Bisphosphonate Update

Health Care, Medicine, Social Health Community 1,599 Comments
  • A FDA advisory committee wants FDA to limit the duration of bisphosphonate therapy for treatment of osteoporosis, but the committee could not agree on what that time limit should be.
  • FDA wants bisphosphonates use warning on the label that optimal duration of use hasn’t been determined, and that all patients on bisphosphonate therapy should have their need for continued therapy re-evaluated periodically.
  • The issue has become a hot potato for the FDA as reports have emerged linking long-time bisphosphonate therapy with increased risk of atypical fractures.
  • Placebo-controlled trials typically provide data for only five years of therapy, but there is no strong clinical evidence that bisphosphonates work better after they’re used for a long period of time, nor is there firm evidence that long-term use causes harm.
  • Bisphosphonates have been shown to reduce the risk of breaking a hip by 40% to 50% and fracturing a vertebra by between 40% and 70% by inhibiting bone resorption to prevent loss of bone mass.
  • In 2010, the FDA required makers of bisphosphonate drugs to add a warning to their labels about a small increased risk of atypical femur fractures after an American Society for Bone and Mineral Research task force concluded that the risk, although it is small, is real.
  • The panel was also concerned with the drug’s link to deterioration of the jawbone. In 2005, the FDA added a warning on bisphosphonates about osteonecrosis of the jaw, a rare disease in which the bone in the jaw dies.
  • There are also some data suggesting a link to long-term use of bisphosphonates and esophageal cancer. A study in the New England Journal of Medicine used data from FDA’s Adverse Event Reporting System to identify and describe 23 patients taking alendronate who were diagnosed with esophageal cancer.
  • There’s no doubt that these are very efficacious drugs that reduce fractures and mortality. But the issue is that should this drug be used for more than three years.
  • Some suggest taking a “drug holiday” or taking a break for bisphosphonate treatment in order to minimize risks.

Intensive medical treatment prevents second stroke not intra cranial stenting

Health Care, Medicine, Social Health Community 1,530 Comments

Patients at a high risk for a second stroke who received intensive medical treatment had fewer strokes and deaths than patients who received a brain stent in addition to the medical treatment. The investigators published the results in the online first edition of the New England Journal of Medicine.

The National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health, funded the trial. The medical regimen included daily blood-thinning medications and aggressive control of blood pressure and cholesterol.

New enrolment in the study was stopped in April because early data showed significantly more strokes and deaths occurred among the stented patients at the 30-day mark compared to the group who received the medical management alone.

In addition to the intensive medical program, half of the patients in the study received an intervention of a self-expanding stent that widens a major artery in the brain and facilitates blood flow. One possible explanation for the higher stroke rate in the stented group is that patients who have had recent stroke symptoms sometimes have unstable plaque in their arteries which the stent could have dislodged, the study authors suggest. The study device, the Gateway-Wingspan intracranial angioplasty and stenting system, is the only system currently approved by the U.S. Food and Drug Administration (FDA) for certain high-risk stroke patients. The study participants were in the highest risk category, with blockage or narrowing of arteries of 70 to 99 percent.

Intensive medical management included a daily dosage of 325 milligrams of aspirin; 75 milligrams a day of Clopidogrel, for 90 days after enrollment; and aggressive management of key stroke risk factors—high blood pressure and high levels of low density lipoprotein (LDL), the unhealthy form of cholesterol. All patients also participated in a lifestyle modification program which focused on quitting smoking, increasing exercise, and controlling diabetes and cholesterol.

“The SAMMPRIS study results have immediate implications for clinical practice. Stroke patients with recent symptoms and intracranial arterial blockage of 70 percent or greater should be treated with aggressive medical therapy alone.

[New England Journal of Medicine, published online September 7, 2011].

Ventilator-associated tracheobronchitis

Health Care, Medicine, Social Health Community 372 Comments

Ventilator-associated tracheobronchitis (VAT) has the same clinical implications as ventilator-associated pneumonia (VAP). An observational study of 28 patients with VAT and 83 patients with VAP [1] showed that VAT groups had a similar length of intensive care unit stay, length of hospital stay, duration of mechanical ventilation, survival rate to discharge, need for tracheostomy, and need for antibiotics.

Ventilator induced diaphragmatic atrophy

Controlled mechanical ventilation can lead to a very rapid type of disuse atrophy involving the diaphragmatic muscle fibers. An observational study found that diaphragmatic strength decreased progressively during mechanical ventilation and that long-term (>24 hours) mechanical ventilation was associated with diaphragmatic muscle injury, atrophy, and proteolysis compared to short-term mechanical ventilation (2-3 hours).(2)

Starting enteral nutrition in a patient on ventilator

Starting enteral nutrition with a low infusion rate improves tolerability, compared to initiation at the target rate. A randomized study of 200 mechanically ventilated patients showed that enteral feeding ( at the target rate or at 10 mL/hr for six days before being incrementally increased to the target rate) showed no differences in mortality, ventilator-free days, or ICU-free days, but the group that began at the target rate had more episodes of elevated gastric residual volumes and a trend toward more diarrhea. (3)

References
1. Dallas J, Skrupky L, Abebe N, et al. Ventilator-associated tracheobronchitis in a mixed surgical and medical ICU population. Chest 2011;139:513-8.
2. Jaber S, Petrof BJ, Jung B, et al. Rapidly progressive diaphragmatic weakness and injury during mechanical ventilation in humans. Am J Respir Crit Care Med 2011;183:364-71.
3. Rice TW, Mogan S, Hays MA, et al. Randomized trial of initial trophic versus full-energy enteral nutrition in mechanically ventilated patients with acute respiratory failure. Crit Care Med 2011;39:967-74.

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