Post-marketing study of clinical experience of atorvastatin 80 mg vs 40 mg in Indian patients with acute coronary syndrome- a randomized, multi-centre study (CURE-ACS).

OBJECTIVE: To generate comparative clinical data in Indian patients with acute coronary syndrome (ACS) in terms of safety and efficacy of atorvastatin 80 mg vis-à-vis atorvastatin 40 mg MATERIALS AND METHODS: A total of 236 patients with diagnosed ACS (with TIMI Risk score > or = 3) within preceding 10 days were randomized to receive either atorvastatin 80 mg or atorvastatin 40 mg once daily for 12 weeks. Out of 236 patients, data for 173 was analyzed who had both baseline and post-baseline lipid assessment. The primary end point of the trial was percentage change in LDL-C at the end of treatment from baseline. Other end points were change in high sensitivity C reactive protein, incidence of increase in liver enzymes > or = 3 times upper limit of normal and incidence of myotoxicity (with or without elevation of creatinine phosphokinase) at the end of treatment. RESULTS: A dose-dependent response was observed with greater reduction of LDL -C in atorvastatin 80 mg (27.5% vs 19.04%) than that of atorvastatin 40 mg group. Both the treatment groups had a significant reduction (p < 0.001) in LDL-C at the end of 6 and 12 weeks in comparison to baseline. hs-CRP was also significantly reduced (p < 0.001) in both the treatment groups i.e. atorvastatin 80 mg (76.15%) and atorvastatin 40 mg (84.4%) from baseline at the end of 12 weeks. Both doses of atorvastatin were well tolerated. No patient had elevation of (> or = 3 times of upper limit of normal) liver enzymes or creatinine phosphokinase. One patient on atorvastatin 80 mg complained of myalgia. There were no dose-related differences in incidence of adverse events between two treatment groups. CONCLUSION: The CURE-ACS trial indicated that atorvastatin 80 mg was more effective than atorvastatin 40 mg in terms of reduction in LDL cholesterol and was as safe and well tolerated as 40 mg dose in Indian patients with ACS.

Anti-HMG-CoA reductase myopathy, an undesirable evolution of statin induced myopathy: a case report.

Statins are commonly used lipid lowering agents which play a pivotal role in reducing cardiovascular morbidity and mortality. Often well tolerated, these HMG-CoA reductase (HMGCR) inhibitors can sometimes cause severe muscle weakness and elevated creatinine kinase (CK) often labeled as statin intolerance or statin induced myopathy. These symptoms improve after discontinuation of the offending drug along with normalization of the enzyme levels. However, an entity called Immune Mediated Necrotizing Myopathy (IMNM), a type of autoimmune mediated myopathy, has been recognized and characterized in patients with history of statin exposure where there is persistence of proximal muscle weakness, CK elevation and myofiber necrosis can be seen on muscle biopsy even after stopping statins. With the increased use of statins, there seems to be a higher incidence of IMNM cases in recent years. Here we discuss a case of anti-HMG-CoA myopathy, one of the three recognized types of IMNM that has been more commonly associated with statin exposure and highly responsive to immunotherapy.

Percutaneous transluminal coronary angioplasty in patients over the age of 65 years.

PTCA performed in 672 patients (646 patients < 65 years and 26 patients > or = 65 years) from March 1986 to September 1990 consisting of 619 males and 53 females are being discussed for the purpose of comparison of the results between patients in the < 65 years and > or = 65 years age groups. It was found that diabetes mellitus (50 vs 24.4.%, P < 0.01), obesity (46.1 vs 26%, P < 0.05), and hyperlipidaemia (66 vs 37.1%, p < 0.01) had a higher incidence among the elderly. Of the total 1047 lesions observed, 662 lesions in the < 65 years age group and 37 lesions in the > or = 65 years age group were dilated by PTCA (1.02 lesions/patient and 1.4 lesions/patient respectively). The lesion morphology showed higher degree of irregular contour in the < 65 years age group (23.6 vs 8.1%, p < 0.05), though the number of lesions with PTCA attempted in all age groups were almost similar. Major complications included one MI (3.8%) and two deaths (7.6%) in the > or = 65 years age group. During followup (mean duration: 8.2 months > or = 65 years and 13.5 months < 65 years age group) significantly higher percentage of patients < 65 years were asymptomatic when compared to elderly (50.2 vs 15.4% p < 0.05). Angina status was same more often in the elderly (23.1 vs 2.8% p < 0.01). The cumulative rate for repeat PTCA was similar for elderly and younger patients.

An analysis of initial results of percutaneous transluminal coronary angioplasty for totally occluded coronary arteries.

A retrospective analysis of 680 Percutaneous Transluminal Coronary Angioplasties (PTCA) performed from April 1986 to October 1990 revealed that 81 patients had PTCA performed on 86 totally occluded coronary arteries (1.06 lesions/patient). Four of the 86 were acute occlusions. Angiographic success in the group as a whole was achieved in 57 (66%). Multivariate analysis identified only the target vessel as a statistically significant factor predictive of angiographic success from among a host of clinical and angiographic morphologic variables. Left anterior descending artery lesions were identified with the highest success. In addition the duration of occlusion was significantly lower for the successfully versus the unsuccessfully dilated chronic occlusions.

Phytochemical characterisation and anti-microbial activity of vitex negundu leaves.

Fresh leaves of vitex negundu were collected and macroscopic and microscopic characters were determined. Soxhlet extraction of the powdered leavers was carried out using petroleum ether (40:60) and chloroform. Idenitification of important phytoconstituents was carried out. Characterization by TLC showed the presence of vitexin. The processed leaf extract was tested for antimicrobial activity. The results indicated antibacterial activity of the extract.