FDA approves azilsartan medoxomil tablets for hypertension treatment
The FDA today announced the approval of azilsartan medoxomil, an angiotensin II receptor blocker, for the treatment of hypertension in adults.
Azilsartan medoxomil tablets (Edarbi, Takeda Pharmaceuticals) will be made available in 80 mg and 40 mg doses. The agency approved the drug based on data from more than 5,900 patients showing that azilsartan medoxomil was more effective at lowering 24-hour BP than valsartan (Diovan, Novartis) and olmesartan (Benicar, Daiichi Sankyo).
The 40 mg dose, according to a press release, will be available for patients taking high-dose diuretics.
“High BP is often called the ‘silent killer’ because it usually has no symptoms until it causes damage to the body,” Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Drugs Products at the FDA’s Center for Drug Evaluation and Research, said in the press release. “High BP remains inadequately controlled in many people diagnosed with the condition, so having a variety of treatment options is important.”
The boxed warning that accompanied azilsartan medoxomil specified that the drug not be used in pregnant women during the second or third trimester.
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Stroke and death rates similar in stenosis patients undergoing stenting or endarterectomy
Silver F. Stroke.2011;42:675-680. S
Researchers have found no significant difference in stroke and death rates in patients with carotid stenosis treated with carotid artery stenting or with carotid endarterectomy; however, periprocedural stoke and death rates were much lower in symptomatic patients who received stents.
The Carotid Revascularization Endarterectomy Vs. Stenting Trial (CREST) was a randomized endpoint trial that compared the safety and efficacy of carotid artery stenting (CAS) vs. carotid endarterectomy (CEA) in patients with high-grade carotid stenosis. The study was supported by the National Institute of Neurological Disorders and Stroke and the NIH, with additional funding from Abbott Vascular Solutions Inc.
Patients were defined as symptomatic if they exhibited relative symptoms up to 180 days of randomization. A total of 1,321 symptomatic patients and 1,181 asymptomatic patients were enrolled at 117 sites throughout the United States and Canada. The primary endpoint included stroke, MI, death within the periprocedural period or ipsilateral stroke within 4 years.
Operators included surgeons who performed 12 or more CEAs per year; interventionalists were experienced in CAS and received hands-on training using the stenting and embolic-protection devices being observed in the study.
In both arms, the periprocedural aggregate of stroke, MI and death were similar (5.2% vs. 4.5%; HR=1.18; 95% CI, 0.82-1.68). The stroke and death rate was higher for CAS than for CEA (4.4% vs. 2.3%; HR=1.90; 95% CI, 1.21-2.98). For symptomatic patients, the periprocedural stroke and death rates were 6 ± 0.9% for CAS and 3.2 ± 0.7% for CEA (HR=1.89; 95% CI, 1.11-3.21). For asymptomatic patients, stroke and death rates were 2.5 ± 0.6% for CAS and 1.4 ± 0.5% for CEA (HR=1.88; 95% CI, 0.79-4.42). Rates were lower in patients aged younger than 80 years.
“CREST has demonstrated that, with experienced surgeons and interventionalists, both CEA and CAS are viable options for carotid revascularization because the overall complication rates for both procedures are within current treatment guidelines,” researchers wrote.
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Low, high BMI increased mortality in Asians
Zheng W. N Engl J Med. 2011;364:719-729.
A study involving more than 800,000 East Asians has shown that both low and high BMI increased the likelihood of death from any cause, as well as cause-specific death.
However, researchers looked at nearly 300,000 Indians and Bangladeshis and found that only low BMI elevated the risk for death.
The more than 1.14 million participants who comprised the study were recruited in 19 Asian cohorts. Investigators defined 10 BMI levels, ranging from lowest (≤15) to highest (>35) and carried out pooled analyses of individuals to determine the association between BMI (mean 22.9 ± 3.6) and mortality risk.
During a mean follow-up of 9.2 years, approximately 120,700 cohort members died, with CVDs reported as the main cause of death (35.7%), followed by cancer (29.9%). For East Asians, or those from China, Japan or Korea, the lowest risk for death was among those with a BMI between 22.6 and 27.5. The risk was elevated for those with a BMI of 15 or less by a factor of 2.8 and for those with a BMI of more than 35 by a factor of 1.5.
For the cohorts composed of Indians and Bangladeshis, the risk for death from any cause was increased among those with a BMI of 20 or less vs. those with a BMI between 22.6 and 25, but not for those with a higher BMI.
“Overall, the risk of death among Asians, as compared with Europeans, seems to be more strongly affected by a low BMI than by a high BMI,” the researchers concluded. “Given the limitations of the current study, in which the risk of death was used as the outcome, additional studies are needed to quantify the association between BMI and the incidence of disease, in order to better define BMI criteria for overweight and obesity in Asians.” – by Brian Ellis
This is an interesting study. The “obesity paradox“ in Western countries is already known. Although obesity is a risk factor for diabetes, hypertension, CAD and premature death, in the systolic HF (stage C ) population, higher BMI is associated with a better prognosis. Similarly, in patients undergoing CABG, higher BMI is associated with a better prognosis. Cardiac cachexia (increased tumor necrosis factor-alpha) is associated with poor prognosis in systolic HF and in cancer.
Based upon my personal knowledge about Asian Indians, Bangladeshis and Pakistanis, the life expectancy is lower due to a variety of causes in urban people. In rural areas, even though the people are thinner, they live longer. I think lifestyles play an important role in regulating BMI in every country.