TABLE 1.

WHI RCT and GPRD STUDIES IN WOMEN WITH AN INTACT UTERUS TREATED WITH COMBINED HORMONE RECPLACEMENT THERAPY

	WHI RCTa (50 – 79 yrs)			WHI RCTb (50 – 70 yrs)			WHI RCTb (50 – 59 yrs)
	Treatede	Placeboe	HR (95% CI)f	Treatede	Placeboe	HR (95% CI)f	Treatede	Placeboe	HR (95% CI)f
	Estrogen & Progestin			Estrogen & Progestin			Estrogen & Progestin
(n)	8506	8102		6692	6340		2839	2683
CHDj	164	122	1.32 [1.02–1.74]	116	99	1.11 [0.84–1.47]	38	27	1.29 [0.79–2.12]
CVAk	127	85	1.41 [1.07–1.85]	98	64	1.45 [1.05–2.02]	26	16	1.41 [0.75–2.65]
DEATH	231	218	0.98 [0.82–1.18]	146	141	0.98 [0.77–1.25]	35	47	0.69 [0.44–1.07]
				GPRD STUDYc (55 – 79 yrs)			GPRD STUDYd (50 – 55 yrs)
				Expg	UnExph	Adj HR (95% CI)i	Expg	UnExph	Adj HR (95% CI)i
				Estrogen & Progestin			Estrogen & Progestin
(n)				13,658	37,730		20,654	30,102
MI				141	491	0.95 [0.78–1.16]L	96	150	0.91 [0.69–1.20]n
CVA				138	405	1.23 [0.99–1.52]m	101	109	1.52 [1.11–2.08]o
DEATH				317	1378	0.75 [0.65–0.86]	231	429	0.76 [0.65–0.91]

^aReference (5), 21.5% of subjects > age 70 vs. 2.5% in GPRD study.

^bReference (8)

^cReference (10)

^dReference (11)

^eNumber of events

^fHazard ratio (95% confidence interval)

^gExposed, number of events

^hUnexposed, number of events

ⁱCox adjusted hazard ratio (95% confidence interval)

^jCoronary Heart Disease (CHD) a combination of myocardial infarction and coronary death was the primary outcome in the WHI RCT; however the results for myocardial infarction alone were similar. Results in the GPRD studies are all acute myocardial infarctions (MI).

^kCerebrovascular accident

^lAdjusted hazard ratio using Prior event rate ratio (PERR) = 1.40 (0.87 – 2.44)

^mAdjusted hazard ratio using PERR = 2.63 (1.38 – 7.43)

ⁿAdjusted hazard ratio using PERR = 0.77 (0.41–1.42)

^oAdjusted hazard ratio using PERR = 2.20 (1.12–5.45)