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Effect of Lacidipine and Nifedipine GITS on Platelet Function in Patients with Essential Hypertension

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Effect of Lacidipine and Nifedipine GITS on Platelet Function in Patients with Essential Hypertension Journal of Human Hypertension (2000) 14, Suppl 1, S91–S95 2000 Macmillan Publishers Ltd All rights reserved 0950-9240/00 $15.00 www.nature.com/jhh Effect of lacidipine and nifedipine GITS on platelet function in patients with essential hypertension MC Armas-Padilla1, MJ Armas-Herna´ndez1, R Herna´ndez-Herna´ndez1, M Velasco2, B Pacheco1, AR Carvajal1 and A Castillo-Moreno1 1Clinical Pharmacology Unit, School of Medicine, Universidad Centroccidental Lisandro Alvarado, Barquisimeto, Venezuela; 2Clinical Pharmacology Unit, Vargas Medical School, Central University of Venezuela, Caracas, Venezuela With the aim of evaluating the effects on blood pressure, Both drugs reduced systolic and diastolic blood press- platelet function and insulin sensitivity of the dihydro- ure at the same level, however there were observable piridines lacidipine and nifedipine GITS, a parallel dou- differences in the rate of reduction. The nifedipine GITS ble-blind study was carried out in a group of 20 patients reduced supine systolic blood pressure by 25 mm Hg in with mild to moderate essential hypertension. They the first week, while the lacidipine did so by 11 mm Hg. received a placebo for 4 weeks; then were divided at At the end of the study period nifedipine reduced supine random into two groups of 10 patients each. Nifedipine systolic blood pressure by 28 mm Hg and lacidipine by GITS, 30 mg and lacidipine, 4 mg, were given during 16 20 mm Hg. Heart rate was increased slightly but signifi- weeks of active treatment. Blood pressure and heart cantly in the nifedipine GITS group only in the standing rate were measured at the clinic in supine, sitting and position. Both drugs reduced platelet aggregation ex -standing positions, 24 ؎ 1 h after the last dose. After the vivo only marginally but they modified the malondial placebo and active phases were carried out, a platelet dehyde production, indicating an action on the arachi- aggregation test was performed to determine platelet donic acid metabolic pathway. Journal of Human Hyper- malondialdehyde production and a tolerance to 100 g of tension (2000) 14, Suppl 1, S91–S95. glucose by measuring glucaemia and plasma insulin. Keywords: lacidipine; nifedipine GITS; malondialdehyde; insulin sensitivity Introduction ipine GITS allows the drug to be released through the intestinal tract over a long enough period to Calcium antagonists reduce arterial blood pressure maintain stable plasma levels for 24 h with a single by relaxing the smooth arteriole muscle and dimin- daily dose.11 1 ishing peripheral vascular resistance. Platelets play an important role in the The pharmacodynamic and pharmacokinetic atherosclerotic process in the hypertensive patient, characteristics of different calcium antagonists vary not only in initial vessel damage but also in the pro- 2,3 considerably. According to the agent, the effect cess of acute lumen obstruction.12,13 Eicosanoids may last from a short to a very long time period, produced by platelets are important to regulate their which has important clinical implications in the activity.12 Either tromboxano A-2 or malondial- protection of the hypertensive patient throughout 4,5 dehyde production can be determined to estimate the 24 h period. arachidonic acid and prostaglandin metabolism at Lacidipine, a dihydropyridine derived calcium the platelet level.14 Antihypertensive treatment antagonist, has relative prolonged action: the admin- should ideally not only modify blood pressure to istration of 4 mg once a day reduces blood pressure 6,7 control level, but also contribute to modify other over 24 h with one, daily dosage. In comparison risk factors. with short-acting dihydropyridine drugs which The aim of the present study was to evaluate the resulted in a fluctuation in blood pressure and some effects on blood pressure, platelet aggregation and side effects associated with rapid vasodilatation and insulin and glucose levels by lacidipine and nifedip- 3,8,9 sympathetic activation. ine GITS given once daily, in a parallel, double- Regular nifedipine requires three or four doses per blind, randomised study on patients with mild to day to have a sustained effect over 24 h. The osmotic moderate hypertension. slow release formulation (GITS) has been developed to allow administration in one dose per day.10 Nifed- Patients and methods Correspondence: Dr Marı´a Cristina Armas Padilla, Unidad de Ter- Twenty patients with mild to moderate hyperten- apia Me´dica, Calle 55 entre Ave. PL Torres Y Carrera 21, Edificio sion, who also fulfilled pre-established selection cri- El Bosque, Apto. A01, Barquisimeto, Venezuela teria, were the subjects of this study. The patients Effect of lacidipine and nifedipine GITS on platelet function MC Armas-Padilla et al S92 average age was 50 ± 2.3 years. The patient’s charac- Measurement of platelet malondialdehyde pro- teristics can be seen in Table 1. duction: Malondialdehyde was measured by the All patients initially received placebo tablets in a thiobarbituric acid methods,15,16 using N-ethylmalei- simple blind test for 4 weeks. Then patients were mide (Sigma Chemical Co) as activator, at the end allocated at random either in lacidipine or nifedip- of placebo and active therapy. Venous blood was ine GITS groups; 10 patients to, each group. Patients collected from the antecubital vein and mixed with received two tablets daily (one placebo and one 3.8% sodium citrate solution. The platelet-rich active tablet), taken between 7 and 8 am over the 16- plasma and platelet-poor plasma were obtained as week treatment. described previously. The platelet-rich plasma Patients were evaluated every 2 weeks at the adjusted at 300 000 platelet/␮L, was divided into 2- hypertension clinic. Systolic and diastolic blood ml aliquots and centrifuged at 250 g for 18 min to pressure were measured using phase I and V Korot- obtain platelet buttons. The supernatant was dis- koff sounds in supine, seated and standing pos- carded. itions. Heart rate was taken in the same positions. Either 2 ml of N-ethylmaleimide (NEM) in 1 mM All measurements were carried out 24 ± 1 h from the or 2 ml of isotonic saline were added, then incu- last dose of the tablets. Side effects were recorded. bated at 37°C for 60 min in a water bath. Malondial- Compliance of treatment was assessed by counting dehyde was determined using 2 ml of a mixer of tablets, every visit. thiobarbituric acid (0.53% in perchloric acid and 2.3% in PCA 7%, ratio 2:1). The solution was heated in a boiling water bath Platelet function evaluation for 15 min, cooled off to room temperature and cen- Platelet aggregation: At the end of the placebo and trifuged. The optical density was read at 534 nM in active medication phases a 20-ml antecubital blood a Spectronic 20D (Milton Roy Company, USA) sample was taken and mixed with a solution of against a blank. sodium citrate at 3.8% in a ratio of 9:1. The blood To calculate the malondialdehyde concentration, was centrifuged to obtain platelet-rich and platelet- the molar coefficient of extinction was 1.47 × 105. poor plasma. The concentration of platelet-rich The ratio MDA-basal (isotonic saline)/MDA-acti- plasma was adjusted in every case to 300 000 vated (NEM) was calculated as described by Makris platelets/␮L using the platelet-poor plasma. Platelet et al.16 aggregation test was carried out with a Biodata PAP- 4 Aggregometer (Biodata Corporation, Hatboro, PA, USA) using the following proaggregation agents: Statistical analysis (1) Adenosine Diphosphate (ADP) (Sigma Chemical Co, St Louis, MO, USA) in concentrations of 2.0; The data were grouped and the mean and standard 5.0 and 10 ␮M. error calculated. Statistical significance was (2) Adrenaline (Sigma Chemical Co) in concen- obtained using the Student’s t-test (P Ͻ 0.05, two- trations of 2.0, 5.0 and 10.0 ␮M. tailed) for paired and unpaired data: as well as for (3) Collagen (Horm Chemie, West Germany) in con- the analysis of variance (ANOVA). centrations of 0.5, 1.0 and 2.0 ␮g/ml. Platelet-rich plasma, adjusted to 300 000 platelets/␮L was placed in the test tube with a mag- Results netic agitator at a velocity of 1100 rotations per minute. The paper was allowed to run for a minute Blood pressures and heart rate to check spontaneous aggregation after which the pro-aggregate agent was added and the test was In the lacidipine group supine blood pressures allowed to run for 5 min. At the end of this period (systolic/diastolic) during the placebo were 168/103 the percentage aggregation produced was measured. mm Hg; after weeks 1 and 16 of active treatment The test was repeated twice and the values averaged blood pressure was reduced to 157/94 (P Ͻ 0.02) in each case. and 148/91 (P Ͻ 0.001), respectively. Statistical comparison between weeks 1 and 16 in active treat- Table 1 Patients characteristics ment was significant (Table 2). In the nifedipine GITS group the results for the Age Sex Hypertension Basal blood supine position were 165/105 mm Hg in the placebo (years) (male/ evolution pressure phase, 140/90 mm Hg (P Ͻ 0.001) in the first week female) time (years) (SBP/DBP) (mm Hg) and 137/88 mm Hg after 16 weeks of treatment (P Ͻ 0.001). Statistical comparison between week 1 Lacidipine Group and week 16 showed equivalent results Mean 52.36 7/3 8.3 168/103 In the supine position, the heart rate in the lacidi- Standard Error 3.29 – 1.4 4.5/1.10 pine group varied from 74 bpm to 82 bpm and to 75 bpm in the placebo phase between the first week Nifedipine OROS Ͼ Group and week 16 of active treatment (P 0.05).
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