Controversy is building around agent development for cancer prevention. The withdrawal of rofecoxib (Vioxx, Merck) from the market and safety concerns raised by studies of other cyclooxygenase-2-selective inhibitors and an over-the-counter nonsteroidal anti-inflammatory drug have alarmed patients, physicians, and regulatory authorities. Evidence of nonsteroidal anti-inflammatory drug–associated...

2014 Pregnancy is associated with significant hemodynamic, tissue and hematic changes in the maternal cardiovascular system, which could result in worsening some previously asymptomatic cardiac conditions. Since the last 30 years, new techniques and devices have been introduced in the field of structural and coronary heart disease. In this review, we describe the balance between the risk and be...

Non-inferiority (NI) trials attempt to demonstrate that the loss in efficacy by a new treatment compared to a standard treatment is limited to a certain pre-specified margin, usually compensated by some form of benefit in the form of safety, ease in administration, tolerability, costs, etc. The lack of mention of the benefit of the new treatment and its importance have been pointed out recently...