CUANDO COMENZAR, HASTA CUANTO LLEGAR Y CON QUE TRATAR AL PACIENTE HIPERTENSO CON DM2

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1 CUANDO COMENZAR, HASTA CUANTO LLEGAR Y CON QUE TRATAR AL PACIENTE HIPERTENSO CON DM2 Patricio López-Jaramillo MD PhD FACP Director de Investigaciones y de la Clínica de Síndrome Metabólico, Prediabetes y Diabetes, FOSCAL Director de Investigaciones de la Facultad de Medicina UDES Presidente de la Sociedad Latinoamericana de Hipertension (LASH) Bucaramanga-Colombia

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12 RRR RRR RRR OF COMBINATION AND EACH INTERVENTION VS DOUBLE PLACEBO Co-Primary 2 50% 40% 30% 28% Overall 26% 20% 10% 6% 50% 40% 30% 20% 40% 0% Combo Highest Third of SBP 24% 20% Rosuva Only 50% 40% 30% 20% Cand + HCTZ Only Lower Two Thirds of SBP 19% 31% 10% 10% Cand + HCTZ Only 0% Combo Rosuva Only Cand+HCTZ Only 0% Combo Rosuva Only -8% 34

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15 Initiation of Antihypertensive Treatment Grade 2 and 3 Hypertension The body of evidence in favor of antihypertensive treatment provided by randomized controlled trials was obtained in hypertensive patients whose baseline SBP was 160 mm Hg, who could presently be classified as grade 2 or 3 hypertensives. Some recent trials included patients with lower SBP values at randomization, but these patients already were under background antihypertensive treatment at the time of randomizationand could likely be classified at least as grade 2 hypertensives. Therefore, the large reduction of fatal and nonfatal cardiovascular events induced by BP lowering in these trials and their meta-analyses provides the strong recommendation that all individuals with BP in grade 2 or 3 hypertension range be treated with drugs In all patients, drug treatment should be accompanied by lifestyle measures, and in grade 2 hypertensives, lifestyle measures can be used alone for a few weeks to test their effectiveness and the need for addition of drugs.

16 Grade 1 Hypertension The constancy of the relative risk reduction throughout the hypertension grades shown by the HOPE 3 study and a recent meta-analysis favors the conclusion that all grades of hypertension benefit from BP lowering and provides a stronger support to the recommendation to initiate drug treatment in grade 1 low-to-moderate risk hypertensives than the arguments that could be used in the 2013 LASH guidelines. It is thought that this recommendation could be given now a higher level, such as Class I, Level A or B.

17 High Normal Blood Pressure The very recent results of the Heart Outcomes Prevention Evaluation (HOPE)-3 trial support that antihypertensive treatment in patients at intermediate risk without previous cardiovascular events and high normal blood pressure is not associated with a reduction of major cardiovascular events compared with placebo. Only in patients with a basal SBP higher than mm Hg (mean 154 mm Hg) a benefit in reducing the primary outcomes was observed. Therefore, at present, no evidence is available suggesting initiation of antihypertensive drug treatment in high normal blood pressure individuals. When other risk factors are present in these subjects, as often occurs, lifestyle measures or pharmacological treatment of these risk factors (such as cholesterol or blood glucose lowering drugs) are likely to be more definitely beneficial.

18 Blood Pressure Treatment Targets The Lower the Better Versus the J-Shaped Curve Hypothesis The Latin America consensus on hypertension in patients with type 2 diabetes mellitus and metabolic syndrome recommended a SBP target of less than 140 mm Hg as in nondiabetic hypertensive individuals. The overall reductions in stroke and all vascular events were related to the degree of BP lowering achieved in the range between 140 and 130 mm Hg, but in no one of these studies was the average achieved BP <130 mm Hg. The results of SPRINT and another recent trial have been included in an updated meta-analysis of all 35 trials of BP lowering ( individuals) that could be stratified according to the usual cutoffs of achieved SBP. Lowering SBP below 130 mm Hg was found to reduce relative risk of major cardiovascular outcomes, but the absolute cardiovascular risk reduction was definitely smaller, and the risk of permanent treatment discontinuations for adverse events significantly greater than in the trials in which SBP was lowered across the cutoff of 140 mm Hg.

19 LASH Guidelines: A useful tool for our region En la mayoria de patientes hipertensos con diabetes tipo 2 el blanco de PA no es alcanzado con monoterapia y se debe incluir dos o mas agentes hipotensores. Si antes del inico del tratamiento la PA esta muy elevada, es recomendado iniciar con una combinacion de dos drogas. Una combinacion de dosis fija de un IECA o ARA con CCB o un diuretico son recomendados

20 Recomendaciones de las Guías LASH 2013 Combinaciones de antihipertensivos Efecto antihipertensivo Protección cardiovascular Optima tolerabilidad -bloqueantes Diurético s Preferentes Utiles Posibles No recomendadas ARA II Otros Antagonistas del Calcio IECA

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26 Males: Time to Adjudicated Primary Outcome 1 - CV Death MI Stroke Females: Time to Adjudicated Primary Outcome 1 - CV Death MI Stroke Proportion with events # at Risk st nd rd th th Log rank test P: 1st vs. 5th: < nd vs. 5th: < rd vs. 5th: th vs. 5th: st 2nd 3rd 4th 5th Proportion with events # at Risk st nd rd th th Log rank test P: 1st vs. 5th: < nd vs. 5th: < rd vs. 5th: th vs. 5th: st 2nd 3rd 4th 5th Years of Follow-up Years of Follow-up

27 HAZARD RATIOS: MEN AND WOMEN Adj HR (95%CI) P Events Per 1 Kg Increase N (%) Rate Composite 0.91 (0.90, 0.93) < (18.1) 3.2 Adj HR (95%CI) P Events Per 1 Kg Increase N (%) Rate Composite 0.76 (0.72, 0.80) < (13.2) 2.3 CV Death 0.88 (0.86, 0.90) < (10.0) 1.7 MI 0.97 (0.94, 1.00) (6.3) 1.1 Stroke 0.90 (0.87, 0.93) < (5.4) 0.9 Revascularization 0.99 (0.97, 1.01) (17.4) 3.3 Heart Failure 0.89 (0.86, 0.91) < (5.8) 1.0 CV Death 0.70 (0.66, 0.75) < (7.8) 1.3 MI 0.79 (0.72, 0.86) < (3.4) 0.6 Stroke 0.84 (0.77, 0.90) < (4.7) 0.8 Revascularization 0.90 (0.85, 0.96) < (8.0) 1.4 Heart Failure 0.70 (0.64, 0.76) < (4.0) 0.7 Death 0.87 (0.85, 0.88) < (16.6) 2.8 Death 0.70 (0.67, 0.73) < (12.9) Hazard Ratio Hazard Ratio Reduced Risk Increased Risk Reduced Risk Increased Risk Lopez-Jaramillo et al. Int J Cardiol 2014; 172;

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38 FOSCAL/FOSCAL INTERNACIONAL GRACIAS