Patients should contact their healthcare provider promptly if they experience: Severe, persistent abdominal pain that worsens or differs from typical bloating Inability to pass gas or have bowel movements (possible obstruction) Persistent vomiting that prevents adequate hydration or medication adherence Unintentional weight loss beyond expected therapeutic effects Blood in stool or black, tarry stools Fever accompanying gastrointestinal symptoms Right upper quadrant pain or yellowing of skin/eyes (possible gallbladder disease) Severe constipation with abdominal distension (possible ileus/obstruction) Signs of dehydration (excessive thirst, dark urine, dizziness) These symptoms may indicate complications such as pancreatitis, gallbladder disease, bowel obstruction, or acute kidney injuryall noted in FDA prescribing information as potential risks
Wilkinson MJ, Manoogian ENC, Zadourian A, Lo H, Fakhouri S, Shoghi A et al (2020) Ten-hour time-restricted eating reduces cardiometabolic risk
This is negotiable 5
Shorter faster treatment option
This estimand is therefore also referred to as a hybrid estimand in the study protocol
All these studies have proven cardiovascular safety for the respective DPP-4 inhibitors