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Variation in Number of Doses, Bottle Volume, and Calculated Yearly Cost of Generic and Branded Latanoprost for Glaucoma. - American journal of ophthalmology
To evaluate discrepancies in doses per bottle, bottle fill volume, and cost among branded and generic formulations of latanoprost.Comparative economic analysis.This study was conducted at the Ruiz Department of Ophthalmology and Visual Science at The University of Texas Health Science Center at Houston (UTHealth). Four regionally available latanoprost formulations were measured. Number of drops per bottle and actual bottle fill volume were measured for a calculated sample size (10 bottles). Annual cost (using average wholesale price), days use per bottle, drops per milliliter, and number of bottles used per year were calculated. Data were summarized using mean and standard deviation; 1-way analysis of variance and post hoc Tukey's studentized range test were used for comparing means among manufacturers.Pfizer's branded lantanoprost, Xalatan (New York, New York, USA), had the largest fill volume (PÂ <Â .001). Pfizer had the highest yearly cost at $1198 (P < .001), whereas Akorn (Lake Forest, Illinois, USA) and Bausch & Lomb (Rochester, New York, USA) had the lowest ($184 and $201, respectively). Pfizer and Bausch & Lomb had the most drops per bottle (87.3 and 88.7, respectively), which was statistically more (P < .001) than either Akorn or Sandoz (Princeton, New Jersey, USA) (77.6 and 76.6, respectively), but there was no statistical difference among the standard deviation of drops per bottle (Levene 0.14).Annual cost and number of doses per bottle, factors important to patients, vary significantly depending on the manufacturer of latanoprost. Practitioners can better advise patients by being aware of theseÂ differences.Copyright Â© 2016 Elsevier Inc. All rights reserved.
Efficacy and safety of a 21/7-active combined oral contraceptive with continuous low-dose ethinyl estradiol. - Contraception
Substituting low-dose ethinyl estradiol (EE) for the hormone-free interval in combined oral contraceptives (COCs) may enhance ovarian suppression and improve tolerability. This noncomparative phase 3 study evaluated the efficacy and safety of a 21/7-active COC regimen including 21days of desogestrel (DSG)/EE followed by 7days of EE.This multicenter, open-label, phase 3, single-arm study enrolled sexually active women aged 18-40years at risk for pregnancy. Women received up to 1year, or 13 consecutive 28-day cycles, of DSG 150mcg/EE 20mcg for 21days and EE 10mcg alone for 7days. Participants kept diaries to record compliance, bleeding/spotting and other contraceptive use. Efficacy was measured using the Pearl Index (PI) and life-table approach. Safety and tolerability were assessed primarily through reported adverse events (AEs).A total of 2858 women enrolled and 1680 completed the study. Forty-six pregnancies in 2401 women aged 18-35years occurred after COC initiation and up to 7days after last DSG/EE or EE-only tablet was taken. When cycles in which another contraceptive method was used were excluded, the PI was 2.68 [95% confidence interval (CI), 1.96-3.57]. The cumulative pregnancy rate after 1year of treatment was 2.47% (95% CI, 1.85-3.29) for all users aged 18-35years. When only cycles during which women considered compliant were included, the PI was 2.00 (95% CI, 1.39-2.80). AEs were similar to those seen with other oral contraceptives.This 21/7-active DSG/EE COC with 7days of low-dose EE was efficacious and well tolerated for pregnancy prevention.This phase 3 open-label study demonstrated that a 21/7-active COC regimen including 21days of DSG 150mcg/EE 20mcg and 7days of EE 10mcg was efficacious and well tolerated for pregnancy prevention.Copyright Â© 2015 Elsevier Inc. All rights reserved.
Outcomes of a dedicated stent in coronary bifurcations with large side branches: A subanalysis of the randomized TRYTON bifurcation study. - Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
To examine the benefit of the Tryton dedicated side branch (SB) stent compared with provisional stenting in the treatment of complex bifurcation lesions involving large SBs.The TRYTON Trial was designed to evaluate the utility of a dedicated SB stent to treat true bifurcation lesions involving large (â‰¥2.5 mm by visual estimation) SBs. Patient enrolled in the trial had smaller SB diameters than intended (59% SB â‰¤2.25 mm by Core Lab QCA). The TRYTON Trial did not meet its primary endpoint due to an increased rate of peri-procedural myocardial infarctions (MIs).The TRYTON Trial randomized 704 patients to the Tryton SB stent with main vessel DES versus provisional SB treatment with main vessel DES. The rates of the primary end point of target vessel failure and the secondary powered end point of angiographic percent diameter stenosis in the SB at 9 months were assessed and compared between the two treatment strategies among patients with a SB â‰¥2.25 mm diameter at baseline determined by Core Lab QCA.Among the 704 patients enrolled in the TRYTON Trial, 289 patients (143 provisional and 146 Tryton stent; 41% of entire cohort) had a SB â‰¥2.25 mm. The primary end point of TVF was numerically lower in the Tryton group compared with the provisional group (11.3% vs. 15.6%, Pâ€‰=â€‰0.38), and was within the non-inferiority margin. No difference among the rates of clinically driven target vessel revascularization (3.5% vs. 4.3% Pâ€‰=â€‰0.77) or cardiac death (0% both groups) were seen. In-segment percent diameter stenosis of the SB was significantly lower in the Tryton group compared with the provisional group (30.4% vs. 40.6%, Pâ€‰=â€‰0.004).Analysis of the TRYTON Trial cohort of SB â‰¥2.25 mm supports the safety and efficacy of the Tryton SB stent compared with a provisional stenting strategy in the treatment of bifurcation lesions involving large SBs. Â© 2015 Wiley Periodicals, Inc.Â© 2015 Wiley Periodicals, Inc.
Overweight status of the primary caregivers of orphan and vulnerable children in 3 Southern African countries: a cross sectional study. - BMC public health
Africa is facing a nutritional transition where underweight and overweight coexist. Although the majority of programs for orphan and vulnerable children (OVC) focus on undernourishment, the association between OVC primary caregiving and the caregivers' overweight status remains unclear. We investigated the association between OVC primary caregiving status with women's overweight status in Namibia, Swaziland and Zambia.Demographic Health Survey (DHS) cross-sectional data collected during 2006-2007 were analyzed using weighted marginal means and logistic regressions. We analyzed data from 20-49 year old women in Namibia (N 6638), Swaziland (N 2875), and Zambia (N 4497).The overweight prevalence of the primary caregivers of OVC ranged from 27.0% (Namibia) to 61.3% (Swaziland). In Namibia, OVC primary caregivers were just as likely or even less likely to be overweight than other primary caregivers. In Swaziland and Zambia, OVC primary caregivers were just as likely or more likely to be overweight than other primary caregivers. In Swaziland and Zambia, OVC primary caregivers were more likely to be overweight than non-primary caregivers living with OVC (Swaziland AORâ€‰=â€‰1.56, Zambia AORâ€‰=â€‰2.62) and non-primary caregivers not living with OVC (Swaziland AORâ€‰=â€‰1.92, Zambia AORâ€‰=â€‰1.94). Namibian OVC caregivers were less likely to be overweight than non-caregivers not living with an OVC only in certain age groups (21-29 and 41-49 years old).African public health systems/OVC programs may face an overweight epidemic alongside existing HIV/AIDS, tuberculosis and malaria epidemics. Future studies/interventions to curb overweight should consider OVC caregiving status and address country-level differences.
Self-report and Clinical Response to Peyronie's Disease Treatment: Peyronie's Disease Questionnaire Results From 2 Large Double-Blind, Randomized, Placebo-Controlled Phase 3 Studies. - Urology
To evaluate the clinical usefulness of the Peyronie's Disease Questionnaire (PDQ). The relationship between subject-reported changes in PDQ psychosexual symptoms and clinical response to Peyronie's disease (PD) treatment was examined.Combined data from the collagenase Clostridium histolyticum phase 3 study program, IMPRESS (Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) I and II, were examined. Changes in the PDQ PD symptom bother, psychological and physical symptoms, and penile pain were examined relative to changes in the penile curvature deformity, including penile curvature absolute mean and percent change. PDQ changes relative to sexual function, including International Index of Erectile Function overall satisfaction and erectile function domains, and treatment responder status, including global assessment of PD and composite responder status, were also assessed. Individual PDQ questions were examined to provide a clinical perspective on the change in psychosexual symptoms experienced by men with PD during treatment.Improvement in PDQ PD symptom bother and psychological and physical symptoms was significantly correlated with clinical improvement in penile curvature deformity (PÂ â‰¤.0008) and sexual function (PÂ <.0001). Significant differences in PD symptom bother and psychological and physical symptoms improvement were found between treatment responders vs nonresponders (PÂ <.02). PDQ penile pain improvement among subjects reporting baseline painÂ â‰¥4 was significantly correlated with clinical improvement in sexual function (PÂ â‰¤.0004) and was found to be greater in treatment responders vs nonresponders (PÂ = .003).The utility of the PDQ for monitoring PD-specific psychosexual symptom severity, progression, and treatment response, both clinically and in trials of men with PD, was supported.Copyright Â© 2015 Elsevier Inc. All rights reserved.
Younger age at onset of sporadic Parkinson's disease among subjects occupationally exposed to metals and pesticides. - Interdisciplinary toxicology
An earlier age at onset of Parkinson's disease (PD) has been reported to be associated with occupational exposures to manganese and hydrocarbon solvents suggesting that exposure to neurotoxic chemicals may hasten the progression of idiopathic PD. In this study the role of occupational exposure to metals and pesticides in the progression of idiopathic PD was assessed by looking at age at disease onset. The effects of heritable genetic risk factors, which may also influence age at onset, was minimized by including only sporadic cases of PD with no family history of the disease (n=58). Independent samples Student t-test revealed that subjects with occupational exposure to metals and/or pesticides (n=36) were significantly (p=0.013) younger than unexposed controls (n=22). These subjects were then divided into three groups [high (n=18), low (n=18), and unexposed (n=22)] to ascertain if duration of exposure further influenced age at onset of PD. One-way ANOVA revealed that subjects in the high exposure group were significantly (p=0.0121) younger (mean age: 50.33 years) than unexposed subjects (mean age: 60.45 years). Subjects were also stratified by exposure type (metals vs. pesticides). These results suggest that chronic exposure to metals and pesticides is associated with a younger age at onset of PD among patients with no family history of the disease and that duration of exposure is a factor in the magnitude of this effect.
Effect of Laser Peripheral Iridotomy on Anterior Chamber Angle Anatomy in Primary Angle Closure Spectrum Eyes. - Journal of glaucoma
To evaluate the change in trabecular-iris circumference volume (TICV) after laser peripheral iridotomy (LPI) in primary angle closure (PAC) spectrum eyes.Forty-two chronic PAC spectrum eyes from 24 patients were enrolled. Eyes with anterior chamber abnormalities affecting angle measurement were excluded. Intraocular pressure, slit lamp examination, and gonioscopy were recorded at each visit. Anterior segment optical coherence tomography (ASOCT) with 3D mode angle analysis scans were taken with the CASIA SS-1000 before and after LPI. Forty-two pre-LPI ASOCT scans and 34 post-LPI ASOCT scans were analyzed using the Anterior Chamber Analysis and Interpretation (ACAI) software. A mixed-effect model analysis was used to compare the trabecular-iris space area (TISA) changes among 4 quadrants, as well as to identify potential factors affecting TICV.There was a significant increase in all average angle parameters after LPI (TISA500, TISA750, TICV500, and TICV750). The magnitude of change in TISA500 in the superior angle was significantly less than the other angles. The changes in TICV500 and TICV750 were not associated with any demographic or ocular characteristics.TICV is a useful parameter to quantitatively measure the effectiveness of LPI in the treatment of eyes with PAC spectrum disease.
A Needs Assessment of Health Issues Related to Maternal Mortality Rates in Afghanistan: A Pilot Study. - International quarterly of community health education
Maternal death rates in Afghanistan were among the highest in the world during the reign of the Taliban. Although these figures have improved, current rates are still alarming. The aim of this pilot study was to develop a needs assessment of the major health issues related to the high maternal mortality rates in Afghanistan. In-depth interviews were conducted with managerial midwives, clinical midwives, and mothers. Results of the interviews indicate that the improvement in the maternal mortality rate may be attributed to the increase in the involvement of midwives in the birthing process. However, barriers to decreasing maternal mortality still exist. These include transportation, access to care, and sociocultural factors such as the influence of the husband and mother-in-law in preventing access to midwives. Therefore, any programs to decrease maternal mortality need to address infrastructure issues (making health care more accessible) and sociocultural factors (including husbands and mother-in-laws in maternal health education). However, it should be noted that these findings are based on a small pilot study to help develop a larger scale need assessment.Â© The Author(s) 2015 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.
Efficacy and safety of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent: the EVOLVE II Randomized Trial. - Circulation. Cardiovascular interventions
Drug eluting stents with durable polymers may be associated with hypersensitivity, delayed healing, and incomplete endothelialization, which may contribute to late/very late stent thrombosis and the need for prolonged dual antiplatelet therapy. Bioabsorbable polymers may facilitate stent healing, thus enhancing clinical safety. The SYNERGY stent is a thin-strut, platinum chromium metal alloy platform with an ultrathin bioabsorbable Poly(D,L-lactide-co-glycolide) abluminal everolimus-eluting polymer. We performed a multicenter, randomized controlled trial for regulatory approval to determine noninferiority of the SYNERGY stent to the durable polymer PROMUS Element Plus everolimus-eluting stent.Patients (n=1684) scheduled to undergo percutaneous coronary intervention for non-ST-segment-elevation acute coronary syndrome or stable coronary artery disease were randomized to receive either the SYNERGY stent or the PROMUS Element Plus stent. The primary end point of 12-month target lesion failure was observed in 6.7% of SYNERGY and 6.5% PROMUS Element Plus treated subjects by intention-to-treat (P=0.83 for difference; P=0.0005 for noninferiority), and 6.4% in both the groups by per-protocol analysis (P=0.0003 for noninferiority). Clinically indicated revascularization of the target lesion or definite/probable stent thrombosis were observed in 2.6% versus 1.7% (P=0.21) and 0.4% versus 0.6% (P=0.50) of SYNERGY versus PROMUS Element Plus-treated subjects, respectively.In this randomized trial, the SYNERGY bioabsorbable polymer everolimus-eluting stent was noninferior to the PROMUS Element Plus everolimus-eluting stent with respect to 1-year target lesion failure. These data support the relative safety and efficacy of SYNERGY in a broad range of patients undergoing percutaneous coronary intervention.URL: http://www.clinicaltrials.gov. Unique identifier: NCT01665053.Â© 2015 American Heart Association, Inc.
Optimal number of angle images for calculating anterior angle volume and iris volume measurements. - Investigative ophthalmology & visual science
We determined the optimal number of angle images required to obtain reliable measurements of trabecular-iris circumferential volume (TICV) and iris volume (IV) using swept-source Fourier domain anterior segment optical coherence tomography (SSFD-ASOCT) scans in narrow angle eyes.Scleral spur landmarks (SSL) were manually identified on ASOCT angle images from 128 meridians from each of 24 eyes with chronic primary angle closure (PAC) spectrum of disease. The anterior and posterior corneal curves, and the anterior and posterior iris surfaces were identified automatically by the anterior chamber analysis and interpretation (ACAI) software, then manually examined and edited by the reader if required. Trabecular-iris circumferential volume at 750 Î¼m from SSL (TICV750) and IV were subsequently calculated using varying numbers of angle images. Threshold error was determined to be less than the lower 95% confidence limit of mean absolute percent error (MAPE) of the change in TICV or IV resulting from laser peripheral iridotomy, which would be 17% for TICV and 5% for IV, based on previous studies. The optimal number of angle images was the smallest number of images where MAPE was less than this threshold for TICV and IV.A total of 32 equally-spaced angle images (16 meridians) was required to estimate TICV750 and 16 angle images (8 meridians) to estimate IV. Both were within 4.6% and 1.6% of MAPE, respectively.It is possible to determine TICV and IV parameters reliably in narrow angles without evaluating all 128 meridians obtained with SSFD-ASOCT.
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