Evaluation of the relationship between effervescent paracetamol and blood pressure: clinical trial
| Autor: | Riera Ciurana-Tost, Natalia Burgos-Alonso, Josep Agudo-Ugena, Jon de la Iglesia Berrojalbiz, Rosa Morros-Pedrós, Ernest Vinyoles-Bargalló, Montserrat Teixidó-Colet, Mariano De La Figuera Von Wichmann, Josep Maria Bordas-Julve, Ma Antònia Vila-Coll, Carlos Roca-Sánchez, Rosa Maria Coma-Carbó, Lucas Mengual-Martínez, Antoni Dalfó-Baqué, Josep M. Pepió i Vilaubí, Oriol Rebagliato-Nadal, Mència Benı́tez-Camps, Ignacio López-Pavón, Carlos Blanco-Mata, Rosa Pou-Vila, Francisco Javier Pelegrina-Rodríguez, Rosa Aragonès-Forès, Carmen Yuste-Marco, Helena Pera-Pujadas, Maria Cruz Gomez-Fernandez |
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| Přispěvatelé: | Universitat de Barcelona |
| Předmět: |
Ambulatory blood pressure
Time Factors Visual analogue scale Chemistry Pharmaceutical Blood Pressure Pressió sanguínia Risk Assessment Assaigs clínics de medicaments Study Protocol Analgèsics Clinical Protocols Risk Factors Control Clinical endpoint Medicine Humans Antihypertensive Agents Acetaminophen Analgesics Intention-to-treat analysis Cross-Over Studies business.industry Drug testing Analgesics Non-Narcotic Blood Pressure Monitoring Ambulatory Carbon Dioxide Crossover study Intention to Treat Analysis Clinical trial Blood pressure Treatment Outcome Solubility Research Design Spain Anesthesia Ambulatory Hypertension Polypharmacy Effervescent paracetamol Cardiology and Cardiovascular Medicine business |
| Zdroj: | Recercat. Dipósit de la Recerca de Catalunya instname BMC Cardiovascular Disorders r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau Instituto de Salud Carlos III (ISCIII) Dipòsit Digital de la UB Universidad de Barcelona |
| ISSN: | 1471-2261 |
| Popis: | Background: Paracetamol's solubility is achieved by adding to the excipient sodium salts, either as bicarbonate, carbonate or citrate. As the relationship between salt and hypertension is well known, due to the sodium content it has raised a hypothesis that may interfere with the control of that risk factor. Therefore, the objective of this study is to evaluate the effect on blood pressure of effervescent paracetamol compared to non-effervescent, in hypertensive patients. Methods/Design: This is the protocol of a phase IV multicenter clinical trial, randomized, controlled, crossover, open, which will compare the effect of two different formulations of paracetamol (effervescent or non-effervescent) in the blood pressure of hypertensive patients, with a seven weeks follow up. 49 controlled hypertensive patients will be included (clinical BP lower than 150 and 95 mmHg, and lower than 135 mmHg and 85 mmHg in patients with diabetes or a history of cardiovascular event, and daytime ambulatory measurements lower than 140 and 90 mmHg) and mild to moderate pain (Visual Analog Scale between 1 and 4). The study was approved by the ethics committee of the Fundacio Jordi Gol i Gurina and following standards of good clinical practice. The primary endpoint will be the variations in systolic BP in 24 h Ambulatory Blood Pressure Monitoring, considering significant differences 2 or more mmHg among those treated with non-effervescent and effervescent formulations. Intention-to-treat and per-protocol analysis will be held. Discussion: Despite the broad recommendation not to use effervescent drugs in patients with hypertension, there are relatively little studies that show exactly this pressor effect due to sodium in salt that gives the effervescence of the product. This is the first clinical trial designed to study the effect of effervescence compared to the non-effervescent, in well-controlled hypertensive patients with mild to moderate pain, performed in routine clinical practice |
| Databáze: | OpenAIRE |
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