59 research outputs found
Statins: Cost analysis in Indian scenario from eight major clinical trials
Background and Aims: Coronary heart disease (CHD) is the leading cause
of death in India resulting in loss of young Indians. Statins have
proved to reduce the CHD mortality in various clinical trials. The aim
of the study is to find the cost-effectiveness ratio (CER) for each
major coronary event averted and a coronary death avoided by use of
statins in different clinical settings based on the data from the major
clinical trials on statins. Materials and Methods: Using electronic
database and as per our inclusion and exclusion criteria we selected
the West of Scotland Coronary Prevention Study (WOSCOPS), the Air Force
Coronary Atherosclerosis Prevention Study (AFCAPS) and the
Anglo-Scandinavian Cardiac Outcomes Trial--Lipid Lowering Arm
(ASCOT-LLA) study for primary prevention; the Cholesterol and Recurrent
Events Trial (CARE), the Long-term Intervention with Pravastatin in
Ischemic Disease (LIPID) Study and the Scandinavian Simvastatin
Survival Study (4S) for secondary prevention and two studies, the Heart
Protection Study (HPS) and the Pravastatin in elderly individuals at
risk of vascular disease (PROSPER) study for high-risk patients. The
results of these studies were used for cost-effectiveness analysis of
statins in different patient groups. Statistical Analysis: Absolute
risk reduction, Number Needed to Benefit (NNTB), NNTB/year for total
sample and in subgroups of males, females and age >65 was derived.
CER for branded and generic versions was calculated by using the prices
of statins listed in Indian Drug Review Triple i. Results:
Cost-effectiveness ratio (CER) in primary prevention studies i.e., the
WOSCOPS, the AFCAPS and the ASCOT-LLA was Rs. 25.8 lacs, Rs. 23.8 lacs
and Rs. 7.9 lacs per major coronary event averted respectively. CER in
secondary prevention studies i.e., the CARE and the LIPID was
approximately Rs. 20 lacs per major coronary event averted while it was
Rs. 52.4 lacs and Rs. 37 lacs per coronary heart disease (CHD) death
avoided. CER from the 4S was Rs. 6.9 lacs per major coronary event and
Rs. 16.9 lacs per CHD death averted. CER in the HPS and the PROSPER
study was Rs. 17.9 lacs and Rs. 27.1 lacs per major coronary event
avoided in high-risk patients. Conclusion: Cost associated with the use
of statins is higher in primary prevention as compared to secondary
prevention. More studies are needed to confirm the cost-effectiveness
of statins to make any decision for health policy
Statins: Cost analysis in Indian scenario from eight major clinical trials
Background and Aims: Coronary heart disease (CHD) is the leading cause of death in India resulting in loss of young Indians. Statins have proved to reduce the CHD mortality in various clinical trials. The aim of the study is to find the cost-effectiveness ratio (CER) for each major coronary event averted and a coronary death avoided by use of statins in different clinical settings based on the data from the major clinical trials on statins. Materials and Methods: Using electronic database and as per our inclusion and exclusion criteria we selected the West of Scotland Coronary Prevention Study (WOSCOPS), the Air Force Coronary Atherosclerosis Prevention Study (AFCAPS) and the Anglo-Scandinavian Cardiac Outcomes Trial--Lipid Lowering Arm (ASCOT-LLA) study for primary prevention; the Cholesterol and Recurrent Events Trial (CARE), the Long-term Intervention with Pravastatin in Ischemic Disease (LIPID) Study and the Scandinavian Simvastatin Survival Study (4S) for secondary prevention and two studies, the Heart Protection Study (HPS) and the Pravastatin in elderly individuals at risk of vascular disease (PROSPER) study for high-risk patients. The results of these studies were used for cost-effectiveness analysis of statins in different patient groups. Statistical Analysis: Absolute risk reduction, Number Needed to Benefit (NNTB), NNTB/year for total sample and in subgroups of males, females and age >65 was derived. CER for branded and generic versions was calculated by using the prices of statins listed in Indian Drug Review Triple i. Results: Cost-effectiveness ratio (CER) in primary prevention studies i.e., the WOSCOPS, the AFCAPS and the ASCOT-LLA was Rs. 25.8 lacs, Rs. 23.8 lacs and Rs. 7.9 lacs per major coronary event averted respectively. CER in secondary prevention studies i.e., the CARE and the LIPID was approximately Rs. 20 lacs per major coronary event averted while it was Rs. 52.4 lacs and Rs. 37 lacs per coronary heart disease (CHD) death avoided. CER from the 4S was Rs. 6.9 lacs per major coronary event and Rs. 16.9 lacs per CHD death averted. CER in the HPS and the PROSPER study was Rs. 17.9 lacs and Rs. 27.1 lacs per major coronary event avoided in high-risk patients. Conclusion: Cost associated with the use of statins is higher in primary prevention as compared to secondary prevention. More studies are needed to confirm the cost-effectiveness of statins to make any decision for health policy
Ethics in Clinical Research: The Indian Perspective
Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. Ethical guidelines for clinical research were formulated only after discovery of inhumane behaviour with participants during research experiments. The Nuremberg Code was the first international code laying ethical principles for clinical research. With increasing research all over, World Health Organization formulated guidelines in the form of Declaration of Helsinki in 1964. The US laid down its guidelines for ethical principles in the Belmont Report after discovery of the Tuskegee's Syphilis study. The Indian Council of Medical Research has laid down the ‘Ethical Guidelines for Biomedical Research on Human Subjects’ in the year 2000 which were revised in 2006. It gives twelve general principles to be followed by all biomedical researchers working in the country. The Ethics Committee stands as the bridge between the researcher and the ethical guidelines of the country. The basic responsibility of the Ethics Committee is to ensure an independent, competent and timely review of all ethical aspects of the project proposals received in order to safeguard the dignity, rights, safety and well-being of all actual or potential research participants. A well-documented informed consent process is the hallmark of any ethical research work. Informed consent respects individual's autonomy, to participate or not to participate in research. Concepts of vulnerable populations, therapeutic misconception and post trial access hold special importance in ethical conduct of research, especially in developing countries like India, where most of the research participants are uneducated and economically backward
Ramosetron hydrochloride for the prevention of cancer chemotherapy induced nausea and vomiting: The Indian experience
Background: Despite the advent of 5-HT 3 antagonists, control of delayed gastrointestinal adverse events with cancer chemotherapy is still not optimal. This open label, active controlled, multicentric clinical trial was undertaken to assess the comparative efficacy and safety of ramosetron with ondansetron for the prevention of acute and delayed nausea and vomiting associated with emetogenic cancer chemotherapy in adult patients in India. Materials and Methods: Enrolled patients received treatment with ramosetron hydrochloride 0.1 mg or ondansetron hydrochloride 4 mg tablets once daily in the morning for 5 days starting 1 h before the start of chemotherapy. Severity grades of nausea and vomiting were recorded on a daily basis for a period of 5 days and complete response rate (CRR) and effective rate (ER) were calculated. Clinical adverse events were recorded and hematological and biochemical investigations were performed for safety assessment. Results: A total of 114 patients in ramosetron group and 100 patients in ondansetron group completed the study and were eligible for efficacy and safety analysis. CRR and ERs show that while ramosetron is non-inferior to ondansetron in the control of early nausea and vomiting (occurring during the first 24 h) after the treatment with emetogenic chemotherapy, it is superior to ondansetron in the control of delayed nausea and vomiting (occurring after the first 24 h). The proportion of patients achieving a cumulative complete response (for the entire study period) is significantly greater in ramosetron group as compared to ondansetron group (27.2% vs. 7.0%; P < 0.001). Ramosetron was well tolerated by all the study participants. Conclusions: Ramosetron is significantly more effective than ondansetron for the control of delayed nausea and vomiting induced by emetogenic cancer chemotherapy
Immunogenicity and safety of the first indigenously developed Indian tetravalent influenza vaccine (split virion) in healthy children (6 months to 17 years of age): a randomized, multicenter, phase III clinical trial
This phase III clinical trial was conducted to evaluate the immunogenicity and safety of the Tetravalent Influenza Vaccine (Split virion) I.P. (TetIV), containing two strains each of influenza A and B, developed indigenously in the country for the first time by M/s Cadila Healthcare Limited, India for use in the pediatric population (6 months −17 years of age), and compare it to that of a licensed seasonal Trivalent Influenza Vaccine (TriIV) of Sanofi Pasteur India Private Limited, containing two influenza A and one influenza B strains. Three hundred six subjects of either sex, 6 months to 17 years of age, were randomized in a 1:1 ratio to receive either TetIV or TriIV. Immunogenicity assessments (antibodies against A/H1N1, A/H3N2, B/Phuket, and B/Brisbane) were performed using the hemagglutination inhibition assay at baseline and 28 days after the last vaccination. TetIV was found to fulfill the criteria set by the United States Food and Drug Administration on the requirements of clinical data for licensure of seasonal inactivated influenza vaccines for the pediatric population. The seroconversion rates with TetIV were 94.6% for A/H1N1, 93.9% for A/H3N2, 91.2% for B/Brisbane, and 87.2% for B/Phuket strains. TetIV showed non-inferiority and superiority in immune response, as compared to TriIV, against the shared strains and an additional B strain, respectively. Both the vaccines were tolerated well by all the study participants, and an addition of the fourth strain in TetIV did not compromise the safety as compared to that of TriIV. The most common adverse event reported in both groups was fever
Drug-induced Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and SJS-TEN overlap: A multicentric retrospective study
Background : Stevens-Johnson syndrome (SJS) and toxic epidermal
necrolysis (TEN) are rare immune-mediated severe cutaneous adverse
reactions with incidence rate of 0.05 to 2 persons per million
populations per year. Drugs are the most commonly implicated in 95% of
cases. Aims : To audit the causative drugs, clinical outcome, and cost
of management in SJS, TEN, and SJS-TEN overlap. Setting and Design:
Tertiary care hospitals-based multicentric retrospective study (case
series). Materials and Methods : Indoor case papers of SJS, TEN, and
SJS-TEN overlap admitted between January 2006 and December 2009 in four
tertiary care hospitals of Gujarat were scrutinized. Data were
collected for demographic information, causative drugs, investigations,
treatment given, duration of hospital stay, time interval between onset
of symptoms and drug intake, clinical outcome, and complications. Data
were analyzed to find out proportion of individual drugs responsible,
major complications, and clinical outcome in SJS, TEN, and SJS-TEN
overlap. Total cost of management was calculated by using cost of
drugs, investigations, and consumables used during entire hospital
stay. Statistical Analysis : One-way Analysis of Variance followed by
Tukey-Kramer multiple comparison test was used for comparison of
incubation period, duration of hospital stay, and cost of management.
Results : Antimicrobials (50%), nonsteroidal anti-inflammatory drugs
(22.41%), and antiseizure drugs (18.96%) were the most commonly
associated groups. Nevirapine (28.12%) was the most common drug.
Antiseizure drugs were more often associated with serious form of
adverse reaction (TEN: 81.8%) than other drugs. Duration of hospital
stay (20.6 vs 9.7 days) and cost of management (Rs 7 910/- vs Rs 2
460/-) were significantly higher in TEN than SJS (P=0.020 and
P<0.001, respectively). Time duration between drug intake and onset
of symptoms (17.7 vs 27.5 days) was nonsignificantly lower in TEN as
compared with SJS. Secondary infection (28.12%) was the most common
complication noted. Mortality rate was 15.6% among all cases; 9% in SJS
and 26.7% in TEN. Conclusion : Antimicrobial drugs are the most
commonly implicated drugs and cost of managing these adverse drug
reactions is higher than other serious ADRs
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