Devicare is presenting the positive results of the PREVENTLIT clinical study today which have been published in Clinical Medicine Insights Urology. The results show the efficacy and tolerance of its products Lit-Control® pH Up and Lit-Control® pH Down to regulate urinary pH in patients with renal lithiasis. The study confirms that maintaining urinary pH within the appropriate range (between 5.5 and 6.2 pH) decreases the likelihood of new events related to kidney stones from appearing by more than 50%.
The investigators led by Dr Juan Antonio Galán, Director of the Urolithiasis and Endourology Unit of the General University Hospital Alicante (Spain) and board member of the Urolithiasis Section at the European Association of Urology (EAU), have also evaluated more than 90% of the cases as having good or very good tolerance, both in patients from the alkalising group (where the pH is increased) as well as patients in the acidifying group (where the pH is decreased).
PREVENTLIT is a prospective, multicentre clinical trial with the participation of 143 patients with renal lithiasis related to pH alterations. The medical check-ups were held after 30, 60 and 90 days in 15 different renowned Spanish hospitals: Hospital Clínic of Barcelona, Bellvitge University Hospital (L’Hospitalet de Llobregat), Santa Lucía de Cartagena University Hospital (Murcia), Vinalopo University Hospital (Elche), Dr Peset University Hospital (Valencia), Germans Trias i Pujol University Hospital (Badalona), Juan Canalejo University Hospital (A Coruña), La Fe University Hospital (Valencia), Valme University Hospital (Seville), Virgen del Rocio University Hospital (Seville), Puigvert Foundation (Barcelona), Manacor Hospital (Balearic Islands), Sanitas Hospital (Madrid), Technological Medical Institute of Barcelona and Miramar Polyclinic (Balearic Islands).
“The results obtained with a representative sample of patients from the entire country are very promising. With a simple action, based on regulating urinary pH, relapses in lithiasis can be reduced in all types of patients who suffer from this disease. Lit-Control®, in its different formulations, can alkalise or acidify urine. The latter has been very difficult until now” explains Dr Juan Antonio Galán.
Good adherence results have also been observed. During the study, 56% of patients adhered to the treatment Lit-Control® throughout the 90 days, an important figure considering that the World Health Organisation (WHO) in its Adherence to long-term therapies: evidence for action report states that between 50% and 75% of patients with chronic diseases do not complete their therapy. Treatment adherence and effectiveness are directly related, but the figures from the WHO are convincing and confirm a highly important healthcare problem for chronic diseases (psychiatric diseases, high blood pressure, diabetes, high cholesterol, lithiasis...).
“The most important finding that we have seen during the study is that patients are involved by monitoring their own urinary pH with a simple and reliable system (Lit-Control® pH Meter) in order to adjust the treatment. It also seems that there is a reduction the number of painful episodes associated with lithiasis among the patients in the study” states Dr Galán.
With the PREVENTLIT study, Devicare reiterates its commitment to clinical innovation and improving scientific knowledge in urology. “It is very satisfying that clinical research and practice have verified that the solutions we offer the medical community through our Lit-Control® products provide benefits in the clinical management of patients with lithiasis” explains Xavier Peris, Director of Sales and Marketing of Devicare. Ten percent of the Spanish population suffer from this disease and this figure is on the rise.
In fact, PREVENTLIT forms part of Devicare's global research programme to provide clinical evidence for its nutraceuticals and medical foods with the collaboration of the best urologists in Spain and across the globe. The company currently features 5 products on the market, 49 patents, 6 clinical studies and 10 scientific publications.
The investigators will present the study during the 5th Meeting of the European Association of Urology Section of Urolithiasis (EULIS) from 3-5 October in Milan.
Galan J., Torrecilla C., Luque MP., Peris X., Cuñé J. (2019). Urinary pH as a Target in the Management of Lithiasic Patients in Real-World Practice: Monitoring and Nutraceutical Intervention for a Nonlithogenic pH Range. Clinical Medicine Insights. doi: 10.1177/1179561119853556.
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Photo: From left to right, Dr Jordi Cuñé, Medical Director at Devicare, Xavier Peris, Sales and Marketing Director at Devicare, and Dr Juan Antonio Galán, Director of the Urolithiasis and Endourology Unit of the General University Hospital Alicante