Highly purified chondroitin sulfate: a literature review on clinical efficacy and pharmacoeconomic aspects in osteoarthritis treatment

Osteoarthritis (OA) is the most prevalent musculoskeletal disease and a major cause of negative relevant outcomes, associated with an ever-increasing societal burden. Pharmaceutical-grade chondroitin sulfate (CS) was repeatedly reported to reduce pain and improve function in patients with OA. This article aims to review the evidence for the role of highly purified (hp) CS (Condrosulf®, IBSA) in the treatment of OA. We collected and reported evidence concerning (1) efficacy of hpCS 800 mg/day in the treatment of OA affecting the knee, hand and hip; (2) efficacy and safety of hpCS 1200 mg/day also in the oral gel formulation; (3) the safety profile of hpCS; (4) the difference of hpCS and pharmaceutical-grade formulations versus food supplements; (5) pharmacoeconomic added value of hpCS. The data support that hpCS is an effective and safe treatment of OA, with its effect already evident at 30 days; in addition, its beneficial action is prolonged, being maintained for at least 3 months after the drug is discontinued. Full safety reports’ analyses confirm that CS is safe to use and has almost no side effects, in particular, it showed better gastrointestinal tolerance if compared with non-steroidal anti-inflammatory drugs (NSAIDs). Moreover, the therapeutic strategy has proved to be cost-effective: treatment with CS reduced the use of NSAIDs and their side effects. © 2020, The Author(s)

Nutritional status and nutritional treatment are related to outcomes and mortality in older adults with hip fracture

Malnutrition is very prevalent in geriatric patients with hip fracture. Nevertheless, its importance is not fully recognized. The objective of this paper is to review the impact of malnutrition and of nutritional treatment upon outcomes and mortality in older people with hip fracture. We searched the PubMed database for studies evaluating nutritional aspects in people aged 70 years and over with hip fracture. The total number of studies included in the review was 44, which analyzed 26,281 subjects (73.5% women, 83.6 ± 7.2 years old). Older people with hip fracture presented an inadequate nutrient intake for their requirements, which caused deterioration in their already compromised nutritional status. The prevalence of malnutrition was approximately 18.7% using the Mini-Nutritional Assessment (MNA) (large or short form) as a diagnostic tool, but the prevalence was greater (45.7%) if different criteria were used (such as Body Mass Index (BMI), weight loss, or albumin concentration). Low scores in anthropometric indices were associated with a higher prevalence of complications during hospitalization and with a worse functional recovery. Despite improvements in the treatment of geriatric patients with hip fracture, mortality was still unacceptably high (30% within 1 year and up to 40% within 3 years). Malnutrition was associated with an increase in mortality. Nutritional intervention was cost effective and was associated with an improvement in nutritional status and a greater functional recovery. To conclude, in older people, the prevention of malnutrition and an early nutritional intervention can improve recovery following a hip fracture

Reducing Stigma toward the Transgender Community: An Evaluation of a Humanizing and Perspective-Taking Intervention

Transgender (TG) individuals, or those whose gender identities, expressions and/or behaviors differ from their biological sex (Kirk & Kulkarni, 2006) feel there is a pervasive pattern of discrimination and prejudice directed toward them (Lombardi et al., 2001). In comparison to their heterosexual peers, LGBT youth and emerging adults are at increased risk for a host of adverse outcomes including: suicide, depression, harassment, and victimization (IOM, 2011). Stigma has been characterized as encompassing several components: labeling, making an association between the label and a negative stereotype, separating those who are different as an “out-group” and discriminating. In a recent analysis of the transgender experience, Hill (2002) described three key constructs that can be used to understand negative emotions and behaviors toward transgender individuals: transphobia – an emotional disgust toward gender non-conforming individuals; genderism – a belief that gender non-conforming individuals are pathological or disordered; gender bashing – assault or harassment of gender non-conforming individuals. Recent work on minority stress posits a distal-proximal model of stress in which a person identifies with and makes proximal, distal social attitudes that can have negative effects on their psychological well-being (Meyer, 2003). Thus, stigmatized attitudes and behaviors not only have the potential to contribute to violence or discriminatory behavior but also have a direct impact on the psychological health of the target individual. Thus, the question of how to change negative attitudes and behaviors toward TG individuals is paramount. Researchers have sought to develop interventions aimed at reducing stigma with three basic strategies identified: protest, education and contact (Corrigan & Penn, 1999). However, to date only two such strategies have garnered empirical support: contact and education. In relation to mental illness, education strategies have received limited support (Holmes et al., 1999; see Luty et al., 2007 for an exception). In contrast, contact-based interventions yield the most dramatic changes in attitudes and behaviors; contact involving media depictions have also been demonstrated to yield positive attitude change. Comparing traditional diagnosis-centered teaching about mental illness to a humanizing approach that required students to write a first-person narrative about suffering from a mental illness, Mann and Himelein (2008) found that attitudes changed only when students were required to adopt the perspective of a mentally ill individual. In their recent meta-analysis, Pettigrew and Tropp (2006) demonstrated that contact reduces prejudice and is particularly effective when it occurs under favorable conditions (e.g., conditions of equality, cooperation, and institutional support). While a wealth of research has supported the contact hypothesis related to changing negative attitudes toward ethnic minorities, the mentally ill, the homeless, gays/lesbians and other stigmatized groups, there have been a limited number of studies evaluating associations between contact and attitudes toward the TG community (Harvey, 2002; Hill & Willoughby, 2005) and no controlled studies to evaluate the efficacy of such methods. The current study extends work evaluating anti-stigma interventions to the TG community and seeks to evaluate whether attitude change will differ between participants receiving basic education about the transgender community and those who are educated about TG through media depictions of TG families and are asked to engage in a perspective-taking task. We hypothesize that participants in the humanizing condition who view a documentary and write a first-person narrative of transgender experiences will show a more significant change in transphobia, genderist attitudes and desire for social distance across time relative to participants in the education-only condition signaling less stigmatized and prejudicial attitudes at post-test. Hodson (2011) recently examined the existing contact literature and found that, consistent with Pettigrew’s (1998) focus on individual differences, intergroup contact was effective (and perhaps even more effective) among individuals who were intolerant and cognitively rigid. Religious fundamentalism has been associated with anti-homosexual sentiment (Fulton et al., 1999). Whether religiosity is similarly associated with negative attitudes toward TG individuals will be explored. Whether religiosity and prior contact with the LGBTQ community will moderate intervention outcomes will also be explored

Comment on: The Effect of Intra-articular Hyaluronic Acid Injections and Payer Coverage on Total Knee Arthroplasty Procedures: Evidence From Large US Claims Database

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Cost-effectiveness of buffered soluble alendronate 70 mg effervescent tablet for the treatment of postmenopausal women with osteoporosis in Italy

Summary: The use of buffered soluble alendronate 70 mg effervescent tablet, a convenient dosing regimen for bisphosphonate therapy, seems a cost-effective strategy compared with relevant alternative treatments for postmenopausal women with osteoporosis aged 60 years and over in Italy. Introduction: To assess the cost-effectiveness of buffered soluble alendronate (ALN) 70 mg effervescent tablet compared with relevant alternative treatments for postmenopausal osteoporotic women in Italy. Methods: A previously validated Markov microsimulation model was adjusted to the Italian healthcare setting to estimate the lifetime costs (expressed in €2019) per quality-adjusted life-years (QALY) of buffered soluble ALN compared with generic ALN, denosumab, zoledronic acid and no treatment. Pooled efficacy data derived from the NICE network meta-analysis were used for bisphosphonate treatments. Two treatment duration scenarios were assessed: 1 year using persistence data derived from an Italian prospective observational study including 144 and 216 postmenopausal osteoporotic women on buffered soluble ALN and oral ALN, respectively, and 3 years. Analyses were conducted for women 60–80 years of age with a bone mineral density T-score ≤ − 3.0 or with existing vertebral fractures. Results: In all simulated populations, buffered soluble ALN was dominant (more QALYs, lower costs) compared to denosumab. The cost per QALY gained of buffered soluble ALN compared to generic ALN and no treatment always falls below €20,000 per QALY gained. In the 1-year treatment scenario, zoledronic acid was associated with more QALY than buffered soluble ALN but the cost per QALY gained of zoledronic acid compared with buffered soluble ALN was always higher than €70,000, while buffered soluble ALN was dominant in the 3-year treatment scenario. Conclusion: This study suggests that buffered soluble ALN represents a cost-effective strategy compared with relevant alternative treatments for postmenopausal osteoporosis women in Italy aged 60 years and over. © 2021, The Author(s)

Monthly oral ibandronate is well tolerated and efficacious in postmenopausal women: Results from the monthly oral pilot study

Context: Ibandronate, a potent, nitrogen-containing bisphosphonate developed for intermittent administration in postmenopausal osteoporosis, aims to overcome current adherence issues with daily and weekly oral bisphosphonates through once-monthly oral dosing. Objective: The purpose of this study was to investigate the safety, pharmacodynamics, and pharmacokinetics of once-monthly oral ibandronate. Design: A randomized, 3-month, double-blind, placebo-controlled, phase I study (Monthly Oral Pilot Study) was conducted. Setting: The study was conducted at five clinical trial centers in the United Kingdom and Belgium. Patients or Other Participants: Subjects were postmenopausal women (age, 55 - 80 yr; >= 3 yr post menopause; n = 144). Intervention(s): Once-monthly oral ibandronate 50, 100, or 150 mg or placebo was used. After the first cycle, the 50-mg arm was split, with participants continuing on either 50 or 100 mg. Main Outcome Measure(s): Primary outcome measures were safety, serum and urinary C-telopeptide (CTX), and serum ibandronate AUC(0-infinity). Results: Once- monthly oral ibandronate was well tolerated, with a similar overall and upper gastrointestinal safety profile to placebo. Once- monthly ibandronate was also highly effective in decreasing bone turnover; substantial reductions from baseline in serum CTX (-56.7% and -40.7% in the 150- and 100- mg arms, respectively; P < 0.001 vs. placebo) and urinary CTX (-54.1% and -34.6%, respectively; P < 0.001 vs. placebo) were observed at d 91 (30 d after the final dose). Analysis of the area under the effect curve (d1 - 91) for change from baseline (percent x days) in serum CTX and urinary CTX indicated a dose- response relationship. The AUC(0-infinity) for ibandronate increased with dose but not in a dose- proportional manner. Conclusions: These findings indicate a potential role for once-monthly oral ibandronate in the treatment of postmenopausal osteoporosis

Pharmacological Treatment of Ambulatory Schizophrenic Patients in Belgium

peer reviewedBACKGROUND: the objective of this study was twofold:1) Describe the use of antipsychotic treatments in ambulatory patients suffering from schizophrenia in Belgium.2) Evaluate to which extend antipsychotic treatment prescribing patterns are in accordance with published treatment guidelines. METHOD: A cross-sectional survey was carried out in 16 Belgian hospitals selected from a sample of 67 hospitals. The hospitals were equally distributed between the north and south part of the country and were representative of Belgian practice. During 2 months, participating psychiatrists were asked to record the medication use as well as demographic parameters of all consecutive ambulatory patients seen at their consultation or attending a day-hospital. Data concerning 1000 ambulatory patients with schizophrenia or schizoaffective disorder were collected. RESULTS: In Belgium, the use of atypical antipsychotics is frequent (69%) in ambulatory patients with schizophrenia. In the overall sample, 73% receive only one antipsychotic drug. The majority of patients are treated with drugs of only one antipsychotic drug group, either first- typical (29.8%) or second-generation, atypical antipsychotics (53.2%). 15.8% of patients combine different types of antipsychotics. Antipsychotic dosing is adequate for the majority of patients but about one fifth receives a higher than recommended dose as per package inserts. Polypharmacy remains within reasonable limits. The use of concomitant medication varies according the antipsychotic treatment: patients who take second-generation antipsychotics only, receive the least additional drugs. CONCLUSION: Atypical antipsychotics appear to be the first line treatment for schizophrenic psychosis. Psychiatrists working with ambulatory patients are well aware of treatment guidelines and follow them quite adequately

Intravenous ibandronate injections are at least as effective as daily oral ibandronate: consistent effect across subgroups

peer reviewe

Long-term treatment of postmenopausal osteoporotic women with strontium ranelate : results at 10 years

Peer reviewe

An update on the use of conventional and biological disease-modifying anti-rheumatic drugs in hand osteoarthritis

Osteoarthritis (OA) is a highly prevalent condition worldwide associated with pain, progressive disability, reduced participation in social activities, and impaired quality of life. Despite its growing burden, the therapeutic options are still limited and almost exclusively addressed to symptoms’ management, while no disease-modifying OA drugs able to prevent or retard disease progression are actually available. For these reasons, in the last decades, relevant efforts to find new potential therapeutic targets in OA have been made and a number of existing conventional and biological disease-modifying anti-rheumatic drugs (DMARDs), including hydroxychloroquine (HCQ), methotrexate (MTX), tumor necrosis factor (TNF)-α, interleukin (IL)-1, and IL-6 inhibitors, commonly used to treat inflammatory rheumatic diseases, have been repurposed for the treatment of OA and explored also in hand osteoarthritis (HOA). The current narrative review was aimed to provide a comprehensive and updated understanding of the possibilities and the criticisms related to the treatment of HOA with conventional and biological DMARDs. Unfortunately, therapy with conventional and biologic drugs in HOA has not achieved the expected success, despite a rationale for their use exists. Thus, our findings outline the urgent need to enhance the exploration of HOA basic molecular mechanisms to find new potential therapeutic targets, personalized for each patient, and appropriate for the different subsets of HOA and for the different phases of disease