And because studies involving uncomplicated populations are cheapest and easiest to interpret, patients with multiple diseases are routinely shut out of drug trials.
The overall incidence of uncomplicated PUD in this population was 1.41 per 1000 person-years and was higher than the incidence calculated for the general population [ 13, 16].
Unlike the DARE study population with uncomplicated type 2 diabetes, the majority of type 2 diabetic patients suffer from some form of muscle weakness, osteoarthritis, mobility impairments, peripheral and/or cardiovascular disease, not only resulting in reduced exercise tolerance [ 23], but also in a potentially high risk of overload injuries [3, Praet et al., unpublished results].
In 2003, the Joint National Committee (JNC) on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure published (1) revised recommendations (JNC 7) on the management of hypertension that recommended a lower target for patients with diabetes (130/80 mmHg) than for the general population with uncomplicated essential hypertension (140/90 mmHg).
Another part of the healthy population will develop uncomplicated (and undiagnosed) diabetes.
No considerable differences were found between RRs calculated in the general population or in uncomplicated pregnancies only.
Cuspidi et al 18 found significantly higher BMI and SBP with enlarged LAD in a population of 2500 uncomplicated patients with hypertension.
Based on these estimates we calculated the potential use of thiazides for the management of uncomplicated hypertension for the total population in each country.
The safety and pharmacokinetic profile of OZ439 merits progression to phase 2a proof of concept studies in the target population of acute uncomplicated malaria.
In conclusion, the pharmacokinetic and safety profile of OZ439 in both single and multiple dose studies in healthy subjects provides confidence to progress this agent to patient studies in the target population of acute uncomplicated malaria.
The management of uncomplicated symptomatic UTI in the female population has been the subject of several randomized controlled trials.
