Meta-analyses of the RCTs confirm the findings, estimating odds ratio (OR) values for these adverse effects at around 1.50. Randomized controlled trials (RCTs) conducted in men with BPH show that these drugs impair libido and cause erectile dysfunction. When controlling the confounding effect due to strata formed by centers (or trials) on patients response in a multicenter study (or a meta-analysis), we commonly employ stratified analysis and obtain a summary estimate of the treatment effect.Finasteride and dutasteride are 5α-reductase inhibitor drugs that are used to treat benign prostatic hyperplasia (BPH). The odds ratio (OR) has been recommended to measure the relative treatment effect in therapeutic equivalence or meta-analysis.
Odds are not as easily understood as risks are. In contrast, an OR of 1.50 means that the odds with drug are 50% higher than the odds with placebo understanding this requires a knowledge of what the odds with placebo are as well as an understanding of what odds mean. Had the RR been 1.50, the reader would conclude that the risk with drug is 50% higher than the risk with placebo this is easily understood because the risk with placebo would be available from the RCTs.
Healed or not healed) can by represented by arranging the observed counts into fourfold (2 by 2) tables. Case-control studies of dichotomous outcomes (e.g. Other issues related to risk, odds, RR, and OR are also discussed.AnalysisMeta-analysisOdds Ratio. Smallness of risk, in this context, has been conservatively stated as 10%, but it could be possible to use a higher cutoff, such as 20%. The difference between the OR and the RR becomes increasingly large when the risks are dissimilar in the two groups and when the risk in the group of interest is not small. The difference between the OR and the RR is numerically small when the risks are similar in the two groups and also when the risks are dissimilar but the risk is small in the group of interest.
As seen the relative weighting of studies in the two models are quite. The image below shows the result for meta-analysis of the odds ratio data, for both random and fixed effects model. Results can be obtained by clicking on Run Analysis. By Yashika Kapoor and Priya Chetty on December 25, 2017. Into age bands.Summary results and analysis for odds ratio.
There is therefore a need to better understand the sexual AEs of 5ARIs in men with BPH.Sexual Adverse Effects of Finasteride and Dutasteride in Benign Prostatic HyperplasiaCorona et al 2 described a systematic review and meta-analysis of the sexual AEs of finasteride and dutasteride specifically in men with BPH. Importantly, the risks of these sexual AEs were not significantly impacted in men with AGA a possible explanation is that lower doses of 5ARIs are used in AGA. In a systematic review and meta-analysis of 17 randomized controlled trials (RCTs pooled N = 17,494) o f t he sexual adverse effects (AEs) o f t hese two 5ARIs, Liu et al 1 found that the drugs were associated with a 69% increase in the risk of impaired libido and a 55% increase in the risk of erectile dysfunction in men with BPH both findings were statistically significant. Of meta-analysis of odds ratios and relative risks, for example.© Copyright 2018 Physicians Postgraduate Press, Inc.T he 5α -reductase inhibitor (5ARI) drugs finasteride and dutasteride are used to treat benign prostatic hyperplasia (BPH) and androgenetic alopecia (AGA). 2018 79(6):18f12641.Decisions to combine studies should be based on thorough investigation of variability.
Finasteride was, by way of example, associated with increased odds of erectile dysfunction the odds ratio (OR) was 1.45 ( Table 1). 3 Most important of all, these numbers could easily be communicated to patients, and patients would easily understand the risks involved with treatment.Next, consider the relative increase in risk. These numbers could also have been used to calculate numbers needed to harm statistics. For example, was the risk of erectile dysfunction 4% in the placebo group and was it elevated to 6% with finasteride? Or was it 30% in the placebo group and was it elevated to 50% with finasteride? These numbers would have been available in the RCTs on which the meta-analysis was based, and these numbers would have provided us with an immediate understanding of the absolute magnitude of the problem when 5ARIs are prescribed to men with BPH.
Because odds and ORs are not easy to intuitively understand, the authors of the meta-analysis 2 should have presented RRs instead of ORs. 4 Such an interpretation would also have been easy to explain to patients. Such an interpretation would be correct had the statistic been the relative risk (RR) instead of the OR. It does not tell us how much more common in a way that we could understand and explain to patients.Note that an OR of 1.45 does not mean that finasteride is associated with a risk that is 45% higher than that in the comparison (placebo) group. So, knowing that the OR was 1.45 just tells us that erectile dysfunction was more common with finasteride. However, we don’ t know what the odds of erectile dysfunction with placebo were, and odds are anyway a little difficult to understand, as will be explained below.
Most of the data suggest that the absolute risks for drug vs placebo are single-digit numbers, with a few studies suggesting absolute risks that are in the 10%-20% range. However, this meta-analysis also did not present the absolute risks.What the absolute risks for each drug are depend on the RCT, the year of follow-up after treatment initiation, the method of ascertainment of the sexual adverse effects, and other matters. 6, 7So what are the relative and absolute risks of sexual AEs with finasteride and dutasteride? The meta-analysis of Liu et al, 1 referred to in the introduction to this article, indicated that these drugs are associated with a 69% increase in the risk of impaired libido (RR, 1.69 95% CI, 1.03-2.79) and a 55% increase in the risk of erectile dysfunction (RR, 1.55 95% CI, 1.14-2.12) in men with BPH. 5 Authors of meta-analyses in other contexts have also done likewise.
Similarly, the risk that a rolled die will display the number 4 is 1/6 because there is only one 4 on a die and there are 6 numbers that the die may display.The odds of an event is the ratio of the number of favorable events to the number of unfavorable events. This is because the number of favorable events (heads) is 1 and because the total number of possible events (heads and tails) is 2. For example, the risk of a tossed coin falling heads is 1/2 or 0.5. Or, it may be stated as the number of times something happened divided by the number of times it could have happened. It is calculated as the number of favorable events divided by the total number of possible events.
The odds of that AE are 1:99, which is like saying 1/99 or 0.01. The risk of that AE is 1 in 100 or 1/100 or 0.01. However, when an event is common, the risk and the odds of that event can be widely dissimilar, as evident from the examples below.Consider an AE that occurs in 1% of patients. When an event is rare, the risk and the odds of that event are similar. Or, the odds that a rolled die will display the number 4 is 1:5 or 1/5 because there is one favorable event (the number 4) and 5 unfavorable events (the numbers 1, 2, 3, 5, and 6).Risk and Odds: When They Are Similar and When They Are NotNow here is something important. Thus, the odds of a tossed coin falling heads is 1:1 because there is 1 favorable event (heads) and 1 unfavorable event (tails).
There is a huge difference between 0.9 and 9.0. The risk of the event is 90/100 or 0.9 whereas the odds are 90:10 or 9.0. There is a very big difference between 0.5 and 1.0.And consider an AE that occurs in 90% of patients. The odds of that AE are 50:50, which is like saying 50/50 or 1.0. The risk of that AE is 50 in 100 or 50/100 or 0.5.
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