Optimizing outcomes with polymethylmethacrylate fillers.

INTRODUCTION: The ideal filler should be long-lasting, biocompatible, chemically inert, soft and easy to use, and have a long history of safety. This review focuses on the evolution and development of the PMMA-collagen gel, Bellafill, and the 10 years of postmarketing experience of Bellafill since it received premarket approval (PMA) from the FDA as Artefill in 2006. Artefill was rebranded to Bellafill in 2015. METHODS: The authors conducted a literature search on PubMed for key articles describing the steps in which Arteplast, a PMMA filler developed in 1989, led to the development of Bellafill, the only PMMA filler approved by the US FDA for the treatment of nasolabial folds and acne scar correction. The factors governing efficacy and safety were also evaluated for the major PMMA fillers available in the world. RESULTS: The process of manufacturing and purifying PMMA has played a major role in minimizing adverse events for Bellafill. Postmarketing surveillance data for the 2007-2016 period show that for more than 530 000 Bellafill syringes distributed worldwide, 11 confirmed granulomas (excluding clinical trial data) (0.002% of syringes sold) have been reported. Data on other PMMA fillers are limited and inconsistent. The authors suggest that adverse events are often attributable to lack of proficiency in treatment technique and other factors. CONCLUSION: Bellafill has demonstrated an excellent safety and effectiveness profile in multiple clinical studies, customer feedback, and 10 years of postmarketing surveillance experience. Adverse events occur with all fillers for a variety of reasons. In addition to quality of the product, injector skill and technique are critical to ensuring good clinical outcomes.

Costs of eprosartan versus diuretics for treatment of hypertension in a geriatric population: an observational, open-label, multicentre study.

BACKGROUND: Diuretics are considered to be agents of first choice when treating hypertension in the elderly because of their clinical efficacy and, in particular, their low cost. Indeed, the latter consideration has been used by health resource managers to promote the use of diuretics. However, when considering the costs of treating hypertension in a population it is also necessary to assess the adverse effects that diuretics produce, particularly in elderly people. OBJECTIVE: To compare the overall expenditure associated with the treatment of hypertension (specifically the angiotensin II type 1 receptor antagonist eprosartan vs diuretics) in an elderly population, taking into consideration not only the drug acquisition costs but also the adverse effects of treatment and the costs associated with such adverse effects. METHODS: This was a prospective, observational, nonrandomized, open-label, multicentre study based in eight community health centres and the Hypertension Unit of the University Hospital of Salamanca, Spain. The study included 220 hypertensive geriatric outpatients (males and females aged >or=65 years) referred from general practitioners and the Hypertension Unit, with a mean age of 71.8 years and distributed into two groups: one (n = 90) treated with diuretics and the other (n = 130) treated with eprosartan. Following an initial clinical assessment of patients at the beginning of the study, monitoring of treatment continued for 1 year with follow-up consultations scheduled for 3, 6 and 12 months. Both the costs relating to acquisition of the drugs and the costs derived from secondary adverse effects of drug treatment were included in the analysis. RESULTS: The response to the antihypertensive therapy was similar in both groups. In patients taking diuretics, adverse events resulted in increased use of healthcare resources because of urinary incontinence, purchase of adsorbents, hyponatraemia and the need to admit two patients to hospital. The patient/day cost was euro 1.05 for the group treated with diuretics and euro 0.98 for the group treated with eprosartan (year of costing 2006). CONCLUSION: In the geriatric population, the acquisition cost of the prescribed diuretics is not representative of the actual antihypertensive treatment expenditure. According to the results obtained in our study, the overall costs of eprosartan therapy were no different to those of diuretics, despite the fact that eprosartan had a higher acquisition cost. This is consistent with a more favourable safety profile for eprosartan, which may possibly contribute to improved prescription compliance. This conclusion should be taken into consideration when evaluating economic restrictions on the use of drugs.

Cost-utility analysis of eprosartan compared to enalapril in primary prevention and nitrendipine in secondary prevention in Europe--the HEALTH model.

OBJECTIVE: To investigate the cost-utility of eprosartan versus enalapril (primary prevention) and versus nitrendipine (secondary prevention) on the basis of head-to-head evidence from randomized controlled trials. METHODS: The HEALTH model (Health Economic Assessment of Life with Teveten for Hypertension) is an object-oriented probabilistic Monte Carlo simulation model. It combines a Framingham-based risk calculation with a systolic blood pressure approach to estimate the relative risk reduction of cardiovascular and cerebrovascular events based on recent meta-analyses. In secondary prevention, an additional risk reduction is modeled for eprosartan according to the results of the MOSES study ("Morbidity and Mortality after Stroke--Eprosartan Compared to Nitrendipine for Secondary Prevention"). Costs and utilities were derived from published estimates considering European country-specific health-care payer perspectives. RESULTS: Comparing eprosartan to enalapril in a primary prevention setting the mean costs per quality adjusted life year (QALY) gained were highest in Germany (Euro 24,036) followed by Belgium (Euro 17,863), the UK (Euro 16,364), Norway (Euro 13,834), Sweden (Euro 11,691) and Spain (Euro 7918). In a secondary prevention setting (eprosartan vs. nitrendipine) the highest costs per QALY gained have been observed in Germany (Euro 9136) followed by the UK (Euro 6008), Norway (Euro 1695), Sweden (Euro 907), Spain (Euro -2054) and Belgium (Euro -5767). CONCLUSIONS: Considering a Euro 30,000 willingness-to-pay threshold per QALY gained, eprosartan is cost-effective as compared to enalapril in primary prevention (patients >or=50 years old and a systolic blood pressure >or=160 mm Hg) and cost-effective as compared to nitrendipine in secondary prevention (all investigated patients).

Assessment of once-daily eprosartan, an angiotensin II antagonist, in patients with systemic hypertension. Eprosartan Study Group.

A multicenter, randomized, double-masked, placebo-controlled trial was conducted to assess the efficacy of once-daily eprosartan, a nonbiphenyl, nontetrazole angiotensin II-receptor antagonist, in 243 patients with mild-to-moderate systemic hypertension (sitting diastolic blood pressure [SitDBP], 95-114 mm Hg). After a 3-to 5-week single-masked placebo run-in period to obtain baseline values, patients were randomly allocated to receive 600 mg eprosartan once daily or placebo for 8 weeks. All clinic blood pressure measurements were made 24 hours +/-90 minutes after dosing. Eprosartan produced statistically and clinically significant reductions in SitDBP(-7.5+/-0.8 mm Hg) and sitting systolic blood pressure (SitSBP) (-6.0+/-1.3 mm Hg) compared with placebo (SitDBP -1.9+/-0.7 mm Hg; SitSBP 0.8+/-1.2 mm Hg). The 95% confidence intervals for the difference from placebo were -8.1 to 4.1 for SitDBP and -11.0 to -4.0 for SitSBP (both, P<0.0001). The proportion of patients responding (SitDBP was <90 mm Hg or had decreased by > or =10 mm Hg from baseline at study end point) to eprosartan was significantly higher than the proportion of those responding to placebo (42% vs. 21%, respectively; P = 0.0003). Similar results were obtained in a subgroup analysis comparing patients aged <65 years with those aged > or =65 years. The total number of adverse events was similar in the eprosartan and placebo groups. Eprosartan 600 mg once daily was both well tolerated and effective, providing significant blood pressure reduction 24 hours after dosing in patients with mild-to-moderate systemic hypertension, regardless of age.