PreprintArticleVersion 1Preserved in Portico This version is not peer-reviewed
Safety and Effectiveness of Naproxen 220mg + Paracetamol 300mg + Pamabrom 25mg Fixed Dose Combination in Women With Premenstrual Syndrome: A Post-marketing, Open-Label, Prospective, Multicenter, Observational Study
Peña-Jiménez, Á.E.; Benitez-Aguilar, O.; Villegas, J.E.; González-de la-Parra, M.; Delgado-Roche, L. Safety and Effectiveness of Naproxen 220 mg + Paracetamol 300 mg + Pamabrom 25 mg Fixed Dose Combination in Women with Premenstrual Syndrome: A Post-Marketing, Open-Label, Uncontrolled, Prospective, Multicenter, Observational Study. Women2024, 4, 13-21.
Peña-Jiménez, Á.E.; Benitez-Aguilar, O.; Villegas, J.E.; González-de la-Parra, M.; Delgado-Roche, L. Safety and Effectiveness of Naproxen 220 mg + Paracetamol 300 mg + Pamabrom 25 mg Fixed Dose Combination in Women with Premenstrual Syndrome: A Post-Marketing, Open-Label, Uncontrolled, Prospective, Multicenter, Observational Study. Women 2024, 4, 13-21.
Peña-Jiménez, Á.E.; Benitez-Aguilar, O.; Villegas, J.E.; González-de la-Parra, M.; Delgado-Roche, L. Safety and Effectiveness of Naproxen 220 mg + Paracetamol 300 mg + Pamabrom 25 mg Fixed Dose Combination in Women with Premenstrual Syndrome: A Post-Marketing, Open-Label, Uncontrolled, Prospective, Multicenter, Observational Study. Women2024, 4, 13-21.
Peña-Jiménez, Á.E.; Benitez-Aguilar, O.; Villegas, J.E.; González-de la-Parra, M.; Delgado-Roche, L. Safety and Effectiveness of Naproxen 220 mg + Paracetamol 300 mg + Pamabrom 25 mg Fixed Dose Combination in Women with Premenstrual Syndrome: A Post-Marketing, Open-Label, Uncontrolled, Prospective, Multicenter, Observational Study. Women 2024, 4, 13-21.
Abstract
Premenstrual syndrome is characterized by pain and symptoms affecting the women´s quality of life. We aimed to evaluate the safety and effectiveness of an oral fixed dose combination containing naproxen 220 mg + paracetamol 300 mg + pamabrom 25 mg tablet (Analgen Fem®) during the routine clinical practice. A prospective, open-label, multicenter, observational post-marketing study was conducted from December 2017 to December 2019 including 270 women older than 18 years. Primary endpoint was the proportion of adverse events, meanwhile the pain intensity, premenstrual syndrome symptoms, and patient proportion with a pain score reduction by at least 50% were secondary endpoints. The mean age of population was 28.9 ± 8.8 years. Among the 270 women, 8 (3%) experienced 10 adverse events. These were headache (5/8), gastritis (2/8) dyspepsia (1/8), diarrhea (1/8) and nausea (1/8). The investigator discontinued the study medication in 3/8 patients because of adverse events. The median of differences between the pain intensity at baseline and at last observation (-4.5, 95%CI; -5, -4) demonstrated that naproxen 220 mg + paracetamol 300 mg + pamabrom 25 mg fixed dose combination reduced pain intensity (p<0.001). In addition, the proportion of patients with pain reduction by at least 50% at the end of the treatment was 70.7%. The study demonstrated that this drug represents a safe and tolerated treatment, reducing pain intensity and premenstrual symptoms.
Medicine and Pharmacology, Obstetrics and Gynaecology
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
,
,
,
,
*
