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1.
J Thromb Thrombolysis ; 55(1): 189-194, 2023 Jan.
Article in English | MEDLINE | ID: mdl-36515793

ABSTRACT

The association between thromboembolic events (TE) and COVID-19 infection is not completely understood at the population level in the United States. We examined their association using a large US healthcare database. We analyzed data from the Premier Healthcare Database Special COVID-19 Release and conducted a case-control study. The study population consisted of men and non-pregnant women aged ≥ 18 years with (cases) or without (controls) an inpatient ICD-10-CM diagnosis of TE between 3/1/2020 and 6/30/2021. Using multivariable logistic regression, we assessed the association between TE occurrence and COVID-19 diagnosis, adjusting for demographic factors and comorbidities. Among 227,343 cases, 15.2% had a concurrent or prior COVID-19 diagnosis within 30 days of their index TE. Multivariable regression analysis showed a statistically significant association between a COVID-19 diagnosis and TE among cases when compared to controls (adjusted odds ratio [aOR] 1.75, 95% CI 1.72-1.78). The association was more substantial if a COVID-19 diagnosis occurred 1-30 days prior to index hospitalization (aOR 3.00, 95% CI 2.88-3.13) compared to the same encounter as the index hospitalization. Our findings suggest an increased risk of TE among persons within 30 days of being diagnosed COVID-19, highlighting the need for careful consideration of the thrombotic risk among COVID-19 patients, particularly during the first month following diagnosis.


Subject(s)
COVID-19 , Thromboembolism , Male , Female , Adult , Humans , United States/epidemiology , COVID-19/complications , COVID-19/epidemiology , Case-Control Studies , COVID-19 Testing , Risk Factors , Thromboembolism/epidemiology , Thromboembolism/etiology , Hospitalization , Retrospective Studies
2.
MMWR Morb Mortal Wkly Rep ; 71(39): 1241-1246, 2022 Sep 30.
Article in English | MEDLINE | ID: mdl-36173745

ABSTRACT

INTRODUCTION: Sickle cell disease (SCD), a group of inherited blood cell disorders that primarily affects Black or African American persons, is associated with severe complications and a >20-year reduction in life expectancy. In 2014, an expert panel convened by the National Heart, Lung, and Blood Institute issued recommendations to prevent or reduce complications in children and adolescents with the most severe SCD subtypes, known as sickle cell anemia (SCA); recommendations included 1) annual screening of children and adolescents aged 2-16 years with transcranial Doppler (TCD) ultrasound to identify those at risk for stroke and 2) offering hydroxyurea therapy to children and adolescents aged ≥9 months to reduce the risk for several life-threatening complications. METHODS: Data from the IBM MarketScan Multi-State Medicaid Database were analyzed. TCD screening and hydroxyurea use were examined for 3,352 children and adolescents with SCA aged 2-16 years and continuously enrolled in Medicaid during 2019. Percentage change during 2014-2019 and variation by health subgroups were assessed. Analyses were stratified by age. RESULTS: During 2014-2019, TCD screening increased 27% among children and adolescents aged 10-16 years; hydroxyurea use increased 27% among children aged 2-9 years and 23% among children and adolescents aged 10-16 years. However, in 2019, only 47% and 38% of children and adolescents aged 2-9 and 10-16 years, respectively, had received TCD screening and 38% and 53% of children and adolescents aged 2-9 years and 10-16 years, respectively, used hydroxyurea. For both prevention strategies, usage was highest among children and adolescents with high levels of health care utilization and evidence of previous complications indicative of severe disease. CONCLUSION AND IMPLICATIONS FOR PUBLIC HEALTH PRACTICE: Despite increases since 2014, TCD screening and hydroxyurea use remain low among children and adolescents with SCA. Health care providers should implement quality care strategies within their clinics and partner with patients, families, and community-based organizations to address barriers to delivering and receiving recommended care.


Subject(s)
Anemia, Sickle Cell , Hydroxyurea , Adolescent , Anemia, Sickle Cell/complications , Anemia, Sickle Cell/therapy , Child , Delivery of Health Care , Humans , Hydroxyurea/therapeutic use , Ultrasonography, Doppler, Transcranial , United States/epidemiology , Vital Signs
4.
Public Health Rep ; 137(2): 234-238, 2022.
Article in English | MEDLINE | ID: mdl-35060794

ABSTRACT

Sickle cell disease (SCD) is associated with increased risk of poor health outcomes from respiratory infections, including COVID-19 illness. We used US death data to investigate changes in SCD-related mortality before and during the COVID-19 pandemic. We estimated annual age- and quarter-adjusted SCD-related mortality rates for 2014-2020. We estimated the number of excess deaths in 2020 compared with 2019 using the standardized mortality ratio (SMR). We found 1023 SCD-related deaths reported in the United States during 2020, of which 86 (8.4%) were associated with COVID-19. SCD-related deaths, both associated and not associated with COVID-19, occurred most frequently among adults aged 25-59 years. The SCD-related mortality rate changed <5% year to year from 2014 to 2019 but increased 12% in 2020; the sharpest increase was among adults aged ≥60 years. The SMR comparing 2020 with 2019 was 1.12 (95% CI, 1.06-1.19). Overall, 113 (95% CI, 54-166) excess SCD-related deaths occurred in 2020.


Subject(s)
Anemia, Sickle Cell/mortality , COVID-19/epidemiology , Adolescent , Adult , Age Distribution , Anemia, Sickle Cell/complications , COVID-19/complications , Child , Child, Preschool , Ethnicity , Humans , Infant , Middle Aged , Mortality/trends , Race Factors , SARS-CoV-2 , Time Factors , United States/epidemiology
5.
MMWR Surveill Summ ; 69(5): 1-18, 2020 09 04.
Article in English | MEDLINE | ID: mdl-32881847

ABSTRACT

PROBLEM/CONDITION: Hemophilia is an X-linked genetic disorder that primarily affects males and results in deficiencies in blood-clotting proteins. Hemophilia A is a deficiency in factor VIII, and hemophilia B is a deficiency in factor IX. Approximately one in 5,000 males are born with hemophilia, and hemophilia A is about four times as common as hemophilia B. Both disorders are characterized by spontaneous internal bleeding and excessive bleeding after injuries or surgery. Hemophilia can lead to repeated bleeding into the joints and associated chronic joint disease, neurologic damage, damage to other organ systems, and death. Although no precise national U.S. prevalence estimates for hemophilia exist because of the difficulty identifying cases among persons who receive care from various types of health care providers, two previous state-based studies estimated hemophilia prevalence at 13.4 and 19.4 per 100,000 males. In addition, these studies showed that 67% and 82% of persons with hemophilia received care in a federally funded hemophilia treatment center (HTC), and 86% and 94% of those with the most severe cases of hemophilia (i.e., those with the lowest levels of clotting factor activity in the circulating blood) received care in a federally funded HTC. As of January 2020, the United States had 144 HTCs. PERIOD COVERED: 1998-2019. DESCRIPTION OF THE SYSTEM: Surveillance for hemophilia, which is a complex, chronic condition, is challenging because of its low prevalence, the difficulty in ascertaining cases uniformly, and the challenges in routinely characterizing and tracking associated health complications. Over time, two systems involving many stakeholders have been used to conduct ongoing hemophilia surveillance. During 1998-2011, CDC and the HTCs collaborated to establish the Universal Data Collection (UDC) surveillance system. The purposes of the UDC surveillance system were to monitor human immunodeficiency virus (HIV) and bloodborne viral hepatitis in persons with hemophilia, thereby tracking blood safety, and to track the prevalence of and trends in complications associated with hemophilia. HTC staff collected clinical data and blood specimens from UDC participants and submitted them to CDC. CDC tested specimens for viral hepatitis and HIV. In 2011, the UDC surveillance system was replaced by a new hemophilia surveillance system called Community Counts. CDC and the HTCs established Community Counts to expand laboratory testing and the collection of clinical data to better identify and track emerging health issues in persons with hemophilia. RESULTS: This report is the first comprehensive summary of CDC's hemophilia surveillance program, which comprises both UDC and Community Counts. Data generated from these surveillance systems have been used in the development of public health and clinical guidelines and practices to improve the safety of U.S. blood products and either prevent hemophilia-related complications or identify complications early. Several factors have played a role in the effectiveness of the UDC and Community Counts systems, including 1) a stable data collection design that was developed and is continually reviewed in close partnership with HTC regional leaders and providers to ensure surveillance activities are focused on maximizing the scientific and clinical impact; 2) flexibility to respond to emerging health priorities through periodic updates to data collection elements and special studies; 3) high data quality for many clinical indicators and state-of-the-art laboratory testing methods for hemophilia treatment product inhibitors (developed and refined in part based on CDC research); 4) timely data and specimen collection and submission, laboratory specimen testing, analysis, and reporting; and 5) the largest and most representative sample of persons with hemophilia in the United States and one of the largest and most comprehensive data collection systems on hemophilia worldwide. INTERPRETATION: CDC has successfully developed, implemented, and maintained a surveillance system for hemophilia. The program can serve as an example of how to conduct surveillance for a complex chronic disease by involving stakeholders, improving and building new infrastructure, expanding data collection (e.g., new diagnostic assays), providing testing guidance, establishing a registry with specimen collection, and integrating laboratory findings in clinical practice for the individual patient. PUBLIC HEALTH ACTION: Hemophilia is associated with substantial lifelong morbidity, excess premature deaths, and extensive health care needs throughout life. Through monitoring data from Community Counts, CDC will continue to characterize the benefits and adverse events associated with existing or new hemophilia treatment products, thereby contributing to maximizing the health and longevity of persons with hemophilia.


Subject(s)
Hemophilia A/epidemiology , Population Surveillance/methods , Adolescent , Adult , Aged , Centers for Disease Control and Prevention, U.S. , Child , Child, Preschool , Data Collection , Female , Humans , Infant , Male , Middle Aged , Program Evaluation , Residence Characteristics , United States/epidemiology , Young Adult
6.
Ann Emerg Med ; 76(3S): S28-S36, 2020 09.
Article in English | MEDLINE | ID: mdl-32928459

ABSTRACT

STUDY OBJECTIVE: We provide an updated assessment of trends in sickle cell disease (SCD)-related mortality, a significant source of mortality in the United States among black persons, using 1979 to 2017 US mortality data. METHODS: SCD-related deaths were identified with International Classification of Diseases codes. Because SCD-related death is rare in other races, the analysis focused on black decedents. Age-specific and average annual SCD-related death rates were calculated. Causes of death codes were categorized into 20 groups relevant to SCD outcomes. SCD-related deaths were compared with non-SCD-related deaths after matching on race, sex, age group, and year of death. RESULTS: There were 25,665 SCD-related deaths reported among blacks in the United States from 1979 through 2017. During that period, the annual SCD-related death rate declined in children and increased in adults, and the median age at death increased from 28 to 43 years. Acute causes of death, such as infection and cerebrovascular complications, were more common in younger age groups. Chronic complications were more common in adults. SCD-related deaths were more likely to be related to acute cardiac, pulmonary, and cerebrovascular complications; acute infections; and chronic cardiac and pulmonary complications and renal disorders; and less likely to be related to drug overdose and chronic infections than non-SCD-related deaths. CONCLUSION: These data indicate SCD-related deaths are now more likely to be related to chronic complications of the disease than to acute complications. More research regarding prevention and treatment of chronic complications of SCD is necessary because persons with SCD are living longer.


Subject(s)
Anemia, Sickle Cell/mortality , Adolescent , Adult , Age Factors , Anemia, Sickle Cell/complications , Cardiovascular Diseases/etiology , Cardiovascular Diseases/mortality , Cause of Death , Child , Child, Preschool , Female , Humans , Male , Middle Aged , Sex Factors , United States/epidemiology , Young Adult
8.
Haemophilia ; 25(4): 575-580, 2019 Jul.
Article in English | MEDLINE | ID: mdl-31329369

ABSTRACT

INTRODUCTION: The major complication of protein replacement therapy for haemophilia A is the development of anti-FVIII antibodies or inhibitors that occur in 25%-30% of persons with severe haemophilia A. Alternative therapeutics such as bypassing agents or immune tolerance induction protocols have additional challenges and are not always effective. AIM: Assemble a National Heart, Lung and Blood Institute (NHLBI) State of the Science (SOS) Workshop to generate a national blueprint for research on inhibitors to solve the problem of FVIII immunogenicity. METHODS: An Executive Steering Committee was formed in October 2017 to establish the scientific focus and Scientific Working Groups for the SOS Workshop in May 2018. Four working groups were assembled to address scientific priorities in basic, translational and clinical research on inhibitors. RESULTS: Working Group 1 was charged with determining the scientific priorities for clinical trials to include the integration of non-intravenous, non-factor therapeutics including gene therapy into the standard of care for people with haemophilia A with inhibitors. Working Group 2 established the scientific priorities for 21st-century data science and biospecimen collection for observational inhibitor cohort studies. The scientific priorities for acquiring an actionable understanding of FVIII immunogenicity and the immunology of the host response and FVIII tolerance were developed by Working Group 3. Working Group 4 designed prospective pregnancy/birth cohorts to study FVIII immunogenicity, inhibitor development and eradication. CONCLUSION: The NHLBI SOS Workshop generated a focused summary of scientific priorities and implementation strategies to overcome the challenges of eradicating and preventing inhibitors in haemophilia A.


Subject(s)
Education/organization & administration , Factor VIII/antagonists & inhibitors , National Institutes of Health (U.S.) , Research/education , Clinical Trials as Topic , Hemophilia A/drug therapy , Humans , United States
9.
Semin Perinatol ; 43(4): 200-204, 2019 06.
Article in English | MEDLINE | ID: mdl-30935751

ABSTRACT

In the U.S., deaths due to pulmonary embolism (PE) account for 9.2% of all pregnancy-related deaths or approximately 1.5 deaths per 100,000 live births. Maternal deaths and maternal morbidity due to PE are more common among women who deliver by cesarean section. In the past decade, the clinical community has increasingly adopted venous thromboembolism (VTE) guidelines and thromboprophylaxis recommendations for pregnant women. Although deep vein thrombosis rates have decreased during this time-period, PE rates have remained relatively unchanged in pregnancy hospitalizations and as a cause of maternal mortality. Changes in the health profile of women who become pregnant, particularly due to maternal age and co-morbidities, needs more attention to better understand the impact of VTE risk during pregnancy and the postpartum period.


Subject(s)
Pregnancy Complications, Cardiovascular/mortality , Venous Thromboembolism/complications , Venous Thromboembolism/mortality , Anticoagulants/therapeutic use , Cesarean Section/statistics & numerical data , Female , Hospitalization , Humans , Maternal Age , Maternal Mortality , Patient Safety , Postpartum Period , Pregnancy , Risk Factors , United States/epidemiology , Venous Thromboembolism/prevention & control
10.
Future Cardiol ; 14(1): 15-26, 2018 01.
Article in English | MEDLINE | ID: mdl-29218998

ABSTRACT

AIM: The study objectives were to investigate the association between selected CYP2C9 and VKORC1 single nucleotide polymorphisms with serious bleeding or thrombotic risk, and to estimate mean daily maintenance dose of warfarin and international normalized ratio measurements among Blacks receiving warfarin anticoagulation. METHODS: We conducted a retrospective cohort study among 230 Black adults receiving warfarin for a minimum of three consecutive months with a confirmed date of first dosage. RESULTS: A lower mean daily maintenance dosage of warfarin was required to maintain an international normalized ratio measurement within the therapeutic range among Blacks with the VKORC1-1639G>A variant alleles ([G/A vs G/G, p = 0.02], [A/A vs G/A, p = 0.008] and [A/A vs G/G, p = 0.001]). CONCLUSION: Data indicated that VKORC1-1639A variant allele influenced warfarin daily maintenance dosage among our small, likely admixed Black patient population.


Subject(s)
Black or African American , Polymorphism, Single Nucleotide , Thrombosis/genetics , Vitamin K Epoxide Reductases/genetics , Warfarin/administration & dosage , Alleles , Anticoagulants/administration & dosage , Dose-Response Relationship, Drug , Female , Follow-Up Studies , Genotype , Georgia/epidemiology , Humans , Incidence , Male , Middle Aged , Polymerase Chain Reaction , Retrospective Studies , Thrombosis/drug therapy , Thrombosis/ethnology , Time Factors , Vitamin K Epoxide Reductases/metabolism
11.
Res Pract Thromb Haemost ; 1(1): 33-40, 2017 Jul.
Article in English | MEDLINE | ID: mdl-29202121

ABSTRACT

BACKGROUND: One previous pilot study suggested the association of low plasma glucosylceramide (GlcCer) levels with venous thrombosis (VTE) risk. OBJECTIVE: We aimed to confirm and evaluate the association of low plasma GlcCer levels with VTE and myocardial infarction (MI) occurrence, respectively. PATIENTS AND METHODS: We evaluated the association of GlcCer in two independent case-control studies of Caucasian VTE populations (N = 210 and 636) and one case-control study of Caucasian MI patients (N = 345). RESULT: Plasma GlcCer levels in VTE patients were lower compared to controls in two independent VTE populations (5.0 vs 5.8 µg/mL, p = 0.003 for the Scripps registry, and 5.6 vs 6.0 µg/mL, p = 0.001 for the Valencia registry, respectively). A low plasma GlcCer level (below 10th percentile of controls) was associated with increased VTE occurrence [odds ratio (OR) = 3.7 (95%CI, 1.8-7.9) for Scripps registry and OR = 2.1 (95%CI, 1.3-3.3) for Valencia registry, respectively). For the MI study, the median GlcCer plasma level was lower in MI patients than in controls (4.3 vs 5.6 µg/mL, p<0.001), and a low level of GlcCer (below 10th percentile of control) was associated with higher MI occurrence [OR = 7.7, (95%CI, 4.3-13.8)]. CONCLUSION: Lower concentration of GlcCer was associated with VTE occurrence in two independent studies and also with MI occurrence in one study.

13.
J Clin Dent ; 27(3): 71-75, 2016 Sep.
Article in English | MEDLINE | ID: mdl-28390200

ABSTRACT

OBJECTIVES: The purpose of this study was to determine the safety and plaque-reducing effectiveness of a newly designed manual toothbrush compared to that of a leading marketed toothbrush and a reference standard manual toothbrush control. METHODS: This examiner-blind, randomized, single-use study used a cross-over design. Sixty-eight qualifying male and female subjects were randomly assigned either an Arm & Hammer™ Truly Radiant™ Deep Clean manual toothbrush (TR), a Colgate® Extra Clean manual toothbrush (C), or an ADA reference standard manual toothbrush (SM) according to one of three computer-generated sequences. Following instruction in the use of their assigned brush, subjects brushed at home with a standard fluoride toothpaste twice daily for two minutes during a one-week familiarization period. At the end of this period, the subjects returned to the study site after refraining from oral hygiene for 12-16 hours and from eating and drinking for four hours. Plaque was disclosed and scored using the Rustogi Modification of the Navy Plaque Index (RMNPI). Subjects brushed under supervision with their assigned toothbrush for two minutes in a room without mirrors and apart from the dental examiner, after which plaque was disclosed and rescored. They were then given one of the alternate toothbrushes according to their assigned sequence, and the familiarization routine and evaluations were repeated until each of the subjects used each of the three brushes. Within-treatment and between-treatment whole mouth RMNPI scores and scores at each of twelve subsets of sites were analyzed using paired t-tests and appropriate ANCOVA models, respectively. RESULTS: Within-group analyses showed that all three toothbrushes produced statistically significant reductions from the pre-brushing baseline in whole mouth RMNPI scores (p < 0.0001), with respective reductions of 68.2%, 58.3%, and 48.5% for TR, C, and SM. Between-group analyses showed that TR was significantly more effective (p < 0.0001) than C and SM with 16.4% and 40.3% greater reductions in whole mouth scores, respectively. TR also produced statistically significant greater reductions (p < 0.0001) than the other two manual brushes at each of the twelve subsets of sites examined, with the greatest differences at the lingual and gingival sites, especially sites presenting difficulty in access, such as those in the posterior lingual gingival region. CONCLUSIONS: While all three manual toothbrushes produced significant supragingival plaque reductions with a single use, the Truly Radiant Deep Clean brush was significantly more effective than the Colgate Extra Clean and ADA manual brushes in reducing wholemouth plaque, as well as plaque at all subsets of sites analyzed including difficult-to-reach areas.


Subject(s)
Dental Plaque Index , Dental Plaque/therapy , Toothbrushing , Adult , Cross-Over Studies , Equipment Design , Female , Humans , Male , Single-Blind Method
14.
J Clin Dent ; 27(3): 76-79, 2016 Sep.
Article in English | MEDLINE | ID: mdl-28390201

ABSTRACT

OBJECTIVES: The purpose of this study was to determine the plaque removal effectiveness of a new powered toothbrush and compare it to that of a manual brush. METHODS: This examiner-blind, randomized study used a cross-over design. Sixty-two (62) qualifying subjects were randomly assigned either to the powered brush (Arm & Hammer Spinbrush™ Truly Radiant™ Clean & Fresh Battery-Powered Toothbrush), or a standard manual toothbrush (ADA Standard Manual Toothbrush) and instructed to brush at home with a standard fluoride toothpaste twice daily for two minutes during a one-week familiarization period. At the end of this period, the subjects returned to the study site. After refraining from oral hygiene for 12-16 hours and from eating and drinking for four hours, plaque was disclosed by rinsing with an erythrosine dye solution and scored using the Rustogi Modification of the Navy Plaque Index (RMNPI). Subjects then brushed under supervision with their assigned toothbrush for two minutes, and plaque was disclosed and rescored. They were then given the alternate toothbrush, and the familiarization routine and evaluation process were repeated. The primary outcome variable was mean whole mouth RMNPI score with additional analyses performed on regional subsets of tooth surfaces. RESULTS: Within-group analysis showed that both toothbrushes produced statistically significant reductions from the pre-brushing baseline in whole mouth and regional plaque scores (p < 0.01), with respective whole mouth reductions of 40.7% and 24.9% for the powered brush and the manual brush. Between-group analyses showed that the powered brush produced a statistically significantly greater plaque reduction than the manual brush, both whole mouth (63.7%, p < 0.0001) and at all 12 subsets of sites. CONCLUSIONS: When evaluated using this single-use clinical model, the Arm & Hammer Spinbrush Truly Radiant Clean & Fresh powered toothbrush was statistically significantly more effective in reducing plaque than the manual toothbrush, both whole mouth and at all regional subsets of tooth surfaces, including difficult-to-reach sites.


Subject(s)
Dental Plaque Index , Dental Plaque/therapy , Toothbrushing , Adult , Cross-Over Studies , Equipment Design , Female , Humans , Male , Single-Blind Method , Treatment Outcome
15.
J Clin Dent ; 27(3): 80-83, 2016 Sep.
Article in English | MEDLINE | ID: mdl-28390202

ABSTRACT

OBJECTIVES: This randomized, prospective clinical trial was conducted to determine the safety and effectiveness of a new whitening dentifrice formulation in comparison to that of both a negative and a positive control dentifrice. METHODS: Seventy-nine qualifying subjects were randomly assigned to either the new whitening dentifrice (Arm & Hammer® Truly Radiant™ Clean & Fresh Toothpaste), a positive control whitening dentifrice (Crest® 3-D White® Radiant Mint Toothpaste), or a negative control regular dentifrice (Colgate® Cavity Protection Toothpaste). The subjects brushed with their assigned dentifrice for two minutes, twice daily, for five days. Extrinsic tooth stain was assessed using a Modified Lobene Stain Index (MLSI) at baseline and after five days of product use. RESULTS: All entering subjects completed the study. There were no significant differences (p > 0.05) in stain among the three groups at baseline. The Arm & Hammer Truly Radiant and positive control groups had statistically significant (p < 0.001) mean composite MLSI reduction scores of 13.2% and 7.8%, respectively, from baseline to day five. The negative control dentifrice group was virtually unchanged during this period. Intergroup comparisons showed the Truly Radiant group to have significantly greater stain removal (p < 0.0001) scores than the negative control. The Truly Radiant group also had greater stain removal than the positive control, though the differences were not statistically significant. CONCLUSIONS: This study demonstrates that five-days' use of Arm & Hammer Truly Radiant Clean & Fresh dentifrice was significantly more effective in stain removal than a regular (non-whitening) dentifrice and comparable in effectiveness to a whitening dentifrice positive control.


Subject(s)
Dentifrices/therapeutic use , Tooth Bleaching , Tooth Discoloration/therapy , Adult , Analysis of Variance , Coloring Agents , Female , Humans , Male , Prospective Studies , Silicon Dioxide , Sodium Fluoride , Toothpastes , Treatment Outcome
16.
J Clin Dent ; 26(3): 66-71, 2015.
Article in English | MEDLINE | ID: mdl-26665288

ABSTRACT

OBJECTIVE: This randomized controlled clinical trial was conducted to determine the effectiveness and safety of a new whitening dentifrice. METHODS: One hundred eighty-two qualifying subjects were randomly assigned to either a whitening dentifrice group (Arm & Hammer Truly Radiant Toothpaste), a negative control dentifrice group (Colgate Cavity Protection Toothpaste), or a positive control dentifrice group (Crest 3-D White Radiant Mint Toothpaste) and were instructed to brush twice daily with their assigned dentifrice for six weeks. Extrinsic tooth stain was assessed using a Modified Lobene Stain Index (MLSI) and tooth shade was assessed using the VITA Classic Shade Guide at baseline and after five days and two, four, and six weeks of dentifrice use. Safety was monitored by clinical examinations and panelist assessment at each evaluation period. RESULTS: The Arm & Hammer Truly Radiant group showed a statistically significant improvement from baseline in mean composite MLSI and VITA shade at each examination period (p < 0.0001). Significant improvements on day 5 progressively increased with increasing duration of product use. By week 6, there was a 45.4% reduction in stain and a 2.08 improvement in tooth shade. The between-group comparison revealed that Truly Radiant toothpaste was significantly more effective than both the negative and positive control dentifrices for these parameters (p < 0.0001) at each exam time. CONCLUSION: This study showed that the new dentifrice formulation is safe and effective on stain removal and tooth whitening.


Subject(s)
Dentifrices/therapeutic use , Tooth Bleaching Agents/therapeutic use , Adolescent , Adult , Aged , Calcium Phosphates/therapeutic use , Color , Female , Follow-Up Studies , Humans , Male , Middle Aged , Peroxides/therapeutic use , Prospective Studies , Safety , Silicon Dioxide/therapeutic use , Single-Blind Method , Sodium Bicarbonate/therapeutic use , Sodium Fluoride/therapeutic use , Tooth/drug effects , Tooth Discoloration/classification , Tooth Discoloration/drug therapy , Treatment Outcome , Young Adult
17.
J Clin Dent ; 26(3): 72-5, 2015.
Article in English | MEDLINE | ID: mdl-26665289

ABSTRACT

OBJECTIVE: This study was conducted to evaluate the effectiveness of Arm & Hammer (A&H) Truly Radiant Rejuvenating toothpaste in removing extrinsic tooth stain compared to that of a conventional fluoride/silica-containing dentifrice. METHODS: This was a randomized, examiner-blind, parallel-design study with two groups of subjects who brushed unsupervised with their assigned dentifrice for two minutes, twice daily, for five days. Extrinsic stain was measured on the labial surfaces of the eight incisor teeth by the Modified Lobene Stain Index (MLSI) at baseline and following five days of product use. After balancing for baseline MLSI, beverage and tobacco use, fifty-four healthy adults with existing stain were randomly distributed into two comparable groups: Arm and Hammer Truly Radiant Rejuvenating toothpaste or Colgate Cavity Protection toothpaste (negative control). Within-treatment comparisons between baseline and day five were made using matched-pair t-tests, and between-treatment comparisons of MSLI scores were performed using ANCOVA, with baseline scores as covariates. RESULTS: Twenty-eight subjects in the Truly Radiant Rejuvenating toothpaste group and twenty-six subjects in the negative control group completed the study. The groups had comparable mean scores at baseline (p > 0.05). The Truly Radiant Rejuvenating toothpaste produced a statistically significant 23.1% total (composite) stain reduction from baseline after five days of product use (p < 0.0001) while the negative control was essentially unchanged (p > 0.05). Between-treatment analysis showed statistically significantly (p < 0.0001) greater stain removal for Truly Radiant Rejuvenating toothpaste compared to the Colgate control following five days of product use. There were no adverse events reported during the study. CONCLUSION: The A&H Truly Radiant Rejuvenating toothpaste is safe and effective in reducing extrinsic stain compared to a regular toothpaste control.


Subject(s)
Dentifrices/therapeutic use , Tooth Bleaching Agents/therapeutic use , Tooth Discoloration/drug therapy , Adolescent , Adult , Aged , Calcium Phosphates/therapeutic use , Female , Follow-Up Studies , Humans , Incisor/drug effects , Male , Middle Aged , Peroxides/therapeutic use , Prospective Studies , Safety , Silicon Dioxide/therapeutic use , Single-Blind Method , Sodium Bicarbonate/therapeutic use , Sodium Fluoride/therapeutic use , Tooth Discoloration/classification , Treatment Outcome , Young Adult
18.
J Clin Dent ; 26(3): 76-9, 2015.
Article in English | MEDLINE | ID: mdl-26665290

ABSTRACT

OBJECTIVE: This randomized, controlled clinical trial was conducted to assess the extrinsic stain reduction achieved by brushing with a whitening dentifrice and powered toothbrush, and to determine whether the addition of a whitening booster paste to this regimen would enhance its stain reducing effectiveness. METHODS: Sixty qualifying subjects were randomly assigned either to Regimen One, a whitening dentifrice (Arm & Hammer Truly Radiant [TR] toothpaste] and powered toothbrush (Arm & Hammer Truly Radiant [TR] Extra Whitening Spinbrush); Regimen Two, the dentifrice and powered toothbrush with the addition of a whitening booster; or Regimen Three, a negative control (Colgate Cavity Protection toothpaste and an ADA standard manual brush). They were instructed in the use of their assigned products and then brushed unsupervised at home for two minutes, twice daily, for 14 days. Extrinsic tooth stain was assessed at baseline and after two, five, and 14 days using a Modified Lobene Stain Index (MLSI) with Lobene inclusion criteria of ≥ 1.5. RESULTS: All three treatment groups had statistically significant (p < 0.0001) mean total MLSI reductions from baseline at each time point, in a time-dependent manner. Day 14 reductions were 22.2% for Colgate Cavity Protection, 29.1% for Regimen One, and 34.4% for Regimen Two. Reductions for Regimen One and Regimen Two were significantly greater compared to Regimen Three, the negative control, at each time period (p < 0.01), and those for Regimen Two were significantly greater compared to Regimen One on days 2 and 14 (p < 0.05) and directionally more effective on day 5 (p = 0.0673). CONCLUSION: The combination of Truly Radiant toothpaste and Truly Radiant Spinbrush provides safe and effective stain removal that can be further enhanced by the addition of the whitening booster.


Subject(s)
Dentifrices/therapeutic use , Tooth Bleaching Agents/therapeutic use , Tooth Discoloration/drug therapy , Toothbrushing/instrumentation , Toothpastes/therapeutic use , Adolescent , Adult , Aged , Calcium Phosphates/therapeutic use , Female , Follow-Up Studies , Humans , Male , Middle Aged , Peroxides/therapeutic use , Prospective Studies , Safety , Silicon Dioxide/therapeutic use , Single-Blind Method , Sodium Bicarbonate/therapeutic use , Sodium Fluoride/therapeutic use , Tooth Discoloration/classification , Treatment Outcome , Young Adult
19.
Thromb Res ; 136(6): 1165-8, 2015 Dec.
Article in English | MEDLINE | ID: mdl-26489726

ABSTRACT

INTRODUCTION: No study has examined how the relationship between polycystic ovary syndrome (PCOS) and atherosclerotic cardiovascular diseases (aCVD), of ischemic stroke (ISCH), acute myocardial infarction (AMI), and peripheral vascular disease (PAD), differ in the presence of venous thromboembolism (VTE). MATERIALS AND METHODS: We performed a cross-sectional analysis using Truven Health Analytics MarketScan® Commercial databases from 2004-2011. The association between women aged 18-64 years with and without PCOS, and aCVD was assessed using VTE-stratified multivariable logistic regression models. RESULTS: Overall, women with PCOS were more likely to have aCVD, (aOR, 1.27; 95% CI, 1.10-1.46) especially ISCH (aOR, 1.56; 95% CI, 1.30-1.88), than women without PCOS. When stratified by VTE status, women with PCOS and a VTE diagnosis had a decreased odds of having any aCVD (aOR 0.67; 95% CI, 0.46-0.98), and VTE diagnosis more often preceded the occurrence of ISCH and AMI among women with PCOS compared with women without PCOS. CONCLUSIONS: Overall, women with PCOS were more likely to have aCVD, with stroke being the most prevalent manifestation. Although VTE often occurred before any aCVD, it appeared to have an inverse association with the development of ISCH, AMI, and PAD among women with PCOS, suggesting that aggressively treating VTE or aCVD early may limit the chances of developing the other thrombogenic condition among women with PCOS.


Subject(s)
Cardiovascular Diseases/etiology , Polycystic Ovary Syndrome/complications , Venous Thromboembolism/etiology , Adolescent , Adult , Brain Ischemia/etiology , Cross-Sectional Studies , Female , Humans , Middle Aged , Myocardial Infarction/etiology , Peripheral Vascular Diseases/etiology , Stroke/etiology
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