Evaluation of the relationship between effervescent paracetamol and blood pressure: clinical trial

Benítez, Mència; Vinyoles, Ernest; Rebagliato-Nadal, Oriol; Morros-Pedrós, Rosa; Pera-Pujadas, Helena; Dalfó-Baqué, Antoni; López-Pavón, Ignacio; Roca-Sánchez, Carlos; Coma-Carbó, Rosa Maria; Wichmann, Mariano de la Figuera von; Mengual-Martínez, Lucas; Yuste-Marco, Carmen; Colet, M.; Vilaubí, Josep Maria Pepió; Ciurana-Tost, Riera; Pou-Vila, Rosa; Vila-Coll, M.A.; Bordas-Julve, Josep Maria; Aragonès-Forès, Rosa; Pelegrina-Rodríguez, Francisco Javier; Agudo-Ugena, Josep; Blanco-Mata, Carlos; Berrojalbiz, Jon de la Iglesia; Burgos-Alonso, Natalia; Gómez-Fernández, María Cruz

doi:10.1186/s12872-015-0161-7

Cited by 4 publications

(2 citation statements)

References 28 publications

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“…There is a controversy regarding anions in sodium salts. There are studies which have confirmed effect of sodium chloride on blood pressure, but do not associate sodium bicarbonate unambiguously [18,19]. Sodium bicarbonate is excipient found in each analyzed formulation (Table 4.…”

Section: Discussionmentioning

confidence: 98%

Drug sodium intake: Warning in cardiovascular diseases treatment

Čanji¹,

Todorović²,

Čović³

et al. 2020

Hosp Pharm Int Multi J

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Introduction: Hypertension is a condition which represents one of the main risk factors for the development of cardiovascular diseases. High sodium intake contributes to occurrence of hypertension, increasing the volume of extracellular fluid. Therefore, World Health Organization (WHO) and other associations involved with hypertension research advise to decrease intake of sodium. Effervescent dosage forms usually contain high levels of sodium which could lead to above mentioned health issues. Aim: The aim of this study was to evaluate the levels of sodium in the effervescent dosage forms available in the Serbian drug market. Methods: Data about sodium levels, and excipients was obtained from Summary of Product Characteristics from website of Medicines and Medical Devices Agency of Serbia (ALIMS). Maximum daily doses recommended by the manufacturer and approved by ALIMS were observed. Exposure to sodium through consumption of maximum daily doses was calculated as percentages of the adequate daily intake given by Food and Nutrition Board (Institute of Medicine, National Academies, Washington D.C., USA), and also as percentage of recommended daily intake of sodium given by WHO. Results: There are five formulations with exposure to sodium through consumption of maximum daily doses higher than 100% of the adequate daily intake (2 g), all of which are effervescent tablet formulations. The highest exposure to sodium was found in effervescent tablets containing acetylsalycic acid (500 mg) as active pharmaceutical ingredient: 250.62 % for people aged 51 to 70 years; 271.50 % for people aged 70 and older. Conclusion: In effervescent dosage forms available on Serbian market, level of sodium can be very high, even up to 271.50% of adequate daily intake when maximum daily doses are consumed. Major cause for concern is for vascular patients who use effervescents for chronic therapy. This data should be considered during prescribing and dispensing this category of medicines as well as during analyzing pharmacovigilance.

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Section: Discussionmentioning

confidence: 98%

Drug sodium intake: Warning in cardiovascular diseases treatment

Čanji¹,

Todorović²,

Čović³

et al. 2020

Hosp Pharm Int Multi J

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“…Our search strategy identified a protocol for a randomized controlled trial published in 2015, which is still recruiting patients, which will evaluate the relationship between effervescent paracetamol (as a HSCD) and blood pressure [ 32 ]. This crossover trial is recruiting 49 hypertensive patients > 18 years of age with controlled hypertension.…”

Section: Discussionmentioning

confidence: 99%

Cardiovascular risk associated with high sodium-containing drugs: A systematic review

Perrin¹,

Korb-Savoldelli²,

Karras³

et al. 2017

PLoS ONE

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BackgroundExcess dietary sodium is associated with increased blood pressure (BP). Some drugs are associated with high sodium intake (in particular effervescent tablets), but the cardiovascular risk associated with such high sodium-containing drugs (HSCD) is largely underevaluated.ObjectivesTo summarize the evidence for a potential cardiovascular risk associated with exposure to HSCD, and to highlight possible risk factors associated with this iatrogenic issue; in general and/or specific populations.MethodsWe conducted a systematic review, by searching electronic databases including MEDLINE, EMBASE, Web of Science, CENTRAL and grey literature between 1960 and 2015. We included studies that reported modification of cardiovascular parameters or incidence/prevalence of cardiovascular outcomes, between a group of subjects exposed to HSCD relative to a non-exposed group. The threshold used to identify HSCD was 391 mg/day. We did not consider studies evaluating exposure to sodium as an active ingredient or those focusing on dialysis solutions or enteral/parenteral nutrition. Study quality was assessed using the EPHPP tool.ResultsA total of eight studies met our inclusion criteria. Four reported results for short-term exposure to HSCD (≤ 7 days) on BP fluctuations. One study reported an elevation of BP (associated sodium intake: 1,656 mg/day). Four studies evaluated a long-term exposure (≥ 2 years or discontinuation of a chronic treatment). Two studies reported iatrogenic risk. For these studies, drug associated sodium intake was high (> 1,500 mg/day) in patients with comorbidities (in particular, diabetes mellitus and hypertension).ConclusionDespite numerous study limitations, this systematic review suggests three potential synergistic risk factors for cardiovascular complications after exposure to HSCD: a high sodium intake (≥ 1,500 mg/day), a long duration of exposure, and the presence of comorbidities. Further studies are required to characterize this iatrogenic risk.Trial registrationPROSPERO CRD42016047086.

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