Bisher AKIL, MD

Archive for May, 2009|Monthly archive page

HIV infection, inflammation and heart disease

In Heart, HIV on May 20, 2009 at 5:22 pm

Growing evidence suggests that the risk for atherosclerosis is higher among HIV-infected individuals than among HIV-negative persons; potential explanations include deleterious effects of antiretroviral therapy (ART), virus-induced endothelial injury, and chronic inflammation. To examine the role of these factors, investigators studied carotid intima-media thickness (IMT; a measure of atherosclerosis) and C-reactive protein (CRP; a marker for systemic inflammation) levels in HIV elite controllers (infected patients who maintain undetectable viral loads without taking ART), untreated HIV-infected patients, HIV-infected patients on ART, and HIV-negative controls (total, 494 participants). The median carotid IMT was significantly higher in HIV-infected patients than in HIV-negative individuals, even after adjustment for cardiovascular risk factors. The median carotid IMT in elite controllers was significantly higher than that in HIV-negative individuals and was similar to that in untreated HIV-infected patients. The median CRP level was significantly higher in HIV-infected patients, including controllers, than in HIV-negative patients. Published in Journal Watch. Hsue PY et al. Role of viral replication, antiretroviral therapy, and immunodeficiency in HIV-associated atherosclerosis. AIDS 2009 Apr 22. Comments: these data and others seems to suggest that HIV infection by itself , not medications, cause inflammation maybe due to viral replication (with and without treatment for HIV); this inflammation can lead to atherosclerosis and heart disease. People with HIV infection should be screened for heart disease early and aggressively _BA

Exercises to help Sleep Apnea

In General Health on May 20, 2009 at 5:13 pm

Continuous positive airway pressure (CPAP) is tolerated poorly by many patients with obstructive sleep apnea (OSA). Certain patients have experienced positive outcomes with less-obtrusive interventions (e.g., mandibular advancement devices, weight reduction), and, now, Brazilian researchers introduce yet another alternative — oropharyngeal exercises. A study that published in May 2009 looked at oropharyngeal exercises to help OSA. Thirty-one patients with moderate OSA (apnea-hypopnea index, 15–30 events hourly) were randomized to weekly sessions that involved instruction in either oropharyngeal exercises (intervention group) or deep-breathing exercises (control group); patients repeated the exercises at home daily. A speech pathologist taught the intervention program, which involved repetitive exercises of the soft palate, tongue, and facial muscles, as well as breathing, speech, swallowing, and chewing exercises (video). At 3 months, mean apnea-hypopnea indexes were unchanged in the control group but had decreased significantly in the intervention group (from about 22 to about 13 events hourly). Sleepiness and sleep-quality scores also improved significantly only in the intervention group. Source: Published in Journal Watch. Guimarães KC et al. Effects of oropharyngeal exercises on patients with moderate obstructive sleep apnea syndrome. Am J Respir Crit Care Med 2009 May 15; 179:962. Comments: although no diet, weight loss or improvement in over health has been studied in combination with these exercises, it seems that simply  reducing the size of the neck would help reduce sleep apnea._BA

Can we predict dementia?

In General Health on May 14, 2009 at 7:44 pm

The goal is too develop a late-life dementia risk index that can accurately stratify older adults into those with a low, moderate, or high risk of developing dementia within 6 year. The authors of this paper developed a 15-point risk index can identify older adults at low, intermediate, and high risk for dementia. Researchers studied nearly 3375 adults aged 65 or older,without evidence of dementia at baseline. We used logistic regression to identify those factors most predictive of developing incident dementia within 6 years and developed a point system based on the logistic regression coefficients.14% of whom developed dementia over 6 years’ follow-up. The researchers then identified independent predictors of dementia — including older age, poor cognitive test scores, history of coronary bypass, slow physical performance, and lack of alcohol consumption — and incorporated them into a risk prediction tool. Each factor was assigned 1 to 2 points, for a maximum score of 15. The tool accurately predicted which participants were likely to develop dementia. For example, dementia developed in 56% of subjects with high risk scores but only 4% of those with low scores. The authors say their prediction tool “could be used clinically to identify older adults who do not currently have overt dementia symptoms but who should be monitored more closely for signs of cognitive impairment.”. Published  online before print on May 13, 2009 (Neurology 2009)

C-Reactive Protein (CRP) and Heart Disease in HIV

In Heart, HIV on May 14, 2009 at 7:26 pm

Inflammation is suspected to contribute to increased risk for both AIDS- and non–AIDS-related outcomes in HIV-positive patients. To evaluate how HIV infection and elevated C-reactive protein (CRP) levels each influence risk for acute myocardial infarction (MI), investigators reviewed data from a large patient registry in Massachusetts. Analysis included 487 HIV-infected patients and 69,870 HIV-uninfected patients, all of whom had CRP data available from between 1997 and 2006. Patients who had an MI were eligible for analysis only if their most recent CRP level was obtained 3 years to 1 week before the MI. In a univariate analysis, HIV infection and elevated CRP levels were each significantly associated with increased risk for acute MI (odds ratios, 2.1 and 2.5, respectively). In a model adjusted for age, sex, race, hypertension, diabetes, and dyslipidemia, both of these associations remained significant (ORs, 1.9 and 2.1, respectively). HIV-infected patients with elevated CRP levels were four times more likely to have an acute MI than HIV-uninfected patients with normal CRP levels. Overall, these findings suggest that CRP levels might help predict MI risk in HIV-positive patients. Published in Journal Watch and original paper: Triant VA et al. Association of C-reactive protein and HIV infection with acute myocardial infarction. J Acquir Immune Defic Syndr2009 Apr 21. Comments: There is a bias in this trial, since only patients with CRP levels were included. To better evaluate the role of CRP and other inflammatory markers, a study of all comers is more useful. In the meantime, this is something to watch _ BA

One tablet or more?

In HIV on May 14, 2009 at 7:15 pm

Many patients have heard about the one-a-day treatment for HIV, and wondered if they could switch to  it. To answer that, here is a 48-week, multicenter, open-label trial, 306 patients who had viral loads <200 copies/mL on stable PI- or NNRTI-based ART were randomized to either stay on their baseline regimen or simplify to once-daily efavirenz/tenofovir/FTC (Atripla). Per study protocol, all patients were either receiving their first ART regimen or had documented virologic suppression on a PI-based regimen before switching to their baseline regimen. Study participants were primarily young, healthy men who had demonstrated ≥96% adherence to ART (median duration, 3 years; 53% PI based). Several members of the research team were employees of the makers of efavirenz/tenofovir/FTC.

Treatment simplification was noninferior to treatment continuation, with 89% and 88% of each group, respectively, maintaining viral loads <200 copies/mL at 48 weeks. Similar results were seen with a more stringent threshold for virologic suppression (<50 copies/mL) and in analyses stratified by baseline treatment regimen (PI based vs. NNRTI based). Discontinuation rates were similar between the treatment arms. The most common reasons for discontinuation were adverse effects in the simplification group (5%; primarily nervous system or psychiatric symptoms in patients previously treated with PIs) and withdrawal of consent in the continuation group (7%).

Adherence rates remained high in both groups throughout the study. Not surprisingly, patients randomized to simplification preferred the new regimen and reported improvements in quality of life, as well as in symptoms related to HIV treatment, such as diarrhea, abdominal bloating, body image, and sexual dysfunction. Published in Journal Watch. Original article: DeJesus E et al. Simplification of antiretroviral therapy to a single-tablet regimen consisting of efavirenz, emtricitabine, and tenofovir disoproxil fumarate versus unmodified antiretroviral therapy in virologically suppressed HIV-1–infected patientsJ Acquir Immune Defic Syndr 2009 Apr 7;

Comments: Although we have over 23 different medications to treat HIV, the number of combination are in fact much less than that. A change of a regimen is usually advised when the regimen fails, or the patient is not compliant with the treatment and there is a concern about that regimen failing. In this study, neither situation exists. This is mainly a post marketing study sponsored by a company who wishes many more people would take their drug over their existing and functioning regimen. BA

Testim & Androgel have new FDA warning

In General Health on May 14, 2009 at 7:03 pm

The FDA is requiring that two prescription testosterone gels — AndroGel 1% and Testim 1% — carry boxed warnings after reports of adverse events in children who had secondary exposure to the gels.

 

Eight children (aged 9 months to 5 years) were inadvertently exposed to the gels through skin-to-skin contact with people using the products, which are approved for men who produce low levels of testosterone. The adverse events in children included inappropriate genital enlargement, early pubic hair growth, advanced bone age, increased libido, and aggressive behavior. Usually, these symptoms regressed when the children were no longer exposed.

To minimize the risk for secondary exposure, the FDA recommends that adults using the gels:

  • wash their hands after every use;
  • cover the application area with clothing after the gel has dried;
  • wash the area when skin-to-skin contact with another person is expected.

In addition, other people should not touch the application area. 

FDA release could be viewed at

http://www.fda.gov/bbs/topics/NEWS/2009/NEW02011.html