Blended e-learning and certification for medicines development professionals: results of a 7-year collaboration between King's College, London and the GMDP Academy, New York.

Introduction: The field of Medicines Development faces a continuous need for educational evolution to match the interdisciplinary and global nature of the pharmaceutical industry. This paper discusses the outcomes of a 7-year collaboration between King's College London and the Global Medicines Development Professionals (GMDP) Academy, which aimed to address this need through a blended e-learning program. Methods: The collaboration developed a comprehensive curriculum based on the PharmaTrain syllabus, delivered through a combination of asynchronous and synchronous e-learning methods. The program targeted a diverse range of professionals serving in areas related to Medical Affairs. Results: Over seven annual cohorts, 682 participants from eighty-six countries were enrolled in the program. The program's effectiveness was assessed using Kirkpatrick's model, showing elevated levels of satisfaction (over 4.0 on a five-point scale), suggesting significant gains in competence at the cognitive level and leveraged performance. Notably, 70% of responding alumni reported significant improvement in their functions, corroborated by 30% of their supervisors. The further long-term impact of the program on their respective organization has not been established. Discussion: The GMDP Academy's program has significantly contributed to life-long learning in Medicines Development, addressing educational gaps and fostering interdisciplinary collaboration. Its success highlights the importance of continuous education in keeping pace with the industry's evolving demands and underscores the potential of blended learning in achieving educational objectives in pharmaceutical medicine.

Epidemiology of cardioprotective pharmacological agent use in stable coronary heart disease.

OBJECTIVE: To determine use of class and type of cardioprotective pharmacological agents in patients with stable coronary heart disease (CHD) we performed a prescription audit. METHODS: A cross sectional survey was conducted in major districts of Rajasthan in years 2008-09. We evaluated prescription for classes (anti-platelets, ß-blockers, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB), calcium channel blockers (CCB) and statins) and specific pharmacological agents at clinics of physicians in tertiary (n = 18), secondary (n = 69) and primary care (n = 43). Descriptive statistics are reported. RESULTS: Prescriptions of 2290 stable CHD patients were audited. Anti-platelet use was in 2031 (88.7%), ß-blockers 1494 (65.2%), ACE inhibitors 1196 (52.2%), ARBs 712 (31.1%), ACE inhibitors - ARB combinations 19 (0.8%), either ACE inhibitors or ARBs 1908 (83.3%), CCBs 1023 (44.7%), statins 1457 (63.6%) and other lipid lowering agents in 170 (7.4%). Among anti-platelets aspirin-clopidogrel combination was used in 88.5%. Top three molecules in ß-blockers were atenolol (37.8%), metoprolol (26.4%) and carvedilol (11.9%); ACE inhibitors ramipril (42.1%), lisinopril (20.3%) and perindopril (10.9%); ARB's losartan (47.7%), valsartan (22.3%) and telmisartan (14.9%); CCBs amlodipine (46.7%), diltiazem (29.1%) and verapamil (9.5%) and statins were atorvastatin (49.8%), simvastatin (28.9%) and rosuvastatin (18.3%). Use of metoprolol, ramipril, valsartan, diltiazem and atorvastatin was more at tertiary care, and atenolol, lisinopril, losartan, amlodipine and simvasatin in primary care (p < 0.01). CONCLUSIONS: There is low use of ß-blockers, ACE inhibitors, ARBs and statins in stable CHD patients among physicians in Rajasthan. Significant differences in use of specific molecules at primary, secondary and tertiary healthcare are observed.

Metabolic cardiovascular risk factors worsen continuously across the spectrum of body mass index in Asian Indians.

OBJECTIVES: To determine relationship of body mass index (BMI) with multiple cardiovascular risk factors. METHODS: Population-based surveys were performed and 1893 subjects aged 20-59 years evaluated. Data were collected using anthropometry and fasting glucose and lipid estimation. Statistical analyses were performed using curve fit and logistic regression. RESULTS: Body mass index was correlated significantly (Rho, R(2)) with weight (0.80, 0.64), waist (0.74, 0.55) and waist hip ratio (0.24, 0.06) (P < 0.05). Linear relationship was observed with systolic blood pressure (SBP) (0.39, 0.15), diastolic blood pressure (DBP) (0.29, 0.08), fasting glucose (0.13, 0.02), cholesterol (0.10, 0.01), high-density lipoprotein cholesterol (HDL-c) (-0.16, 0.03), and triglycerides (0.12, 0.01). Significant trends of risk factors with each increasing BMI unit (χ(2) test, P < 0.001) were observed for hypertension (HTN) (214.4), diabetes (29.5), metabolic syndrome (108.9), and low HDL-c (40.5), and weaker trends with hypercholesterolemia (20.6), and hypertriglyceridemia (9.6). There was exponential relationship of BMI with age- and sex-adjusted odds ratios for HTN, diabetes, and metabolic syndrome. CONCLUSION: Metabolic cardiovascular risk factors continuously worsen with increasing BMI.

Secondary prevention therapies for coronary heart disease in patients with type 2 diabetes: an audit.

BACKGROUND: Use of evidence based pharmacotherapy reduces risk of secondary events in patients with established coronary heart disease (CHD). To determine frequency of their use in diabetic CHD we performed prescription audits. METHODS: Frequency of prescriptions of aspirin, beta-blockers, angiotensin converting enzymes inhibitors (ACEI) or angiotensin receptor blockers (ARB), lipid-lowering medicines, and other drugs in CHD patients at primary, secondary and tertiary levels of care in out-patients' departments in Rajasthan was determined. Patients' and physicians' demographic details and prescribing patterns were obtained. Descriptive statistics are reported. RESULTS: We audited prescriptions of 2290 CHD patients aged 60.9 +/- 8.7 years. There were 1033 patients of CHD with diabetes (45.1%, age 61.9 +/- 8.6) and 1257 without (54.9%, age 59.9 +/- 8.9). In CHD patients with diabetes vs. without, use of beta blockers was lower (59.4 vs 69.2%) while ACEI/ARB (86.5 vs 82.1%) and statins (67.1 vs 59.7%) greater. Use of other drugs such as aspirin (88.7 vs 88.3%), fibrates (11.9 vs 11.1%), non-dihydropyridine CCB (16.0 vs 17.9%) and nitrates (38.8 vs 14.5%) was similar. Use of beta blockers was lowest among diabetologists (37.6%) as compared to other physicians (64.4%) and cardiologists (59.4%) and was the lowest in primary care. CONCLUSIONS: Low use of beta-blockers is observed in diabetic CHD patients.

Persistent high prevalence of cardiovascular risk factors in the urban middle class in India: Jaipur Heart Watch-5.

BACKGROUND AND OBJECTIVE: Urban subjects have high burden of cardiovascular risk factors, therefore, to evaluate risk factors in middle socioeconomic subjects and to study secular trends we performed an epidemiological study. METHODS: The study was performed at urban middle class locations defined according to municipal records in years 2009-10. Stratified random sampling using house-to-house survey was performed. Details of medical history, anthropometry and clinical examination were recorded and biochemical tests performed for estimation of fasting glucose and lipids. Current definitions were used for risk factor classification. Descriptive statistics are provided. Trends were calculated using ANOVA or Mantel Haenszel chi-square. Univariate and multivariate logistic regression was performed to assess risk factor determinants. To determine secular trends we compared risk factors with previous cross-sectional studies performed in same locations in years 2002-3 and 2004-5 in subjects 20-59 years age. RESULTS: We evaluated 739 subjects (men 451, women 288, response 67%). Age-adjusted prevalence (%) of risk factors in men and women respectively was smoking 95 (21.1) and 12 (4.2), low physical activity 316 (69.6) and 147 (52.3), high fat intake > or = 20 gm/day 278 (73.4) and 171 (68.7), low fruits and vegetables intake < 3 helpings/day 249 (70.3) and 165 (76.4), overweight/obesity 205 (46.2) and 142 (50.7), high waist size 58 (12.9) and 76 (26.6), high waist:hip 143 (31.9) and 154 (53.9), hypertension 177 (39.5) and 71 (24.6), high total cholesterol > or = 200 mg/ dl 148 (33.0) and 93 (32.7), low HDL cholesterol < 40/50 mg/dl 113 (25.1) and 157 (55.3), diabetes 62 (15.5) and 25 (10.8) and metabolic syndrome 109 (25.1) and 61 (22.0). Age-associated increase was observed in body mass index, waist size, waist ratio:hip, systolic blood pressure and fasting and total cholesterol, non-HDL cholesterol and triglycerides in women (Ptrend < 0.01). Age related increase was also observed in prevalence of obesity, truncal obesity, hypertension, diabetes and metabolic syndrome (Ptrend < 0.01). On univariate analysis significant determinants of risk factors were low educational and socioeconomic status for smoking, high fat diet for obesity and hypertension, low fruits and vegetables intake for metabolic syndrome, and low physical activity or obesity but on age-and sex-adjusted multivariate analysis only association was high fat diet with obesity and hypertension (logistic regression analysis p < 0.05). Compared to studies performed at similar locations in years 2002-03 and 2005-06 there was increasing trend in prevalence of high non-HDL cholesterol and hypertriglyceridemia (Ptrend < 0.05) while other risk factors did not change significantly. CONCLUSIONS: There is a high prevalence of multiple cardiovascular risk factors in Indian middle class individuals. Secular trends demonstrate a persistent high prevalence and increasing non-HDL cholesterol and triglycerides over 8-year period.

Translating evidence into policy for cardiovascular disease control in India.

Cardiovascular diseases (CVD) are leading causes of premature mortality in India. Evidence from developed countries shows that mortality from these can be substantially prevented using population-wide and individual-based strategies. Policy initiatives for control of CVD in India have been suggested but evidence of efficacy has emerged only recently. These initiatives can have immediate impact in reducing morbidity and mortality. Of the prevention strategies, primordial involve improvement in socioeconomic status and literacy, adequate healthcare financing and public health insurance, effective national CVD control programme, smoking control policies, legislative control of saturated fats, trans fats, salt and alcohol, and development of facilities for increasing physical activity through better urban planning and school-based and worksite interventions. Primary prevention entails change in medical educational curriculum and improved healthcare delivery for control of CVD risk factors-smoking, hypertension, dyslipidemia and diabetes. Secondary prevention involves creation of facilities and human resources for optimum acute CVD care and secondary prevention. There is need to integrate various policy makers, develop effective policies and modify healthcare systems for effective delivery of CVD preventive care.

Effects of high-dose versus low-dose losartan on clinical outcomes in patients with heart failure (HEAAL study): a randomised, double-blind trial.

BACKGROUND: Angiotensin-receptor blockers (ARBs) are effective treatments for patients with heart failure, but the relation between dose and clinical outcomes has not been explored. We compared the effects of high-dose versus low-dose losartan on clinical outcomes in patients with heart failure. METHODS: This double-blind trial was undertaken in 255 sites in 30 countries. 3846 patients with heart failure of New York Heart Association class II-IV, left-ventricular ejection fraction 40% or less, and intolerance to angiotensin-converting-enzyme (ACE) inhibitors were randomly assigned to losartan 150 mg (n=1927) or 50 mg daily (n=1919). Allocation was by block randomisation stratified by centre and presence or absence of beta-blocker therapy, and all patients and investigators were masked to assignment. The primary endpoint was death or admission for heart failure. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00090259. FINDINGS: Six patients in each group were excluded because of poor data quality. With 4.7-year median follow-up in each group (IQR 3.7-5.5 for losartan 150 mg; 3.4-5.5 for losartan 50 mg), 828 (43%) patients in the 150 mg group versus 889 (46%) in the 50 mg group died or were admitted for heart failure (hazard ratio [HR] 0.90, 95% CI 0.82-0.99; p=0.027). For the two primary endpoint components, 635 patients in the 150 mg group versus 665 in the 50 mg group died (HR 0.94, 95% CI 0.84-1.04; p=0.24), and 450 versus 503 patients were admitted for heart failure (0.87, 0.76-0.98; p=0.025). Renal impairment (n=454 vs 317), hypotension (203 vs 145), and hyperkalaemia (195 vs 131) were more common in the 150 mg group than in the 50 mg group, but these adverse events did not lead to significantly more treatment discontinuations in the 150 mg group. INTERPRETATION: Losartan 150 mg daily reduced the rate of death or admission for heart failure in patients with heart failure, reduced left-ventricular ejection fraction, and intolerance to ACE inhibitors compared with losartan 50 mg daily. These findings show the value of up-titrating ARB doses to confer clinical benefit. FUNDING: Merck (USA).

Cardiovascular risk according to educational status in India.

OBJECTIVE: Influence of socioeconomic status on cardiovascular risk has not been well studied in low income countries. To determine risks in various educational status (ES) subjects we performed a study in India. METHODS: Epidemiological study was performed in years 1999-2003 in Jaipur (India) for coronary risk factors among 1280 adults 20-59 years (men 619, women 661). ES was categorized into low (education ≤5 years); middle (6-12 years) and high (>12 years). Prevalence of risk factors and Framingham risk scores were determined. RESULTS: Low ES was in 306, middle in 436 and high in 538. In low, middle and high ES respectively age-adjusted prevalence (%) of smoking was 19.0, 19.3, and 11.7; obesity 9.5, 16.7, and 22.1, hypertension 15.3, 30.5, and 44.0; hypercholesterolemia ≥200mg/dl 46.0, 48.4, and 54.6; low HDL cholesterol <40mg/dl 46.4, 56.4, and 38.3; metabolic syndrome 20.9, 25.7, and 28.6; and diabetes 6.9, 5.5, and 26.4. Framingham risk score was 5.7±4.8, 6.3±5.7 and 4.7±5.1 and calculated cardiovascular risk probability 5.2±5.7, 6.8±7.8 and 5.2±6.0 (P(trend)<0.05). Framingham risk score was significantly greater in low and middle ES (6.1±5.3) compared to high (4.7±5.1) (p<0.001). Adjustment for smoking attenuated the risk. CONCLUSION: Low and middle educational status urban subjects in India have greater cardiovascular risk.

Strategies for initial management of hypertension.

High blood pressure (BP) is a major public health problem in India and its prevalence is rapidly increasing among urban and rural populations. Reducing systolic and diastolic BP can decrease cardiovascular risk and this can be achieved by non-pharmacological (lifestyle measures) as well as pharmacological means. Lifestyle changes should be the initial approach to hypertension management and include dietary interventions (reducing salt, increasing potassium, alcohol avoidance, and multifactorial diet control), weight reduction, tobacco cessation, physical exercise, and stress management. A number of pharmaceutical agents, well evidenced by large randomized clinical trials, are available for initial treatment of high BP. These include older molecules such as thiazide diuretics and beta-blocking agents and newer molecules, dihydropyridine calcium channel blockers (CCB), angiotensin converting enzyme (ACE) inhibitors, and angiotensin receptor blockers (ARB). In view of the recent clinical trials data, some international guidelines suggest that CCB, ACE inhibitors or ARB and not beta-blockers or diuretics should be the initial therapy in hypertension management. Comprehensive hypertension management focuses on reducing overall cardiovascular risk by lifestyle measures, BP lowering and lipid management and should be the preferred initial treatment approach.

Design of the heart failure endpoint evaluation of AII-antagonist losartan (HEAAL) study in patients intolerant to ACE-inhibitor.

BACKGROUND: In patients with heart failure and reduced left ventricular ejection fraction, angiotensin receptor blockers have been found to reduce mortality and morbidity and to prevent or reverse left ventricular remodelling, compared to optimized background treatment. In light of these data, The Heart failure Endpoint evaluation of Angiotensin II Antagonist Losartan (HEAAL) study was developed to determine whether losartan 150 mg is superior to losartan 50 mg (antihypertensive dose) in reducing morbidity and mortality among patients with symptomatic heart failure who are intolerant of angiotensin-converting enzyme (ACE)-inhibitors. AIMS/METHODS: To compare the effect of high and moderate doses of losartan on the primary endpoint of all-cause mortality and hospitalisation due to heart failure in patients (n = 3834) with symptomatic heart failure and an ejection fraction < or = 40% who are intolerant of ACE-inhibitor treatment. RESULTS: This paper presents the rationale, trial design, and baseline characteristics of the study population. The study, which completed recruitment on 31 March 2005, is event-driven and is estimated to accrue the target of 1710 adjudicated primary events during the latter half of 2008. CONCLUSIONS: The results of HEAAL should facilitate selection of an optimal dosing regimen for losartan in patients with symptomatic heart failure who are intolerant of ACE-inhibitors.

Secular trends in cholesterol lipoproteins and triglycerides and prevalence of dyslipidemias in an urban Indian population.

BACKGROUND: Coronary heart disease is increasing in urban Indian subjects and lipid abnormalities are important risk factors. To determine secular trends in prevalence of various lipid abnormalities we performed studies in an urban Indian population. METHODS: Successive epidemiological Jaipur Heart Watch (JHW) studies were performed in Western India in urban locations. The studies evaluated adults > or = 20 years for multiple coronary risk factors using standardized methodology (JHW-1, 1993-94, n = 2212; JHW-2, 1999-2001, n = 1123; JHW-3, 2002-03, n = 458, and JHW-4 2004-2005, n = 1127). For the present analyses data of subjects 20-59 years (n = 4136, men 2341, women 1795) have been included. In successive studies, fasting measurements for cholesterol lipoproteins (total cholesterol, LDL cholesterol, HDL cholesterol) and triglycerides were performed in 193, 454, 179 and 252 men (n = 1078) and 83, 472, 195, 248 women (n = 998) respectively (total 2076). Age-group specific levels of various cholesterol lipoproteins, triglycerides and their ratios were determined. Prevalence of various dyslipidemias (total cholesterol > or = 200 mg/dl, LDL cholesterol > or = 130 mg/dl, non-HDL cholesterol > or = 160 mg/dl, triglycerides > or = 150 mg/dl, low HDL cholesterol <40 mg/dl, high cholesterol remnants > or = 25 mg/dl, and high total:HDL cholesterol ratio > or = 5.0, and > or = 4.0 were also determined. Significance of secular trends in prevalence of dyslipidemias was determined using linear-curve estimation regression. Association of changing trends in prevalence of dyslipidemias with trends in educational status, obesity and truncal obesity (high waist:hip ratio) were determined using two-line regression analysis. RESULTS: Mean levels of various lipoproteins increased sharply from JHW-1 to JHW-2 and then gradually in JHW-3 and JHW-4. Age-adjusted mean values (mg/dl) in JHW-1, JHW-2, JHW-3 and JHW-4 studies respectively showed a significant increase in total cholesterol (174.9 +/- 45, 196.0 +/- 42, 187.5 +/- 38, 193.5 +/- 39, 2-stage least-squares regression R = 0.11, p < 0.001), LDL cholesterol (106.2 +/- 40, 127.6 +/- 39, 122.6 +/- 44, 119.2 +/- 31, R = 0.11, p < 0.001), non-HDL cholesterol (131.3 +/- 43, 156.4 +/- 43, 150.1 +/- 41, 150.9 +/- 32, R = 0.12, p < 0.001), remnant cholesterol (25.1 +/- 11, 28.9 +/- 14, 26.0 +/- 11, 31.7 +/- 14, R = 0.06, p = 0.001), total:HDL cholesterol ratio (4.26 +/- 1.3, 5.18 +/- 1.7, 5.21 +/- 1.7, 4.69 +/- 1.2, R = 0.10, p < 0.001) and triglycerides (125.6 +/- 53, 144.5 +/- 71, 130.1 +/- 57, 158.7 +/- 72, R = 0.06, p = 0.001) and decrease in HDL cholesterol (43.6 +/- 14, 39.7 +/- 8, 37.3 +/- 6, 42.5 +/- 6, R = 0.04, p = 0.027). Trends in age-adjusted prevalence (%) of dyslipidemias in JHW-1, JHW-2, JHW-3 and JHW-4 studies respectively showed insignificant changes in high total cholesterol (26.3, 35.1, 25.6, 26.0, linear curve-estimation coefficient multiple R = 0.034), high LDL cholesterol > or = 130 mg/dl (24.2, 36.2, 31.0, 22.2, R = 0.062), and high low HDL cholesterol < 40 mg/dl (46.2, 53.3, 55.4, 33.7, R = 0.136). Increase was observed in prevalence of high non-HDL cholesterol (23.0, 33.5, 27.4, 26.6, R = 0.026), high remnant cholesterol (40.1, 40.3, 30.1, 60.6, R = 0.143), high total:HDL cholesterol ratio > or = 5.0 (22.2, 47.6, 53.2, 26.3, R = 0.031) and > or = 4.0 (58.6, 72.5, 70.1, 62.0, R = 0.006), and high triglycerides (25.7, 28.2, 17.5, 34.2, R = 0.047). Greater correlation of increasing non-HDL cholesterol, remnant cholesterol, triglycerides and total:HDL cholesterol ratio was observed with increasing truncal obesity than generalized obesity (two-line regression analysis p < 0.05). Greater educational level, as marker of socioeconomic status, correlated significantly with increasing obesity (r2 men 0.98, women 0.99), and truncal obesity (r2 men 0.71, women 0.90). CONCLUSION: In an urban Indian population, trends reveal increase in mean total-, non-HDL-, remnant-, and total:HDL cholesterol, and triglycerides and decline in HDL cholesterol levels. Prevalence of subjects with high total cholesterol did not change significantly while those with high non-HDL cholesterol, cholesterol remnants, triglycerides and total-HDL cholesterol ratio increased. Increasing dyslipidemias correlate significantly with increasing truncal obesity and obesity.

Cholesterol lipoproteins and prevalence of dyslipidemias in urban Asian Indians: a cross sectional study.

OBJECTIVE: To determine levels of cholesterol lipoproteins and prevalence of dyslipidemias in urban Asian Indians. METHODS: Population based 6123 subjects (men 3388) were evaluated. Mean±1SD of various cholesterol lipoproteins (total, HDL, LDL and non-HDL cholesterol) and triglycerides were reported. Subjects were classified according to US National Cholesterol Education Program. RESULTS: Age-adjusted levels in men and women were cholesterol total 178.4 ± 39 and 184.6 ± 39, HDL 44.9 ± 11 and 51.1 ± 11, LDL 102.5 ± 33 and 106.2 ± 33, total:HDL 4.15 ± 1.2 and 3.79 ± 1.0 and triglycerides 162.5 ± 83 and 143.7 ± 83 mg/dl. Age-adjusted prevalence (%) in men and women, respectively were, total cholesterol ≥200 mg/dl 25.1 and 24.9, LDL cholesterol ≥130 mg/dl 16.3 and 15.1 and ≥100 mg/dl 49.5 and 49.7, HDL cholesterol <40/<50 mg/dl 33.6 and 52.8, total:HDL cholesterol ≥4.5 29.4 and 16.8, and triglycerides ≥150 mg/dl 42.1 and 32.9%. Cholesterol level was significantly greater in subjects with better socioeconomic status, body mass index and waist circumference while triglycerides were more among those with high socioeconomic status, fat intake, body mass index and waist circumference (p < 0.05). Hypercholesterolemia awareness (15.6%), treatment (7.2%) and control (4.1%) were low. CONCLUSIONS: Mean cholesterol and LDL cholesterol are low and triglycerides were high in urban Asian Indians. Most prevalent dyslipidemias are borderline high LDL, low HDL and high triglycerides. Subjects with high socioeconomic status, high fat intake and greater adiposity have higher total and LDL cholesterol and triglyceride and lower HDL cholesterol.

Normotension, prehypertension, and hypertension in urban middle-class subjects in India: prevalence, awareness, treatment, and control.

OBJECTIVE: We conducted a multisite study to determine the prevalence and determinants of normotension, prehypertension, and hypertension, and awareness, treatment, and control of hypertension among urban middle-class subjects in India. METHODS: We evaluated 6,106 middle-class urban subjects (men 3,371; women, 2,735; response rate, 62%) in 11 cities for sociodemographic and biological factors. The subjects were classified as having normotension (BP < 120/80), prehypertension (BP 120-139/80-89), and hypertension (documented or BP ≥ 140/90). The prevalence of other cardiovascular risk factors was determined and associations evaluated through logistic regression analysis. RESULTS: The age-adjusted prevalences in men and women of normotension were 26.7% and 39.1%, of prehypertension 40.2% and 30.1%, and of hypertension 32.5% and 30.4%, respectively. The prevalence of normotension declined with age whereas that of hypertension increased (P-trend < 0.01). A significant association of normotension was found with younger age, low dietary fat intake, lower use of tobacco, and low obesity (P < 0.05). The prevalence of hypercholesterolemia, diabetes, and metabolic syndrome was higher in the groups with prehypertension and hypertension than in the group with normotension (age-adjusted odds ratios (ORs) 2.0-5.0, P < 0.001). The prevalences in men and women, respectively, of two or more risk factors were 11.1% and 6.4% in the group with normotension, 25.1% and 23.3% in the group with prehypertension, and 38.3% and 39.1% in the group with hypertension (P < 0.01). Awareness of hypertension in the study population was in 55.3%; 36.5% of the hypertensive group were receiving treatment for hypertension, and 28.2% of this group had a controlled BP (< 140/90 mm Hg). CONCLUSIONS: The study found a low prevalence of normotension and high prevalence of hypertension in middle-class urban Asian Indians. Significant associations of hypertension were found with age, dietary fat, consumption of fruits and vegetables, smoking, and obesity. Normotensive individuals had a lower prevalence of cardiometabolic risk factors than did members of the prehypertensive or hypertensive groups. Half of the hypertensive group were aware of having hypertension, a third were receiving treatment for it, and quarter had a controlled BP.

Twenty-year trends in cardiovascular risk factors in India and influence of educational status.

BACKGROUND: Urban middle-socioeconomic status (SES) subjects have high burden of cardiovascular risk factors in low-income countries. To determine secular trends in risk factors among this population and to correlate risks with educational status we performed epidemiological studies in India. METHODS: Five cross-sectional studies were performed in middle-SES urban locations in Jaipur, India from years 1992 to 2010. Cluster sampling was performed. Subjects (men, women) aged 20-59 years evaluated were 712 (459, 253) in 1992-94, 558 (286, 272) in 1999-2001, 374 (179, 195) in 2002-03, 887 (414, 473) in 2004-05, and 530 (324, 206) in 2009-10. Data were obtained by history, anthropometry, and fasting blood glucose and lipids estimation. Response rates varied from 55 to 75%. Mean values and risk factor prevalence were determined. Secular trends were identified using quadratic and log-linear regression and chi-squared for trend. RESULTS: Across the studies, there was high prevalence of overweight, hypertension, and lipid abnormalities. Age- and sex-adjusted trends showed significant increases in mean body mass index (BMI), fasting glucose, total cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides (quadratic and log-linear regression, p < 0.001). Systolic blood pressure (BP) decreased while insignificant changes were observed for waist-hip ratio and low-density lipoprotein (LDL) cholesterol. Categorical trends showed increase in overweight and decrease in smoking (p < 0.05); insignificant changes were observed in truncal obesity, hypertension, hypercholesterolaemia, and diabetes. Adjustment for educational status attenuated linear trends in BMI and total and LDL cholesterol and accentuated trends in systolic BP, glucose, and HDL cholesterol. There was significant association of an increase in education with decline in smoking and an increase in overweight (two-line regression p < 0.05). CONCLUSION: In Indian urban middle-SES subjects there is high prevalence of cardiovascular risk factors. Over a 20-year period BMI and overweight increased, smoking and systolic BP decreased, and truncal obesity, hypercholesterolaemia, and diabetes remained stable. Increasing educational status attenuated trends for systolic BP, glucose and HDL cholesterol, and BMI.

Regional variations in cardiovascular risk factors in India: India heart watch.

Cardiovascular disease (CVD) is an important cause of mortality and morbidity in India. Mortality statistics and morbidity surveys indicate substantial regional variations in CVD prevalence and mortality rates. Data from the Registrar General of India reported greater age-adjusted cardiovascular mortality in southern and eastern states of the country. Coronary heart disease (CHD) mortality is greater in south India while stroke is more common in the eastern Indian states. CHD prevalence is higher in urban Indian populations while stroke mortality is similar in urban and rural regions. Case-control studies in India have identified that the common major risk factors account for more than 90% of incident myocardial infarctions and stroke. The case-control INTERHEART and INTERSTROKE studies reported that hypertension, lipid abnormalities, smoking, obesity, diabetes, sedentary lifestyle, low fruit and vegetable intake, and psychosocial stress are as important in India as in other populations of the world. Individual studies have reported that there are substantial regional variations in risk factors in India. At a macro-level these regional variations in risk factors explain some of the regional differences in CVD mortality. However, there is need to study the prevalence of multiple cardiovascular risk factors in different regions of India and to correlate them with variations in CVD mortality using a uniform protocol. There is also a need to determine the "causes of the causes" or fundamental determinants of these risk factors. The India Heart Watch study has been designed to study socioeconomic, anthropometric and biochemical risk factors in urban populations in different regions of the country in order to identify regional differences.

Migrating husbands and changing cardiovascular risk factors in the wife: a cross sectional study in Asian Indian women.

OBJECTIVE: The authors studied the influence of migration of husband on cardiovascular risk factors in Asian Indian women. METHODS: Population-based studies in women aged 35-70 years were performed in four urban and five rural locations. 4608 (rural 2604 and urban 2004) of the targeted 8000 (57%) were enrolled. Demographic details, lifestyle factors, anthropometry, fasting glucose and cholesterol were measured. Multivariate logistic and quadratic regression was performed to compare influence of migration and its duration on prevalence of risk factors. RESULTS: Details of migration were available in 4573 women (rural 2267, rural-urban migrants 455, urban 1552 and urban-rural migrants 299). Majority were married, and illiteracy was high. Median (interquartile) duration of residence in urban locations among rural-urban migrants was 9 (4-18) years and in rural areas for urban-rural migrants 23 (18-30) years. In rural, rural-urban migrants, urban and urban-rural migrants, age-adjusted prevalence (%) of risk factors was tobacco use 41.9, 22.7, 18.8 and 38.1; sedentary lifestyle 69.7, 82.0, 79.9 and 74.6; high-fat diet 33.3, 54.2, 66.1 and 61.1; overweight 21.3, 42.7, 46.3 and 29.7; large waist 8.5, 38.5, 29.2 and 29.2; hypertension 30.4, 49.4, 47.7 and 38.4; hypercholesterolaemia 14.4, 31.3, 26.6 and 9.1 and diabetes 3.9, 15.8, 14.9 and 8.4, respectively (p<0.001). In rural-urban migrants, there was a significant correlation of duration of migration with waist size, waist-to-hip ratio and systolic blood pressure (quadratic regression, p<0.001). Association of risk factors with migration remained significant, though attenuated, after adjustment for socioeconomic, lifestyle and obesity variables (logistic regression, p<0.01). CONCLUSIONS: Compared with rural women, rural-urban migrants and urban have significantly greater cardiometabolic risk factors. Prevalence is lower in urban-rural migrants. There is significant correlation of duration of migration with obesity and blood pressure. Differences are attenuated after adjusting for social and lifestyle variables.

Association of educational, occupational and socioeconomic status with cardiovascular risk factors in Asian Indians: a cross-sectional study.

BACKGROUND: To determine correlation of multiple parameters of socioeconomic status with cardiovascular risk factors in India. METHODS: The study was performed at eleven cities using cluster sampling. Subjects (n = 6198, men 3426, women 2772) were evaluated for socioeconomic, demographic, biophysical and biochemical factors. They were classified into low, medium and high socioeconomic groups based on educational level (<10, 10-15 and >15 yr formal education), occupational class and socioeconomic scale. Risk factor differences were evaluated using multivariate logistic regression. RESULTS: Age-adjusted prevalence (%) of risk factors in men and women was overweight or obesity in 41.1 and 45.2, obesity 8.3 and 15.8, high waist circumference 35.7 and 57.5, high waist-hip ratio 69.0 and 83.8, hypertension 32.5 and 30.4, hypercholesterolemia 24.8 and 25.3, low HDL cholesterol 34.1 and 35.1, high triglycerides 41.2 and 31.5, diabetes 16.7 and 14.4 and metabolic syndrome in 32.2 and 40.4 percent. Lifestyle factors were smoking 12.0 and 0.5, other tobacco use 12.7 and 6.3, high fat intake 51.2 and 48.2, low fruits/vegetables intake 25.3 and 28.9, and physical inactivity in 38.8 and 46.1%. Prevalence of > = 3 risk factors was significantly greater in low (28.0%) vs. middle (23.9%) or high (22.1%) educational groups (p<0.01). In low vs. high educational groups there was greater prevalence of high waist-hip ratio (odds ratio 2.18, confidence interval 1.65-2.71), low HDL cholesterol (1.51, 1.27-1.80), hypertriglyceridemia (1.16, 0.99-1.37), smoking/tobacco use (3.27, 2.66-4.01), and low physical activity (1.15, 0.97-1.37); and lower prevalence of high fat diet (0.47, 0.38-0.57),overweight/obesity (0.68, 0.58-0.80) and hypercholesterolemia (0.79, 0.66-0.94). Similar associations were observed with occupational and socioeconomic status. CONCLUSIONS: Low educational, occupational and socioeconomic status Asian Indians have greater prevalence of truncal obesity, low HDL cholesterol, hypertriglyceridemia, smoking or tobacco use and low physical activity and clustering of > = 3 major cardiovascular risk factors.

Ongoing tirofiban in myocardial infarction evaluation (On-TIME) 2 trial: rationale and study design.

AIMS: Delays in initiation of treatment because of transportation of high-risk patients with ST-elevation myocardial infarction (STEMI) are associated with worse clinical outcome. Glycoprotein IIb/IIIa receptor inhibitors improve initial patency of the infarct-related vessel and reduce thrombotic complications in patients undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS: The Ongoing Tirofiban In Myocardial infarction Evaluation (On-TIME) 2 trial is a randomised, double-blind, European clinical trial to evaluate the benefits of pre-hospital initiation of high-dose bolus of tirofiban, a glycoprotein IIb/IIIa receptor inhibitor, on background therapy of aspirin, unfractionated heparin and high dose clopidogrel, for patients with STEMI who undergo primary PCI. Eligible patients will be randomised 1:1 to pretreatment with a 25 microg/kg bolus and 0.15 microg/kg/min maintenance infusion of tirofiban or placebo. The primary endpoint is the extent of residual ST-segment deviation (defined as percentage of patients with >3 mm deviation of ST segment) 1 hour after PCI. The key secondary endpoint is the combined occurrence of death, recurrent myocardial infarction, urgent target vessel revascularisation, or thrombotic bailout at 30 days. The trial will continue until 958 patients are randomly assigned to treatment. CONCLUSIONS: The On-TIME 2 trial evaluates whether pre-hospital initiation of high-dose bolus tirofiban is effective for patients with STEMI who are candidates to undergo PCI. This placebo-controlled trial will provide important evidence regarding the benefit of initiating a GP IIb/IIIa inhibitor, in combination with high-dose clopidogrel and unfractionated heparin.