Comparison of the efficacy and tolerability of chondroitin plus glucosamine and D-002 (beeswax alcohols) in subjects with osteoarthritis symptoms

Background/AIMS: Osteoarthritis (OA), the commonest joint disorder, is a leading cause of disability. Symptomatic slow-acting drugs for OA (SYSADOA), particularly glucosamine plus chondroitin sulphate (GS/CS), are effective for symptom relief, protect joint cartilage and delay OA progression, with a good safety profile. D-002, a mixture of beeswax alcohols that inhibits both cyclooxygenase and 5-lipoxygenase activities, has been effective in experimental and clinical OA studies, showing also a chondroprotective effect.OBJECTIVES: To compare the effects of D-002 and GS/SC administered for 12 weeks on OA symptoms.METHODS: Participants were randomized to GS/CS (375/300 mg) or 50?mg D-002 once daily for 12 weeks. Symptoms were assessed by the Western Ontario and McMaster Individual Osteoarthritis Index (WOMAC) and the visual analogy scale (VAS) scores. The primary outcome was the reduction of the total WOMAC score. Secondary outcomes included WOMAC pain, stiffness and function scores, VAS score and rescue medication consumption.RESULTS: Of 60 randomized patients, 59 completed the study. D-002 and GS/SC reduced significantly total WOMAC score (72.1% and 78.5%, respectively), and pain, joint stiffness and physical function scores versus baseline. VAS scores decreased significantly with D-002 (76.6%) and GS/SC (76.8%). The reductions, significant from the second week, were enhanced over the trial. Rescue medications were consumed by 3/30 D-002 and 4/30 GS/SC patients. No differences between groups were found. Treatments were well tolerated.CONCLUSIONS: D-002 (50 mg/day) administered for 12 weeks was safe and comparable to GS/SC for alleviating OA symptoms (pain, stiffness, and functional limitation) (RPCEC00000180).</h4

Effects of D-003 (sugarcane wax acids) on the physical exercise on static bicycle test

Physical inactivity and low maximal exercise oxygen consumption (VO2max) are predictors of mortality and coronary events in adults, respectively. Lowering serum cholesterol and platelet aggregation benefits cardiovascular function in aging persons. D-003, a mixture of sugarcane wax acids, exhibits antiplatelet and cholesterol-lowering effects, and could benefit the performance of middle-aged and older subjects in effort tests. This randomised, double-blinded, placebo-controlled study investigated the effects of D-003 (10 mg/day) for 12 weeks on the effort test in the static bicycle and the health status of 50 subjects (50-70 years old). Compared with baseline and placebo, D-003 improved significantly VO2 max values, pain/discomfort and health perception EuroQoL scores, and the cardiovascular capacity assessed by the Specific Activity Scale. Also, D-003 displayed cholesterol-lowering effects versus placebo, being well tolerated. There were no study withdrawals. Concluding, D-003 improved VO2 max values in the effort test, lipid profile, health perception and cardiovascular status of study subjects.Colegio de Farmacéuticos de la Provincia de Buenos Aire

Comparison of the antioxidant effects of D-002 (beeswax alcohols) and grape seed extract (GSE) on plasma oxidative variables in healthy subjects

Increased oxidative stress is implicated in several diseases. D-002, a mixture of six higher aliphatic alcohols purified from beeswax, and grape seed extract (GSE) (rich in flavonoids), have been shown antioxidant effects. This randomised, double-blinded study compared the effects of both substances on plasma malondialdehyde (MDA), total hydroxyperoxides (TOH), carbonyl groups (CG) and blood superoxide dismutase (SOD) in healthy volunteers. Fifty eligible subjects were randomized to D-002 (50 mg/day) or GSE (85 mg proanthocianydine/day) for 8 weeks. Both D-002 and GSE reduced significantly plasma MDA (30.0% and 34.0%, respectively), TOH (31.6% and 34.0%, respectively) and CG (21.4% and 14.3 %, respectively), but unchanged SOD. No significant differences between groups were found. Both treatments were well tolerated. No subject dropped out because of adverse experiences (AE). Then, D-002 and GSE administered for 8 weeks were similarly effective for lowering plasma markers of lipid and protein oxidation, and similarly safe.Colegio de Farmacéuticos de la Provincia de Buenos Aire

Comparison of the antioxidant effects of lipid extracts of Roystonea regia (D-004) and saw palmetto on blood oxidative variables of healthy men

D-004, a lipid extract of Roystonea regia fruits that prevents testosterone-induced prostate hyperplasia in rodents, and saw palmetto (SP) lipid extract, used to treat benign prostate hyperplasia, have been shown antioxidant effects. This randomized, double-blind study compared their antioxidant effects in forty healthy men randomised to D-004 or SP (320 mg/day) capsules for 8 weeks. D-004 significantly (p < 0.001) reduced plasma malondialdehyde (MDA) (32.7 %), sulphydril groups (SH-G) (24.6 %) and (p < 0.01) total hydroxyperoxides (TOH) (26.5 %) values and increased (p < 0.001) total antioxidant status (TAS) (44.1 %) and catalase (CAT) (100.0 %) activity. Treatment with SP lowered (p < 0.001) MDA (26.6 %), SH-G (24.1 %), (p < 0.01) TOH (26.3 %) values, and raised (p < 0.001) TAS (57.4 %) and (p < 0.01) CAT (85.7 %) activity. Both treatments were similarly effective and well tolerated. Concluding, D- 004 and SP (320 mg/day) for 8 weeks similarly reduced plasma lipid peroxidation (MDA, TOH) and protein oxidation (SH-G) markers, increased TAS and CAT activity and were well tolerated in healthy men.Colegio de Farmacéuticos de la Provincia de Buenos Aire

Farmacoterapia de la dislipidemia en el anciano

El paciente anciano posee características peculiares que determinan que los medicamentos tengan una farmacodinamia diferente a la de los adultos de menor edad. Esto también tiene plena validez para los medicamentos hipolipemiantes. La conveniencia de indicar tratamientos hipolipemiantes en el adulto mayor ha suscitado interesantes polémicas; sin embargo, parece haber consenso en el sentido de que los ancianos con buena perspectiva de vida debe tratarse la dislipidemia. Los medicamentos deben seleccionarse de acuerdo con las características individuales del paciente de avanzada edad. El policosanol es uno de los medicamentos que por su eficacia y tolerabilidad se ajusta mejor a las condiciones del anciano dislipidémico.The aged patient has peculiar characteristics which determine that drugs have a dynamics different from that of the younger patients. This is also valid for antilipemic drugs. The convinience of indicating antilipemic treatment in the elderly has brought about interesting controversies; however, there seems to be consensus in the sense that dislipidemia must be treated in those old patients with good life expectancy. Drugs must be selected according to the individual characteristics of the aged patient. Policosanol is one of the drugs that due to its efficacy and tolerability is better for the conditions of the dislipidemic elderly

La dislipidemia en el paciente diabético: Parte I Bioquímica patológica

La hipertrigliceridemia es la dislipidemia más frecuente en el diabético, y la hipercolesterolemia es más frecuente que en las personas no diabéticas. Además, en el diabético se presentan alteraciones estructurales de las lipoproteínas que alteran la función plaquetaria y el sistema inmunológico, todo lo cual tiene en su conjunto un efecto que favorece el proceso aterogénicoHipertriglyceridemia is the most frequent dyslipidaemia in the diabetic, and hypercholesterolemia is more common among them than in the non-diabetic patients. Besides, there are structural modifications of lypoproteins that alter the platelet function and the immunological system, which altogether have an effect that favors the atherogenic process

La dislipidemia en el paciente diabético: Parte II Manejo de la dislipidemia en el paciente diabético

La dislipidemia del paciente diabético tiene como primera condición la regulación de la glicemia y como primera opción terapéutica en caso de que no se restablezca el perfil lipídico normal, medida de control dietético y reducción del peso corporal si fuera necesario. Al iniciar la farmacoterapia, cuando fallen estas medidas, debe tomarse en consideración el nivel de los lípidos séricos y la presencia o no de macroangiopatía. La selección de los medicamentos que se deben utilizar debe ser cuidadosa a fin de no introducir reacciones colaterales particularmente adversas en estos pacientes.Displipydemia of the diabetic patients has as a primary condiction the regulation of glycaemia and as o firts therapeutical choice the diet control and the reduction of body weight in case the normal lipidic prolife is nor reestablished. On beginning the pharmacotherapy, the level of the serum lipidis and the presence or not of macroangiopathy should be taken into o consideration if these measures fail. Drugs should be carefully selected so as not to introduce side effects particulary adverse for these patient

Effects of D-002 (Beeswax Alcohols) on lipid peroxidation in middle-aged and older subjects

El D-002 es una mezcla de alcoholes alifáticos primarios superiores (tetracosanol, hexacosanol, octacosanol, triacontanol, dotriacontanol, tetratriacontanol) purificada de la cera de abejas con efectos antioxidantes, cuyos efectos sobre los niveles plasmáticos de hidroperóxidos totales (OHPT) no habían sido investigados. Este estudio aleatorizado, doble ciego y controlado con placebo investigó los efectos del D-002 (50 mg/día) sobre los valores plasmáticos de OHPT y otras variables oxidativas en 56 sujetos que recibieron aleatoriamente placebo ó D-002 durante 12 semanas. D-002, no el placebo, redujo significativamente los niveles plasmáticos de malondialdehido (MDA) (22,6%) y OHPT (23,8%), y aumentó el estado antioxidante total del plasma (EAOTP) (19,7%) versus los basales y del placebo. El D-002 no afectó los indicadores de seguridad. Hubo 6 bajas (4 placebo, 2 D-002), sólo una (placebo) debida a experiencias adversas (EA). Seis sujetos (5 placebo, 1 D- 002) refirieron alguna EA. Concluyendo, el D-002 (50 mg/día) redujo significativamente los niveles plasmáticos de OHPT y MDA, aumentó el EAOTP y fue bien tolerado por los sujetos de estudio, lo que expande el conocimiento previo sobre sus efectos antioxidantes en humanos.D-002 is a mixture of higher aliphatic alcohols (tetracosanol, hexacosanol, octacosanol, triacontanol, dotriacontanol, tetratriacontanol) purified from beeswax with antioxidant effects, whose effects on plasma total hydroxyperoxides (TOHP) had not been investigated. This randomised, double-blinded, placebo-controlled study investigated the effects of D-002 (50 mg/day) on plasma TOHP and other oxidative variables in 56 subjects who received placebo or D-002 for 12 weeks. D-002, not placebo, reduced significantly plasma malondialdehyde (MDA) (22.6%) and TOHP (23.8%), and increased plasma total antioxidant status (TAS) (19.7%) versus baseline and placebo. D-002 did not affect safety indicators. There were 6 withdrawals (4 placebo, 2 D-002), only one (placebo) due to adverse experiences (AE). Six subjects (5 placebo, 1 D-002) referred some AE. Concluding, D-002 (50 mg/day) reduced significantly plasma TOHP and MDA, increased TAS, and was well tolerated by study subjects, which expands previous knowledge on its antioxidant effects in humans.Colegio de Farmacéuticos de la Provincia de Buenos Aire