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Diabetes – Summer 2012
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Fluids & Electrolytes
In a large study of patients with type 2 diabetes, fenofibrate lowered the risk of first amputation and minor amputation in people without known large-vessel disease. Researchers analyzed 9,795 patients ages 50 to 75. For 5 years, half of the patients took fenofibrate 200 mg/day and the others took a placebo. Information on amputation was routinely collected. Amputations below the ankle were classified as minor and those above the ankle were major. The amputations were also classified by the amount of large-vessel disease present in the limb. This classification distinguished amputations related to large-artery atherosclerosis from those related to diabetic microvascular disease.
Researchers identified 115 patients with one or more nontraumatic lower limb amputations due to diabetes. The risk of having a first amputation was significantly lower for patients who took fenofibrate compared with those taking placebo. The risk of minor amputations in patients without known large-vessel disease was also lower for those who took fenofibrate. The risk of major amputation was similar for both groups.
Researchers say their findings could "lead to a change in standard treatment for the prevention of diabetes-related lower-limb amputations."
Source: Rajamani K, Colman PG, Li LP, Best JD, Voysey M. Effect of fenofibrate on amputation events in people with type 2 diabetes mellitus (FIELD study): a prespecified analysis of a randomised controlled trial. Lancet. 2009;373(9677):1780-1788.
The debate continues over which nonsteroidal anti-inflammatory drugs (NSAIDs) are safest for people with heart disease. Researchers performed a retrospective cohort study to compare the cardiovascular safety of various NSAIDs in 48,566 patients who'd been hospitalized for myocardial infarction, coronary revascularization, or unstable angina. The study included more than 111,000 patient years of follow-up. Pharmacy and physician records identified which drugs patients took outside the hospital.
Results indicate that naproxen was safer for patients with cardiovascular problems than diclofenac, ibuprofen, and higher doses of celecoxib and rofecoxib. Noting some study limitations, the researchers caution that study findings don't apply to the early postdischarge period, when NSAID use may be especially risky for patients.
This is the first study to focus on the safety of NSAID use among patients with cardiovascular disease.
Source: Ray WA, Varas-Lorenzo C, Chung CP, et al. Cardiovascular risks of nonsteroidal anti-inflammatory drugs in patients after hospitalization for serious coronary heart disease. Circ Cardiovasc Qual Outcomes. 2009;2:155-163.
Many hospitalized patients receive acid-suppressing medication, despite "lack of an accepted indication in the majority of these patients." To explore a possible link between this medication and hospital-acquired pneumonia, researchers conducted a large prospective cohort study at a large urban hospital from January 2004 through December 2007. They evaluated the use of acid-suppressive drugs and subsequent hospital-acquired pneumonia in all patients age 18 and older who were admitted during the study period. Only patients who were hospitalized for at least 3 days were included in the study, and those who spent time in the ICU were excluded. Acid-suppressive medication use was defined as any order for a proton pump inhibitor or histamine receptor antagonist. In all, the study involved 63,878 admissions.
Acid-suppressive drugs were ordered in 52% of admissions, and hospital-acquired pneumonia occurred in 2,219 admissions (3.5%). Five percent of the group who took acid-suppressive drugs developed hospital-acquired pneumonia, compared with 2% in the group who didn't.
The researchers calculated that using acid-suppressing drugs raises the risk of hospital-acquired pneumonia by 30%. However, subsequent analysis demonstrated a significant risk for proton pump inhibitors only.
Source: Herzig SJ, Howell MD, Ngo LH, Marcantonio ER. Acid-suppressive medication use and the risk for hospital-acquired pneumonia. JAMA. 2009;301(20):2120-2128.
A unique liquid embolic system allows an endovascular neurosurgeon to repair wide-necked cerebral aneurysms with a minimally invasive endovascular procedure. These unusual cerebral aneurysms are difficult or impossible to treat with current therapies.
To perform the new procedure, the neurosurgeon uses a small catheter to reach the aneurysm and fill it with a liquid embolic material. Solidifying in about 5 minutes, this embolic material blocks blood flow into the aneurysm and helps prevent it from expanding or rupturing.
The new treatment has been FDA-approved under a humanitarian device exemption. Fewer than 4,000 Americans need the treatment per year, and only a few neurosurgeons nationwide are currently qualified to use it.
For more information about the liquid embolic system, Onyx HD-500, visit the FDA's Web site at http://www.fda.gov or the manufacturer's Web site at http://www.ev3.net.
After 30 years of failed attempts, researchers are reporting success with immune therapies for cancer. The treatments are called vaccines, but unlike conventional vaccines that help prevent disease, cancer vaccines are designed to treat disease. As reported at an oncology conference earlier this year, experimental vaccines for follicular lymphoma, prostate cancer, melanoma, and neuroblastoma have showed positive results in late-stage testing. Researchers characterized these recent successes as a breakthrough.
Because cancer develops from the host's own cells, the immune system doesn't recognize it as foreign. Cancer vaccines work by helping the immune system recognize cancer as an invader. A substance from the cancer cell's surface is attached to something that the immune system recognizes as foreign-in the case of the lymphoma vaccine, a shellfish protein.
In a study, patients given a cancer vaccine for follicular lymphoma had an average of 44 months until their cancer worsened, compared with 30 months for patients who didn't receive the vaccine. In a study involving children with neuroblastoma, 86% of those who received a cancer vaccine were still alive after 2 years, compared with 75% of those who didn't get the vaccine. A vaccine for prostate cancer, currently under consideration for FDA approval, extended the lives of men with very advanced disease by 4 months.
Although promising, cancer vaccines have some significant shortcomings. For example, many must be customized to individual patients, an expensive process. Also, no one can say how long benefits will last or if patients will need booster doses to prolong remissions.
The vaccine studies were reported at the annual meeting of the American Society of Clinical Oncology.
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