2,325 research outputs found

    Ibandronate (Bonviva) in the Treatment of Postmenopausal Osteoporosis

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    peer reviewedIbandronate is a nitrogen-containing bisphosphonate which has been shown to reduce vertebral fracture rates, when given orally either daily or intermittently. Non-vertebral antifracture efficacy of ibandronate has been derived from a post-hoc analysis focusing on patients at high risk of developing non-vertebral fractures (low bone mineral density at the femoral neck). Once-monthly administration of oral ibandronate has been linked to significantly greater increases in bone mineral density, at the spine, hip and femoral neck, compared to daily formulation. This monthly formulation has a safety profile similar to the one observed with the daily administration of the compound. Adherence to monthly bisphosphonates appears to be significantly higher than for daily or weekly administration

    Patient preference in the management of postmenopausal osteoporosis with bisphosphonates

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    The leading treatments for postmenopausal osteoporosis are the nitrogen-containing bisphosphonates, which are required long term for optimal benefit. Oral bisphosphonates have proven efficacy in postmenopausal osteoporosis in clinical trials, but in practice the therapeutic benefits are often compromised by patients’ low adherence. Nonadherence to bisphosphonate therapy negatively impacts outcomes such as fracture rate; fractures are in turn associated with decreased quality of life. The most common reason cited by patients for their nonadherence is that the strict dosing instructions for bisphosphonates are difficult to follow. One aspect of bisphosphonate administration that can be changed is dosing frequency and several studies have evaluated patient preferences for different dosing schedules. Studies have shown a preference for a weekly bisphosphonate regimen versus daily dosing and it has been demonstrated that this preference for reduced dosing frequency impacts on adherence. Ibandronate is the first nitrogen-containing oral bisphosphonate for osteoporosis that can be administered in a monthly regimen and two robust clinical studies demonstrated a strong patient preference for this monthly regimen versus a weekly regimen. It is important that physicians consider patient preference when prescribing treatment for osteoporosis to ensure that the disease is effectively managed for the long-term benefit of the patient

    Economic evaluation of osteoporosis screening strategy conducted in the Province of Liège with the cooperation of Liège Province Santé

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    peer reviewedThe Province of Liege has conducted an osteoporosis screening strategy for women aged 50 to 69 years. The objective of this study is to investigate the economic characteristics of the screening strategy and to assess its cost-effectiveness, using a Markov microsimulation model. Our analyses suggest that the osteoporosis screening strategy is efficient if the medical community and the patients fulfill the recommendations of the Province of Liege health authorities and if persistence is optimized. Therefore, bone mineral density (BMD) measurement should be performed in all individuals with positive ultrasound screening; individuals having a positive BMD diagnosis should be treated and adherence to therapy should be increased. Furthermore, to improve the efficiency of the screening strategy, we suggest to target screening on women with one or more clinical risk factors, or on women aged 65 years and older

    Critical analysis of valuation and strategical orientation of merger and acquisition deals in the pharmaceutical industry

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    Introduction: The pharmaceutical industry is undergoing major shifts due to changing macro and micro factors. As the industry is highly capital intensive and patents are expiring, the outlook is on generating inorganic growth, mainly through M&A. Using the income valuation approach, one analyses two completed deals in 2016 above 1bn USD. Thereafter one outlines the main motives behind M&A deals and concluded by discussing whether M&A harms medical innovations. Areas covered: The paper is based on empirical study questioning existing literature in order to critically analyse valuation and the strategical orientation of pharmaceutical companies Expert commentary: Pharmaceutical companies understand the changing market conditions and favour their expertise. The restructuring of the industry moves to small niche companies (I.e. Biopharma or biotech companies) researching key innovations and big companies purchasing them to develop them, create clinical trials and distribute them as this is a costly manner Conclusion: One can expect more M&A deals during the next years focusing on value rather than volume. Pharmaceutical players resilient to the market changes may survive if they change their business model from a traditional vertical one to outsourcing and diversification including external players

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

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    peer reviewedOsteoarthritis (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)

    Anti-fracture efficacy of intravenous ibandronate: how to translate epidemiological studies into daily clinical practice

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    peer reviewedNumerous epidemiological approaches are used to demonstrate the efficacy of a new chemical entity. In postmenopausal osteoporosis, anti-fracture efficacy can be assessed through prospective, randomized controlled trials, meta-analyses or real-life setting studies. Intravenous ibandronate was recently marketed, with the aim of optimizing drug absorption and adherence to treatment. Furthermore, this new formulation avoids gastrointestinal side effects and constrains linked to the oral intake of the medication. Spinal anti-fracture efficacy of IV ibandronate derives from a non-inferiority bridging study, using surrogate endpoints, i.e., bone mineral density and biochemical markers of bone turnover, compared to the oral daily formulation, previously registered for the treatment of osteoporosis in Europe. Coherent results from two separate meta-analyses have suggested that the non-vertebral anti-fracture efficacy of IV ibandronate is similar to that observed with oral, daily and weekly bisphosphonates. Similarly, a recent real-life setting study, based on claims from an US database, suggests that hip fractures are reduced, with IV ibandronate, to the same extend as they are with oral bisphosphonates. Notwithstanding, those results should probably be confirmed in an European setting, before being extrapolated, in daily practice, to the Belgian population
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