Comparison of the efficacy and tolerability of policosanol with atorvastatin in elderly patients with type II hypercholesterolaemia

BACKGROUND: Hypercholesterolaemia is a risk factor for coronary heart disease (CHD). Clinical studies have shown that lowering elevated serum total cholesterol (TC) levels, and particularly low density lipoprotein-cholesterol (LDL-C) levels, reduces the frequency of coronary morbidity and deaths, whereas high serum levels of high density lipoprotein-cholesterol (HDL-C) protect against CHD. Policosanol is a cholesterol-lowering drug purified from sugar cane wax with a therapeutic dosage range from 5-20 mg/day. Atorvastatin is an HMG-CoA reductase inhibitor which across its dosage range (10-80 mg/day) has shown significantly greater lipid-lowering effects than all previously marketed statins. OBJECTIVE: This study was undertaken to compare the efficacy and tolerability of policosanol with atorvastatin in older patients with type II hypercholesterolaemia. PATIENTS AND METHODS: This randomised, single-blind, parallel-group study was conducted in older patients (60-80 years) with type II hypercholesterolaemia. After 4 weeks on a cholesterol-lowering diet, 75 patients were randomised to policosanol or atorvastatin 10mg tablets taken once daily with the evening meal for 8 weeks. An interim and final check-up were performed at 4 and 8 weeks, respectively, after treatment was initiated. RESULTS: At 4 (p < 0.0001) and 8 (p < 0.00001) weeks, policosanol 10 mg/day significantly lowered serum LDL-C levels by 17.5 and 23.1%, respectively compared with baseline; corresponding values for atorvastatin were 28.4 and 29.8%. At study completion, policosanol significantly (p < 0.0001) reduced serum TC (16.4%), LDL-C/HDL-C ratio (25.5%) and TC/HDL-C ratio (19.3%), as well as (p < 0.001) triglyceride levels (15.4%). Atorvastatin significantly (p < 0.0001) decreased serum TC (22.6%), LDL-C/HDL-C (26.2%) and TC/HDL-C (19.8%) ratios, as well as (p < 0.001) triglyceride levels (15.5%). Atorvastatin was significantly more effective than policosanol in reducing LDL-C and TC, but similar in reducing both atherogenic ratios and triglyceride levels. Policosanol, but not atorvastatin, significantly (p < 0.05) increased serum HDL-C levels by 5.3%. Both treatments were well tolerated. At study completion, atorvastatin mildly, but significantly (p < 0.05) increased creatine phosphokinase (CPK) and creatinine, whereas policosanol significantly reduced AST and glucose (p < 0.01) and CPK (p < 0.05) levels. All individual values, however, remained within normal limits. Three atorvastatin but no policosanol patients withdrew from the study because of adverse events: muscle cramps (1 patient), gastritis (1 patient) and uncontrolled hypertension, abdominal pain and myalgia (1 patient). Overall, no policosanol and seven atorvastatin patients (18.9%) reported a total of nine mild or moderate adverse events during the study (p < 0.01). CONCLUSIONS: This study shows that policosanol (10 mg/day) administered for 8 weeks was less effective than atorvastatin (10 mg/day) in reducing serum LDL-C and TC levels in older patients with type II hypercholesterolaemia. Policosanol, but not atorvastatin, however, significantly increased serum HDL-C levels, whereas both drugs similarly reduced atherogenic ratios and serum triglycerides. Policosanol was better tolerated than atorvastatin as revealed by patient withdrawal analysis and overall frequency of adverse events. Nevertheless, further studies must be conducted in larger sample sizes and using dose-titration methods to achieve target lipid levels in order to reach wider conclusions.     

Natural swarming behaviour of the molecular M form of Anopheles gambiae

In Anopheles gambiae, as in most species of mosquitoes, mating is initiated in flight. The males aggregate in aerial swarms and conspecific females individually fly to these swarms where they mate with males. In this study, we investigated the swarming behaviour of A. gambiae and conducted 2 surveys in the rice field area of the Vallée du Kou in Burkina Faso in 1999 and 2002. A high number of anopheline mosquitoes were observed in this area and both molecular M and S forms of A. gambiae were found in sympatry. Swarms formed a few minutes after sunset in different places and no obvious markers were associated with their occurrence. However, swarms occurred close to cow herds generally in open flat areas, 2-3 m above the ground. Overall, 2829 anopheline mosquitoes were collected from 21 swarms composed primarily of males. A few specimens of Culex quinquefasciatus were collected from 3 swarms. Although both molecular M and S forms were found in sympatry in the village, swarms were composed almost exclusively of the molecular M form. This suggests that there are alternative swarming habits for both molecular M and S forms of A. gambiae in nature.     

Contribution of bronchial fibroscopy in pneumonology services in developing countries

Bronchial fibroscopy is a recent investigation method that requires equipment and facilities difficult to implement in respiratory diseases units in developing countries. In Burkina Faso, this technique was introduced for the first time in February 1997. The purpose of this study was to determine the contribution of bronchial fibroscopy for the diagnosis of respiratory disease in countries with limited resources. This study was conducted between February 1997 and October 1998 at the respiratory diseases unit of the Yalgado Ouedraogo National Hospital Center in Ouagadougou, Burkina Faso. Thirty-five cases of tuberculosis were diagnosed, including 29 cases with bronchial node involvement, where bronchial fibroscopy is an essential diagnostic examination, and 6 cases of bacteriologically proven pulmonary tuberculosis. Ten cases of lung cancer were diagnosed (40% squamous cell carcinoma). Malignant disease is a reality in developing countries despite low rates of diagnosis due to insufficient diagnostic facilities. For tuberculosis, the importance of specific treatment is certainly well established and should always be initiated, even if fibroscopy cannot be performed. This contrasts with the situation for malignant disease, where the high prevalence of lung cancer (9.9% of the bronchial fibroscopies performed) is associated with total lack of treatment due to the absence of a thoracic surgery unit or a radiotherapy unit, and the impossibility of providing satisfactory surveillance of anti-cancer chemotherapy.     

Effect of Foot and Ankle Immobilization on Leg and Thigh Muscles' Volume and Morphology: A Case Study Using Magnetic Resonance Imaging

Our aim was to determine the time course of any changes in muscle volume and shape in the lower limbs following immobilization. A healthy young woman (29 years) had suffered a fracture of the fifth metatarsal of the right foot. MRI scanning of her right thigh and calf muscles had been performed 1 month before the injury (Pre) during a scan initially planned as a teaching tool, 2 days following a 4‐week immobilization period (Post), and after a 2‐month recovery period (Post+2). The results show muscle volume decrements in the triceps surae (TS), quadriceps (Quad), and hamstring (Ham) of 21.9%, 24.1%, and 6.5%, respectively, between the Pre and Post measurements. At Post+2, the Quad and TS muscle volumes were still 5.2% and 9.5% lower, compared with the Pre data. The Ham muscle volume, however, was 2.7% greater than at the Pre phase. Following recovery, the increase in individual TS muscles volume was limited to both proximal and medial (with respect to the knee joint) segments of the muscles. These results indicate very substantial and rapid losses in muscle volumes, both proximally and distally to the immobilization site. The results also show that recovery is far from complete up to 2 months post cast removal. The results have implications for the requirements for rehabilitation for orthopedic patients. Anat Rec, 2008. © 2008 Wiley‐Liss, Inc.     

Design of epidemiological studies measuring genital and plasma HIV-1 outcomes: lessons from a randomised controlled trial

Objective  HIV-1 genital viral loads have not been extensively used as markers of HIV transmissibility. We set out to determine whether the variability of genital HIV-1 RNA over time necessitates design adjustments in studies measuring genital shedding to account for this variability.
Methods  We used data from a completed trial of HSV suppressive therapy to estimate the correlation of plasma and genital HIV-1 RNA quantities sampled at different times. These correlation estimates were used to estimate the relative sample sizes needed to detect an impact on HIV-1 genital and plasma quantities assuming a variable number of pre- and post-randomisation repeated measurements. The treatment effect on quantities of genital and plasma HIV-1 RNA were analysed using random effects linear regression.
Results  Post-randomisation plasma HIV-1 RNA was highly correlated within-women, while genital HIV-1 RNA was less strongly correlated. Related to this, the sample size required to detect a treatment effect on genital HIV-1 RNA decreased with increasing numbers of post-randomisation measurements up to 6–7 measurements, but varied less for plasma HIV-1 RNA. In contrast, repeated pre-randomisation measurements of plasma HIV-1 RNA increased study power more than genital HIV-1 RNA because of the high correlation of plasma HIV-1 RNA measurements between the pre- and post-randomisation samples. Re-analysis of the trial data illustrated the increased precision of the treatment effect on genital HIV-1 with increasing post-randomisation measurements.
Conclusions  Designs allowing for repeated post-randomisation measures should be used to increase the precision in estimates of genital HIV-1 RNA. Repeated post-randomisation measurements of plasma HIV-1 RNA are of limited benefit.