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T201606036.Pdf Clinical Therapeutics/Volume 38, Number 10, 2016 Original Research Blood Pressure and Cholesterol-lowering Efficacy of a Fixed-dose Combination With Irbesartan and Atorvastatin in Patients With Hypertension and Hypercholesterolemia: A Randomized, Double-blind, Factorial, Multicenter Phase III Study Sang-Hyun Kim, MD, PhD1,2; Sang-Ho Jo, MD, PhD3; Sang-Cheol Lee, MD, PhD4; Sung-Yoon Lee, MD, PhD5; Myung-Ho Yoon, MD, PhD6; Hyang-Lim Lee, MD, PhD7; Nae-Hee Lee, MD, PhD8; Jong-Won Ha, MD, PhD9; Nam-Ho Lee, MD, PhD10; Dong-Woon Kim, MD, PhD11; Gyu-Rok Han, MD, PhD12; Min-Su Hyon, MD, PhD13; Deok-Gyu Cho, MD, PhD14; Chang-Gyu Park, MD, PhD15; Young-Dae Kim, MD, PhD16; Gyu-Hyung Ryu, MD, PhD17; Cheol-Ho Kim, MD, PhD2,18; Kee-Sik Kim, MD, PhD19; Myung-Ho Chung, MD, PhD20; Sung-Chul Chae, MD, PhD21; Ki-Bae Seung, MD, PhD22; and Byung-Hee Oh, MD, PhD2,23 1Seoul Boramae Hospital, Seoul, Republic of Korea; 2SeoulNationalUniversityCollegeofMedicine,Seoul, Republic of Korea; 3Hallym University Sacred Hospital, Pyeongchon, Republic of Korea; 4Samsung Seoul Hospital, Seoul, Republic of Korea; 5Baek University Ilsan Hospital, Goyang, Republic of Korea; 6Ajou University Hospital, Goyang, Republic of Korea; 7Seoul Bukbu Hospital, Seoul, Republic of Korea; 8Sooncheonhyang University Bucheon Hospital, Bucheon, Republic of Korea; 9Yonsei University Severance Hospital, Seoul, Republic of Korea; 10Hallym University Gangnam Sacred Hospital, Seoul, Republic of Korea; 11Chungbook University Hospital, Cheongju, Republic of Korea; 12Hallym University Gangdong Sacred Hospital, Seoul, Republic of Korea; 13Sooncheonhyang University Seoul Hospital, Seoul, Republic of Korea; 14Gwandong University Myungji Hospital, Seoul, Republic of Korea; 15Korea University Guro Hospital, Seoul, Republic of Korea; 16Dong-A University Hospital,Busan,RepublicofKorea;17Hallym University Dongtan Sacred Hospital, Hwaseong, Republic of Korea; 18Seoul National University Bundang Hospital, Seongnam, Republic of Korea; 19Keimyung University Hospital,Daegu,RepublicofKorea;20Cheonnam University Hospital, Gwangju, Republic of Korea; 21Gyungbook University Hospital, Daegu, Republic of Korea; 22Catholic University Seoul St Mary Hospital, Seoul, Republic of Korea; and 23SeoulNationalUniversityHospital, Seoul, Republic of Korea ABSTRACT It may also improve patient drug compliance to Purpose: A fixed-dose combination of a stain and an help control risk factors of cardiovascular disease. This antihypertensive drug may be useful for the treatment study was designed to evaluate the blood pressure– of patients with hypertension and hyperlipidemia. lowering and cholesterol-lowering effect of a fixed-dose Accepted for publication April 24, 2016. Scan the QR Code with your phone to obtain http://dx.doi.org/10.1016/j.clinthera.2016.09.005 0149-2918/$ - see front matter FREE ACCESS to the articles featured in the Clinical Therapeutics topical updates or text & 2016 The Authors. Published by Elsevier HS Journals, Inc. This is an GS2C65 to 64842. To scan QR Codes your open access article under the CC BY-NC-ND license phone must have a QR Code reader installed. (http://creativecommons.org/licenses/by-nc-nd/4.0/). October 2016 2171 Clinical Therapeutics combination of irbesartan-atorvastatin compared with INTRODUCTION monotherapy by either agent over an 8-week treatment Hypertension and hyperlipidemia are 2 of the most period. important risk factors in the development of cardio- – Methods: Patients with comorbid hypertension and vascular disease, and they often coexist.1 3 These risk hypercholesterolemia were screened for this randomized, factors act synergistically in disease progression, and double-blind, Phase III study. Eligible study patients were results from the Framingham Heart Study showed that randomly assigned to test groups receiving a combina- even a moderate increase in blood pressure (BP) and tion of irbesartan 300 mg and atorvastatin 40 mg or 80 cholesterol dysregulation has as much of a 10-year mg (IRB300 þ ATO40 and IRB300 þ ATO80). Com- congestive heart disease risk as marked elevation of parator groups comprised monotherapy groups with either factor alone.4 Recent guidelines for the irbesartan 300 mg (IRB300) or atorvastatin 40 mg management of hypertension and hyperlipidemia, as (ATO40) or atorvastatin 80 mg (ATO80), or placebo. recommended by the Joint National Committee on Patients who were eligible at screening were subjected to Prevention, Detection, Evaluation and Treatment of a 4- to 6-week washout period before commencing 8 High Blood Pressure 2014 (JNC VIII)5 and the weeks of therapy per their assigned group. The primary American College of Cardiology/American Heart efficacy end points were percent change in LDL-C and Association 2013 blood cholesterol guideline,6 res- sitting diastolic blood pressure (DBP) levels from baseline pectively, emphasize the overall assessment of BP and to end of therapy. Tolerability profiles of combination serum lipid levels in evaluating cardiovascular risk therapy were compared with other groups. rather than assessment of each risk factor individually.7 Findings: A total of 733 patients with comorbid Presently, the drugs with a preferred mechanism of hypertension and hypercholesterolemia were screened cardiovascular protection for antihypertensive therapy for this study; 230 eligible patients were randomized to are those that inhibit the renin-angiotensin system treatment. The mean age of patients was 58.9 (8.5) (RAS).8 Two classes of the drugs (the angiotensin- years, and their mean body mass index was 25.8 (3.2) converting enzyme [ACE] inhibitors and the angiotensin kg/m2. More than two thirds (70.9%) of the study II receptor blockers [ARBs]) have been discovered to patients were male. Mean LDL-C and sitting DBP levels have RAS inhibitory activity, albeit by different at baseline were 149.54 (29.19) mg/dL and 92.32 (6.03) mechanisms. Although ACE inhibitors hinder the mm Hg, respectively. Percent reductions in LDL-C after production of angiotensin II through the inhibition 8 weeks were 46.74% (2.06%) in the IRB300 þ of ACE, ARBs prevent the interaction of angiotensin II ATO40 group and 48.98% (2.12%) in the IRB300 þ with its receptor (AT1), which subsequently prevents ATO80 group; these values were 47.13% (3.21%) and aldosterone secretion. However, ACE inhibitors may 48.30% (2.98%) in the ATO40 and ATO80 compara- also lead to the production of certain immunomodu- tor groups. Similarly, a reduction in sitting DBP after 8 latory peptides such as bradykinin and substance P, weeks was –8.50 (1.06) mm Hg in the IRB300 þ which can result in dry cough and angioedema. In ATO40 group and 10.66 (1.08) mm Hg in the IRB300 contrast, ARBs, owing to their specificity for AT1, þ ATO80 group compared with 8.40 (1.65) mm Hg in provide sufficient BP lowering without these side – the IRB300 group. The incidence rate for treatment- effects.9 11 emergent adverse events was 22.27% and was similar Many studies have shown a positive correlation between the monotherapy and combination groups. between blood cholesterol levels and cardiovascular Implications: A once-daily combination product of disease, and thus a reduction in cholesterol levels can irbesartan and atorvastatin provided an effective, safe, significantly reduce the risk.12,13 Drugs belonging to and more compliable treatment for patients with the hydroxymethylglutaryl coenzyme A reductase in- coexisting hypertension and hyperlipidemia. Clinical- hibitors (statins) are the most commonly prescribed Trials.gov identifier: NCT01442987. (Clin Ther. antihyperlipidemic agents. They act by inhibiting the 2016;38:2171–2184) & 2016 The Authors. Published formation of mevalonate, the rate-limiting step in the by Elsevier HS Journals, Inc. biosynthesis of cholesterol. Moreover, statins such as Key words: atorvastatin, combination, hyperlipide- atorvastatin also increase LDL receptors on hepato- mia, hypertension, irbesartan. cytes, thereby enhancing its uptake from blood. The latest, more potent statins such as atorvastatin can also 2172 Volume 38 Number 10 S.-H. Kim et al. effectively reduce plasma levels of LDL-C, total choles- 2011 to February 2013. Eligible patients were aged terol (TC), apolipoprotein B, VLDL-C, and triglycerides Z19 years and r75 years, provided informed (TG). Atorvastatin therapy has also led to a reduction in consent at screening, and presented with hypertension the incidence of adverse cardiovascular events in pa- and hyperlipidemia that could be categorized into tients with other risk factors in addition to dyslipidemia groups A, B, or C (in increasing order of disease such as hypertension14 and type 2 diabetes.15 severity) based on BP and fasting serum lipid levels at Given the multifactorial nature of cardiovascular the randomization visit. The following describes disease, physicians have to rely on prescription of each group: multiple drugs to successfully manage the various Group A: 0 to 1 cardiovascular risk factor or Z2 concomitant pathologies. The resulting polyphar- risk factors and 10-year risk o10%; BP, 140 r macy, with numerous medications with varying regi- systolic BP (SBP) o180 mm Hg and 90 r diastolic mens, is one of the major reasons for nonadherence of BP (DBP) o110 mm Hg; fasting serum lipid, 130 r patients to their prescribed therapies and subsequent LDL-C r 250 mg/dL; and TG o400 mg/dL. failure in managing their disease.16 Hence, a patient- Group B: Z2 cardiovascular risk factors and10- friendly regimen, preferably with the least number of year risk of 10% to 20%; BP, 140
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