In politics, humanitarian aid, and the social sciences, hunger is defined as a condition in which a person does not have the physical or financial capability to eat sufficient food to meet basic nutritional needs for a sustained period. In the field of hunger relief, the term hunger is used in a sense that goes beyond the common desire for food that all humans experience, also known as an appetite. The most extreme form of hunger, when malnutrition is widespread, and when people have started dying of starvation through lack of access to sufficient, nutritious food, leads to a declaration of famine. Throughout history, portions of the worlds population have often suffered sustained periods of hunger. In many cases, hunger resulted from food supply disruptions caused by war, plagues, or adverse weather. In the decades following World War II, technological progress and enhanced political cooperation suggested it might be possible to substantially reduce the number of people suffering from hunger. While progress was uneven, by 2014, the threat of extreme hunger had receded for a large portion of the worlds population. According to the FAOs 2021 The State of Food Security and Nutrition in the World (SOFI) report, the number of people suffering from chronic hunger began to rise gradually between 2014 and 2019. In 2020, there was a significant increase, resulting in 768 million people suffering from malnutrition.While most of the worlds people continue to live in Asia, much of the increase in hunger since 2015 occurred in Africa and South America.
In clinical trials, a similar increase in heart rate was observed in both Cleviprex and comparator arms. Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Heart failure patients should be monitored carefully. Cleviprex gives no protection against the effects of abrupt beta-blocker withdrawal. Most common adverse reactions (>2%) are headache, nausea, and vomiting. Cleviprex should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Maintain aseptic technique while handling Cleviprex. Cleviprex contains phospholipids and can support microbial growth. Do not use if contamination is suspected. Once the stopper is punctured, use or discard within 12 hours. Drug interactions
No clinical drug interaction studies were conducted. Cleviprex does not have the potential for blocking or inducing any CYP enzymes. Storage
Cleviprex is available in ready-to-use 50- and 100-mL glass vials at a concentration of 0.5 mg/mL of clevidipine butyrate. Vials should be refrigerated at 2-8oC (36-46 °F). Cleviprex can be stored to controlled room temperature for up to 2 months. Cleviprex is photosensitive and storage in cartons protects against photodegradation. Protection from light during administration is not required. Phase III clinical trial results
Cleviprex has been evaluated in 6 Phase III clinical studies including the perioperative and emergency department/intensive care settings. These include ESCAPE-1, ESCAPE-2, ECLIPSE, and VELOCITY trials. ESCAPE-1 was a double-blind, randomized, placebo-controlled efficacy trial of 105 cardiac surgery patients.