M Velasco¹, E Lezama¹, F Contreras¹, R Hernández², MJ Hernández², L Alcocer³ and A Reyes⁴.

1. Clinical Pharmacology Unit, Vargas Hospital and Department of Pharmacology, Vargas School of Medicine, Central University of Venezuela. Caracas, Venezuela.
2. Universidad centro Occidental "Lisandro Alvarado", Barquisimeto, Venezuela.
3. Universidad Nacional Autónoma de Mexico, Servicio de Cardiología, México, DF.
4. Instituto de Cardiología Teórica, Montevideo, Uruguay.

The main objective of this study was to evaluate well being and physical activity of two hundred and forty eight hypertensive patients, of which, one hundred and seventy seven were female, who had previously finished the Latin Amerícan Study on Lacidipine in Hypertension (LASTLHY). This was an open study carried out in twelve clinical centers situated in Argentina, Brazil, Colombia, Mexico and Venezuela, to compare, over a period of sixteen weeks, the antihypertensive actions of fixed-dose once daily oral monopharmacotherapy of 4 rng of lacidipine (n = 120) patients VS. 30 mg of nifedipine (n = 128) patients aged between 40-65 years old, with mild to moderate hypertension beginning at the end of a four weeks placebo run-in (end of week -1). Well being and physical activity were assessed through an experimental single questionnaire, which was administered taking into consíderation the physical and cultural diversities amongst the clinical centers and patients. The questionnaire included thirteen multiple-choice and eight contingent open questions. The score to each question was multiplied by a coefficient according to the importance of each question for each patient (semipersonal ization); the coefficient was evaluated from cultural and socioeconomic information collected at the time of enrollment. The semipersonalization was carried out by a blind psychological study with respect to the medication and had a high repeatability in the assignment of personalized coefficients to the score of each question. The scores of each question were added to obtain an overall weil being and activity scoring. The possible theoretical range for the overall scoring in this study was 10- 124.

Key Words: Arterial blood pressure, Semipersonalized, Hypertension, Lacidipine, Nidedipine.

Usually, the psychological evaluations related to the quality of life during antihypertensive therapy are in disagreement due to the differences between patients^(1,2,3,4). Moreover, it has also been demonstrated that lacidipine is about 10 times more potent than nifedipine in reducing the vasoconstrictor response induced by sympathetic stimulation of the rat smooth muscle; this action is not accompanied by cardiodepression⁽⁶⁾.

Lacidipine has an antiatherosclerotic effect, and also, it protects the smooth muscle from damage produced by hypertension at the therapeutic doses used in humans^(7,8). It has been demonstrated in recent studies that lacidipine improves the sensibility to insulin in patients with type II diabetes⁽⁹⁾.

This study was performed in twelve clinical centers of five different countries: Argentina, Brazil, Colombia, Mexico and Venezuela. Range ages of patients were between 40–65 years old with diastolic blood pressure between 100 –115 mmHg after one week of placebo period. Arterial blood pressure was measured in the supine position using a sphygmomanometer. The active treatment was performed during 16 weeks. Non pharmacological treatment and a low sodium diet was prescribed at the beginning of the study. Nifedipine was prescribed to 128 hypertensive patients in daily doses of 30 mg and lacidipine (4 mg) was administered in a similar manner to 120 hypertensive patients during 16 weeks.

The psychological semipersonalized score was named PSS. After adding the score of each question, this result was multiplied by the personalized coefficient. A theoretic range for this study was established between 10 –124, establishing that a high score of PSS reflect a good quality of life and physical activity.

p* < 0.0001 >0.05

Once established the size of the sample and the real value of the psychological semipersonalized score (PSS), this variable was considered as a metrical variable and was used statistically as they are used in psychological studies (Repeated measured ANOVA and Dunnet test).

Semipersonalized psychological studies evaluating the quality of life and the side effects produced by two calcium channel blockers such as lacidipine and nifedipine in hypertensive patients have not yet been performed. In previous work of phase II in 2000 hypertensive patients was reported a relative incidence of the following side effects: headache, vomit, edema, dizziness, palpitations, fatigue and gastric disorders⁽¹⁰⁾.

In the present prospective study we observed a significant decrease in the side effects reported for lacidipine, this absence of side effects make this drug with an excellent tolerance and at the same time the quality of life of the hypertensive patients improve in a significant manner. However, this is not the case for nifedipine, although the questionnaire of the side effects was not in a spontaneous manner, in which we could not differentiate the score very good.

We also observed a significant decrease of the nervousness with lacidipine but not with nifedipine, which in turn give a better improvement in the daily activity and also in the quality of life and possibly at the end of the treatment the arterial blood pressure for the group of hypertensive patients treated with lacidipine will be lower than for the group treated with nifedipine.

In conclusion, our study reveal that the administration of calcium channel blockers such as lacidipine and nifedipine, and specifically, lacidipine produced less incidence of side effects and because of that also improve the quality of life.