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Module 3- Case Phase II Trials

Abstract

The hypertension detection and follow up program (HDFP) was a clinical trial in 14 centers which sought to investigate the results of treating systemic hypertension for in a period of five years. In this study, out of 178,009 who were first selected for screening, 10,940 were arbitrarily divided into two groups. The stepped care group (SC) was given antihypertensive therapy in special centers which followed an increased stepwise drug approach. This was done to achieve and maintain a lowered blood pressure to or below the set standard.

The second group, the referred care (RC) group was given treatment in their usual care centers. The findings indicated a better blood pressure control among the SC group than the RVC group, with the death arising from the same being reduced to 17% for the whole SC group and 20% amongst those suffering from mild hypertension. This paper attempts to explain the reasons behind using the clinical trials as opposed to placebo controlled group in the clinical trials. At the same time, the paper examines the reasons the trials screened many people and if the affected the findings of the study.

Introduction

            The hypertension detection and follow-up program (HDFP) information is indicated by diastolic blood

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pressure (DBP) stratum with regards to four race-sex subgroups. With regards to stratum I was made up of black male, black female, white male, as well as white (American Society of Hypertension, 1992). Those who participated in the stepped care (SC) showed a reduced mortality rate as opposed to referred care (RC). HDFP was developed ton investigate the variations in total 5 year mortality between SC and RC (Journal of Community Health, 2005).

Control Group
In this study, the researcher decided to make use of the RC as the control group as opposed to the placebo controlled group. In this regard, the analysis of the SC and RC subgroups could be subject to a big variation thereby calling for the need for the exercise of caution in the interpretation of results (American Society of Hypertension, 1992).  The value of thorough treatment of mild hypertension in not only males and females but also blacks and whites as well as the value of treating all strata of blood pressure among the blacks is proved in this analysis (Journal of Community Health, 2005).

            The researcher chose RC group in a bid to address the issue of efficiency of the systematic antihypertensive therapy (SC) in lowering the mortality in all adults suffering from hypertension which was to be compared to the RC method (Journal of Community Health, 2005). The researcher reason the researcher of this clinical trial used the referred group chose the RC group was to investigate how effective antihypertensive therapy had on particular subgroups of people for which the significance of such therapy had not yet been proved. Such groups of people included women and blacks (American Society of Hypertension, 1992).

Findings as Mortality Report as Opposed to Ischemic Heart Disease Events
At the same time, the researchers investigating this clinical trial report reported the findings as mortality from any cause. This the researchers did contrary to reporting the same as ischemic heart events of heart diseases like death resulting from cardiovascular causes and non fatal strokes among others. Usually a combination of fixed dosage has always been kept for patients who are unresponsive to monotherapy. These combinations always contain the complete conventional doses of all the drugs. What this means is that combinations of fixed dosage as the initial therapy have long been discouraged (Kronig et al, 1997). The reasons usually given include the capability of titrating individual components, difficulty in differentiating individual toxicities alongside with unnecessary exposure of patients with regards to superfluous therapy (American Society of Hypertension, 1992).

Screening
With regards to patient selection, the researchers in this clinical trial screened many people. In this regard, all those who participated had mild to regulate essential hypertension (American Society of Hypertension, 1992). To qualify to enter into the double-blind stage of the trial, the researchers in this case required the participants to posses a DBP of between 100-114mm Hg having relaxed in a sitting posture for a minimum of 10 minutes. The sitting BP value was established as the median of a minimum of five valid sequential measurements with a semi automated cuff-oscillometric sphygmomanometer (Kronig et al, 1997). Therefore the essence of screening many people was to obtain objective results. The screening of many people definitely affected the results of the study owing to the fact that it directly affected the accuracy of the results. The bigger the sample size the lower the margin of error thus the higher the reliability of the presented findings.

Conclusion
In the final analysis, inhibition of ACE with trandolaprin reduced the incidence of ECG-LVG in patients suffering from arterial hypertension as well as type 2 diabetes in a significant way (Crout, 1974, pp. 249-254). This was more than non-ACE inhibitor therapy. The protective result of trandolapril as opposed to ECG-LVH was prior evident at one year after random assignment and progressively increased upon follow up (Kronig et al, 1997). The reduction in the incidence of ECG-LVG with trandolapril was not given an explanation by the small variation in blood pressure control between the two trial groups owing to the fact that risk reduction had significant effects. In the final analysis, the researcher employed many people in the screening process with the sole intention of increasing the reliability of the findings. This has the implication the size of the people who were screened greatly influenced the findings.

References
American Society of Hypertension. (1992). Recommendations for routine blood

pressure measurement by indirect cuff sphygmomanometer.  Am J Hypertens.

Crout, J. R. (1974). Fixed combination prescription drugs. J Clin Pharmacol, (14):

249-254

Journal of Community Health. (2005). Hypertension detection and Follow-up

Program Cooperative Group. Springer Netherlands. DOI 10.1007/BF01338731

Kronig, B., Pittrow, D. B., Kirch, W., Weidinger, G. (1997). Different Concepts in

Firsts- Line Treatment of Essential Hypertension: Comparison of a Low-Dose Reserpine- Thiazide Combination With Nitrendipine Monotherapy. American heart Association Inc.

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