052 (HPTN 052) showed that early antiviral therapy in HIV-infected individuals who were in serodiscordant sexual relationships reduced transmission to their uninfected partners by 96% (N. Engl. J. Med. 2011;365:493-505). This means that now, part of the clinical decision about starting treatment involves consideration of the patient’s sexual contacts and their protection as well.

There is still concern about the side effects (such as insomnia, gastrointestinal problems, and bone demineralization) of antiretrovirals, as well as uncertainty about long-term adherence when treatment is started early. However, the new data on transmission have shifted the risk/benefit equation in favor of treating more people. In HPTN 052, treatment was started at CD4 counts of 350-550 cells per mcL. Now, many experts advocate starting HIV-infected individuals at T cell counts of 500 or greater, for both improved outcome in the individual and reduction in the risk of HIV transmission.

• Prophylaxis as prevention. With the approval of the combination emtricitabine and tenofovir disoproxil fumarate (Truvada) for pre-exposure prophylaxis, we now have the option of not only treating the HIV-infected partner in serodiscordant couples, but also prophylaxing the uninfected partner in order to prevent transmission.

To do this, the individual must be tested and prove to be HIV negative prior to starting on pre-exposure prophylaxis. Regular testing must also be done every 3-6 months thereafter for as long as the person is taking Truvada. Such testing is necessary because Truvada (which comprises two reverse transcriptase inhibitors) does not sufficiently suppress viral replication by itself, and must be used in combination with antiretrovirals of other classes in the treatment of HIV-infected individuals. If a person were to become HIV infected while taking only Truvada without other classes of antiretrovirals, there is a high risk for the development of resistance as a result of mutations in the replicating virus.

Of course, it could be argued that it is more ethical to treat the person who actually has the disease than to subject an uninfected person to potential antiretroviral toxicity. However, consider the following case I saw recently: A pregnant woman said that her HIV-infected partner was taking his medication, but the partner’s physician said he hadn\'t seen the patient in many months and didn’t know if he was still taking the antiretrovirals. The woman was in labor, and said she’d had sex with the man recently. If there had been time, we would have started her on nevirapine and AZT (zidovudine) prior to delivery. But in this case, she delivered too quickly. So we put the infant on antiretrovirals and tested the mother a month later. She was negative, so we were able to take the infant off the drugs.

There are many examples like this, in which the real world doesn’t quite line up with what we try to achieve through research and guidelines.

Of course, cost is a consideration as well. Insurance will typically cover some or all of the cost ($800-$1,000 per month) for antiretroviral treatment, but it’s too early to know whether that coverage will extend to prophylaxis. I think the cost will limit its use in that capacity, at least until reasonable clinical guidelines are developed to determine which patients would be best targeted with this approach. And just to note: Although Truvada is approved for treating those as young as age 12 years, thus far its use as prophylaxis is restricted to adults aged 18 years and older.

Dr. Pelton is chief of pediatric infectious disease and coordinator of the maternal-child HIV program at Boston Medical Center. He said he had no relevant financial disclosures.

The Olympic Games have dominated the news in the past week. Part of the appeal is that the athletes seem so normal. They have parents. They go to school. They eat. In fact, there is now a Facebook page called "My Name Is Usain Bolt And I Love Chicken Nuggets."

When we listen to their stories, transfixed as we are by the minutiae of their lives, it is as if, in their "normalcy," we can almost see ourselves; as if by achieving the same degree of masochistic discipline, we might also turn ourselves into the better versions of ourselves that we know are hiding somewhere.

But I think another reason the athletes fascinate us is that there is a meditative, almost spiritual quality to them. It seems to permeate everything, from their training regimens to their very demeanor on that nerve-wracking world stage of Olympic sports.

I ran my first half marathon in March of this year, a few months before my 37th birthday.

There are no elaborate explanations for how I started running. I used to run in college, until I didn’t want to anymore. For a long time, I maintained a sedentary lifestyle. Medical school, marriage, residency, and fellowship provided convenient excuses.

But 3 years ago, a friend was diagnosed with cancer, and soon after that she started running. She started off with just 2 miles every day, and I thought to myself that if she, with her new life-altering reality, can run, shouldn’t I, too, be challenging myself to do something good for myself?

I couldn’t even run 2 miles. I started with half a mile and was done.

Three years later I finally ran a half-marathon. Three years. There are books out there that promise you can go from "couch to [insert whatever goal you want]" in 13 weeks or 26 weeks. It took me 3 years.

The reality is, if you keep at something consistently, you’ll get comfortable with it, and it may take 13 weeks, but it may not. When I encourage patients to exercise, I don’t frame it in terms of achieving a goal in a given time period. Consistency is very frequently just as important as goal setting; there is no need to torture yourself by setting expectations too high.

I don’t particularly enjoy running, but I don’t mind it either. It is inexpensive, does not require a lot of training, and your only competitor is yourself. You decide when you’re done. You can run and chat with friends or listen to music or podcasts. Or you can run with only your internal monologue for company. You can run at the gym and watch your favorite reality show (anyone with a guilty pleasure out there?), or run in your neighborhood and make friends with neighborhood pets.

Another added advantage, for those who might have some expendable income, is that you can run for a cause. The Arthritis Foundation, for example, is a great cause we can all get behind.

And then there’s the proverbial "runner’s high." If this is real (and there is not much evidence that it is), I didn’t get it. Or at least I did not experience what I expected it to feel like. However, I did feel an overwhelming sense of having accomplished something when I ran the half marathon. The last 2 miles of the race course were lined with spectators cheering us on, reaching out to slap hands with us, and holding up signs of people running for various causes. This was an extremely emotional moment for reasons I cannot explain scientifically, but I cried seeing those placards.

After that first half-marathon, I did not run as consistently as I should have, for various reasons (a family emergency; a subsequent soleus injury from, perhaps, stretching too enthusiastically after a run). But I signed up for another half marathon, coming up in 2 weeks, thereby forcing myself to get back to my regimen. And I discovered a wonderful thing when I started up again: My mood improved greatly. I did not even know that I was dysthymic until I started running again.

Haruki Murakami, famous writer of (really strange) Japanese fiction, is also an avid runner and has several marathons under his belt. Not only has he run the Boston Marathon, one of the hardest marathon courses, he has also run the real Marathon, from the site of the battle of Marathon to Athens (which thankfully survived, in contrast to Pheidippides’s unfortunate outcome). Murakami started running later in life as well, and documents this in his book "What I Talk About When I Talk About Running" (New York: Alfred A. Knopf, 2008).

Perhaps my favorite line in the book, and my ultimate reason for running: "Somerset Maugham once said that in each shave lies a philosophy. ... No matter how mundane some action might appear, keep at it long enough and it becomes a contemplative, even meditative act."

And, in fact, that previously mentioned Facebook page, the one called "My Name Is Usain Bolt And I Love Chicken Nuggets," its page description says "like if you love Usain Bolt’s calm relaxed personality."

Dr. Chan practices rheumatology in Pawtucket, R.I.

The Olympic Games have dominated the news in the past week. Part of the appeal is that the athletes seem so normal. They have parents. They go to school. They eat. In fact, there is now a Facebook page called "My Name Is Usain Bolt And I Love Chicken Nuggets."

When we listen to their stories, transfixed as we are by the minutiae of their lives, it is as if, in their "normalcy," we can almost see ourselves; as if by achieving the same degree of masochistic discipline, we might also turn ourselves into the better versions of ourselves that we know are hiding somewhere.

But I think another reason the athletes fascinate us is that there is a meditative, almost spiritual quality to them. It seems to permeate everything, from their training regimens to their very demeanor on that nerve-wracking world stage of Olympic sports.

I ran my first half marathon in March of this year, a few months before my 37th birthday.

There are no elaborate explanations for how I started running. I used to run in college, until I didn’t want to anymore. For a long time, I maintained a sedentary lifestyle. Medical school, marriage, residency, and fellowship provided convenient excuses.

But 3 years ago, a friend was diagnosed with cancer, and soon after that she started running. She started off with just 2 miles every day, and I thought to myself that if she, with her new life-altering reality, can run, shouldn’t I, too, be challenging myself to do something good for myself?

I couldn’t even run 2 miles. I started with half a mile and was done.

Three years later I finally ran a half-marathon. Three years. There are books out there that promise you can go from "couch to [insert whatever goal you want]" in 13 weeks or 26 weeks. It took me 3 years.

The reality is, if you keep at something consistently, you’ll get comfortable with it, and it may take 13 weeks, but it may not. When I encourage patients to exercise, I don’t frame it in terms of achieving a goal in a given time period. Consistency is very frequently just as important as goal setting; there is no need to torture yourself by setting expectations too high.

I don’t particularly enjoy running, but I don’t mind it either. It is inexpensive, does not require a lot of training, and your only competitor is yourself. You decide when you’re done. You can run and chat with friends or listen to music or podcasts. Or you can run with only your internal monologue for company. You can run at the gym and watch your favorite reality show (anyone with a guilty pleasure out there?), or run in your neighborhood and make friends with neighborhood pets.

Another added advantage, for those who might have some expendable income, is that you can run for a cause. The Arthritis Foundation, for example, is a great cause we can all get behind.

And then there’s the proverbial "runner’s high." If this is real (and there is not much evidence that it is), I didn’t get it. Or at least I did not experience what I expected it to feel like. However, I did feel an overwhelming sense of having accomplished something when I ran the half marathon. The last 2 miles of the race course were lined with spectators cheering us on, reaching out to slap hands with us, and holding up signs of people running for various causes. This was an extremely emotional moment for reasons I cannot explain scientifically, but I cried seeing those placards.

After that first half-marathon, I did not run as consistently as I should have, for various reasons (a family emergency; a subsequent soleus injury from, perhaps, stretching too enthusiastically after a run). But I signed up for another half marathon, coming up in 2 weeks, thereby forcing myself to get back to my regimen. And I discovered a wonderful thing when I started up again: My mood improved greatly. I did not even know that I was dysthymic until I started running again.

Haruki Murakami, famous writer of (really strange) Japanese fiction, is also an avid runner and has several marathons under his belt. Not only has he run the Boston Marathon, one of the hardest marathon courses, he has also run the real Marathon, from the site of the battle of Marathon to Athens (which thankfully survived, in contrast to Pheidippides’s unfortunate outcome). Murakami started running later in life as well, and documents this in his book "What I Talk About When I Talk About Running" (New York: Alfred A. Knopf, 2008).

Perhaps my favorite line in the book, and my ultimate reason for running: "Somerset Maugham once said that in each shave lies a philosophy. ... No matter how mundane some action might appear, keep at it long enough and it becomes a contemplative, even meditative act."

And, in fact, that previously mentioned Facebook page, the one called "My Name Is Usain Bolt And I Love Chicken Nuggets," its page description says "like if you love Usain Bolt’s calm relaxed personality."

Dr. Chan practices rheumatology in Pawtucket, R.I.

The Olympic Games have dominated the news in the past week. Part of the appeal is that the athletes seem so normal. They have parents. They go to school. They eat. In fact, there is now a Facebook page called "My Name Is Usain Bolt And I Love Chicken Nuggets."

When we listen to their stories, transfixed as we are by the minutiae of their lives, it is as if, in their "normalcy," we can almost see ourselves; as if by achieving the same degree of masochistic discipline, we might also turn ourselves into the better versions of ourselves that we know are hiding somewhere.

But I think another reason the athletes fascinate us is that there is a meditative, almost spiritual quality to them. It seems to permeate everything, from their training regimens to their very demeanor on that nerve-wracking world stage of Olympic sports.

I ran my first half marathon in March of this year, a few months before my 37th birthday.

There are no elaborate explanations for how I started running. I used to run in college, until I didn’t want to anymore. For a long time, I maintained a sedentary lifestyle. Medical school, marriage, residency, and fellowship provided convenient excuses.

But 3 years ago, a friend was diagnosed with cancer, and soon after that she started running. She started off with just 2 miles every day, and I thought to myself that if she, with her new life-altering reality, can run, shouldn’t I, too, be challenging myself to do something good for myself?

I couldn’t even run 2 miles. I started with half a mile and was done.

Three years later I finally ran a half-marathon. Three years. There are books out there that promise you can go from "couch to [insert whatever goal you want]" in 13 weeks or 26 weeks. It took me 3 years.

The reality is, if you keep at something consistently, you’ll get comfortable with it, and it may take 13 weeks, but it may not. When I encourage patients to exercise, I don’t frame it in terms of achieving a goal in a given time period. Consistency is very frequently just as important as goal setting; there is no need to torture yourself by setting expectations too high.

I don’t particularly enjoy running, but I don’t mind it either. It is inexpensive, does not require a lot of training, and your only competitor is yourself. You decide when you’re done. You can run and chat with friends or listen to music or podcasts. Or you can run with only your internal monologue for company. You can run at the gym and watch your favorite reality show (anyone with a guilty pleasure out there?), or run in your neighborhood and make friends with neighborhood pets.

Another added advantage, for those who might have some expendable income, is that you can run for a cause. The Arthritis Foundation, for example, is a great cause we can all get behind.

And then there’s the proverbial "runner’s high." If this is real (and there is not much evidence that it is), I didn’t get it. Or at least I did not experience what I expected it to feel like. However, I did feel an overwhelming sense of having accomplished something when I ran the half marathon. The last 2 miles of the race course were lined with spectators cheering us on, reaching out to slap hands with us, and holding up signs of people running for various causes. This was an extremely emotional moment for reasons I cannot explain scientifically, but I cried seeing those placards.

After that first half-marathon, I did not run as consistently as I should have, for various reasons (a family emergency; a subsequent soleus injury from, perhaps, stretching too enthusiastically after a run). But I signed up for another half marathon, coming up in 2 weeks, thereby forcing myself to get back to my regimen. And I discovered a wonderful thing when I started up again: My mood improved greatly. I did not even know that I was dysthymic until I started running again.

Haruki Murakami, famous writer of (really strange) Japanese fiction, is also an avid runner and has several marathons under his belt. Not only has he run the Boston Marathon, one of the hardest marathon courses, he has also run the real Marathon, from the site of the battle of Marathon to Athens (which thankfully survived, in contrast to Pheidippides’s unfortunate outcome). Murakami started running later in life as well, and documents this in his book "What I Talk About When I Talk About Running" (New York: Alfred A. Knopf, 2008).

Perhaps my favorite line in the book, and my ultimate reason for running: "Somerset Maugham once said that in each shave lies a philosophy. ... No matter how mundane some action might appear, keep at it long enough and it becomes a contemplative, even meditative act."

And, in fact, that previously mentioned Facebook page, the one called "My Name Is Usain Bolt And I Love Chicken Nuggets," its page description says "like if you love Usain Bolt’s calm relaxed personality."

Dr. Chan practices rheumatology in Pawtucket, R.I.

A paper published in the May/June issue of the Journal of Hospital Medicine shows that a collaborative approach to medication reconciliation ("med rec") appears to both prevent adverse drug events and pay for itself.

The paper, "Nurse-Pharmacist Collaboration on Medication Reconciliation Prevents Potential Harm," found that 225 of 500 surveyed patients had at least one unintended discrepancy in their house medication list (HML) on admission or discharge. And 162 of those patients had a discrepancy ranked on the upper end of the study's risk scale.

However, having nurses and pharmacists work together "allowed many discrepancies to be reconciled before causing harm," the study concluded.

"It absolutely supports the idea that we need to approach medicine as a team game," says hospitalist and lead author Lenny Feldman, MD, FACP, FAAP, SFHM, of John Hopkins School of Medicine in Baltimore. "We can't do this alone, and patients don't do better when we do this alone."

The study noted that it cost $113.64 to find one potentially harmful medication discrepancy. To offset those costs, an institution would have to prevent one discrepancy for every 290 patient encounters. The Johns Hopkins team averted 81 such events, but Dr. Feldman notes that without a control group, it’s difficult to say how many of those potential issues would have been caught at some other point in a patient's stay.

Still, he says, part of the value of a multidisciplinary approach to med rec is that it can help hospitalists improve patient care. By having nurses, physicians, and pharmacists working together, more potential adverse drug events could be prevented, Dr. Feldman says.

"That data-gathering is difficult and time-consuming, and it is not something hospitalists need do on their own," he adds.

A paper published in the May/June issue of the Journal of Hospital Medicine shows that a collaborative approach to medication reconciliation ("med rec") appears to both prevent adverse drug events and pay for itself.

The paper, "Nurse-Pharmacist Collaboration on Medication Reconciliation Prevents Potential Harm," found that 225 of 500 surveyed patients had at least one unintended discrepancy in their house medication list (HML) on admission or discharge. And 162 of those patients had a discrepancy ranked on the upper end of the study's risk scale.

However, having nurses and pharmacists work together "allowed many discrepancies to be reconciled before causing harm," the study concluded.

"It absolutely supports the idea that we need to approach medicine as a team game," says hospitalist and lead author Lenny Feldman, MD, FACP, FAAP, SFHM, of John Hopkins School of Medicine in Baltimore. "We can't do this alone, and patients don't do better when we do this alone."

The study noted that it cost $113.64 to find one potentially harmful medication discrepancy. To offset those costs, an institution would have to prevent one discrepancy for every 290 patient encounters. The Johns Hopkins team averted 81 such events, but Dr. Feldman notes that without a control group, it’s difficult to say how many of those potential issues would have been caught at some other point in a patient's stay.

Still, he says, part of the value of a multidisciplinary approach to med rec is that it can help hospitalists improve patient care. By having nurses, physicians, and pharmacists working together, more potential adverse drug events could be prevented, Dr. Feldman says.

"That data-gathering is difficult and time-consuming, and it is not something hospitalists need do on their own," he adds.

A paper published in the May/June issue of the Journal of Hospital Medicine shows that a collaborative approach to medication reconciliation ("med rec") appears to both prevent adverse drug events and pay for itself.

The paper, "Nurse-Pharmacist Collaboration on Medication Reconciliation Prevents Potential Harm," found that 225 of 500 surveyed patients had at least one unintended discrepancy in their house medication list (HML) on admission or discharge. And 162 of those patients had a discrepancy ranked on the upper end of the study's risk scale.

However, having nurses and pharmacists work together "allowed many discrepancies to be reconciled before causing harm," the study concluded.

"It absolutely supports the idea that we need to approach medicine as a team game," says hospitalist and lead author Lenny Feldman, MD, FACP, FAAP, SFHM, of John Hopkins School of Medicine in Baltimore. "We can't do this alone, and patients don't do better when we do this alone."

The study noted that it cost $113.64 to find one potentially harmful medication discrepancy. To offset those costs, an institution would have to prevent one discrepancy for every 290 patient encounters. The Johns Hopkins team averted 81 such events, but Dr. Feldman notes that without a control group, it’s difficult to say how many of those potential issues would have been caught at some other point in a patient's stay.

Still, he says, part of the value of a multidisciplinary approach to med rec is that it can help hospitalists improve patient care. By having nurses, physicians, and pharmacists working together, more potential adverse drug events could be prevented, Dr. Feldman says.

"That data-gathering is difficult and time-consuming, and it is not something hospitalists need do on their own," he adds.

Clinical question: Is azithromycin use associated with an increased risk of cardiovascular death?

Background: Accumulating evidence suggests that azithromycin might have pro-arrhythmic effects on the heart. Other macrolides, including erythromycin and clarithromycin, can increase the risk for serious ventricular arrhythmias and are associated with an increased risk of sudden cardiac death. The risk of cardiac death associated with azithromycin use is unclear.

Study design: Retrospective cohort study.

Setting: Statewide database of patients enrolled in the Tennessee Medicaid program.

Synopsis: This study matched patients who took a five-day course of azithromycin (347,795 prescriptions) with those who took no antibiotics (1,391,180 control periods). Patients taking azithromycin had an increased risk of cardiovascular death (hazard ratio [HR], 2.88; P<0.001) and death from any cause (HR, 1.85; P=0.002).

Additional control groups of patients taking other antibiotics were included in this study for comparison. Patients who took amoxicillin did not have an increased risk of death. Relative to amoxicillin, azithromycin was associated with a significantly increased risk of cardiovascular death, with an estimated 47 additional cardiovascular deaths per 1 million courses. The risk of cardiovascular death was greater with azithromycin than with ciprofloxacin but did not differ significantly from levofloxacin.

Importantly, patients with factors conferring a high risk of death were excluded from analysis. The increased risk of death did not appear to persist after azithromycin therapy ended. A major limitation of this study was confounding associated with antibiotic use, which the authors attempted to mitigate with the use of multiple control groups.

Bottom line: A five-day treatment course of azithromycin is associated with a small absolute increase in cardiovascular deaths and deaths from any cause.

Citation: Ray WA, Murray KT, Hall K, Arbogast PG, Stein CM. Azithromycin and the risk of cardiovascular death. N Engl J Med. 2012;366:1881-1890.

Clinical question: Is azithromycin use associated with an increased risk of cardiovascular death?

Background: Accumulating evidence suggests that azithromycin might have pro-arrhythmic effects on the heart. Other macrolides, including erythromycin and clarithromycin, can increase the risk for serious ventricular arrhythmias and are associated with an increased risk of sudden cardiac death. The risk of cardiac death associated with azithromycin use is unclear.

Study design: Retrospective cohort study.

Setting: Statewide database of patients enrolled in the Tennessee Medicaid program.

Synopsis: This study matched patients who took a five-day course of azithromycin (347,795 prescriptions) with those who took no antibiotics (1,391,180 control periods). Patients taking azithromycin had an increased risk of cardiovascular death (hazard ratio [HR], 2.88; P<0.001) and death from any cause (HR, 1.85; P=0.002).

Additional control groups of patients taking other antibiotics were included in this study for comparison. Patients who took amoxicillin did not have an increased risk of death. Relative to amoxicillin, azithromycin was associated with a significantly increased risk of cardiovascular death, with an estimated 47 additional cardiovascular deaths per 1 million courses. The risk of cardiovascular death was greater with azithromycin than with ciprofloxacin but did not differ significantly from levofloxacin.

Importantly, patients with factors conferring a high risk of death were excluded from analysis. The increased risk of death did not appear to persist after azithromycin therapy ended. A major limitation of this study was confounding associated with antibiotic use, which the authors attempted to mitigate with the use of multiple control groups.

Bottom line: A five-day treatment course of azithromycin is associated with a small absolute increase in cardiovascular deaths and deaths from any cause.

Citation: Ray WA, Murray KT, Hall K, Arbogast PG, Stein CM. Azithromycin and the risk of cardiovascular death. N Engl J Med. 2012;366:1881-1890.

Clinical question: Is azithromycin use associated with an increased risk of cardiovascular death?

Background: Accumulating evidence suggests that azithromycin might have pro-arrhythmic effects on the heart. Other macrolides, including erythromycin and clarithromycin, can increase the risk for serious ventricular arrhythmias and are associated with an increased risk of sudden cardiac death. The risk of cardiac death associated with azithromycin use is unclear.

Study design: Retrospective cohort study.

Setting: Statewide database of patients enrolled in the Tennessee Medicaid program.

Synopsis: This study matched patients who took a five-day course of azithromycin (347,795 prescriptions) with those who took no antibiotics (1,391,180 control periods). Patients taking azithromycin had an increased risk of cardiovascular death (hazard ratio [HR], 2.88; P<0.001) and death from any cause (HR, 1.85; P=0.002).

Additional control groups of patients taking other antibiotics were included in this study for comparison. Patients who took amoxicillin did not have an increased risk of death. Relative to amoxicillin, azithromycin was associated with a significantly increased risk of cardiovascular death, with an estimated 47 additional cardiovascular deaths per 1 million courses. The risk of cardiovascular death was greater with azithromycin than with ciprofloxacin but did not differ significantly from levofloxacin.

Importantly, patients with factors conferring a high risk of death were excluded from analysis. The increased risk of death did not appear to persist after azithromycin therapy ended. A major limitation of this study was confounding associated with antibiotic use, which the authors attempted to mitigate with the use of multiple control groups.

Bottom line: A five-day treatment course of azithromycin is associated with a small absolute increase in cardiovascular deaths and deaths from any cause.

Citation: Ray WA, Murray KT, Hall K, Arbogast PG, Stein CM. Azithromycin and the risk of cardiovascular death. N Engl J Med. 2012;366:1881-1890.

Click here to listen to Dr. Huang

Click here to listen to Dr. Huang

Click here to listen to Dr. Huang

Abbott announced on August 7 that the U.S. Food and Drug Administration (FDA) approved the Omnilink Elite® Vascular Balloon-Expandable Stent System for the treatment of iliac artery disease, The FDA approval was based on positive clinical data from the MOBILITY (Omnilink Elite or Absolute Pro® Stent Used in the Iliac Artery) study.

The Omnilink Elite stent is based on the Multi-Link stent design with a cobalt chromium alloy. According to Abbott, cobalt chromium is stronger and more radiopaque than stainless steel, making the stent easy to see under X-ray while maintaining thin, flexible struts. These features are designed to enable the easier navigation of the stent in complex anatomy and to facilitate accurate placement of the device.

"At nine months, patients experienced significant improvements in walking distance and speed, and were able to climb more stairs than they could before treatment,\" said Dr. Tony S. Das, director, Peripheral Vascular Interventions, Presbyterian Heart Institute in Dallas, Texas, and co-principal investigator of the MOBILITY study.

The MOBILITY study was a prospective, non-randomized, two-arm, multi-center study conducted at 48 centers in the United States to evaluate the effectiveness of two Abbott stents – Absolute Pro Vascular Self-Expanding Stent System and Omnilink Elite Vascular Balloon-Expandable Stent System – in patients who had iliac artery disease with intermittent claudication or critical limb ischemia, including complex lesions. The study did not exclude patients with highly calcified lesions or severe peripheral vascular disease. Of the 304 patients enrolled in the study, 151 were treated with Absolute Pro and 153 were treated with Omnilink Elite.

The study met its primary endpoint: a nine-month major adverse event rate of 6.1 percent for patients treated with Absolute Pro and 5.4 percent for patients treated with Omnilink Elite. Walking ability significantly improved for patients in both arms of the study, according to the press release from Abbot.

Abbott announced on August 7 that the U.S. Food and Drug Administration (FDA) approved the Omnilink Elite® Vascular Balloon-Expandable Stent System for the treatment of iliac artery disease, The FDA approval was based on positive clinical data from the MOBILITY (Omnilink Elite or Absolute Pro® Stent Used in the Iliac Artery) study.

The Omnilink Elite stent is based on the Multi-Link stent design with a cobalt chromium alloy. According to Abbott, cobalt chromium is stronger and more radiopaque than stainless steel, making the stent easy to see under X-ray while maintaining thin, flexible struts. These features are designed to enable the easier navigation of the stent in complex anatomy and to facilitate accurate placement of the device.

"At nine months, patients experienced significant improvements in walking distance and speed, and were able to climb more stairs than they could before treatment,\" said Dr. Tony S. Das, director, Peripheral Vascular Interventions, Presbyterian Heart Institute in Dallas, Texas, and co-principal investigator of the MOBILITY study.

The MOBILITY study was a prospective, non-randomized, two-arm, multi-center study conducted at 48 centers in the United States to evaluate the effectiveness of two Abbott stents – Absolute Pro Vascular Self-Expanding Stent System and Omnilink Elite Vascular Balloon-Expandable Stent System – in patients who had iliac artery disease with intermittent claudication or critical limb ischemia, including complex lesions. The study did not exclude patients with highly calcified lesions or severe peripheral vascular disease. Of the 304 patients enrolled in the study, 151 were treated with Absolute Pro and 153 were treated with Omnilink Elite.

The study met its primary endpoint: a nine-month major adverse event rate of 6.1 percent for patients treated with Absolute Pro and 5.4 percent for patients treated with Omnilink Elite. Walking ability significantly improved for patients in both arms of the study, according to the press release from Abbot.

Abbott announced on August 7 that the U.S. Food and Drug Administration (FDA) approved the Omnilink Elite® Vascular Balloon-Expandable Stent System for the treatment of iliac artery disease, The FDA approval was based on positive clinical data from the MOBILITY (Omnilink Elite or Absolute Pro® Stent Used in the Iliac Artery) study.

The Omnilink Elite stent is based on the Multi-Link stent design with a cobalt chromium alloy. According to Abbott, cobalt chromium is stronger and more radiopaque than stainless steel, making the stent easy to see under X-ray while maintaining thin, flexible struts. These features are designed to enable the easier navigation of the stent in complex anatomy and to facilitate accurate placement of the device.

"At nine months, patients experienced significant improvements in walking distance and speed, and were able to climb more stairs than they could before treatment,\" said Dr. Tony S. Das, director, Peripheral Vascular Interventions, Presbyterian Heart Institute in Dallas, Texas, and co-principal investigator of the MOBILITY study.

The MOBILITY study was a prospective, non-randomized, two-arm, multi-center study conducted at 48 centers in the United States to evaluate the effectiveness of two Abbott stents – Absolute Pro Vascular Self-Expanding Stent System and Omnilink Elite Vascular Balloon-Expandable Stent System – in patients who had iliac artery disease with intermittent claudication or critical limb ischemia, including complex lesions. The study did not exclude patients with highly calcified lesions or severe peripheral vascular disease. Of the 304 patients enrolled in the study, 151 were treated with Absolute Pro and 153 were treated with Omnilink Elite.

The study met its primary endpoint: a nine-month major adverse event rate of 6.1 percent for patients treated with Absolute Pro and 5.4 percent for patients treated with Omnilink Elite. Walking ability significantly improved for patients in both arms of the study, according to the press release from Abbot.