Explore the vast range of titles available.

Hypertension is the most common modifiable cardiovascular risk factor. Policosanol exhibits lipid‐modifying and beneficial vascular pleiotropic effects. Some previous Cuban trials found that policosanol lowered blood pressure in hypercholesterolemic patients. Similar results were found recently in prehypertensive Asian subjects. The aim of this study was to report the effects of 20 mg/day of policosanol on blood pressure in Cuban patients with prehypertension. A double‐blind multicenter trial randomized 400 eligible patients into two strata of 200 patients each (prehypertension and Grade 1 hypertension), treated with placebo or 20 mg/day of policosanol (100 patients/group/stratum) for 12 weeks. The primary outcome was to determine whether policosanol could achieve significant systolic blood pressure (SBP) reductions ≥10 mmHg versus placebo. Changes in diastolic blood pressure (DBP) and lipid profile were secondary outcomes. Safety indicators and adverse events (AE) were assessed. Statistical analyses were conducted by intention‐to‐treat (ITT). Here we report the results of the prehypertension stratum (SBP 120–139 mmHg, DBP 80–89 mmHg). Both groups were similar at randomization. At study completion, policosanol significantly lowered (p < 0.001) SBP and DBP values versus baseline and placebo. Also, more (p < 0.0001) policosanol patients (44%) reached SBP reductions ≥10 mmHg and DBP reductions ≥5 mmHg versus baseline (44% and 61%, respectively) than placebo patients (7% and 22%, respectively). Policosanol significantly lowered low‐density lipoprotein cholesterol (LDL‐C) and total cholesterol (TC) and increased low‐density lipoprotein cholesterol (HDL‐C). Policosanol was well tolerated. Nine patients (4.5%) discontinued the trial, none because of AE. Four patients (3 placebo, 1 policosanol) reported AE. It is concluded that policosanol 20 mg/day given for 12 weeks to Cuban patients with prehypertension lowered SBP and DBP and produced beneficial changes in the lipid profile, being well tolerated.

► We assessed the immunotoxicity of HER1 vaccine in Macaca fascicularis. ► Treated monkeys received 9 doses of vaccination in a 12 months period. ► HER1 vaccine induced specific immune response in M. fascicularis monkeys. ► HER1 vaccine immunization was well tolerated. Human epidermal growth factor receptor (HER1) constitutes a tumor associated antigen. Its overexpression in many epithelial tumors has been associated with bad prognosis and poor survival. Cancer vaccine based on the extracellular domain (ECD) of HER1 and adjuvated in very small sized proteoliposomes (VSSP) and Montanide ISA 51-VG is a new and complementary approach for the treatment of epithelial tumors. The present study deals with the immunogenicity of this vaccine in Macaca fascicularis monkeys and evaluation of its toxicity during 12 months. Twelve monkeys were randomized into two groups of 3 animals per sex: control and vaccinated. Treated monkeys received 9 doses of vaccination and were daily inspected for clinical signs. Body weight, rectal temperature, cardiac and respiratory rates were measured during the study. Humoral immune response, clinical pathology parameters and delayed type hypensensitivity were analyzed. Skin biopsy was performed at the end of the study in all animals. Animal's survival in the study was 100% (n=12). Local reactions were observed at the administration site of four treated animals (n=6), with two showing slight inflammatory cutaneous damage. Clinical pathology parameters were not affected. HER1 vaccine induced high IgG antibodies titers in the treated animals even when DTH was not observed. The induced antibodies recognized HER1+ tumor cell lines, decreased HER1 phosphorylation and showed anti-proliferative and pro-apoptotic effects in H125 cells. In general the present study showed that HER1 vaccine induced specific immune response in M. fascicularis monkeys and was well tolerated, suggesting it could be safely used in clinical studies in epithelial cancer patients.

This study aimed to report the effects of policosanol (20 mg/day) on blood pressure values in Cuban patients with grade I hypertension. A double‐blind multicenter trial randomized 400 eligible patients divided into two strata of patients with either prehypertension or grade I hypertension (200 patients each) treated with either placebo or policosanol 20 mg/day (100 patients/group/stratum) for 12 weeks. Having published the results of pre‐hypertensive patients, here we report the grade I hypertension stratum (SBP 140–159 mmHg, DBP 90–99 mmHg) results. The primary outcome targeted whether policosanol could achieve significant systolic blood pressure (SBP) reductions ≥10 mmHg versus baseline and significantly different from placebo. Changes in diastolic blood pressure (DBP) and lipid profile variables were secondary outcomes. Safety indicators and adverse events were assessed. Statistical analyses were conducted by Intention to Treat. Both groups were similar at randomization. At study completion, policosanol significantly lowered (p < 0.001) SBP, the primary outcome, by more than 10 mmHg related to baseline and placebo, while also significantly decreasing (p < 0.001) DBP values versus baseline and placebo. Also, more (p < 0.001) policosanol patients reached SBP reductions ≥10 mmHg and DBP reductions ≥5 mmHg versus baseline (74% and 91%, respectively) than placebo patients (12% and 15%, respectively). Policosanol significantly lowered low‐density lipoprotein‐cholesterol (LDL‐C) and total cholesterol, while increasing high‐density lipoprotein‐cholesterol (HDL‐C). It is concluded that oral administration of policosanol 20 mg/day for twelve weeks significantly lowered SBP and DBP in Cuban patients with grade I hypertension, and improved lipid profile variables, being safe and well tolerated. Trial registration: Cuban Public Registry of Clinical Trials identifier: RPCEC00000377; IRB approval number: IRB‐120721.

Context • Nonsteroidal, anti-inflammatory drugs effectively relieve osteoarthritis (OA) symptoms but also induce adverse effects (AEs) that limit their long-term use, which drives a search for safer treatments. D-002, a mixture of beeswax alcohols, and D-003, a mixture of sugarcane wax acids, have been effective in experimental and clinical studies for patients with OA. Objective • The study intended to investigate the effects on OA symptoms of a combined therapy using D-002 and D-003 (D-002/D-003), which were administered for 6 wk. Design • The study was a randomized, double-blind, placebo-controlled trial. Setting • The study was conducted at the Surgical Medical Research Center in Havana, Cuba. Participants • Participants were patients with mild-to-moderate OA. Intervention • Participants were randomly assigned to 1 of 4 groups-(1) a control group, which received a placebo; (2) the D-002 group (intervention group), which received 50 mg/d of D-002; (3) the D-003 group (intervention group), which received 10 mg/d of D-003; or (4) the D-002/D-003 group (intervention group), which received a combined therapy of 50 mg/d of D-002 plus 10 mg/d of D-003. The control group received tablets that were indistinguishable in appearance from the D-002 and D-003 tablets and had a similar composition, except that the active ingredients were replaced by lactose. The groups took the medications once per day for 6 wk. Outcome Measures • Symptoms were assessed using the Western Ontario and McMaster Individual Osteoarthritis Index (WOMAC) and a visual analogue scale (VAS). The primary outcome was the reduction in the total WOMAC score. The subscale scores on the WOMAC for pain, stiffness, and physical function, the VAS scores, and the use of rescue medications were secondary outcomes. Results • Of the 120 enrolled participants, 116 completed the study. The treatments with D-002, D-003, and D-002/D-003 reduced the mean total WOMAC scores significantly from baseline to postintervention, by 75.1%, 72.8%, and 91.2%, respectively. Compared with the placebo, the treatments decreased the mean WOMAC scores for pain, joint stiffness, and physical function significantly. The VAS scores significantly decreased, showing a 71.4%, a 66.9%, and an 84.7% reduction for the D-002, D-003, and D-002/D-003 groups, respectively. All the reductions were significant from the first week and were enhanced during the trial. The D-002/D-003 treatment was more effective in improving all of the scores than either monotherapy. With respect to rescue medications, 3/30, 2/30, and 2/30 used the medications in the D-002, D-003, and D-002/D-003 groups, respectively, vs 17/30 in the control group. The treatments were well tolerated. Conclusions • Administered for 6 wk, 50 mg/d of D-002 and 10 mg/d of D-003 ameliorated OA symptoms, but the combined therapy, D-002/D-003, was more effective than either monotherapy. All treatments were well tolerated.

The aim of this study was to conduct a randomized, double-blind and placebo-controlled study to investigate the effects of D-004, a lipid extract of the Roystonea regia fruit that prevents testosterone- and phenylepinephrine-induced prostate hyperplasia in rodents, on plasma oxidative markers in healthy men. We enrolled male volunteers (20-55 years) in good health and without lower urinary tract symptoms. Thirty-four eligible participants were randomized to placebo or D-004 (320 mg) capsules administered daily for 6 weeks. An interim check-up and a final visit were conducted after 3 and 6 weeks of therapy, respectively. Physical examinations were performed at each visit, and laboratory tests were performed at baseline and at treatment completion. Oxidative variables included plasma malondialdehyde (MDA), total hydroxyperoxides (TOH), sulphydryl (SH) groups and total antioxidant status (TAS). We assessed treatment compliance and addressed adverse experiences (AEs) at weeks 3 and 6. At week 6, with D-004, the mean reductions of plasma MDA (26.7%), TOH (18.8%) and SH groups (31.6%), and the mean increase of TAS (35.3%) were significantly different from those of placebo (P<0.001 for plasma TAS, P<0.0001 for all other comparisons). D-004 did not differ from the placebo in safety indicators. There were two withdrawals (both in the D-004 group), with one due to dyspepsia (the only AE during the trial). In conclusion, D-004 displayed antioxidant effects on plasma oxidative markers in healthy men, which was consistent with findings from laboratory experimental studies.

D-003 is a mixture of long-chain aliphatic primary acids isolated from sugar-cane wax and having cholesterol-lowering effects and a safety profile that have been proven in animals and in previous clinical studies in healthy volunteers. Lovastatin, the first member of the statin class, is an effective and well tolerated cholesterol-lowering drug. Some lovastatin-related adverse effects have been reported, and preclinical assessment has shown that the rabbit is the most sensitive species to lovastatin toxicity. To compare the cholesterol-lowering effects and toxicity pattern of D-003 and lovastatin in normocholesterolaemic rabbits. In order to study cholesterol-lowering effects, rabbits were randomly distributed into three groups (eight animals/group): one control group, only receiving the vehicle, and two groups treated with D-003 or lovastatin at 5 and 10 mg/kg/day, respectively. All treatments were orally administered for 30 days. To study toxicity, rabbits were distributed into four groups (six animals/group): one control group and three groups treated with D-003 200 and 400 mg/kg, respectively, or lovastatin 100 mg/kg. After 30 days, D-003 5 mg/kg and lovastatin 10 mg/kg significantly (p < 0.05) and similarly lowered serum total cholesterol (TC) and low-density lipoprotein-cholesterol (LDL-C) levels versus baseline. D-003, but not lovastatin, increased high-density lipoprotein-cholesterol (HDL-C) significantly (p < 0.05), whereas only lovastatin decreased (p < 0.05) triglycerides. Low doses of both drugs did not change safety indicators. D-003 (200 and 400 mg/kg) and lovastatin (100 mg/kg) administered for 10 days reduced TC and LDL-C levels significantly (p < 0.05). HDL-C values increased significantly (p < 0.05) with D-003, but were unchanged with lovastatin. Neither treatment affected triglycerides. No significant changes in lipid profile were observed in the control groups of the two series. Lovastatin 100 mg/kg impaired bodyweight gain and food consumption versus the controls, while D-003 did not. Lovastatin 100 mg/kg increased aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values (p < 0.05 versus baseline and controls) and liver weight (p < 0.05 versus controls). D-003 200 or 400 mg/kg did not affect AST, ALT or liver weight. Lovastatin 100 mg/kg, but not D-003 200 or 400 mg/kg, induced typical hepatocellular and renal tubular necrosis in the rabbits. D-003 5 mg/kg/day administered orally for 30 days to normocholesterolaemic rabbits lowered LDL-C and TC, as did lovastatin 10 mg/kg. D-003 was more effective in increasing HDL-C, while lovastatin was more effective in lowering triglycerides. Administration of higher doses for 10 days did not show D-003-related toxicity, but did demonstrate the typical pattern of lovastatin-induced toxicity in rabbits.