Course Work On Drug Safety

Published: 2021-06-22 00:42:36
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Category: Education, Nursing, Diabetes, Study

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There has been an increased incidence of patients treated with congestive heart failure. The debate concerning the cardiovascular safety was started in 2007 when an analysis concerning risks associated with myocardial infarction was done. This debate has been going on since then, and recently the report from the US Senate Committee on Finance has provided more details about the analysis (Nissen, & Wolski 2010). Rosiglitazone is manufactured by the US pharmaceutical Company GlaxoSmithKline (GSK). This is a drug works as insulin through binding the peroxisome proliferator-activated receptors (PPAR) in fat cells thus making them respond more to insulin. Rosiglitazone is associated with heart failure through retention of excess fluids making the heart unable to pump more blood. A lot of research has been done on the dangers on cardiovascular risks associated with rosiglitazone, and below is a discussion of some of the data collected from these reports.

Rosiglitazone are used for lowering the blood glucose levels in people suffering from type 2 diabetes mellitus. The medication was approved on its ability to reduce blood glucose, but the studies did not discuss the effect of the drug on micro vascular or macro vascular problems of diabetes. The researches carried out on this topic are presented to Food and Drug Administration (FDA) and EMA, who have developed a different respond on this topic. The US Government has put a long a program that limits the use of rosiglitazone, through informing people on the risks associated with it. Since research has shown many people are already using the drug, people with uncontrolled blood sugar have no other option that using this drug. In addition, this program ensures patients who use rosiglitazone have an understanding of the benefits and risks associated with it (MedlinePlus, 2012).

Data on various studies on Rosiglitazone

The New England Journal of Medicine Research

A research was conducted in England that took more than 24 weeks using randomizes control group. The target group composed people who never used rosiglitazone, and the available data from deaths caused by myocardial infarction and cardiovascular causes. 116 trials were done and only 42 gave positive results. From the data collected rasiglitazone was found to have a significance cause on myocardial infarction leading to increased deaths from cardiovascular causes. The study lacked access to the original data making it unable to raise full analysis of the case. The researcher urged on the need for patients with type 2 diabetes and information sources to understand the need for giving the right information regarding their experience using the drug. The treatment of type 2 diabetes mellitus is done using thiazolidinedione drugs. This class of drugs is administered using three agents, troglitazone, rosiglitazone, and pioglitazone. Troglitazone was removed from the market since it caused hepatoxoxicity, and now the most recommended drug, rosiglitazone from GSK has also proven to pose risks to people (American Diabetes Association 2007). Some of the research outcomes are revealed below.

Discussion and conclusion on the report

According to the data from FDA, the clinical tries conducted by GSK revealed that rosiglitazone has adverse effects on myocardial infarction and cardiovascular deaths. Although the test trials never indicated the adjudication of the risks associated with the drug, the collected data was more than enough to justify the cause. Lack of time-to-event data made the research make use of the summary data thus; there was no enough evidence that the studied group possessed both events. According to EMA Guidance on Assessment of Cardiovascular Risk (2010), the authorization of rosiglitazone in 2000 was aimed at helping those patients who had the history of cardiac failure. From that time the European Medicine Agency’s Committee for Medicinal Products (CHMP) gas been monitoring the drug in relation to cardiovascular effects, and other disorders associated with cardiac. CHMP has assessed a number of studies conducted in reference to this case, whereby 90 percent of them have shown the drug being risky. The latest update from CHMP was on September 2006 showing the information about the series of effects from drug use.

The study never included patients who used to take low levels of troglitazone for cardiovascular prevention since it might have contributed to the risks. Many patients suffering from type 2 diabetes mellitus receive rosiglitazone treatments and this is a clear indication that the drug leads to cardiovascular risks. Patients with high blood pressure are exposed to high risks associated with cardiovascular defects, and therefore the conclusion is limited to patients who do not suffer from such conditions. The study by England professionals did not use a pilot study since by doing so; the affected patients would have suffered and left the main study. However, using the pilot study would have assisted in determining the trial methods suitable for use on the main research. Moreover, the researches would be in a better position to carry out the study since they already have an idea of what to ask and look for. In addition, the study did not achieve all the set objectives because the some of the selected patients withdrew from the research in fear of being exposed to the public, while others lost their lives in the process (Nissen & Wolski 2007).

Research by FDA

According to research conducted by FDA, 30% to 43%v of the results indicated that the drug is associated with high risks. The data collected revealed an increased risk of ischaemic myocardial events. FDA then published their results to the public, which made GSK reduce its sales to about 25% of their annual sale levels (Home et al, 2007). From the research FDA was in hurry to approve rosiglitazone as a recommended drug, but failed to address failures the drug as on cardiovascular toxicity. On the other hand, GSK representatives criticized the effects of rosiglitazone claiming that the drug had no side effects. The company representatives intimidated the capability of this drug, though failed to disclose its effects scientifically. Moreover, the research associated the problems of using the drug to heart failure risks although, the warnings were seen by GSK Company as a way of interfering with their promotion and marketing for the drug. FDA also discovered that GSK Company had not done any trials on the effect of rosiglitazone on cardiovascular risks. Out of the trials done on cardiovascular effects, the one that was approved by FDA indicated a high risk level on using the drug (Nissen, 2010).

The study included the meta-analysis that followed a specific criterion for including all trials through a randomized group. The treatment was administered to all study groups for a period of 24 weeks of drug exposure. In order to develop a perfect meta-analysis of the case, an initial screening was undertaken on clinical trials from rosiglitazone manufacturing company GSK (Clinical Study Registry 2010). Since the government had approved the drug, the trials were assumed to be perfect, although it was discovered later that the company never produced all the clinical trials. 202 clinical trials were used for meta-analysis, but 146 trials were excluded due to the following reasons. 73 trials had a short-term phase, 25 trials had less than 24 weeks’ duration, 20 trials lacked control group, and 28 trials had an open-label. From the study 56 trials passed the set criterion and were included in the research. In these 56 trials 35,531 patients were tested whereby 19,509 were assigned to use rosiglitazone while the remaining 16,022 assigned as comparator group (Singh & Furberg 2007).

Discussion and conclusion on the FDA report

The research made use of people in the mean age group of 57 years out of which most had type 2 diabetes mellitus, but some were treated with psoriasis, Alz-heimer disease, and rheumatoid arthritis. The primary outcomes from the study indicated a death toll of 60 for patients using rosiglitazone and 71 for comparator patients. From the results, rosiglitazone seems to have less death cases than the comparator drugs. Since the study seemed biased, conducting an alternative study using smaller groups indicated that more deaths were caused by the use of rosiglitazone. The cardiovascular mortality of rosiglitazone use is a complicated issue as seen from the research since the first publications on use of the drug indicated it increases cardiovascular risks. According to the United States Staff Committee (2010), the main problem of using these studies is that no research has ever used a randomized control for the past 11 years. The above study indicated that those patients who use rosiglitazone do not expose themselves to cardiovascular risks.

Other additional studies

A research was also conducted to evaluate the cardiovascular outcomes in oral agent combination therapy for type 2 diabetes. The study was aimed at testing the cardiovascular outcomes when rosiglitazone was added to metformin or sulfonylurea, within a period of 5-7 years. 4447 patients were studied who had type 2 diabetes, with mean haemoglobin A1c of approximately 79%. The main intention of the study analysis was to treat the patients with type 2 diabetes. The findings from the research indicated that out the patients studied, 321 in rosiglitazone group, and 323 in the active control group recorded positive feedback. High death cases were discovered in patients with myocardial infections, followed by cardiovascular death, and finally stroke. In addition, 61 people in the rosiglitazone group died out of heart failure while 29 from active control group died of the same. From the data collected use of rosiglitazone as a glocuse lowering therapy to patients with type 2 diabetes increases the risks of heart failure. The data also revealed that rosiglotazone has lesser effect on the overall risks of cardiovascular morbidity as compared to other insulin.


American Diabetes Association., 2007, Complications of Diabetes in United States, Retrieved from:

Clinical Study Registry, 2010. GSK Web Site, Retrieved from;

EMA Guidance on Assessment of Cardiovascular Risk, 2010, “Regulatory Landscape for Future

Antidiabetic Drug Development (Part I)”: Journal for Clinical Studies. pp. 38-39.

Nathan, D. M., Buse, J. B., Davidson, M. B, et al. 2009, “American Diabetes Association;

European Association for Study of Diabetes”, Diabetes Care, 32(1), pp. 193-203.

Nissen, E. Steve, & Wolski, K., 2010.An Updated Meta-Analysis for Myocardial Infarction and Cardiovascular Mortality, American Medical Association. Vol. 170, No. 14, p. 1

Nissen, E. S & Wolski, K. 2007, “Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes”, the New England Journal of Medicine, 356 (24). pp. 2466-2469

Nissen, E. S. 2010, The Rise and fall of Rosiglitazone. European Heart Journal, the Cleveland Clinic Foundation, Department. Vol. 31, pp. 773-776

Singh S, Loke YK, & Furberg CD, 2007. Long-term risk of cardiovascular events with rosiglitazone: a meta-analysis. JAMA. 298(10), pp. 1189-1195.

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