Advertisement
Examining Trends in HF Hospitalizations

Examining Trends in HF Hospitalizations

According to recent estimates, heart failure (HF) is one of the most common reasons for hospital admission in the United States. Efforts have been made to reduce the number of hospitalizations related to HF, and several therapies have been developed over the last 20 years that have been shown to reduce disease-related hospitalizations. Furthermore, quality improvement initiatives are being developed and launched to ensure the appropriate delivery of evidence-based therapies in HF. CMS has been reporting on the quality of care and rate of HF rehospitalization for hospitals in an effort to encourage quality improvement initiatives. “While previous analyses have shown that rates of HF hospitalizations increased in the 1980s and 1990s, more recent CMS data indicate that hospitalizations with a primary diagnosis of HF in the elderly declined over the last decade,” explains Saul B. Blecker, MD, MHS. “These findings have been attributed to improvements in treatment and reductions in prevalent HF. However, most hospitalizations involving these patients are for reasons other than acute HF.” Gaining Perspective on Secondary HF Hospitalizations Quality improvement initiatives typically target only hospitalizations with a primary diagnosis of HF. As a result, these initiatives may not affect comorbid conditions that are associated with HF but are not directly caused by it. “Characterizing trends in hospitalizations with HF as a primary or secondary diagnosis can help clinicians further understand and recognize the role of cardiac disease and non-cardiac conditions,” Dr. Blecker says. “It can also help educate future initiatives to improve quality improvement initiatives.” A study by Dr. Blecker and colleagues published in the Journal of the American College of Cardiology evaluated trends in...
A Closer Look at Statin Discontinuation

A Closer Look at Statin Discontinuation

According to current guideline recommendations, once patients are started on statins, they’re virtually mandated to continue taking them for the rest of their lives. This can represent a serious challenge for many patients. Many patients believe the symptoms they experience are the result of taking statins, but the clinical trials suggest the incidence of statin-related side effects is similar to placebo. Analyzing Statin Discontinuation Causes In a study published in Annals of Internal Medicine, my colleagues and I investigated the reasons for statin discontinuation and the role of statin-related events in routine care. The 8-year analysis involved more than 100,000 pa­tients who were prescribed a statin. More than half (53.1%) stopped taking a statin at least once during the course of treatment. Just over two-thirds had a reason documented in their records for statin discontinuation, with the most common reason listed as “no longer necessary.” Other reasons included cost, a change of statin requested by an insurance company, switching to another drug, or patients not wanting to take a statin. Importantly, 17.4% of study participants had a documented statin-related event during the study, the most common being myalgia or myopathy. Of those with these events, most stopped taking the statin temporarily. More than half who stopped therapy were rechallenged with a statin over the following 12 months. Of these patients, 92.2% were taking a statin 12 months after the original statin-related event. For those who stopped taking statins for reasons other than a statin-related event, about two-thirds had another statin prescription over the following 12 months; most of these were for a different statin. Of those who restarted, 98.0%...
Compliance

Compliance

“Why aren’t you taking your cholesterol medication?”  I asked the woman.  With the coronary disease I diagnosed a year ago, my discovery that she had not taken her medication was very troubling. “It made me tired,” she replied matter-of-factly.  ”And besides, the cardiologist said the stress test was negative, so my heart is fine!” I ordered the stress test after her heart calcium score was significantly elevated, revealing significant atherosclerosis.  She totally misunderstood the results, and I needed to fix that problem.  So I pulled out my secret weapon: a good analogy. “The purpose of the calcium score test was to see if you had termites in your home”  I explained.  ”I found them.  The negative stress test just said that the termites hadn’t eaten through your walls.  It’s good news that your walls aren’t falling down, but they will if we don’t stop the termites.” Her eyes opened wide comprehension: the termites were eating her walls.  She was living on borrowed time. “Would you take a medication if it didn’t have side effects?” I asked. She quickly nodded.  Of course she would.  From now on she would be a compliant patient. Compliance is good.  Noncompliance is bad.  It’s something I learned very early in my training: patients who do what their doctors say are compliant (good), and those who don’t follow instructions are noncompliant (bad).  If you are lucky as a doctor, you have compliant patients.  They are the best kind.   They obey their doctors.  They are submissive.  Noncompliant patients are bad; they are a bunch of deadbeats. Please hold your nasty comments; I don’t really believe my patients...
How ED Crowding Affects Outcomes

How ED Crowding Affects Outcomes

Previous studies have sought to establish a definitive relationship between ED crowding and subsequent mortality, but these investigations often have shortcomings, such as small hospital samples and a lack of adjustment for comorbidities, primary illness diagnoses, and potential hospital-level confounders. In addition, many of these analyses restrict data to specific subgroups, such as patients with acute myocardial infarction, trauma, pneumonia, or critical illness. New Evidence on Inpatient Death In an effort to address these limitations, my colleagues and I conducted a study to assess the effect of ED crowding on patient outcomes. Our study, which was published in the Annals of Emergency Medicine, looked at nearly 1 million admissions through EDs across California. Daily ambulance diversion was the measure of ED crowding. According to our results, ED crowding was associated with 5% greater odds of inpatient death. Patients who were admitted on days with high ED crowding had 0.8% longer hospital stays and 1.0% increased costs per admission. Periods of high ED crowding were associated with 300 excess inpatient deaths, 6,200 hospital days, and $17 million in costs. These findings persisted after extensively adjusting for patient demographics, comorbidities, and primary discharge diagnosis. Although other analyses have reported similar associations, our study generalizes these findings to a larger sample of hospitals and unselected admissions from the ED. ED Crowding: A Marker of Poor Quality Care Our findings support the notion that ED crowding is a marker of poor quality of care. Unfortunately, factors underlying the issue of ED crowding are likely to become worse. As Americans are living longer than ever, this has increased the volume, complexity, and acuity of...
Innovative Techniques to Address Bariatric Surgery Complications

Innovative Techniques to Address Bariatric Surgery Complications

Millions of patients find it extremely difficult to achieve durable weight loss without medical intervention. Many opt for bariatric surgery to achieve a healthier weight, but up to 30% of patients who undergo these procedures regain weight. There are a variety of reasons for regaining weight after bariatric surgery. In some cases, there may be dysfunction of the stomach pouch that was surgically created. Others may experience dangerous and painful complications, such as fistulas and leaks. Patients who experience these types of post-bariatric surgical problems are reluctant to undergo another invasive procedure to correct the issues. Alternatives to Bariatric Surgery Complications In recent years, an important treatment alternative has emerged for this patient population thanks to advanced endoscopy. Using this approach, we can address post-bariatric surgery problems like fistulas, ulcers, and lap band erosion with less invasive endoscopic surgery techniques. Advanced endoscopy enables clinicians to: Locate and repair defects. Close leaks and fistulas with endoscopic sutures. Reduce patient discomfort. Reduce postoperative recovery time. Help re-establish proper pouch dimensions. Help stop weight gain and aid in weight loss. With advanced endoscopy, we’re able to perform endoscopic pouch reduction surgery to restore the stomach pouch to its original post-surgery dimensions and halt weight gain. These procedures help patients experience less postoperative discomfort, as there is minimal to no blood loss, no external cuts, and no need to re-route the existing anatomy. This results in shorter hospital recovery times, with most patients going home the same day. Advanced endoscopic techniques can be beneficial to manage complications after bariatric surgery. These include repairing and/or addressing gastric pouch dysfunction/defects, esophageal and gastric fistulas, sleeve...
Functional Outcomes After Treatment for Prostate Cancer

Functional Outcomes After Treatment for Prostate Cancer

Studies have shown that patients with localized prostate cancer have favorable long-term overall survival rates and cancer-specific survival regardless of the treatment that is selected. Few prospective, randomized trials have looked at differences in survival outcomes between radical prostatectomy and external-beam radiation therapy. As a result, the decision-making process for clinicians and patients shifts. Treatment decisions become more about predicting functional outcome than about survival. Investigations with short-term and intermediate follow-up have identified incremental differences in functional outcome between patients undergoing prostatectomy and those receiving radiotherapy. While much is known about what happens the first several years after treatment, less is known about outcomes extending beyond 5 years. “Most patients live 10 to 20 years after treatment,” says David F. Penson, MD, MPH. “A careful evaluation of long-term functional outcomes can help us better understand the experience of men living with a diagnosis of prostate cancer.” Long-Term Function of Prostatectomy Vs Radiotherapy In a study published in the New England Journal of Medicine, Dr. Penson and colleagues prospectively compared urinary, sexual, and bowel function in 1,655 men with clinically localized prostate cancer, 1,164 of whom underwent prostatectomy, while 491 received radiotherapy. The study team also examined the extent to which men were bothered by declines in function at 15 years after prostatectomy or radiotherapy. Most of the men were in their 60s when they first received treatment. According to the results, men receiving prostatectomy were significantly more likely than those in the radiotherapy group to report urinary leakage and erectile dysfunction at 2 and 5 years after treatment. However, these problems increased in both groups over time, including 15...

Who’s At Fault If a Patient Doesn’t Follow Up?

In keeping with the mindset of most Americans today, the answer to the question posed in the title of this post is, “the doctor.” American Medical News reports that “Medical liability experts say missed appointments and failures to follow up pose some of the greatest legal risks for physicians.” And these problems are increasing with more hand-offs and more people being involved with the “team” taking care of the patient. The article began with an anecdote about a patient who needed a cardiac catheterization but wanted to think about it. He went home and died. The family sued and said the doctor did not “tell them how critical it was for him to have the procedure.” The doctor did not document the conversation about the need for the procedure in the chart and lost the case. Failure to make sure that appropriate follow-up was done and failure to contact patients about missed appointments are among the most frequent deficiencies cited as big legal risks for physicians. Get this. “A common claim in lawsuits that involve missed appointments is lack of informed refusal. The allegation arises when patients admit they declined or ignored treatment recommendations, but allege they were not adequately educated about the medical risks of their decision.” Lack of informed refusal. That’s a new one for me. The article says that adequate documentation by the doctor will support his version of events. What is to prevent any patient, who is explained any plan or procedure and declines, from simply saying, “I didn’t realize how serious this was”? And where does this end? Should a doctor call all her...
A Look at Recidivism in COPD Management

A Look at Recidivism in COPD Management

COPD is a group of progressively debilitating respiratory conditions, including emphysema and chronic bronchitis, and it ranks as the third leading cause of death in the United States, according to the CDC. About 16 million Americans are currently diagnosed with COPD, but another 14 million or more remain undiagnosed. In addition, COPD accounts for nearly 2 million ED visits each year, but much of this data is confounded by asthma admissions. “COPD patients who require ED attention or hospitalization are those with the most severe disease,” explains Reynold A. Panettieri, Jr., MD. “Furthermore, hospitalization and ED visits for COPD are more often clustered in the winter. They are associated with exposure to viruses and bacterial pathogens.” People aged 50 and older are more likely than others to get COPD, but the damage starts years before these individuals are diagnosed and can progress even after smoking cessation. Since the disease occurs and is diagnosed later in life, the risk of COPD is especially high for patients older than 45 with a smoking history. Healthcare Utilization & Readmission for COPD Most patients with diagnosed COPD report that symptoms of their disease impair their quality of life, but only about half take at least one daily medication for COPD. The healthcare utilization rate for COPD patients is also substantial. About one in five COPD patients visits an ED or is admitted to a hospital for care within a year. “The bottom line is that patients, providers, and the healthcare system cannot afford recidivism for COPD hospitalization.” Recidivism in healthcare has been defined as the tendency by ill patients to relapse or return...
The Impact of Hospitalist Workload on Patient Care

The Impact of Hospitalist Workload on Patient Care

The workload for hospitalists has increased significantly, thanks in part to increased residency work-hour restrictions, greater access for patients to healthcare, and a general focus among hospitals to improve patient volume and throughput. Further complicating matters is that hospitalists are adept at functioning in different hospital environments and capacities, which has increased their use and workload. To assess the impact of workload on patient safety and quality measures, my colleagues and I conducted a national survey of hospitalists that was published in JAMA Internal Medicine. Hospitalists Reporting Unsafe Workloads According to our results, about 40% of hospitalists reported that their workload exceeded safe levels (more than 15 patients per shift) at least monthly, and 36% said it happened more than once a week. Approximately one-quarter of respondents reported that excessive workload delayed the admission or discharge of patients until the next shift or hospital day, which in turn impacted length of stay and workloads among ED providers. In addition, 25% of respondents reported that they failed to fully discuss treatment options or to answer questions from patients and family members, and 19% said patient satisfaction soured due to unsafe workloads. Furthermore, 18% reported that it adversely affected patient handoffs. More than 20% of physicians reported that their average workload likely contributed to patient transfers, morbidity, or even mortality. High Hospital Admissions Taking a Toll High levels of admissions and unexpected health changes among admitted patients can dramatically affect the workload of hospitalists and ED physicians. In turn, these changes can increase lengths of stay and clog processes of care in the ED. To overcome these issues, a mutual understanding...
Specialist Referral Roulette

Specialist Referral Roulette

“I want you to get me a new doctor,” she told me, a bit of disgust coming out in the sharp tone in her voice. “What happened?” I asked. “He asked me if I was nauseated, and I told him no, I was just vomiting.  Then he asked if I was feeling pain in my stomach, and again I told him no, it was just vomiting.  He then told his nurse to write down nausea and abdominal pain.  When I objected, he just gave me a bad expression and walked out of the room.” I tried to come up with a plausible explanation for his action, but there was none.  ”I’m sorry,” I said.  ”There are a lot of people who come back from him feeling really happy and listened-to.  It’s obvious that you saw none of that from him.” “I asked his nurses if he aways acted this way,” she continued, “and they just shrugged and told me that he sometimes did.” “I’m happy to send you to a different doctor,” I said, shaking my head. I hate it when this happens. I send people to specialists for two main reasons: I am not qualified to offer the treatment or procedures the specialist can give. The specialist has far more experience with the problem, and so can offer better care. But there is one thing I am not doing: giving over care of the patient.  Patients are more than just diseases or problems to be solved.  Patients are more than a single organ system.  It is my job as a PCP to orchestrate and oversee the care my...
Enhancing Access to tPA for Stroke

Enhancing Access to tPA for Stroke

Studies have shown that using tPA within 3 hours of stroke onset raises the chances for good outcomes in some patients who suffer one of these events, but this treatment is often underused. Although more than 11% of patients with stroke are eligible to receive tPA, studies show that 2% or less receive these important thrombolytics. Eliminating delays in the recognition and response to signs and symptoms of stroke could increase the proportion of tPA-eligible patients to as high as 24%. Designated stroke centers have improved the delivery of tPA, but less than one-quarter of patients in the United States live within 30 minutes of one of these centers. “The importance of early treatment for stroke cannot be overstated,” says Phillip A. Scott, MD. “Because of the short treatment window in which tPA can be given, many patients seek treatment at local community hospitals.” Unfortunately, neurologists are frequently unavailable for acute stroke care in community EDs. Furthermore, ED physicians often are hesitant to use thrombolytics due to time and resource issues or lack of experience with tPA. The INSTINCT Trial Few randomized controlled trials have tested practical interventions to increase tPA delivery for stroke patients in community hospitals. Identifying successful interventions could improve stroke care and serve as a model to enhance the adoption of other high-risk treatments. In an effort to increase tPA use in community hospital settings, the Increasing Stroke Treatment through Interventional Change Tactics (INSTINCT) trial was initiated in Michigan. The goal of INSTINCT was to assess the ability of a multilevel, barrier assessment-interactive educational intervention to increase tPA use in community hospitals, explains Dr. Scott,...
Taking a Closer Look at Attending Rounds

Taking a Closer Look at Attending Rounds

Attending rounds has been a long-standing practice for internal medicine physicians, residents, and medical students to direct patient care, communicate with patients and families, and advance their medical education. The model of having senior physicians, trainees, and patients interact has existed for decades, but the features of these rounds have evolved dramatically in more recent years, explains Chad Stickrath, MD. “The format has shifted away from being conducted mostly at the bedside to taking place more frequently in conference rooms and hallways.” The Accreditation Council for Graduate Medical Education (ACGME) program requires that patient-based teaching include direct interaction between residents and attending physicians, bedside teaching, discussion of pathophysiology, and the use of current evidence in diagnostic and therapeutic decisions. The ACGME does not, however, provide additional specific guidelines on how to accomplish these requirements. The structure and content of contemporary attending rounds has not been well described in studies. “Some educators have expressed concerns about how patient communication and physical examination skills are being deemphasized,” adds Dr. Stickrath. Are Patient Rounds Meeting Goals? In a study published in JAMA Internal Medicine, Dr. Stickrath and colleagues sought to determine if current methods of patient rounds are meeting patient care and educational goals. The cross-sectional observational analysis was conducted at four teaching hospitals, involving 56 attending physicians and 279 trainees who treated 807 general medicine inpatients. The study group performed detailed observations of 90 rounds over a course of nearly 2 years.   According to results, most rounds consisted of an attending physician and several resident and student trainees, speaking with a median of nine patients during the course of about...
Group Education & Older Diabetics

Group Education & Older Diabetics

Studies suggest that group-based diabetes education efforts can improve short- and long-term disease control among younger patients, but few analyses have explored the effect of these programs on older adults. Unfortunately, older adults are often underrepresented in diabetes edu­cation interventions because subtle changes in functional, cognitive, and psychosocial status can affect diabetes self-care. Many clinicians are reluctant to refer older patients to group education because they believe they may require more individual attention. In a secondary analysis study published in Diabetes Care, we examined whether community-dwelling older adults aged 60 to 75 with type 1 or type 2 diabetes would benefit from self-management interventions similarly to younger and middle-aged adults. We also tested if older adults benefited from group versus individual self-management interventions. Comparing Benefits of Diabetes Intervention In our analysis, patients were randomly assigned to one of three self-management interventions from diabetes educators that were delivered separately to those with type 1 or type 2 disease: 1. Highly structured group: Five group sessions were conducted over 6 weeks. Patients were taught how food, medication, and exercise affected A1C and actions they could take when levels were out of range. Between classes, patients set daily goals and practiced problem solving 2. Attention control group: Five group sessions were conducted over 6 weeks, but the sessions followed a manual-based standard diabetes education program. 3. Control group: One-on-one sessions were delivered for 6 months. During sessions, patients could receive any type of information they requested. According to our results, A1C levels improved equally in the older and younger groups at 3, 6, and 12 months with all interventions and for those...

Can Dreaming About Exercising Lead to Weight Loss?

I was about to write one of my infrequent but famous spoof articles, and the subject was going to be losing weight by dreaming about exercising. For fun, I decided to search the Internet to see if anyone else might have had the same notion. To my surprise, they had. Here’s what I discovered: To be able to exercise while asleep, one must be able to have a so-called “lucid dream,” which is described as being aware that one is dreaming while dreaming. According to a paper by Daniel Erlacher, 51% of 919 Germans who were questioned said they had experienced at least one lucid dream. Apparently, some lucid dreamers can also control the content of their dreams. In the Harvard Business Review, Erlacher says, “In one experiment we asked participants to dream about doing deep knee bends. Even though their bodies weren’t moving, their heart and respiration rates increased slightly as if they were exercising.” We need to find a group of overweight people who are also lucid dreamers. Finding the former should be easy. If there aren’t enough of the latter, subjects can be taught how to have lucid dreams in only 16 simple steps. After explaining what a triathlon is, we tell them to dream about doing one every night for the next, say, 10 years. Would that work? Probably not. A more scientific discussion of whether calories are actually burned while dreaming appeared in a blog called “The Naked Scientists.” Someone asked whether running in a dream burned calories. They explained that while brain metabolic activity increases and a few calories are expended while dreaming,...
Decreasing 30-Day Morbidity Rates in Surgery Patients

Decreasing 30-Day Morbidity Rates in Surgery Patients

Numerous studies have demonstrated that 30-day postoperative complications resulting from unintended harm adversely affect patients and their families and increase institutional healthcare costs. Several medical societies and associations have developed simple, inexpensive surgical checklists to help reduce postoperative morbidity and mortality. These readily available checklists are capable of shifting the hierarchical culture of the operating room (OR). Although there is evidence that these tools enhance communication and reduce postoperative complications and death, studies suggest they are not used universally. In April 2010, the Association of Perioperative Registered Nurses (AORN) unveiled a comprehensive surgical checklist that incorporates mandated clinical practices required by the World Health Organization, the Joint Commission, and CMS. The one-page document compartmentalizes information to make documentation during the perioperative process easier. It also includes a debriefing component that encourages the OR team to acknowledge concerns and the plan of care for patients to ensure they are safely transitioned to recovery room staff. Taking a Closer Look In the Journal of the American College of Surgeons, Lindsay A. Bliss, MD, and colleagues had a study published that sought to determine if combining a structured, team communications training curriculum with a comprehensive, standardized surgical checklist could reduce 30-day morbidity for patients. The communications training included three 60-minute sessions, with topics such as differences between introverts and extroverts, effective dialogue among all OR personnel, and how to use the AORN’s surgical checklist. High-risk procedures included in the National Surgical Quality Improvement Program database were analyzed for postoperative morbidity. These operations served as the baseline group because the teams carrying out these procedures did not participate in communications training or use...
Wide Variation in Blood Transfusion Use

Wide Variation in Blood Transfusion Use

Current clinical guidelines from three medical societies suggest that the hemoglobin threshold for blood transfusions during surgery should be 7 g/dl or 8 g/dl. These guidelines also note that patients don’t need a transfusion when hemoglobin levels are above 10 g/dl. However, when hemoglobin levels fall between these thresholds, there is little consensus on the best course of action. Although four landmark studies published over the past 5 years suggest that it’s safe to wait until hemoglobin levels fall to 7 g/dl or 8 g/dl before transfusing, wide variation and excessive use of blood transfusions have been reported. Advances in viral testing in recent years have made blood transfusion safer, but risks still exist for these patients, including lung injury, immune suppression, and viral transmission. Blood is also in scarce supply and expensive. Wide Variation of Hemoglobin Thresholds In an issue of Anesthesiology, my colleagues and I had a study published that sought to confirm the wide range of hemoglobin thresholds used by surgeons and anesthesiologists. Over 18 months, we collected data on more than 48,000 surgical patients at Johns Hopkins Hospital. Within the institution, there was a variation of up to 3 g/dl in hemoglobin thresholds among surgeons and anesthesiologists, when compared with their peers. Virtually all providers used thresholds above the ones recommended in guidelines, and none used thresholds below the recommended range. Surprisingly, sicker patients—generally those under-going cardiac surgeries—had the lowest hemoglobin thresholds, whereas those undergoing surgery for pancreatic cancer, orthopedic issues, and aortic aneurysms received blood transfusions at higher thresholds. The amount of blood transfused did not correlate with how sick the patients were or...
UA/NSTEMI: A Guideline Update

UA/NSTEMI: A Guideline Update

Following the recent FDA approval of new medications to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS) and developments in the literature, the American College of Cardiology (ACC) and American Heart Association (AHA) released a focused update to 2007 guidelines on the management of patients with unstable angina (UA)/NSTEMI. The update, published in Circulation, focuses on how antiplatelets and anticoagulants fit into management algorithms for ACS. Key Updates to UA/NSTEMI Guidelines An important change in the ACC/AHA guideline update is that ticagrelor is now considered a treatment option for UA/NSTEMI patients, joining clopidogrel and prasugrel. “We recommend that when aspirin is given with ticagrelor for maintenance therapy, a low dose of aspirin (81 mg) should be used after the initial loading dose,” says Jeffrey L. Anderson, MD, FACC, FAHA, co-author of the guidelines. “Research shows that a high dose of aspirin appears to reduce the benefits of ticagrelor.” Aspirin remains a first-line therapy for managing patients with UA/NSTEMI. “When these patients arrive at the hospital, they should receive aspirin and an anticoagulant,” says Dr. Anderson. “Clinicians should then decide upon a second antiplatelet agent before angiography to define coronary anatomy. Clopidogrel, ticagrelor, or an intravenous glyco­protein IIb/IIIa agent are acceptable options. At or after coronary stenting, prasugrel becomes an additional option.” For patients receiving medical therapy only, the ACC/AHA guidelines recommend antiplatelet therapy with ticagrelor or clopidogrel, in addition to aspirin. Several changes were made in the guideline update regarding patients with renal insufficiency. “It’s important to assure that these patients are well hydrated if they’re going to the cath lab and that they...

ESC Congress 2013

New research is being presented at ESC Congress 2013, the annual meeting of the European Society of Cardiology, from August 31 to September 4 in Amsterdam, Netherlands. Meeting Highlights Women Benefit With Drug-Eluting Stents Telemonitoring Detects Potential Issues With ICDs & CRT-Ds Predicting Treatment Success in Atrial Fibrillation News From the Congress Record Number of Hot Line Submissions Something Old, Something New. The Hokusai-VTE Study Suggests Certain Sub-Groups of Venous Thromboembolism Patients May Need Review Results of the TASTE Trial Challenge Current Practice of Blood Clot Aspiration After Heart Attack TAO Results End Hope for Otamixaban in NSTE-ACS PARIS: Incidence and Impact of Dual Antiplatelet Therapy Cessation On Adverse Cardiac Events Following Percutaneous Coronary Intervention Dabigatran Etexilate Is Contraindicated in Patients with Mechanical Heart Valves LINC Study Finds Mechanical Chest Compressions Are Equally as Effective as Manual CPR A Shorter Interruption of Anti-Thrombotics Does Not Influence Peri-Operative Complications in Cardiac Patients Pre-Treatment with Prasugrel – More Risk, No Benefit: ACCOAST Preventive PCI Results in Better Outcomes than Culprit Artery PCI Alone in ST Elevation MI PURE: Contrasting Associations Between Risk Factor Burden, CVD Incidence and Mortality in High, Middle and Low Income Countries Treatment with the Anti-Diabetic Drug Alogliptin Does Not Increase Cardiovascular Risk in Patients with Acute Coronary Syndromes SAVOR-TIMI 53 Sets New Standard for Cardiovascular Outcome Trials in Diabetes ASSURE: Effect of an Oral Agent Inducing Apo A-I Synthesis on Progression of Coronary Atherosclerosis Common Blood Pressure Drug Reduces Aortic Enlargement in Marfan Syndrome French Tour de France Cyclists Live Longer Than Their Non-Cyclist Countrymen Despite Missing Primary Efficacy Endpoint, ATOMIC-AHF Identifies Positive Trends for Omecamtiv Mecarbil...

FDA Approves Tivicay for HIV Infection

The U.S. Food and Drug Administration today approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection. Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. It is a pill taken daily in combination with other antiretroviral drugs. Tivicay is approved for use in a broad population of HIV-infected patients. It can be used to treat HIV-infected adults who have never taken HIV therapy (treatment-naïve) and HIV-infected adults who have previously taken HIV therapy (treatment-experienced), including those who have been treated with other integrase strand transfer inhibitors. Tivicay is also approved for children ages 12 years and older weighing at least 40 kilograms (kg) who are treatment-naïve or treatment-experienced but have not previously taken other integrase strand transfer inhibitors. “HIV-infected individuals require treatment regimens personalized to fit their condition and their needs,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “The approval of new drugs like Tivicay that add to the existing options remains a priority for the FDA.” About 50,000 Americans become infected with HIV each year and about 15,500 died from the disease in 2010, according to the Centers for Disease Control and Prevention. Tivicay’s safety and efficacy in adults was evaluated in 2,539 participants enrolled in four clinical trials. Depending on the trial, participants were randomly assigned to receive Tivicay or Isentress (raltegravir), each in combination with other antiretroviral drugs, or Atripla, a fixed-dose combination of efavirenz, emtricitabine and tenofovir. Results showed Tivicay-containing regimens were effective in reducing viral loads. A fifth trial...
Page 1 of 212
[ HIDE/SHOW ]