Sunil, N (2009) Efficacy and tolerability of Atorvastatin as an add on therapy in the treatment of chronic stable (moderate-severe) asthma. Masters thesis, Madras Medical College, Chennai.
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Abstract
INTRODUCTION: Asthma is a problem worldwide with an estimated 300 million affected individuals. The prevalence of asthma ranges from 1% to 18% of population in different countries. The World Health Organization has estimated that 15 million disability adjusted life years (DALYs) are cost annually due to asthma, representing 1% of total global disease burden. The annual worldwide deaths from asthma have been estimated at 250,000. Asthma is associated with inflammation of the airway wall. Increased number of various types of inflammatory cells, most notably eosinophils but also basophils, mast cells, macrophages, and certain types of lymphocytes, can be found in airway wall biopsies and bronchoalveolar lavage fluid from asthmatic patients. How bronchial inflammation contributes to asthmatic condition remains poorly understood. Although there are subtypes of asthma (allergic versus non allergic) there are features of airway inflammation common to all asthmatic airways. The lymphocytes that participate in asthma pathology are biased toward the T-helper type 2 (Th2) phenotype, leading to an increase in production of interleukin 4 (IL-4), IL-5, and IL-13. The IL-4 from Th 2 cells (and basophils) provides help for IgE synthesis in B cells. The IL5 provides support for eosinophil survival. The chronic inflammatory response, over time, leads to epithelial shedding and reorganization, mucous hypersecretion, and airway wall remodeling most often exemplified by subepithelial fibrosis and smooth muscle hyperplasia. OBJECTIVES: 1. To evaluate the efficacy of Atorvastatin as an adjuvant in the treatment of chronic moderate-severe,stable asthma. 2. To asses the tolerability of Atorvastatin in asthma patients. METHODOLOGY: STUDY DESIGN: Open label, randomized, comparative, parallel group prospective study. STUDY CENTRE: Department of Chest Medicine, Govt. General Hospital (GGH), Chennai. STUDY PERIOD: Sep 2007 to Mar 2008. STUDY DURATION: 8 weeks for each patient. STUDY POPULATION: Patients attending Chest Medicine Out Patient Department, GGH, Chennai with chronic stable asthma (moderate-severe). STUDY SAMPLE: 90 patients with 30 patients in each group. Group A : Standard therapy (Salbutamol 4 mg BD + Deriphylline 100mg TID), Group B : Standard therapy +Atorvastatin 10 mg, Group C : Standard therapy +Atorvastatin 20 mg. INCLUSION CRITERIA: 1. Age 18 – 55 years. 2. Both genders. 3. Chronic moderate-severe asthma patients - Symptoms of asthma (breathlessness, cough, wheezing chest tightness)for more than one year. - Daily symptoms, daily use of bronchodialators, and or steroids with night or early morning symptoms more than once a week. 4. Patients willing to give informed consent. EXCLUSION CRITERIA: 1. Asthma exacerbations within 3 months necessitating increase in asthma medications. 2. Other respiratory infections, inflammatory disease, autoimmune disease. 3. Abnormal CPK, liver transaminases and renal diseases. 4. Patient already on statin therapy. 5. Unstable asthma. 6. Previous statin sensitivity,myopathy or myositis. 7. Diabetes mellitus. 8. H/o chronic systemic illness. 9. H/o coronary heart disease, hyperlipidemia, other conditions requiring statins. 10. Those taking drugs known to cause interactions with Statins, like: macrolide, antibiotics, azoleantifungals, digoxin, protease inhibitors etc. 11. Pregnant and lactating women. RESULTS: This study was taken up to assess the efficacy and tolerability of atorvastatin in increasing doses as an add on therapy to standard therapy in reducing the frequency and exacerbations of symptoms of chronic stable asthma thereby decreasing the morbidity. Out of 206 patients screened, 66 patients had hypercholesterolemia, 30 were smokers or exsmokers, 10 were diabetic,6 had exacerbations within 3 months needing hospitalization, 2 had elevated liver enzymes,1 had elevated serum creatinine. and 1 was a lactating woman. These patients were excluded from the study. 90 patients, who fulfilled the inclusion criteria, were recruited for the study. They were randomly allocated into 3 groups (group A, B, C), each containing 30 patients by simple randomization method. Group A received standard treatment with salbutamol 4 mg twice and deriphylline200 mg thrice daily. Group B, C received in addition atorvastatin 10, 20 mg daily respectively. Each patient was under treatment for 8 weeks. Clinical, laboratory parameters including spirometry and asthma control score (subjective score) were done at baseline, 4 and 8 weeks. All the 90 patients completed the study. CONCLUSION: Based on the outcome of our study, we conclude that, 1. Atorvastatin, as an adjuvant is beneficial in the treatment of chronic stable asthma (moderate-severe). 2. Higher doses of Atorvastatin 20mg compared to 10mg once daily, as an add on therapy is more efficacious in the treatment of asthma. 3. Atorvastatin in 10mg and 20mg is found to be safe in chronic stable asthmatics.
| Item Type: | Thesis (Masters) |
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| Uncontrolled Keywords: | Efficacy, tolerability, Atorvastatin, add on therapy, chronic stable (moderate-severe) asthma. |
| Subjects: | MEDICAL > Pharmacology |
| Depositing User: | Subramani R |
| Date Deposited: | 31 Jul 2020 17:59 |
| Last Modified: | 01 Aug 2020 08:07 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/12688 |
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