Journal of Human Hypertension (2015) 29, 69–70 & 2015 Macmillan Publishers Limited All rights reserved 0950-9240/15 www.nature.com/jhh
LETTERS TO THE EDITOR
HONEST to clarify association between home blood pressure and cardiovascular events under antihypertensive medication Journal of Human Hypertension (2015) 29, 69; doi:10.1038/ jhh.2013.151; published online 23 January 2014 We thank Professor Tomoyuki Kawada1 for his comments on our recent article2 and are pleased to provide clarification to address his concerns. As Professor Kawada states, the type of antihypertensive therapy used affects cardiovascular risk. In the studies cited, olmesartan– calcium channel blocker combination therapy was more effective than high-dose olmesartan monotherapy in lowering blood pressure (BP),3 and it was more effective than olmesartan–diuretic combination therapy in decreasing home BP variability.4 However, we did not classify patients by the combination of antihypertensive agents used, because an analysis of data from the HONEST study showed no difference in BP level after 16 weeks of olmesartan therapy between patients who had received calcium channel blockers and those who had received no antihypertensive agents. We are preparing for publication of the results of our analysis of the factors that affected systolic BP reductions, including combination antihypertensive therapy. Regarding the second point raised, we did a subanalysis of data from patients with diabetes mellitus and chronic kidney disease, because the Japanese Society of Hypertension Guidelines for the Management of Hypertension define target BP for patients with these conditions. However, we agree with Professor Kawada’s recommendation that analysis of data from patients with dyslipidemia should be done in future studies. In response to Professor Kawada’s final point, our study was certainly not designed to show the superiority of olmesartan to other antihypertensive agents, or to measure the net effect of olmesartan on BP (although, as mentioned in the Discussion, our results were similar to those of previous double-blind clinical trials5–7), therefore, we did not include a control arm. As detailed in a previous article,8 our main purpose in doing this study was to clarify the relation between BP and cardiovascular events, not the relation between the effects of olmesartan and the incidence of cardiovascular events. We are preparing for the publication of the results of a detailed analysis of the characteristics of patients with well-controlled hypertension in the HONEST study. The eligibility criteria were defined to include patients with essential hypertension; however, patients were enrolled at the discretion of their physicians, that is, in a real-world setting and without specific criteria for BP.8 Patients with well-controlled hypertension were enrolled if they were considered at high risk for cardiovascular events. Previously
untreated patients were enrolled if they had a history of hypertension. As explained in the Discussion, these patients may have had normal BP measurements at baseline but drug therapy was indicated because of their previous high BP measurements.
CONFLICT OF INTEREST Dr Kario received honoraria from Daiichi Sankyo Co., Ltd.
ACKNOWLEDGEMENTS This study was supported with funding for data collection and statistical analysis by Daiichi Sankyo Co., Ltd.
K Kario1 Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Shimotsuke, Japan 1
REFERENCES 1 Kawada T. Effect of olmesartan on blood pressure in patients with hypertension: specification on causality. J Hum Hypertens 2015; 29: 69–70. 2 Kario K, Saito I, Kushiro T, Teramukai S, Hiramatsu K, Kobayashi F et al. Effect of the angiotensin II receptor antagonist olmesartan on morning home blood pressure in hypertension: HONEST study at 16 weeks. J Hum Hypertens 2013; 27: 721–728. 3 Ogawa H, Kim-Mitsuyama S, Matsui K, Jinnouchi T, Jinnouchi H, Arakawa K. OlmeSartan and Calcium Antagonists Randomized (OSCAR) Study Group. Angiotensin II receptor blocker–based therapy in Japanese elderly, high-risk, hypertensive patients. Am J Med 2012; 125: 981–990. 4 Matsui Y, O’Rourke MF, Hoshide S, Ishikawa J, Shimada K, Kario K. Combined effect of angiotensin II receptor blocker and either a calcium channel or diuretic on dayby-day variability of home blood pressure: the Japan Combined Treatment With Olmesartan and a Calcium-Channel Blocker Versus Olmesartan and Diuretics Randomized Efficacy Study. Hypertension 2012; 59: 1132–1138. 5 Oparil S, Williams D, Chrysant SG, Marbury TC, Neutel J. Comparative efficacy of olmesartan, losartan, valsartan, and irbesartan in the control of essential hypertension. J Clin Hypertens (Greenwich) 2001; 3: 283–291. 6 Brunner HR, Stumpe KO, Januszewicz A. Antihypertensive efficacy of olmesartan medoxomil and candesartan cilexetil assessed by 24-hour ambulatory blood pressure monitoring in patients with essential hypertension. Clin Drug Investig 2003; 23: 419–430. 7 Smith DH, Dubiel R, Jones M. Use of 24-hour ambulatory blood pressure monitoring to assess antihypertensive efficacy: a comparison of olmesartan medoxomil, losartan potassium, valsartan, and irbesartan. Am J Cardiovasc Drugs 2005; 5: 41–50. 8 Saito I, Kario K, Kushiro T, Teramukai S, Zenimura N, Hiramatsu K et al. Rationale, study design, baseline characteristics and blood pressure at 16 weeks in the HONEST study. Hypertens Res 2013; 36: 177–182.
Effect of olmesartan on blood pressure in patients with hypertension: specification on causality Journal of Human Hypertension (2015) 29, 69–70; doi:10.1038/ jhh.2013.150; published online 23 January 2014 I have read with interest a prospective observational study by Kario et al.1 concerning the effect of olmesartan on clinic and
morning home blood pressures in patients with hypertension. The authors concluded that 16-week olmesartan-based treatment showed a sustained 24-hour blood pressure-lowering effect. As a supportive report, Yanagi et al.2 examined the beneficial effects of olmesartan add-on therapy on nighttime blood pressure and renal injury in hypertensive chronic kidney disease patients
Copyright of Journal of Human Hypertension is the property of Nature Publishing Group and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
LETTERS TO THE EDITOR
HONEST to clarify association between home blood pressure and cardiovascular events under antihypertensive medication Journal of Human Hypertension (2015) 29, 69; doi:10.1038/ jhh.2013.151; published online 23 January 2014 We thank Professor Tomoyuki Kawada1 for his comments on our recent article2 and are pleased to provide clarification to address his concerns. As Professor Kawada states, the type of antihypertensive therapy used affects cardiovascular risk. In the studies cited, olmesartan– calcium channel blocker combination therapy was more effective than high-dose olmesartan monotherapy in lowering blood pressure (BP),3 and it was more effective than olmesartan–diuretic combination therapy in decreasing home BP variability.4 However, we did not classify patients by the combination of antihypertensive agents used, because an analysis of data from the HONEST study showed no difference in BP level after 16 weeks of olmesartan therapy between patients who had received calcium channel blockers and those who had received no antihypertensive agents. We are preparing for publication of the results of our analysis of the factors that affected systolic BP reductions, including combination antihypertensive therapy. Regarding the second point raised, we did a subanalysis of data from patients with diabetes mellitus and chronic kidney disease, because the Japanese Society of Hypertension Guidelines for the Management of Hypertension define target BP for patients with these conditions. However, we agree with Professor Kawada’s recommendation that analysis of data from patients with dyslipidemia should be done in future studies. In response to Professor Kawada’s final point, our study was certainly not designed to show the superiority of olmesartan to other antihypertensive agents, or to measure the net effect of olmesartan on BP (although, as mentioned in the Discussion, our results were similar to those of previous double-blind clinical trials5–7), therefore, we did not include a control arm. As detailed in a previous article,8 our main purpose in doing this study was to clarify the relation between BP and cardiovascular events, not the relation between the effects of olmesartan and the incidence of cardiovascular events. We are preparing for the publication of the results of a detailed analysis of the characteristics of patients with well-controlled hypertension in the HONEST study. The eligibility criteria were defined to include patients with essential hypertension; however, patients were enrolled at the discretion of their physicians, that is, in a real-world setting and without specific criteria for BP.8 Patients with well-controlled hypertension were enrolled if they were considered at high risk for cardiovascular events. Previously
untreated patients were enrolled if they had a history of hypertension. As explained in the Discussion, these patients may have had normal BP measurements at baseline but drug therapy was indicated because of their previous high BP measurements.
CONFLICT OF INTEREST Dr Kario received honoraria from Daiichi Sankyo Co., Ltd.
ACKNOWLEDGEMENTS This study was supported with funding for data collection and statistical analysis by Daiichi Sankyo Co., Ltd.
K Kario1 Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Shimotsuke, Japan 1
REFERENCES 1 Kawada T. Effect of olmesartan on blood pressure in patients with hypertension: specification on causality. J Hum Hypertens 2015; 29: 69–70. 2 Kario K, Saito I, Kushiro T, Teramukai S, Hiramatsu K, Kobayashi F et al. Effect of the angiotensin II receptor antagonist olmesartan on morning home blood pressure in hypertension: HONEST study at 16 weeks. J Hum Hypertens 2013; 27: 721–728. 3 Ogawa H, Kim-Mitsuyama S, Matsui K, Jinnouchi T, Jinnouchi H, Arakawa K. OlmeSartan and Calcium Antagonists Randomized (OSCAR) Study Group. Angiotensin II receptor blocker–based therapy in Japanese elderly, high-risk, hypertensive patients. Am J Med 2012; 125: 981–990. 4 Matsui Y, O’Rourke MF, Hoshide S, Ishikawa J, Shimada K, Kario K. Combined effect of angiotensin II receptor blocker and either a calcium channel or diuretic on dayby-day variability of home blood pressure: the Japan Combined Treatment With Olmesartan and a Calcium-Channel Blocker Versus Olmesartan and Diuretics Randomized Efficacy Study. Hypertension 2012; 59: 1132–1138. 5 Oparil S, Williams D, Chrysant SG, Marbury TC, Neutel J. Comparative efficacy of olmesartan, losartan, valsartan, and irbesartan in the control of essential hypertension. J Clin Hypertens (Greenwich) 2001; 3: 283–291. 6 Brunner HR, Stumpe KO, Januszewicz A. Antihypertensive efficacy of olmesartan medoxomil and candesartan cilexetil assessed by 24-hour ambulatory blood pressure monitoring in patients with essential hypertension. Clin Drug Investig 2003; 23: 419–430. 7 Smith DH, Dubiel R, Jones M. Use of 24-hour ambulatory blood pressure monitoring to assess antihypertensive efficacy: a comparison of olmesartan medoxomil, losartan potassium, valsartan, and irbesartan. Am J Cardiovasc Drugs 2005; 5: 41–50. 8 Saito I, Kario K, Kushiro T, Teramukai S, Zenimura N, Hiramatsu K et al. Rationale, study design, baseline characteristics and blood pressure at 16 weeks in the HONEST study. Hypertens Res 2013; 36: 177–182.
Effect of olmesartan on blood pressure in patients with hypertension: specification on causality Journal of Human Hypertension (2015) 29, 69–70; doi:10.1038/ jhh.2013.150; published online 23 January 2014 I have read with interest a prospective observational study by Kario et al.1 concerning the effect of olmesartan on clinic and
morning home blood pressures in patients with hypertension. The authors concluded that 16-week olmesartan-based treatment showed a sustained 24-hour blood pressure-lowering effect. As a supportive report, Yanagi et al.2 examined the beneficial effects of olmesartan add-on therapy on nighttime blood pressure and renal injury in hypertensive chronic kidney disease patients
Copyright of Journal of Human Hypertension is the property of Nature Publishing Group and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
