Displaying publications 21 - 40 of 205 in total

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  1. Tan JL, Nordin S, Besari AM
    Malays J Med Sci, 2017 Oct;24(5):119-123.
    PMID: 29386980 MyJurnal DOI: 10.21315/mjms2017.24.5.14
    Introduction: Tuberculosis is the second leading cause of death under the category of infectious diseases, after the human immunodeficiency virus (HIV). Tuberculous meningitis (TBM) constitutes about 5% of all extrapulmonary disease worldwide. This report describes a case of Tuberculous meningitis with rare presentation in a 28-year-old woman, who was treated based on a collection of her social background, clinical findings and Multiplex PCR of tuberculosis.

    Case presentation: A 28-year-old Malay woman with no significant medical history presented to HUSM with one month history of on and off fever, two weeks history of generalised limbs weakness and one week history of dysphagia. She was reported to have experienced visual hallucination and significant weight loss. Her laboratory result is significant for leukocytosis, elevated ESR and hypernatremia. Non-enhanced and contrast CT scan of the brain showed severe bilateral frontal cerebral atrophy. Cerebral spinal fluid (CSF) for multiplex PCR for Mycobacterium tuberculosis complex was positive. She was promptly started on anti-TB regime combined with dexamethasone. Subsequent follow-up showed significant improvement.

    Conclusion: This is a rare clinical manifestation of Tuberculous meningitis that demonstrates the importance of recognising and initiating the treatment early to reduce disabilities and improve clinical outcome.

    Matched MeSH terms: Cause of Death
  2. Boo NY
    Singapore Med J, 1992 Feb;33(1):33-7.
    PMID: 1598605
    Between January 1989 to April 1990 (16 months), a prospective observational study was carried out on 329 consecutive very low birthweight (VLBW) less than or equal to 1500 grams) Malaysian neonates born in the Maternity Hospital, Kuala Lumpur before their first discharge from the hospital. The objectives of the study were to determine the common causes of early morbidity and mortality of this group of Malaysian neonates. The study shows that the incidence of Malaysian VLBW neonates was 9.9 per 1000 livebirths (95% confidence intervals 9.0 to 10.8). The mean duration of stay in the hospital was 19.3 days (SD = 21.4). One hundred and ninety-six (59.6 percent) of the VLBW neonates died. They accounted for 60 percent (196/334) of all neonatal deaths in the hospital during the study period. Mortality was significantly higher in neonates of birthweight less than 1000 grams (p less than 0.01) and of gestation of less than 33 weeks (p less than 0.001). The three most common clinical problems were respiratory distress syndrome (RDS) (72.6 percent), septicemia (28.0 percent) and intraventricular haemorrhage (IVH) (21.9 percent). Death occurred in 71.1 percent of the septicemic patients. The most common causative organisms of septicemia were multiresistant klebsiella (52.3 percent) and multiresistant acinetobacter (14.7 percent). RDS (33.2 percent), septicemia (29.6%) and IVH (17.9 percent) were the three most common causes of death. Improvement in the nursing staff situation and basic neonatal care facilities in this hospital and prevention of premature delivery could help to decrease morbidity and mortality in this group of neonates.
    Matched MeSH terms: Cause of Death
  3. Samberkar PN, Samberkar SP, Byard RW
    Med Sci Law, 2020 Oct;60(4):315-318.
    PMID: 32501165 DOI: 10.1177/0025802420926867
    Kerokan is a traditional Indonesian treatment involving abrading the skin over various parts of the body with a blunt object such as a coin or a piece of ginger which may create suspicious injuries. Here, the case of a 30-year-old woman who had undergone kerokan therapy is reported. She was complaining of retro-sternal pain and epigastric discomfort and subsequently became markedly short of breath and died. The observation of injuries predominantly located around the neck initiated a police investigation and forensic autopsy. Scattered abrasions, blisters and bruises were present on the forehead, the bridge of the nose extending to the ala, the upper and anterior aspect of the chin and the sternal notch, with discrete fresh and scabbed abrasions around the neck, over the sternum and on the backs of both hands. There were, however, no facial or conjunctival petechiae and no bruising of the underlying strap muscles, or fractures of the hyoid bone or thyroid cartilage. Histology revealed that myocarditis was the cause of death. Traditional practices may cause unusual bruises, abrasions, blisters and burns that may raise suspicion of inflicted injury from an assault. Knowledge of the manifestations of socio-ethnic practices such as kerokan is important in the evaluation of trauma in specific cultural groups.
    Matched MeSH terms: Cause of Death
  4. Flaherty GT, Caumes E
    J Travel Med, 2018 01 01;25(1).
    PMID: 29635642 DOI: 10.1093/jtm/tay019
    Background: Traumatic deaths, and more particularly suicides, during international travel receive a disproportionately low level of attention in the travel medicine literature. We describe the demographic profile of international travellers whose death occurred at the Cliffs of Moher along the Atlantic seaboard in Ireland.

    Methods: Coroners' files for the 25 years between 1993 and 2017 were interrogated. All cases of death on or at the cliffs were examined, and demographic data were extracted, including date of death, gender, age, nationality, whether the victims were alone at the cliffs prior to their death, whether the fall was witnessed, prevailing weather conditions, post-mortem examinations, toxicology reports and inquest verdicts.

    Results: Overall, 66 deaths occurred on or at the base of the Cliffs of Moher during the period 1993 through August 2017. In total, 18 (27.3%) of the victims were international visitors to Ireland, including 11 males (61.1%). The mean age of travellers (n = 17) was 34.2 years. Victims were nationals of 12 different countries, with 13 being European nationals. Most deaths occurred in summer (n = 7) or spring (n = 6), with eight deaths (44%) reported at weekends. In total, 15 victims (83.3%) had walked along the cliff path alone. A jump or fall from the cliffs was witnessed in only two cases (11.1%). Post-mortem examinations revealed multiple traumatic injuries consistent with a fall from a height. Four cases had evidence of alcohol intoxication. Suicide or open verdicts were returned in 50% (n = 9) of the cases.

    Conclusions: Travelling alone to the site, purchasing one-way tickets, or depositing belongings on the clifftop support the possibility of suicidal intent, while being intoxicated could be a co-factor in suicidal jumps or support the possibility of an accidental fall. This knowledge could help to identify travellers at the greatest risk of death at cliffs.

    Matched MeSH terms: Cause of Death/trends*
  5. Chaiyasothi T, Nathisuwan S, Dilokthornsakul P, Vathesatogkit P, Thakkinstian A, Reid C, et al.
    Front Pharmacol, 2019;10:547.
    PMID: 31191304 DOI: 10.3389/fphar.2019.00547
    Background: Currently, there is a lack of information on the comparative efficacy and safety of non-statin lipid-lowering agents (NST) in cardiovascular (CV) disease risk reduction when added to background statin therapy (ST). This study determine the relative treatment effects of NST on fatal and non-fatal CV events among statin-treated patients. Methods: A network meta-analysis based on a systematic review of randomized controlled trials (RCTs) comparing non-statin lipid-modifying agents among statin-treated patients was performed. PubMed, EMBASE, CENTRAL, and Clinicaltrial.gov were searched up to April 10, 2018. The primary outcomes were CV and all-cause mortalities. Secondary CV outcomes were coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), any stroke, and coronary revascularization. Risks of discontinuations were secondary safety outcomes. Results: Sixty-seven RCTs including 259,429 participants with eight interventions were analyzed. No intervention had significant effects on the primary outcomes (CV mortality and all-cause mortality). For secondary endpoints, proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK) plus statin (PCSK/ST) significantly reduced the risk of non-fatal MI (RR 0.82, 95% CI 0.72-0.93, p = 0.003), stroke (RR 0.74, 95% CI 0.65-0.85, p < 0.001), coronary revascularization (RR 0.84, 95% CI 0.75-0.94, p = 0.003) compared to ST. Combinations of ST and all NST except PCSK and ezetimibe showed higher rate of discontinuation due to adverse events compared to ST. Conclusions: None of NST significantly reduced CV or all-cause death when added to ST. PCSKs and to a lesser extent, ezetimibe may help reduce cardiovascular events with acceptable tolerability profile among broad range of patients.
    Matched MeSH terms: Cause of Death
  6. Gao F, Lam CS, Yeo KK, Machin D, de Carvalho LP, Sim LL, et al.
    J Am Heart Assoc, 2016 10 06;5(10).
    PMID: 27792637
    BACKGROUND: We examined the influence of sex, ethnicity, and time on competing cardiovascular and noncardiovascular causes of death following acute myocardial infarction in a multiethnic Asian cohort.

    METHODS AND RESULTS: For 12 years, we followed a prospective nationwide cohort of 15 151 patients (aged 22-101 years, median age 63 years; 72.3% male; 66.7% Chinese, 19.8% Malay, 13.5% Indian) who were hospitalized for acute myocardial infarction between 2000 and 2005. There were 6463 deaths (4534 cardiovascular, 1929 noncardiovascular). Compared with men, women had a higher risk of cardiovascular death (age-adjusted hazard ratio [HR] 1.3, 95% CI 1.2-1.4) but a similar risk of noncardiovascular death (HR 0.9, 95% CI 0.8-1.0). Sex differences in cardiovascular death varied by ethnicity, age, and time. Compared with Chinese women, Malay women had the greatest increased hazard of cardiovascular death (HR 1.4, 95% CI 1.2-1.6) and a marked imbalance in death due to heart failure or cardiomyopathy (HR 3.4 [95% CI 1.9-6.0] versus HR 1.5 [95% CI 0.6-3.6] for Indian women). Compared with same-age Malay men, Malay women aged 22 to 49 years had a 2.5-fold (95% CI 1.6-3.8) increased hazard of cardiovascular death. Sex disparities in cardiovascular death tapered over time, least among Chinese patients and most among Indian patients; the HR comparing cardiovascular death of Indian women and men decreased from 1.9 (95% CI 1.5-2.4) at 30 days to 0.9 (95% CI 0.5-1.6) at 10 years.

    CONCLUSION: Age, ethnicity, and time strongly influence the association between sex and specific cardiovascular causes of mortality, suggesting that health care policy to reduce sex disparities in acute myocardial infarction outcomes must consider the complex interplay of these 3 major modifying factors.

    Matched MeSH terms: Cause of Death
  7. Lim NL, Nordin MM, Cheah IG
    Med J Malaysia, 1994 Mar;49(1):4-11.
    PMID: 8057989
    An open prospective descriptive pilot study was undertaken to assess the effectiveness and experience in the use of ExosurfNeonatal, a synthetic surfactant, on preterm infants with respiratory distress syndrome in the neonatal intensive care unit of the Paediatric Institute. Of 10 infants treated, seven (70%) survived with no major handicap on discharge. The mean duration of ventilation for these survivors was 6.4 days, mean duration of oxygen therapy 9.1 days and mean length of hospital stay 38.3 days. A comparison was made with a retrospective analysis of 15 neonates who were admitted during an eight month period prior to the pilot study. These infants were mechanically ventilated for respiratory distress syndrome but not given surfactant therapy. Of these, nine (60%) survived (P > 0.1 compared to Exosurf treated infants), but two developed post haemorrhagic hydrocephalus requiring shunting. For these nine survivors, the mean duration of ventilator therapy was 12.6 days, the mean duration of oxygen therapy 20.7 days and the mean length of hospital stay 70.8 days. This difference was statistically significant (P < 0.05). Of the three ExosurfNeonatal treated infants who died, two were extremely premature. Both developed grade IV periventricular haemorrhage while the third infant was admitted in shock and hypothermia and died from intraventricular haemorrhage and pulmonary interstitial emphysema. Except for the very sick and extremely premature infants, surfactant therapy is useful in reducing the mortality and morbidity of premature infants with respiratory distress syndrome in our neonatal intensive unit.
    Matched MeSH terms: Cause of Death
  8. Chang CT, Lee PY, Cheah WL
    Malays J Med Sci, 2012 Apr;19(2):27-34.
    PMID: 22973135 MyJurnal
    Background: Coronary heart disease (CHD) was the second leading cause of death in Malaysia in 2006. CHD has known risk factors including hypertension, diabetes mellitus, and obesity.
    Methods: This cross-sectional study examined the prevalence of cardiovascular risk factors among 260 participants aged 20 to 65 years in a rural community in Sarawak.
    Results: The prevalences of overweight and obesity in this study were 39.6% and 11.9%, respectively. Approximately 13% of participants had hypertension, and 1.5% had a random blood sugar greater than 11.1 mmol/L. Chi-square tests showed significant associations between obesity and gender (P = 0.007), low high-density lipoprotein cholesterol and race (P = 0.05), high total cholesterol and age (P = 0.007), age and hypertension (P = 0.011), smoking and gender (P < 0.001), and smoking and income (P = 0.050). Age-adjusted logistic regression showed that women were 0.246 times more likely to be obese, that older participants (> 45 years) were 0.395 times more likely to have high cholesterol and that those with a higher monthly household income (> RM830) were 2.471 times more likely to smoke.
    Conclusion: These findings indicate that we should be concerned about the high rates of overweight in this rural community to prevent obesity.
    Study site: 8 villages, Serian district, Sarawak, Malaysia
    Keywords: adult; cardiovascular diseases; epidemiology; obesity; prevalence; risk factors.
    Matched MeSH terms: Cause of Death
  9. Tan YY, Yap PK, Xin Lim GL, Mehta M, Chan Y, Ng SW, et al.
    Chem Biol Interact, 2020 Sep 25;329:109221.
    PMID: 32768398 DOI: 10.1016/j.cbi.2020.109221
    Cancer continues to be one of the most challenging diseases to be treated and is one of the leading causes of deaths around the globe. Cancers account for 13% of all deaths each year, with cancer-related mortality expected to rise to 13.1 million by the year 2030. Although, we now have a large library of chemotherapeutic agents, the problem of non-selectivity remains the biggest drawback, as these substances are toxic not only to cancerous cells, but also to other healthy cells in the body. The limitations with chemotherapy and radiation have led to the discovery and development of novel strategies for safe and effective treatment strategies to manage the menace of cancer. Researchers have long justified and have shed light on the emergence of nanotechnology as a potential area for cancer therapy and diagnostics, whereby, nanomaterials are used primarily as nanocarriers or as delivery agents for anticancer drugs due to their tumor targeting properties. Furthermore, nanocarriers loaded with chemotherapeutic agents also overcome biological barriers such as renal and hepatic clearances, thus improving therapeutic efficacy with lowered morbidity. Theranostics, which is the combination of rationally designed nanomaterials with cancer-targeting moieties, along with protective polymers and imaging agents has become one of the core keywords in cancer research. In this review, we have highlighted the potential of various nanomaterials for their application in cancer therapy and imaging, including their current state and clinical prospects. Theranostics has successfully paved a path to a new era of drug design and development, in which nanomaterials and imaging contribute to a large variety of cancer therapies and provide a promising future in the effective management of various cancers. However, in order to meet the therapeutic needs, theranostic nanomaterials must be designed in such a way, that take into account the pharmacokinetic and pharmacodynamics properties of the drug for the development of effective carcinogenic therapy.
    Matched MeSH terms: Cause of Death
  10. Seow SC, Chai P, Lee YP, Chan YH, Kwok BW, Yeo TC, et al.
    J. Card. Fail., 2007 Aug;13(6):476-81.
    PMID: 17675062
    Prognostic indicators and mortality in multiethnic Southeast Asian patients with heart failure (HF) may be different.
    Matched MeSH terms: Cause of Death
  11. Chia YC
    Singapore Med J, 2011 Feb;52(2):116-23.
    PMID: 21373738
    Cardiovascular Disease (CVD) is the leading cause of death in both developed and developing countries. While it is relatively easy to identify those who are obviously at high risk and those at the lowest risk for CVD, it is often the large group of individuals with what appears to be modestly abnormal risk factors who contributes most to the burden of CVD. This is where estimation of CVD risk is necessary. Many tools for risk assessment have been devised. All these risk scores have their own inherent advantages and disadvantages. Furthermore, they may also not be directly applicable to a local population. Ideally, each country should have its own risk score that takes into account other factors as well. In the interim, it is worthwhile to be familiar with one of these scores, select one that is most appropriate for your patient and discuss treatment options based on the estimated risk.
    Matched MeSH terms: Cause of Death/trends
  12. Vermunt J, Bragg F, Halsey J, Yang L, Chen Y, Guo Y, et al.
    PMID: 34728472 DOI: 10.1136/bmjdrc-2021-002495
    INTRODUCTION: We examined the associations between long-term usual random plasma glucose (RPG) levels and cause-specific mortality risks among adults without known diabetes in China.

    RESEARCH DESIGN AND METHODS: The China Kadoorie Biobank recruited 512,891 adults (59% women) aged 30-79 from 10 regions of China during 2004-2008. At baseline survey, and subsequent resurveys of a random subset of survivors, participants were interviewed and measurements collected, including on-site RPG testing. Cause of death was ascertained via linkage to local mortality registries. Cox regression yielded adjusted HR for all-cause and cause-specific mortality associated with usual levels of RPG.

    RESULTS: During median 11 years' follow-up, 37,214 deaths occurred among 452,993 participants without prior diagnosed diabetes or other chronic diseases. There were positive log-linear relationships between RPG and all-cause, cardiovascular disease (CVD) (n=14,209) and chronic kidney disease (CKD) (n=432) mortality down to usual RPG levels of at least 5.1 mmol/L. At RPG <11.1 mmol/L, each 1.0 mmol/L higher usual RPG was associated with adjusted HRs of 1.14 (95% CI 1.12 to 1.16), 1.16 (1.12 to 1.19) and 1.44 (1.22 to 1.70) for all-cause, CVD and CKD mortality, respectively. Usual RPG was positively associated with chronic liver disease (n=547; 1.45 (1.26 to 1.66)) and cancer (n=12,680; 1.12 (1.09 to 1.16)) mortality, but with comparably lower risks at baseline RPG ≥11.1 mmol/L. These associations persisted after excluding participants who developed diabetes during follow-up.

    CONCLUSIONS: Among Chinese adults without diabetes, higher RPG levels were associated with higher mortality risks from several major diseases, with no evidence of apparent thresholds below the cut-points for diabetes diagnosis.

    Matched MeSH terms: Cause of Death
  13. Chia YC, Devaraj NK, Chook JB, Chew MT, Ooi PB, Mohamed M, et al.
    Eur Heart J Suppl, 2021 May;23(Suppl B):B98-B100.
    PMID: 34054370 DOI: 10.1093/eurheartj/suab058
    Despite hypertension remaining the leading cause of death worldwide, awareness of hypertension and its control rate is still suboptimal in Malaysia. This study aims to determine the proportion of both diagnosed and undiagnosed hypertension, awareness and its control rate during the yearly May Measurement Month (MMM) campaign that has been coordinated by the International Society of Hypertension. Participants aged ≥18 years were recruited at various screening sites namely universities, health facilities, shopping malls, and other sites. Participant's socio-demographic, environmental, and lifestyle data were captured using a questionnaire. Three blood pressure (BP) readings as well as anthropometric measurements were obtained from all participants. The mean of the second and third BP readings was used in analyses. Hypertension was defined as a systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg or taking antihypertensive medication. A total of 3062 participants were recruited. The proportion with hypertension in our study was 18.7% (n = 572). The proportion who were aware of their BP status was 63.2%. More than half (57.2%) of the hypertensives were on antihypertensive medication and 70.3% of those treated were controlled. In conclusion, in this BP screening campaign, one in five were hypertensive with almost two thirds aware of their hypertensive status. BP control among those who are taking medications was high at 70% but under 60% of hypertensives were on treatment. Hypertension screening programmes are important to promote awareness and control of hypertension as well as to reduce the devastating complications associated with this disorder.
    Matched MeSH terms: Cause of Death
  14. Koh ET, Seow A, Leong KH, Chng HH
    Lupus, 1997;6(1):27-31.
    PMID: 9116715 DOI: 10.1177/096120339700600104
    We analysed the causes of 67 deaths, over a 4 y period, in our oriental population with systemic lupus erythematosus (SLE). The median disease duration was 48 +/- 60.5 months (range 1-250 months). The mean age at diagnosis and death were 30 and 35.1 y respectively. SLE alone accounted for death in 30 patients (44.8%), infection in 27 (40.3%), pulmonary embolism in 5 (7.5%), malignancy in 4 (5.9%) and rheumatic heart disease in 1 (1.5%). The major organ involvement in those with active disease at death were SLE related thrombocytopenia (n = 23/44, 52.3%), nephritis (n = 21/44), 47.7%), cerebral lupus (n = 16/44, 36.4%), and pulmonary haemorrhage (n = 12/44, 27.3%). As in other series, SLE and infection were the principal causes of death in our population. During this 4 y period, there was no late death due to atherosclerosis.
    Study site: Tan Tock Seng Hospital (TTSH), Singapore
    Matched MeSH terms: Cause of Death
  15. Mahmud MZ, Islam MT, Misran N, Almutairi AF, Cho M
    Sensors (Basel), 2018 Sep 05;18(9).
    PMID: 30189633 DOI: 10.3390/s18092951
    Globally, breast cancer is reported as a primary cause of death in women. More than 1.8 million new breast cancer cases are diagnosed every year. Because of the current limitations on clinical imaging, researchers are motivated to investigate complementary tools and alternatives to available techniques for detecting breast cancer in earlier stages. This article presents a review of concepts and electromagnetic techniques for microwave breast imaging. More specifically, this work reviews ultra-wideband (UWB) antenna sensors and their current applications in medical imaging, leading to breast imaging. We review the use of UWB sensor based microwave energy in various imaging applications for breast tumor related diseases, tumor detection, and breast tumor detection. In microwave imaging, the back-scattered signals radiating by sensors from a human body are analyzed for changes in the electrical properties of tissues. Tumorous cells exhibit higher dielectric constants because of their high water content. The goal of this article is to provide microwave researchers with in-depth information on electromagnetic techniques for microwave imaging sensors and describe recent developments in these techniques.
    Matched MeSH terms: Cause of Death
  16. Goh AY, Lum LC, Chan PW, Bakar F, Chong BO
    Arch Dis Child, 1999 May;80(5):424-8.
    PMID: 10208946
    OBJECTIVES: To compare the modes of death and factors leading to withdrawal or limitation of life support in a paediatric intensive care unit (PICU) in a developing country.

    METHODS: Retrospective analysis of all children (< 12 years) dying in the PICU from January 1995 to December 1995 and January 1997 to June 1998 (n = 148).

    RESULTS: The main mode of death was by limitation of treatment in 68 of 148 patients, failure of active treatment including cardiopulmonary resuscitation in 61, brain death in 12, and withdrawal of life support with removal of endotracheal tube in seven. There was no significant variation in the proportion of limitation of treatment, failure of active treatment, and brain death between the two periods; however, there was an increase in withdrawal of life support from 0% in 1995 to 8% in 1997-98. Justification for limitation was based predominantly on expectation of imminent death (71 of 75). Ethnic variability was noted among the 14 of 21 patients who refused withdrawal. Discussions for care restrictions were initiated almost exclusively by paediatricians (70 of 75). Diagnostic uncertainty (36% v 4.6%) and presentation as an acute illness were associated with the use of active treatment.

    CONCLUSIONS: Limitation of treatment is the most common mode of death in a developing country's PICU and active withdrawal is still not widely practised. Paediatricians in developing countries are becoming more proactive in managing death and dying but have to consider sociocultural and religious factors when making such decisions.

    Matched MeSH terms: Cause of Death
  17. Chia BH, Chia A, Yee NW, Choo TB
    Arch Suicide Res, 2010;14(3):276-83.
    PMID: 20658381 DOI: 10.1080/13811118.2010.494147
    The objective of this study was to investigate suicide trends in Singapore between 1955 and 2004. Suicide cases were identified from the Registry of Birth and Death, Singapore, and analyzed using Poisson regression. Overall, suicide rates in Singapore remained stable between 9.8-13.0/100,000 over the last 5 decades. Rates remain highest in elderly males, despite declines among the elderly and middle-aged males in recent years. Rates in ethnic Chinese and Indians were consistently higher than in Malays. While the rates among female Indians and Chinese have declined significantly between 1995 and 2004, some increase was noted in female Malays. Although there was no increase in overall suicide rates, risk within certain population segments has changed over time.
    Matched MeSH terms: Cause of Death
  18. Serebruany V, Tanguay JF, Benavides MA, Cabrera-Fuentes H, Eisert W, Kim MH, et al.
    Am J Ther, 2020 10 29;27(6):e563-e572.
    PMID: 33109913 DOI: 10.1097/MJT.0000000000001286
    BACKGROUND: Excess vascular deaths in the PLATO trial comparing ticagrelor to clopidogrel have been repeatedly challenged by the Food and Drug Administration (FDA) reviewers and academia. Based on the Freedom of Information Act, BuzzFeed won a court order and shared with us the complete list of reported deaths for the ticagrelor FDA New Drug Application (NDA) 22-433. This dataset was matched against local patient-level records from PLATO sites monitored by the sponsor.

    STUDY QUESTION: Whether FDA death data in the PLATO trial matched the local site records.

    STUDY DESIGN: The NDA spreadsheet contains 938 precisely detailed PLATO deaths. We obtained and validated local evidence for 52 deaths among 861 PLATO patients from 14 enrolling sites in 8 countries and matched those with the official NDA dataset submitted to the FDA.

    MEASURES AND OUTCOMES: Existence, precise time, and primary cause of deaths in PLATO.

    RESULTS: Discrepant to the NDA document, sites confirmed 2 extra unreported deaths (Poland and Korea) and failed to confirm 4 deaths (Malaysia). Of the remaining 46 deaths, dates were reported correctly for 42 patients, earlier (2 clopidogrel), or later (2 ticagrelor) than the actual occurrence of death. In 12 clopidogrel patients, cause of death was changed to "vascular," whereas 6 NDA ticagrelor "nonvascular" or "unknown" deaths were site-reported as of "vascular" origin. Sudden death was incorrectly reported in 4 clopidogrel patients, but omitted in 4 ticagrelor patients directly affecting the primary efficacy PLATO endpoint.

    CONCLUSIONS: Many deaths were inaccurately reported in PLATO favoring ticagrelor. The full extent of mortality misreporting is currently unclear, while especially worrisome is a mismatch in identifying primary death cause. Because all PLATO events are kept in the cloud electronic Medidata Rave capture system, securing the database content, examining the dataset changes or/and repeated entries, identifying potential interference origin, and assessing full magnitude of the problem are warranted.

    Matched MeSH terms: Cause of Death*
  19. Frisch AS, Kallen DJ, Griffore RJ, Dolanski EA
    J Biosoc Sci, 1992 Apr;24(2):175-83.
    PMID: 1583032
    This study used path analysis to assess the chances of survival of babies in a neonatal intensive care unit in Lansing, Michigan, USA. Two paths to neonatal survival were identified and the variables accounted for 20% of the variance in gestational age. The first path showed that prior infant losses were negatively correlated with gestational age while in the second path, gestational age showed negative relationships with pre-pregnancy weight and household job worries.
    Matched MeSH terms: Cause of Death*
  20. Thomson B, Tapia-Conyer R, Lacey B, Lewington S, Ramirez-Reyes R, Aguilar-Ramirez D, et al.
    Int J Epidemiol, 2021 07 09;50(3):955-964.
    PMID: 33659992 DOI: 10.1093/ije/dyab013
    BACKGROUND: Research is needed to determine the relevance of low-intensity daily smoking to mortality in countries such as Mexico, where such smoking habits are common.

    METHODS: Prospective study of 159 755 Mexican adults recruited from 1998-2004 and followed for cause-specific mortality to 1 January 2018. Participants were categorized according to baseline self-reported smoking status. Confounder-adjusted mortality rate ratios (RRs) at ages 35-89 were estimated using Cox regression, after excluding those with previous chronic disease (to avoid reverse causality).

    RESULTS: Among 42 416 men and 86 735 women aged 35-89 and without previous disease, 18 985 men (45%) and 18 072 women (21%) reported current smoking and 8866 men (21%) and 53 912 women (62%) reported never smoking. Smoking less than daily was common: 33% of male current smokers and 39% of female current smokers. During follow-up, the all-cause mortality RRs associated with the baseline smoking categories of <10 cigarettes per day (average during follow-up 4 per day) or ≥10 cigarettes per day (average during follow-up 10 per day), compared with never smoking, were 1.17 (95% confidence interval 1.10-1.25) and 1.54 (1.42-1.67), respectively. RRs were similar irrespective of age or sex. The diseases most strongly associated with daily smoking were respiratory cancers, chronic obstructive pulmonary disease and gastrointestinal and vascular diseases. Ex-daily smokers had substantially lower mortality rates than those who were current daily smokers at recruitment.

    CONCLUSIONS: In this Mexican population, low-intensity daily smoking was associated with increased mortality. Of those smoking 10 cigarettes per day on average, about one-third were killed by their habit. Quitting substantially reduced these risks.

    Matched MeSH terms: Cause of Death
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