LONG-TERM FOLLOW-UP STUDY (12 MONTHS) OF PALMEX IN CLINICAL PRACTICE
Julio César Fernández-Travieso
National Centre forScientificResearch,Havana, Cuba.
JoseIllnait-Ferrer
National Centre forScientificResearch,Havana, Cuba.
Lilia Fernández-Dorta
National Centre forScientificResearch,Havana, Cuba.
Sarahi Mendoza-Castaño
National Centre forScientificResearch,Havana, Cuba.
Raúl Guzmán-Mederos
Salvador Allende Hospital,Havana, Cuba.
Ramona Alfonso-Barreto
Dalmer Laboratories, Havana, Cuba.
Palmex is a lipid extract of the fruits of the royal palm (Roystonearegia), whose taxonomic origin and composition have similarities with those of the lipid extracts of the fruits of Saw palmetto (Serenoarepens), phytotherapeutic product widely used to treat Benign Prostatic Hyperplasia (BPH). Toxicological studies have not shown toxicity associated with Palmex and previous clinical studies have demonstrated its efficacy, safety and excellent tolerability in the short and medium term in patients with BPH. This observational, descriptive and transversal post-marketing study had as objective to track a universe of 100 male patients who acquired the Palmex at the Pharmacy of the Dalmer Laboratories and consumed it during 12 months, was followed up evidence of symptoms of the tract under the urinary tract (STBU) according to the international prostate symptoms score (IPSS), investigated the adverse events that could be reported by the subjects, including those that required medical attention. The average age of the study population was 68 years. No subject died during the follow-up and only 2 cases of the 100 included subjects reported adverse events (flatulence and belching), classified as mild because they did not require treatment and related to treatment. The frequency of advese events detected at this stage was 2%. On the other hand, not only corroborated the results obtained in the medium-term clinical studies related to the significant reduction produced by Palmex on the IPSS and therefore of the STBU, but also demonstrated for the first time these effects are maintained with long-term treatment. This study confirms Palmex's excellent tolerability and efficacy in the long-term (12 months) in clinical practice.
9 , 1 , 2019
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