Reduction in cardiovascular risk using proactive multifactorial intervention versus usual care in younger (< 65 years) and older (≥ 65 years) patients in the CRUCIAL trial.

OBJECTIVE: To compare the reduction in calculated Framingham 10 year coronary heart disease (CHD) risk after 52 weeks' intervention with a proactive multifactorial intervention (PMI) strategy (based on single-pill amlodipine/atorvastatin [SPAA]) versus continuing usual care (UC) (based on investigators' best clinical judgment) among younger (<65 years) and older (≥ 65 years) patients. RESEARCH DESIGN AND METHODS: Sub-analysis of the Cluster Randomized Usual Care versus Caduet Investigation Assessing Long-term risk (CRUCIAL) trial. Eligible patients had hypertension and ≥ 3 cardiovascular risk factors. MAIN OUTCOME MEASURE: Treatment-related reduction in calculated Framingham 10 year CHD risk between baseline and Week 52 in younger and older patients. RESULTS: Nine hundred patients (63.5%) were <65 years (mean age 54.2 years, 57.4% men) and 517 patients (36.5%) were ≥ 65 years (mean age 70.5 years, 42.7% men). Younger patients had lower mean baseline CHD risk versus older patients (17.1% vs. 22.6%). A greater reduction in calculated CHD risk at Week 52 was observed in the PMI versus the UC arm in both younger (-33.2% vs. -2.9%, p < 0.001) and older (-32.7% vs. -5.7%, p < 0.001) patients. Least-squares mean treatment differences (PMI vs. UC) in percentage change from baseline in calculated CHD risk were similar in younger and older patients (-26.3% vs. -25.7%, age interaction p = 0.887). CHD risk reduction was slightly greater among younger men than younger women (-29.3 vs. -23.9, gender interaction p = 0.062). A low proportion of patients discontinued the PMI strategy due to adverse events in both age groups (5.8% vs. 6.1%, respectively). Study limitations included ad-hoc (not pre-specified) sub-group analysis and short duration of follow-up. CONCLUSIONS: The PMI strategy based on the inclusion of SPAA in the treatment regimen is more effective than UC in reducing calculated CHD risk. This strategy may be considered as the treatment of choice in younger and older hypertensive patients with additional cardiovascular risk factors.

Changes in calculated coronary heart disease risk using proactive multifactorial intervention versus continued usual care in Latin-American and non-Latin-American patients enrolled in the CRUCIAL trial.

OBJECTIVE: To compare the change in calculated coronary heart disease (CHD) risk using a proactive multifactorial intervention (PMI) versus usual care (UC), among Latin-American (LA) and non-LA patients enrolled in the CRUCIAL trial. RESEARCH DESIGN AND METHODS: This is a sub-analysis of the Cluster Randomized Usual Care versus Caduet Investigation Assessing Long-term-risk (CRUCIAL) trial. CRUCIAL was a prospective, multinational, open-label, cluster-randomized trial. Eligible patients had hypertension and ≥3 additional cardiovascular risk factors, but no history of CHD and baseline total cholesterol ≤6.5 mmol/l (250 mg/dl). The PMI strategy was implemented by the inclusion of single-pill amlodipine/atorvastatin (SPAA) in the patients' treatment regimen. Overall, 20% of patients resided in the LA region. MAIN OUTCOME MEASURE: Treatment-related change in calculated Framingham 10-year CHD risk between baseline and Week 52 in the LA and non-LA regions. RESULTS: A greater relative reduction in calculated CHD risk after 52 weeks' follow-up was observed for patients in the PMI arm compared with UC arm in both LA (-32.8% vs. -7.5%, p = 0.003) and non-LA regions (-33.1% vs. -3.3%, p < 0.001), region interaction p = 0.316. The proportion of patients discontinuing treatment in the PMI arm due to adverse events (AEs) was low in both regions (both 5.9%). CONCLUSIONS: The PMI approach based on the inclusion of SPAA in the patients' treatment regimen may improve the management of CHD risk among patients residing in LA and non-LA regions. Clinicians may be reassured by the low rate of AEs leading to discontinuation of SPAA in both regions.

Proactive cardiovascular risk management versus usual care in patients with and without diabetes mellitus: CRUCIAL trial subanalysis.

UNLABELLED: Patients with diabetes mellitus (DM) and additional cardiovascular (CV) risk factors are at very high risk for future CV events. This study investigated the efficacy and safety of a proactive, multifactorial CV risk factor-management strategy based on single-pill amlodipine/atorvastatin (SPAA) versus continuing physicians' usual care (UC) over 52 weeks in patients with and without DM. Patients with hypertension and ≥ 3 additional CV risk factors from the Cluster Randomized Usual Care vs Caduet Investigation Assessing Long-Term-Risk (CRUCIAL) trial--an open-label, cluster-randomized trial conducted in 19 countries--were enrolled and randomized to receive proactive intervention (based on SPAA 5/10 to 10/20 mg) or UC (based on investigators' best clinical judgment). Patients were analyzed according to baseline DM status. Six hundred patients had DM. Patients with DM in the SPAA and UC arms had mean ages of 61.8 and 61.5 years, respectively, and an absolute coronary heart disease (CHD) risk of 25.2% and 21.5%, respectively. Among non-DM patients, mean ages were 58.6 and 59.5 years, respectively, and CHD risk was 16.0% vs 15.7%, respectively. Least-squares mean treatment differences in percentage change from baseline in calculated 10-year Framingham CHD risk were -26.3% vs -27.3% among DM and non-DM patients (adjusted for respective baseline values) (both P < 0.0001). Among DM and non-DM patients, adverse events were reported in 52.8% versus 45.6% in the SPAA and 49.6% versus 41.6% in the UC arms, respectively. This global risk-management approach, simultaneously targeting blood pressure and lipids, was more effective for reducing calculated 10-year Framingham CHD risk than UC in patients with DM. While blood pressure changes were of smaller magnitude among patients with DM, this strategy reduced overall risk to an extent comparable with that observed in non-DM patients. Further studies are thus warranted to study this proactive risk factor intervention on CV or mortality endpoints in patients with and without DM. TRIAL REGISTRATION: www.ClinicalTrials.gov identifier NCT00407537.

Proactive multiple cardiovascular risk factor management compared with usual care in patients with hypertension and additional risk factors: the CRUCIAL trial.

OBJECTIVE: To investigate whether a proactive multifactorial risk factor intervention strategy using single-pill amlodipine/atorvastatin (5/10, 10/10 mg) in addition to other antihypertensive and lipid-lowering therapy, as required, resulted in greater reduction in calculated Framingham 10-year coronary heart disease (CHD) risk compared with usual care (UC) after 52-weeks treatment. RESEARCH DESIGN AND METHODS: Prospective, multinational, open-label, cluster randomized trial, with the investigator as the unit of randomization. Eligible hypertensive patients were 35-79 years of age, with ≥3 additional cardiovascular risk factors, but no history of CHD and baseline total cholesterol (TC) ≤6.5 mmol/l. CLINICAL TRIAL REGISTRATION: www.ClinicalTrials.gov ; trial identifier NCT00407537. MAIN OUTCOME MEASURE: The primary endpoint was calculated Framingham 10-year CHD risk at 52 weeks. RESULTS: Of the 140 randomized sites, 136 sites contributed 1461 patients. Mean baseline age and low-density lipoprotein cholesterol (LDL-C) were comparable between treatment arms. Mean baseline BP (150.3/89.7 vs. 144.3/86.5 mmHg) and Framingham CHD risk (20.0 vs. 18.1%) were higher in the proactive intervention versus the UC arm (p < 0.002 for both). At week 52, mean CHD risk was 12.5% in the proactive intervention arm and 16.3% in the UC arm (p < 0.001). The difference, observed at weeks 16 and 52, was primarily driven by significant differences in systolic BP and in TC between the two arms. Overall, adverse events (AEs) were reported in 48.8% and 44.0% of patients in the proactive intervention and the UC arm, respectively. Although there were differences in the incidence of AEs between the treatment arms, the AE profile in the proactive intervention arm was consistent with previous safety experience for this medication. CONCLUSIONS: A proactive multifactorial risk factor intervention strategy that simultaneously treated both BP and cholesterol regardless of individual risk factors per se, is more effective in reducing calculated Framingham 10-year CHD risk than UC in patients with hypertension and additional risk factors.

[Morbidity and mortality by ischemic heart disease and stroke in Mexico. 2005]. / Morbilidad y mortalidad de la enfermedad isquémica del corazón y cerebrovascular en México, 2005.

Cardiovascular diseases are the main cause of death and disability in México. 25% of deaths under 60 years of age are related to chronic degenerative diseases. These disorders are more common in developing countries and are caused by an excessive intake of fatty acids, sodium, alcohol, tobacco consumption and decrease in physical activity. The prevalence of risk factors is increasing not only in adult population but also in youth and children. Data from the Department of Epidemiology from the Mexican Ministry of Health in the period between 1998 and 2000 showed that the death caused by coronary artery disease was more frequent in men (55%) than women (45%) and acute coronary syndrome was responsible for deaths in 83.5% of men and 76.8% in women. Primary Prevention Programs are necessary to decrease the impact of cardiovascular diseases.

Effectiveness and safety of ezetimibe added to statin therapy in patients with primary dyslipidaemia not achieving the LDL-C treatment goal on statin monotherapy.

BACKGROUND AND OBJECTIVE: Elevated serum low-density lipoprotein cholesterol (LDL-C) is a major cardiovascular risk factor. This study aimed to determine the efficacy and safety of co-administration of the cholesterol absorption inhibitor ezetimibe with an HMG-CoA reductase inhibitor (statin) in the treatment of Mexican patients with dyslipidaemia who had not attained the LDL-C treatment goal with statin monotherapy. MATERIAL AND METHODS: We studied 256 patients with elevated serum LDL-C (as defined by the US National Cholesterol Education Program Adult Treatment Panel III guidelines) despite statin therapy. All patients had lipid profiles performed at baseline and after 6-8 weeks of treatment with statin therapy plus ezetimibe 10 mg/day for 6-8 weeks. RESULTS: Addition of ezetimibe to statin treatment reduced mean serum LDL-C levels significantly (from 160 +/- 42.8 to 100 +/- 36 mg/dL; p<0.001) after 6-8 weeks of treatment, with 61.7% of patients achieving LDL-C values below the goal established according to their coronary risk group. Serum LDL-C goals were achieved at the end of the study in 88.2% of the low-risk coronary group, 75.7% of the moderate-risk group and 47.8% of the high-risk group. Ezetimibe was well tolerated; no hepatic or muscle-related adverse events were observed. CONCLUSION: Addition of ezetimibe to statin treatment was both efficacious and safe when used for further reduction of serum LDL-C in dyslipidaemic patients who had not reached their LDL-C treatment goal while taking statin monotherapy.

Morbilidad y mortalidad de la enfermedad isquémica del corazón y cerebrovascular en México, 2005 / Morbidity and mortality by ischemic heart disease and stroke in Mexico. 2005

Cardiovascular diseases are the main cause of death and disability in México. 25% of deaths under 60 years of age are related to chronic degenerative diseases. These disorders are more common in developing countries and are caused by an excessive intake of fatty acids, sodium, alcohol, tobacco consumption and decrease in physical activity. The prevalence of risk factors is increasing not only in adult population but also in youth and children. Data from the Department of Epidemiology from the Mexican Ministry of Health in the period between 1998 and 2000 showed that the death caused by coronary artery disease was more frequent in men (55%) than women (45%) and acute coronary syndrome was responsible for deaths in 83.5% of men and 76.8% in women. Primary Prevention Programs are necessary to decrease the impact of cardiovascular diseases.

Aortoplastía en coartación aórtica congénita del adulto con balón y prótesis endovascular: resultados inmediatos y seguimiento a 6 meses / Aortoplasty in adults with congenital aortic coarctation using balloon and stent placement: a 6 months follow-up

Hasta 1982 el tratamiento de la Coartación Aórtica había sido quirúrgico, con una incidencia de recoartación del 39 por ciento. Desde 1984 se ha practicado exitosamente la aortoplastía con balón en adolescentes y adultos. Presentamos los resultados inmediatos y el seguimiento a más de 6 meses, de 5 pacientes masculinos y un femenino con edad promedio de 28.6 años (15-46), en 4 de ellos se colocó una prótesis. La presión sistólica de aorta ascendente disminuyó de 187.1 mm de Hg (ñ 41.8) a 128 (ñ 25.4) y el gradiente transcoartación de 66 mm de Hg (ñ 21.8) a 4.8 (ñ 7.6). El diámetro luminal de la coartación aumentó de 4.6 mm (ñ 1.41) a 14.3 (ñ 3) en la dilatación con balón, y a 17.8 mm en los pacientes con prótesis, p = NS. En 3 pacientes con prótesis, la angiografía a 6 meses no mostró reestenosis; todos los pacientes tienen menor o ningún requerimiento de medicamentos antihipertensivos. Se trata de un procedimiento simple y exitoso. Está aún por determinarse el índice de complicaciones agudas y crónicas, porcentaje y tiempo de reestenosis, los resultados a largo plazo y el posible beneficio de las prótesis.