Cost-effectiveness analysis of levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg versus other long-acting reversible contraceptives for contraception in Spain.

INTRODUCTION: Condoms and combined oral contraceptive pills are widely used in Spain with high failure rates. Long-Acting Reversible Contraceptive (LARC) methods offer better efficacy and adherence and reduce unintended pregnancies (UP) compared with short-acting reversible contraceptive (SARC) methods. OBJECTIVE: To assess the cost-effectiveness of LNG-IUS 52 mg (Mirena®) versus other LARC for contraception in Spain. MATERIALS AND METHODS: A Markov model with annual cycles and an eight-year time horizon was developed from the Spanish national healthcare system (NHS) perspective, considering costs for contraceptive method acquisition, health care resources (HCR) and UP. Effectiveness was based on failure and discontinuation rates. Sensitivity analyses were performed to test the model's robustness. RESULTS: LNG-IUS 52 mg (Mirena®) resulted in lower costs and fewer UP versus LNG-IUS 13.5 mg (Jaydess®), Implant (Implanon®) and Copper IUD. LNG-IUS 52 mg (Levosert®) prevented the same UP events at a higher cost. LNG-IUS 19.5 mg (Kyleena®) was the most effective option, due to a lower discontinuation rate. CONCLUSIONS: LNG-IUS 52 mg (Mirena®) is the least costly LARC, driven by lower acquisition costs and reduced HCR utilisation. Increasing LNG-IUS 52 mg (Mirena®) uptake in contraception could generate further cost savings for the Spanish NHS and reduce economic burden of UP.

Levonorgestrel-releasing intrauterine system (LNG-IUS; Mirena^®) is an effective and cost-saving long-acting reversible contraceptive (LARC) method compared with other similar methods in Spain over an eight-year time horizon, and Kyleena^® was the most effective option.

Use of Contraceptive Methods Among Women in the General Population and Female Gynecologists in Spain: the ELEGIAN Survey.

Background: The contraceptive preferences of obstetricians and gynecologists (OB/GYNs) are thought to influence the contraceptive counseling they provide. The purpose of this study was to assess contraceptive preferences of OB/GYNs and women in the general population (WGP) in the current Spanish contraceptive scenario. Materials and Methods: Anonymous online survey of 100 OB/GYNs and 1,217 WGP aged 23-49 years. Results: WGP were younger (35.3 ± 7.3 vs. 37.9 ± 6.2 years, respectively) and less likely to have stable partners (64.7% vs. 84.0%) and children (49.1% vs. 62.0%) (all p < 0.05 vs. OB/GYNs). Seventy-nine percent versus 82%, respectively, used contraceptive methods, with condoms used most frequently by WGP (37% vs. 22% by OB/GYNs; p < 0.05) and pills by OB/GYNs (26% vs. 21% by WGP; p > 0.05). Intrauterine devices (IUDs) were more frequently used by OB/GYNs (20% vs. 5%; p < 0.05), especially the levonorgestrel-releasing intrauterine devices (LNG-IUDs) (18% vs. 2.6%; p < 0.05). The highest-rated methods were condoms among WGP and LNG-IUDs among OB/GYNs. Effectiveness was the most valued attribute of contraceptive methods for both. Reasons related to convenience were the main reason for choosing IUDs. OB/GYNs prescribed the contraceptive method in 40% of cases. Conclusions: Our study reveals differences between female OB/GYNs and WGP in contraceptive methods use and rating. The use of LNG-IUDs was much higher among OB/GYNs.

Safety and Efficacy of Bone Marrow-Derived Mesenchymal Stem Cells for Chronic Patellar Tendinopathy (With Gap >3 mm) in Patients: 12-Month Follow-up Results of a Phase 1/2 Clinical Trial.

Background: In a previous study, the authors found that at 6 months after treatment with a 20 × 106 dose of bone marrow-derived mesenchymal stem cells (BM-MSCs), patients showed improved tendon structure and regeneration of the gap area when compared with treatment using leukocyte-poor platelet-rich plasma (Lp-PRP). The Lp-PRP group (n = 10), which had not seen tendon regeneration at the 6-month follow-up, was subsequently offered treatment with BM-MSCs to see if structural changes would occur. In addition, the 12-month follow-up outcomes of the original BM-MSC group (n = 10) were evaluated. Purpose: To evaluate the outcomes of all patients (n = 20) at 12 months after BM-MSC treatment and observe if the Lp-PRP pretreated group experienced any type of advantage. Study Design: Cohort study; Level of evidence, 2. Methods: Both the BM-MSC and original Lp-PRP groups were assessed at 12 months after BM-MSC treatment with clinical examination, the visual analog scale (VAS) for pain during daily activities and sports activities, the Victorian Institute of Sport Assessment-Patella score for patellar tendinopathy, dynamometry, and magnetic resonance imaging (MRI). Differences between the 2 groups were compared with the Student t test. Results: The 10 patients originally treated with BM-MSCs continued to show improvement in tendon structure in their MRI scans (P < .0001), as well as in the clinical assessment of their pain by means of scales (P < .05). Ten patients who were originally treated with Lp-PRP and then with BM-MSCs exhibited an improvement in tendon structure in their MRI scans, as well as a clinical pain improvement, but this was not significant on the VAS for sports (P = .139). Thus, applying Lp-PRP before BM-MScs did not yield any type of advantage. Conclusion: The 12-month follow-up outcomes after both groups of patients (n = 20) received BM-MSC treatment indicated that biological treatment was safe, there were no adverse effects, and the participants showed a highly statistically significant clinical improvement (P < .0002), as well as an improvement in tendon structure on MRI (P < .0001). Preinjection of Lp-PRP yielded no advantages.

Sensitivity to Change of the SAMANTA Questionnaire, a Heavy Menstrual Bleeding Diagnostic Tool, After 1 Year of Hormonal Treatment.

Background: The validated SAMANTA questionnaire allows identification of women with heavy menstrual bleeding (HMB); that is, with excessive menstrual bleeding that interferes with quality of life (QoL). We assessed its value for monitoring HMB treatment in clinical practice. Material and Methods: This is a prospective observational study conducted between December 2018 and March 2021 in consecutively recruited women with HMB attending gynecologists' offices who started a hormonal treatment. Sociodemographic characteristics were recorded at enrollment. At baseline and month 12, we assessed the HMB (SAMANTA questionnaire), the global impression of menstrual bleeding severity in patients (PGI-S) and clinicians (CGI-S), and the QoL (SF36). At month 12, we assessed the global impression of menstrual bleeding change in patients (PGI-C) and clinicians (CGI-C). Changes in SAMANTA questionnaire score at month 12 were compared with the presence of amenorrhea and changes in blood loss, menstrual period duration, and PGI-S, PGI-C, CGI-S, and CGI-C. Results: The study included 371 women aged 41.2 ± 6.5 years, 87% of whom were using the levonorgestrel intrauterine system. The SAMANTA questionnaire score significantly decreased in 97.3% of women. The decrease was greater in women reporting a reduction in blood loss, shorter menstrual bleeding duration, or a strong improvement in menstrual bleeding severity (PGI-S and CGI-S) or amount (PGI-C and CGI-C) (p < 0.001 for all), but not amenorrhea. SF-36 domains improved significantly; changes being inversely associated with changes in the SAMANTA questionnaire score. Conclusions: The SAMANTA questionnaire seems a valuable tool for monitoring hormonal treatment for HMB. ClinicalTrials.gov identifier NCT03751800.

Real-world satisfaction and menstrual bleeding pattern with available LNG-IUD among Spanish young women.

OBJECTIVE: The aim of this study was to evaluate the satisfaction and menstrual bleeding pattern with levonorgestrel-releasing intrauterine systems (LNG-IUD) in young women. METHODS: A prospective, multicentre, non-interventional study with 1-year follow-up was conducted in Spain. Participants were women between 18 and 30 years old who freely choose any available LNG-IUD for contraception. Satisfaction with LNG-IUD was measured with a 5-point Likert scale. Type of LNG-IUD, menstrual bleeding pattern and satisfaction with it, easiness of insertion and pain during procedure were collected. RESULTS: A total of 555 women (37.3% parous, 62.7% nulliparous) (mean age 25.8 ± 3.5) completed the study. After 12 months, 92.4% of women were satisfied or very satisfied with the LNG-IUD, with no differences by parity status, type of IUD or baseline menstrual bleeding pattern. Satisfaction with the LNG-IUD correlated with satisfaction with menstrual bleeding pattern at 12 months. Up to 88.7% of women were satisfied or very satisfied with their menstrual bleeding pattern at 12 months in comparison to 41.5% at baseline (p < 0.001). Adverse events (AE)-related discontinuation rate was low (2.2%). CONCLUSIONS: Satisfaction with LNG-IUD is very high among young Spanish women, regardless of parity and menstrual bleeding pattern at baseline.

Heavy menstrual bleeding and its detection in clinical practice. / Sangrado menstrual abundante y su detección en la práctica clínica.

Heavy menstrual bleeding (HMB) is defined as excessive menstrual blood loss that interferes with quality of life. It is an under-diagnosed and under-treated disorder due to the poor correlation between patient perception and objective menstrual blood loss, as well as the scarcity of validated diagnostic tools. Anaemia caused by HMB is a common problem, underestimated on many occasions and with consequences that go beyond the scope of gynaecology. Despite the condition's negative effect on quality of life, most of the tools validated to detect HBM do not take this into account. The aim of this paper is to review the main instruments available to detect HMB, their advantages and disadvantages, their applicability in routine clinical practice, and to recommend those with the best characteristics.

Effect of Autologous Expanded Bone Marrow Mesenchymal Stem Cells or Leukocyte-Poor Platelet-Rich Plasma in Chronic Patellar Tendinopathy (With Gap >3 mm): Preliminary Outcomes After 6 Months of a Double-Blind, Randomized, Prospective Study.

BACKGROUND: Patellar tendinopathy is common. The success of traditional management, including isometric or eccentric exercises combined with shockwave therapy and even surgery, is limited. Therefore, it is important to determine whether biological treatments such as ultrasound-guided intratendinous and peritendinous injections of autologous expanded bone marrow mesenchymal stem cells (BM-MSCs) or leukocyte-poor platelet-rich plasma (Lp-PRP) improve clinical outcomes in athletic patients with patellar tendinopathy. STUDY DESIGN: Randomized controlled trial; Level of evidence, 2. METHODS: A prospective, double-blinded, randomized, 2-arm parallel group, active controlled, phase 1/2 single-center clinical study was performed in patients who had proximal patellar tendinopathy with a lesion >3 mm. A total of 20 participants (age 18-48 years) with pain for >4 months (mean, 23.6 months) and unresponsive to nonoperative treatments were randomized into 2 groups. Of these, 10 participants were treated with BM-MSC (20 × 106 cells) and 10 with Lp-PRP. Both groups performed the same postintervention rehabilitation protocol. Outcomes included the Victorian Institute of Sport Assessment for pain (VISA-P), self-reported tendon pain during activity (visual analog scale [VAS]), muscle function by dynamometry, tendon thickness and intratendinous vascularity by ultrasonographic imaging and Doppler signal, ultrasound tissue characterization (UTC) echo type changes, and magnetic resonance imaging (MRI) T2-weighted mapping changes. Participants were followed longitudinally for 6 months. RESULTS: The average VAS scores improved in both groups at all time points, and there was a significant reduction in pain during sporting activities (P < .05). In both groups, the average mean VISA-P scores at 6 months were significantly increased compared with baseline (66 BM-MSC group and 72.90 Lp-PRP group), with no significant differences in VAS or VISA-P scores between the groups. There were statistically significant greater improvements in tendon structure on 2-dimensional ultrasound and UTC in the BM-MSC group compared with the Lp-PRP group at 6 months. Similarly, the BM-MSC group demonstrated significant evidence of restoration of tendon structure on MRI compared with the Lp-PRP group at 6 months. Only the participants in the BM-MSC group showed evidence of normalization of tendon structure, with statistically significant differences between the groups on T2-weighted, fat-saturated sagittal and coronal scans and hypersignal in T2-weighted on spin-echo T2-weighted coronal MRI scan. Both treatments were safe, and no significant adverse events were reported in either group. CONCLUSION: Treatment with BM-MSC or Lp-PRP in combination with rehabilitation in chronic patellar tendinopathy is effective in reducing pain and improving activity levels in active participants. Participants who received BM-MSC treatment demonstrated greater improvement in tendon structure compared with those who received Lp-PRP. REGISTRATION: 2016-001262-28 (EudraCT identifier); NCT03454737 (ClinicalTrials.gov identifier).

[Statins diabetogenicity: are all the same? state of art]. / La diabetogenicidad de las estatinas: ¿son todas iguales? Estado de la cuestión.

Statins are the cornerstone of cardiovascular prevention for general population, and in patients with type 2 diabetes mellitus (T2DM). However, statin therapy predisposes to type 2 diabetes, particularly in patients with predisposition to this condition. Some statins have been associated with increases in blood glucose in patients with or without DM2, and others have shown to have neutral effects, varying from one another their glucose or diabetogenic capacity. In many statin trials the incidence of DM2 has not been systematically evaluated and others the power to detect differences between statins is lacking. Evidence highest quality available comes from the meta-analysis of controlled clinical trials. The only controlled clinical trial to evaluate the incidence of new-onset T2DM is the J-PREDICT conducted with pitavastatin in patients with abnormal glucose tolerance. Preliminary results of this study show that pitavastatin is associated with a significant decrease in the incidence of de novo T2DM compared to only modification lifestyle. Therefore, pitavastatin may be an appropriate therapeutic alternative of choice to reduce vascular risk in patients with T2DM or at risk of presenting it.

[Effectivity and satisfaction with the treatment for dyslipidemia with pitavastatin. Multicentric, descriptive, post authorised and observational study (REINA study)]. / Efectividad y satisfacción del tratamiento de la dislipidemia con pitavastatinastudio observacional, postautorización, descriptivo y multicéntrico (estudio REINA).

INTRODUCTION: Evaluating the therapeutical adherence as well as the patient' satisfaction with the treatment should be considered to optimize lipidic control. The REINA Study evaluates the grade of satisfaction in dyslipidemic patients treated with pitavastatin. METHODS: The current study was observational, descriptive, transversal and multi-centric with patients from our country only. The following data were collected in each case: Morisky-Green test and TSQM-9 for patients older than 18 years old, with dyslipidemia treated with pitavastatin in the last 12 weeks. RESULTS: We studied 6,489 patients (60.0% males) from Primary Health (52.7%) and Specialised Health (47.3%), with age (mean) = 60.9 ± 11.2 years by aleatory sampling. 72.3% of patients achieved an adequate control with 2mg/day of pitavastatin. General satisfaction with the treatment was 73.20 points (95% CI: 58.17-87.23). Patients who followed the treatment (65%) showed better data of satisfaction with the drug (77.70 [95% CI: 65.20-90.20]), of global satisfaction (75.00 [95% CI: 61.50-88.50]) and their satisfaction with the drug efficiency was higher (72.50 [95% CI: 57.70-87.30]) than in the patients who did not finish the treatment (72.70 [95% CI: 59.30-85.74]; 68.5 [95% CI: 53.20-83.80] and 67.80 [95% CI: 53.70-81.90], respectively), P < .0001, without any difference between the two primary care systems. CONCLUSIONS: The validation of the satisfaction is a crucial indicator in the evaluation of the services offered in health. Patients with the highest grade of satisfaction present better therapeutical adherence, and such a relation is bidirectional. The individuals who are satisfied and who followed the treatment obtained better clinical results. Pitavastatin is an effective therapeutic alternative for patients with dyslipidemia.