The FDA has issued a complete response letter regarding the new drug application for Bristol-Myers Squibb (BMS) and AstraZeneca's investigational compound dapagliflozin for the treatment of type 2 diabetes in adults, requesting additional clinical data to allow "a better assessment of the benefit-risk profile for dapagliflozin."

St. Jude Medical reported that an interim analysis of the FAME II trial found a "highly statistically significant reduction in the need for hospital readmission and urgent revascularization when fractional flow reserve-guided assessment was used to direct treatment in patients with coronary artery disease." As a result, the FAME II's Data Safety Monitoring Board (DSMB) recommended investigators stop patient enrollment in this trial as the DSMB considers it unethical to continue to randomize patients to optimal medical therapy alone.

Dabigatran is associated with an increased risk of MI or acute coronary syndrome in a broad spectrum of patients when tested against different controls. That led researchers to recommend that clinicians should consider the potential of these serious harmful cardiovascular effects with use of dabigatran. Jeremy M. Jacobs, MBBS, one Archives of Internal Medicine editorialist, who published his article Jan. 9 along with the study, told Cardiovascular Business that caution is needed, especially among patients with known active ischemic heart disease.

Shlomo Yanai, president and CEO of Teva Pharmaceutical Industries, plans to retire May 2012. As part of a succession plan, the board of directors has named Jeremy Levin, MD, a former senior executive at Bristol-Myers Squibb (BMS), to succeed him at that time.

Although the FDA has recommended that CYP2C19 genotyping be considered before prescribing the drug clopidogrel to identify individuals who may be less responsive to the medication, a review and analysis of previous studies did not find an overall significant association between the CYP2C19 genotype and cardiovascular events, based on a study published Dec. 28, 2011 in the Journal of the American Medical Association.

The 60 percent decline in the death rate from cardiovascular disease that has occurred since the 1950s is the result of the development of new drugs and devices, improved medical imaging and new treatment strategies. Challenges now lie in sustaining and improving these gains cost effectively.

Treatment of isolated systolic hypertension with chlorthalidone stepped-care therapy for 4.5 years was associated with longer life expectancy at 22 years of follow-up, based on the long-standing SHEP trial published Dec. 21 in the Journal of the American Medical Association.

Antihypertensive therapy given to people with prehypertensive blood pressure levels reduced the risk of stroke by 22 percent, according to a meta-analysis of 16 randomized controlled clinical trials. The study results appeared Dec. 8 in Stroke.