The use of validated and nonvalidated surrogate endpoints in two European Medicines Agency expedited approval pathways: A cross-sectional study of products authorised 2011-2018.

Background: In situations of unmet medical need or in the interests of public health, expedited approval pathways, including conditional marketing authorisation (CMA) and accelerated assessment (AA), speed up European Medicines Agency (EMA) marketing authorisation recommendations for medicinal products. CMAs are based on incomplete benefit-risk assessment data and authorisation remains conditional until regulator-imposed confirmatory postmarketing measures are fulfilled. For products undergoing AA, complete safety and efficacy data should be available, and postauthorisation measures may include only standard requirements of risk management and pharmacovigilance plans.

Novel stratified medicines approach to manage uncontrolled hypertension due to multiple drug intolerances.

A 61-year-old man with a 30-year history of uncontrolled hypertension was unable to tolerate conventional antihypertensive medications from all classes. At the time of referral to our centre he had discontinued all antihypertensive drugs and felt well. However, his average home blood pressure (HBP) reading was 179/125 mm Hg and echocardiography demonstrated moderate concentric left ventricular hypertrophy.

Childhood constipation: recognition, management and the role of the nurse.

Constipation is a common childhood condition that health professionals will encounter in many different settings. The majority of these cases of childhood constipation are idiopathic in nature. It is considered to exhibit the 'tip of the iceberg' phenomenon as a large number of cases remain undetected due to under-recognition by families, embarrassment regarding the condition, fear of receiving a negative response from health professionals, or parental belief there is actually something more seriously wrong and failure to accept the diagnosis.