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Table 6 Estimated incidence rates and relative risks for moderate or greater MR. The number of expected cases were based on estimated incidence rates utilizing the pooled control (unexposed) groups of these studies. Relative risks and z statistics were calculated within each study. No cases of MR were observed in unexposed groups of the Khan and Hensrud studies making relative risks inestimable. These studies did contribute to the summary estimates.

From: Risk of valvular heart disease associated with use of fenfluramine

Author, year Duration (months) "Incident" MR cases Expected cases p-value by Poisson Relative Risk (RR) Lower 95% CI of RR Upper 95% CI of RR z p-value
Khan, 1998 20.6 2.00 0.873 0.059 - - - 2.7 0.0033
Weissman, 1998 2.4 3.87 0.289 0.00023 14.9 5.2 42.5 5.0 <0.00001
Shively, 1999 6.9 1.82 0.279 0.032 29.7 6.2 142.8 4.2 0.000012
Hensrud, 1999 9.6 0.00 0.033 0.97 - - - - -
Ryan, 1999 16.7 1.00 0.241 0.025 - - - - -
Gardin, 2000 11.9 8.69 0.950 <0.00001 5.0 2.4 10.4 4.3 <0.00001
  6 8.06 0.500 <0.00001 10.5 5.3 20.5 6.8 <0.00001
Jollis, 2000 2 0.00 0.009 0.99 0.0 0.0 - -0.1 0.54
  4.5 2.31 0.253 0.0022 9.5 3.0 30.5 3.8 0.000079
  9 5.83 0.666 0.000069 9.1 3.9 21.1 5.1 <0.00001
  18 3.28 1.018 0.020 3.3 1.0 10.8 2.0 0.022
  30 0.71 0.463 0.37 1.6 0.1 17.3 0.4 0.35
Davidoff, 2001 2.5 0.96 0.120 0.11 3.6 0.5 25.3 1.3 0.096
Summary, 2002 8.89 38.5 5.7 <0.00001 5.9 4.0 8.6 9.1 <0.00001