A recent report [ 38] summarized the safety findings by way of an integrated safety analysis of five randomized, placebo-controlled, double-blind, core abatacept clinical trials, generating 4,764 patient-years of exposure in total.
These studies each included a 26-week, double-blind, core treatment period and a 26-week extension period, and assessed canagliflozin as monotherapy [ 9] or added on to metformin [ 14], metformin plus sulphonylurea [ 15], and metformin plus pioglitazone (Table 1).
The study consisted of a 2-week, single-blind, placebo run-in period; a 26-week, placebo-controlled, double-blind core treatment period followed by a 26-week, active-controlled, double-blind extension period; and a 4-week follow-up period.
During the double-blind, core treatment period, glycaemic rescue therapy (up-titration of current AHAs or step-wise addition of oral or non-oral AHAs) was initiated if FPG >15.0 mmol/l (270 mg/dl) after day 1 to week 6, >13.3 mmol/l (240 mg/dl) after week 6 to week 12, and >11.1 mmol/l (200 mg/dl) after week 12 to week 26.
In recovery, shivering was graded by an investigator blinded to core temperature using a 4 point scale (0 = none, 1 = mild and intermittent shivering, 2 = moderate shivering, 3 = intense and continuous shivering).
If one can see nothing but cynicism in this statement, one will be blind to the core of honor, a little tarnished but real, that I, for one, discern in Bill Clinton.
After the placebo run-in period, all subjects were randomized into a 26-week, double-blind, placebo-controlled, core treatment period, followed by a 26-week, double-blind extension period.
Study design: blinded imaging with core lab analysis (cardiac MR (CMR) and exercise testing) to reduce referral bias, inclusion only of patients who would consider surgery, multicentre, data collection/analysis by independent clinical trials unit.
Two phase IIa, 52-week, multicenter, randomized, double-blind, placebo-controlled core studies (2201 22022) and two 66-week open-label extension studies (2201E; 2202E) were conducted in patients with mild Alzheimer's disease (AD) aged 40 to 85 years.
But, whichever way we go (and this being America, we'll no doubt try to do some hodgepodge of it all), we cannot let the complexities blind us to the core concern.
