Fausto Garmendia

Attaining United States and European Guideline LDL-cholesterol Levels with Simvastatin in Patients with Coronary Heart Disease (the GOALLS Study)

Summary The effectiveness and safety of simvastatin in reducing low-density lipoprotein cholesterol (LDL-C) to target levels in patients with coronary heart disease (CHD) were evaluated in the GOALLS (Getting to Appropriate LDL-C Levels with Simvastatin) study. This multinational, multicentre, prospective, open-label, study consisted of a six-week diet washout period followed by a 14-week titrate-to-goal treatment period with simvastatin. One hundred and ninety-eight men and women with documented CHD and a fasting LDL-C level between 115 mg/dl (3.0 mmol/l) and 180 mg/dl (4.7 mmol/l) and triglycerides (TGs) ≤ 400 mg/dl (4.5 mmol/l) were enrolled. The patients were started on 20 mg simvastatin with dose titration up to 80 mg if the LDL-C remained above 100 mg/dl at weeks 6 and 10. The key efficacy parameters were the percentage of patients achieving US and European LDL-C goals [≤ 100 mg/dl (2.6 mmol/l) and ≤ 115 mg/dl (3.0 mmol/l), respectively]. Safety was evaluated by monitoring laboratory tests and recording adverse events. After 14 weeks of simvastatin (20–80 mg) treatment, approximately 90% of the patients achieved LDL-C goals according to US (87%) and European (94%) guidelines. Most patients (72–93%) achieved target LDL-C levels on 20 mg simvastatin. An estimated 14% of the patients required titration to the 80 mg dose. Treatment with simvastatin (20–80 mg) produced statistically significant improvements in all measured lipid variables by the end of the study. The mean reductions in total cholesterol and LDL-C, and the median reduction in TG, were 28%, 41% and 16%, respectively. The increase in high-density lipoprotein cholesterol and apolipoprotein A-1 were 5% and 4%, respectively. Simvastatin was well tolerated across the dosage range. In conclusion, simvastatin, 20–80 mg/day, was safe and highly effective at reducing LDL-C levels. The recommended US and European LDL-C treatment goals were achieved in approximately 90% of the patients. These goals were similarly achieved for a variety of high-risk sub-groups (hypertensives, diabetics and elderly patients).

Luteinizing hormone and progesterone in women under postcoital contraception with D-norgestrel.

Luteinizing hormone (LH) and progesterone (Pg) levels in blood were measured simultaneously by radioimmunoassay during 53 menstrual cycles in order to investigate the effect of 400 mug of D-norgestrel, administered postcoitally, on pituitary and ovarian function. Of 31 control cycles, 2 appeared to be anovulatory, since the LH peak and subsequent Pg elevation were absent. Twenty-nine cycles showed typical LH surges in the middle of the cycle, followed by a manifold Pg increase. Twelve women received 5 to 13 tables of D-norgestrel. A total absence or at least marked suppression of LH and Pg elevations was observed. In a third group, D-norgestrel was administered on scheduled days. Each woman ingested one to four tablets between the 6th and 18th days of the cycle. Two or more tablets disturbed LH and Pg ovulatory patterns. Of four women who received a tablet on day 10, one failed to show characteristic ovulatory patterns and three exhibited a delay in the time of the LH and Pg increase. These results demonstrate that D-norgestrel in a postcoital regimen alters pituitary and ovarian function, strongly suggesting an antiovulatory effect.

Efecto del aceite de sacha inchi (plukenetia volúbilis l) sobre el perfil lipídico en pacientes con hiperlipoproteinemia

We performed a pilot, experimental, open study in order to know the effect, effective dosage and secondary effects of sacha inchi´s (Plukenetia volubilis L) oil on the lipid profiles of patients with hypercholesterolemia. We included 24 patients of ages 35 to 75, to whom we measured total cholesterol (TC), HDL, triglycerides (Tg), glucose (G), non-esterified fatty acids (NEFA) and insulin (I) levels in blood, then we randomized them to receive sacha inchi oil orally 5 ml or 10 ml of a suspension of sacha inchi oil (2gr/5ml) for four months. The oil intake produced a decrease in the mean values of TC, and NEFA, and a rise in HDL in both subgroups. The subgroup receiving 10 ml was associated to an increase in the insulin levels. Sacha inchi oil appears to have beneficial effects on the lipid profile of patients with dyslipidemia, but their efficacy and security should be evaluated in randomized clinical trials.

Influencia de la Hidroclorotiazida sobre el metabolismo de los Hidratos de Carbono

Se estudio el efecto de la hidroclorotiazida sobre la curva de tolerancia de la glucosa, para cuyo efecto se administro diariamente 200 mq, de hidroclorotiazida durante 7 dias a 53 sujetos: 10 presuntos normales, 20 con hipertension esenciaL 7 con nefropatias difusas e insuficiencia renal, 6 nefropatas sin insuficiencia renal y 10 con diabetes mellitus de moderada intensidad. No se produjo elevacion de la glucosa sanguinea basal, en cambio si hubo un incremento en las curvas de glicemia en todos los grupos a excepcion de los nefropatas. En los pacientes renales sin insuficiencia no se hallo una variacion importante, pero en los que acusaron retencion nitrogenada la curva descendio. Los sujetos normales mostraron una elevacion estadisticamente significativa a los 60 y 90 minutos, pero que no llego a sobrepasar los limites normales. En los pacientes con hipertension se observo la aparicion de un mayor numero de curvas anormales despues de la hidroclorotiazida. Los diabeticos no mostraron un incremento importante de sus curvas de glicemia. Se hace una breve revision de los posibles mecanismos de accion de los tiazidas sobre el metabolismo hidrocarbonado, senalandose, a merito de las investigaciones practicadas, que la hidroclorotiazida ocasiona una elevacion de las curvas de glicemia en sujetos con tolerancia a los hidratos de carbono previamente normal o disminuida, posiblemente por una alteracion en la relacion sodio/potasio intracelular, sin descartarse la concurrencia de otros mecanismos.