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Randomized Trial of Perindopril, Enalapril, Losartan and Telmisartan in Overweight Or Obese Patients with Hypertension

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Randomized Trial of Perindopril, Enalapril, Losartan and Telmisartan in Overweight Or Obese Patients with Hypertension Clin Drug Investig DOI 10.1007/s40261-013-0094-9 ORIGINAL RESEARCH ARTICLE Randomized Trial of Perindopril, Enalapril, Losartan and Telmisartan in Overweight or Obese Patients with Hypertension Serge V. Nedogoda • Alla A. Ledyaeva • Elena V. Chumachok • Vera V. Tsoma • Galina Mazina • Alla S. Salasyuk • Irina N. Barykina Ó Springer International Publishing Switzerland 2013 Abstract other BP, echocardiographic, metabolic and anthropomet- Background and Objectives Obesity exacerbates hyper- ric parameters occurred with all treatments. tension and stimulates the renin–angiotensin–aldosterone Conclusion Full-dose RAAS inhibition, particularly with system (RAAS). Full-dose RAAS inhibition could be a perindopril, effectively reduces BP, improves arterial therapeutic option in overweight or obese patients with structure and regulates cardiovascular risk factors in hypertension. This study compared four RAAS inhibitors overweight or obese patients with hypertension. at full therapeutic doses to determine their effect on blood pressure (BP) and cardiovascular risk factors in these patients. 1 Introduction Methods We conducted a 24-week, single-blind, random- ized, parallel-group study in 120 overweight or obese patients Effective reduction of elevated blood pressure (BP), car- (body mass index C27 kg/m2) with hypertension, aged diovascular prevention and mortality reduction are the 18–60 years. The primary endpoint was the change in mean main goals of antihypertensive therapy [1, 2]. Obesity not 24-h systolic BP and diastolic BP from baseline to study end. only appears to have a substantial pathophysiological effect Central BP, arterial stiffness, and metabolic and cardiac on the haemodynamic changes seen in hypertension but indices were also investigated. Patients were randomly also impairs the response to treatment [3–5]. Optimizing allocated to perindopril 10 mg/day, enalapril 20 mg/day, the management of hypertension in overweight and obese losartan 100 mg/day or telmisartan 80 mg/day. Nonphar- patients is becoming increasingly important: up to 30 % of macological interventions were also recommended. current cases of hypertension are due to obesity, and Results Reductions in mean 24-h systolic BP (and dia- hypertension becomes more prevalent as weight increases stolic BP) were all significant (p \ 0.05 versus baseline) [6–9]. The presence of hypertension in obesity is linked to for perindopril, enalapril, losartan and telmisartan: systolic many pathological disorders, and most patients with BP -22, -11, -12 and -15 mmHg, respectively; (and hypertension and obesity are insulin resistant and show diastolic BP -13, -6, -13 and -12 mmHg, respectively). signs of early target-organ damage [10, 11]. Despite all of Aortic elasticity improved with perindopril and telmisartan. this, there are currently no international recommendations Perindopril was associated with the greatest reductions in for treatment of hypertension in obese patients, principally central aortic BP and leptin levels [30 % versus 2 %, 7 % because of a lack of randomized clinical trials in the field and 14 % with enalapril, losartan and telmisartan, respec- [2, 12]. tively (all p \ 0.05 versus perindopril)]. Reductions in Renin–angiotensin–aldosterone system (RAAS) inhibi- tors are considered the class of choice for the treatment of hypertension in obese patients because of their wide range S. V. Nedogoda (&) Á A. A. Ledyaeva Á of cardiovascular benefits [13]. Clinical evidence suggests E. V. Chumachok Á V. V. Tsoma Á G. Mazina Á that full-dose angiotensin-converting enzyme (ACE) A. S. Salasyuk Á I. N. Barykina Volgograd State Medical University, Volgograd, Russia inhibitor and angiotensin-receptor blocker (ARB) therapy e-mail: [email protected] may be useful for both correction of hypertension and S. V. Nedogoda et al. prevention of cardiovascular events in hypertensive Secondary endpoints were the change in central aortic BP patients at high cardiovascular risk [14–16], including and arterial elasticity. Other parameters investigated those with obesity [17–19]. The phase IV study described included echocardiographic and metabolic indices. here compared four RAAS inhibitors—two ACE inhibitors Using an envelope method, patients were randomly (perindopril and enalapril) and two ARBs (losartan and allocated to four groups: perindopril 10 mg/day (Servier, telmisartan)—at full therapeutic doses to determine their Suresnes, France); enalapril 20 mg/day (Merck Sharp & impact on blood pressure, arterial stiffness and other car- Dohme, Whitehouse Station, NJ, USA); losartan 100 mg/ diovascular risk factors in overweight or obese patients day (Merck Sharp & Dohme); or telmisartan 80 mg/day with hypertension. (Boehringer Ingelheim, Ingelheim, Germany). Patients were blinded to their treatment allocation and took the treatment for 24 weeks in addition to implementing rec- 2 Methods ommended nonpharmacological interventions. These interventions included lifestyle modification and weight This single-blind, randomized, parallel-group study included loss (diet, physical activity) and were initiated 3 months overweight or obese patients [body mass index (BMI) before treatment allocation. Weight loss drugs were not C27 kg/m2] with hypertension, aged 18–60 years. Eligible allowed. All of the patients in the study gave informed patients were untreated or were hypertensive after a 2-week consent before inclusion, and the protocol was approved by washout period, with clinic brachial systolic blood pressure the regional ethical committee of the Volgograd State (SBP) C140 to\160 mmHg in a sitting position and/or dia- Medical University. The study design is shown in Fig. 1. stolic blood pressure (DBP) C90 to\100 mmHg (measured Clinical and demographic characteristics of the groups by the Korotkov method, i.e. three measurements at intervals were assessed at baseline, while parameters of BP, echo- of 1–2 min; BP was the mean of the last two measurements). cardiography, vascular structure, blood biochemistry and A special cuff was used for measuring BP in obese patients. anthropometry were assessed at baseline and 24 weeks. Patients were excluded if they were aged \18 years or had Treatment tolerability was assessed at each follow-up visit. known hypersensitivity, intolerance or contraindications to Ambulatory blood pressure monitoring (ABPM) [using a ACE inhibitors or ARBs; unstable angina; heart failure; renal Spacelabs 90207 machine; Spacelabs Medical Inc., Iss- or hepatic insufficiency; grade 2 or 3 arterial hypertension aquah, WA, USA] was used to determine mean 24-h (C160/100 mmHg); a history of stroke; diagnosed or sus- daytime and night-time SBP and DBP, with measurements pected secondary hypertension; or a serious illness affecting every 15 min during the day (0700–2300 hours) and every their prognosis. Stable coronary artery disease was managed 30 min during the night (2300–0700 hours). A minimum of solely with beta-blocker therapy. 60 BP measurements were required for ABPM data to be The primary endpoint of the study was the change in considered valid for analysis. mean 24-h SBP and DBP from baseline to study end. An Aloka Prosound L7 Premier device (Hitachi Aloka Medical Ltd., Tokyo, Japan) was used to determine echo- cardiographic parameters (ejection fraction, stroke index, end-systolic and end-diastolic diameters, and intima/media thickness). Pulse wave velocity (PWV), a parameter of vas- cular stiffness, was studied using a computerized Complior device (Colson, Garges-les-Gonesses, France), as described elsewhere [20]. The augmentation index and central aortic BP were determined using a SphygmoCor device (AtCor Medical Pty Ltd., West Ryde, NSW, Australia). Fasting blood samples were collected for biochemistry [lipids, glucose, glycosylated haemoglobin, C-peptide, leptin, immunoreactive insulin (IRI), uric acid and creati- nine levels]. Serum leptin was determined using the stan- dard DSL enzyme immunoassay set (Diagnostics System Laboratories Inc., Webster, TX, USA), and C-peptide levels were measured using a C-peptide immunoluminometric assay. Impaired glucose tolerance (IGT) and diabetes mel- litus were determined by fasting and 2-h measurements of Fig. 1 Trial design: comparison of perindopril, enalapril, losartan plasma glucose levels following oral administration of 75 g and telmisartan in overweight patients with hypertension. W week glucose. IGT was established by a fasting glucose level RAAS Inhibitors in Overweight or Obese Hypertensive Patients Table 1 Clinical and demographic characteristics of the study subjects Characteristic Perindopril 10 mg/day Enalapril 20 mg/day Losartan 100 mg/day Telmisartan 80 mg/day (n = 30) (n = 30) (n = 30) (n = 30) Age (years; mean ± SD) 49.7 ± 8.2 47.8 ± 8.1 46.7 ± 8.2 47.4 ± 9.2 BMI (kg/m2; mean ± SD) 31.1 ± 2.9 30.9 ± 2.2 29.4 ± 3.6 31.1 ? 3.1 Sex: male (n [%]) 16 [53] 15 [50] 15 [50] 15 [50] Smokers (n [%]) 16 [53] 14 [47] 12 [40] 13 [43] Duration of hypertension (years; 6.9 ± 3.2 6.2 ± 3.1 5.9 ± 3.1 5.6 ± 3.2 mean ± SD) History of CAD (n [%]) 17 [57] 19 [63] 16 [53] 17 [57] Hypercholesterolaemia (n [%]) 26 [87] 23 [77] 26 [87] 24 [80] Microalbuminuria (n [%]) 18 [60] 16 [53] 15 [50] 17 [57] Left ventricular hypertrophy (n [%]) 29 [97] 28 [93] 29 [97] 27 [90] BMI body mass index, CAD coronary artery disease \7.0 mmol/L and a 2-h glucose level C7.8 mmol/L, while Most patients had left ventricular hypertrophy (93 %) and diabetes mellitus was established by a fasting glucose level hypercholesterolaemia (83 %); over half had microalbu- C7.0 mmol/L and a 2-h glucose level C11.1 mmol/L. minuria (57 %) and a history of coronary artery disease Percentage body fat was determined using an Omron BF306 (57 %); and half were smokers (47 %). There were 30 device (OMRON Healthcare Inc., Lake Forest, IL, USA). patients in each treatment group, and there were no sta- Data are presented as means ± standard deviations or tistically significant between-group differences at baseline. numbers and percentages. A paired student’s t test was used There were no dropouts during the study, and no safety to detect significant changes with treatment; p \ 0.05 was issues were recorded. No changes in beta-blocker dosage in considered statistically significant.
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