Results showed that pravastatin consistently reduced the risk of both coronary heart disease (CHD) (27 percent) and major adverse cardiovascular events (MACE) (25 percent) among those with and without LDL-C ≥190 mg/dl (p-interaction > 0.9).

During the initial 4.9-year study, in participants with LDL-C ≥190 mg/dl, pravastatin reduced CHD risk by 27 percent and MACE by 25 percent. Over the long-term 20-year follow-up, the risk of CHD death, cardiovascular death and all-cause mortality was reduced with pravastatin by 28 percent, 25 percent (p = 0.009) and 18 percent (p = 0.004).

Observational data also found that among the individuals with LDL-C ≥190 mg/dl, reductions in LDL-C of greater than 30 percent or 39 mg/dl with pravastatin were associated with a lower risk of CHD and MACE compared with placebo.

“A major strength of the present analysis is that it explores a group of higher risk individuals (LDL-C ≥190 mg/dl) specifically highlighted in guidelines, but one in which clinical trial evidence is lacking,” the study authors write. “Thus, the present results from a randomized trial provide novel information and evidence to support guideline recommendations.”

Vallejo-Vaz AJ, Robertson M, Catapano AL, et al. Circulation 2017;Sept 6:[Epub ahead of print].

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Results showed that 2,250 of 7,020 patients had CKD at baseline, of whom 67 percent had a diagnosis of T2D for a duration more than 10 years; 58 percent were receiving insulin and 84 percent were taking angiotensin converting enzyme inhibitors or angiotensin receptor blockers.

In patients with CKD at baseline, empagliflozin reduced the risk of cardiovascular death by 29 percent compared with placebo (hazard ratio [HR], 0.71), all-cause mortality by 24 percent (HR, 0.76), hospitalization for heart failure by 39 percent (HR, 0.61) and all-cause hospitalization by 19 percent (HR, 0.81).

The risk reductions were consistent between patients with and without CKD. Effects of empagliflozin on cardiovascular death, all-cause mortality, hospitalization for heart failure and all-cause hospitalization were also consistent across categories of eGFR and of UACR at baseline and across the two doses studied. The adverse event profile of empagliflozin was similar across subgroups by renal function at baseline.

The study authors write, “Our findings add to evidence showing that empagliflozin significantly slowed the progression of kidney diseases and reduced clinically relevant renal events in the overall population of the EMPA-REGOUTCOME trial.”

Wanner C, Lachin JM, Inzucch SE, et al. Circulation 2017;Sept 13:[Epub ahead of print].

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Researchers noted declines in unmet need for those gaining insurance were significantly greater than for the continuously uninsured, while increases in unmet need for those losing insurance were significantly greater than for the continuously insured. However, having insurance did not guarantee coverage completeness or access to care. Additionally, researchers highlighted that patient cost sharing is increasing through higher deductibles, copayments and coinsurance rates, and medical financial hardship is increasingly documented in the U.S., especially in relation to prescription drug use.

“Prescription drug spending is projected to continue rising, increasing fiscal pressures on commercial, federal, state and family budgets,” write Yabroff, et al. “For individuals with high drug costs, these trends may erode some of the protective effect of insurance coverage documented in this study. It is therefore imperative that research continue to monitor the relationship between insurance coverage and unmet need, assess spending and clinical outcomes, and that survey, administrative, and clinical data be available to do so.”

Yabroff KR, Kirby J, Zodet M. JAMA Intern Med 2017;Sept 11:[Epub ahead of print].

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Among the 27,347 women in the study (mean age 63.4 years old; 80.6 percent white), 16,608 women with a uterus were randomized to receive daily oral conjugated equine estrogens (CEE) plus medroxyprogesterone acetate progestin (MPA) or placebo. Additionally, 10,739 women with hysterectomy were randomized to receive daily oral CEE alone or placebo.

During the cumulative 18-year follow-up, 7,489 deaths occurred – 1,088 during the intervention phase and 6,401 during the post-intervention phase. Mortality follow-up was available for more than 98 percent of participants.

"For women with troubling vasomotor symptoms, premature menopause, or early-onset osteoporosis, hormone therapy appears to be both safe and efficacious." — Melissa McNeil, MD, MPH

Results showed all-cause mortality was 27.1 percent in the hormone therapy group vs. 27.6 percent in the placebo group (hazard ratio [HR], 0.99) in the overall pooled cohort. For the individual trials, all-cause mortality was 26.4 percent for CEE plus MPA, compared with 26.0 percent for placebo (HR, 1.02). All-cause mortality in the CEE alone group was 28.3 percent compared with 30.0 percent for placebo (HR, 0.94).

In the overall pooled cohort, cardiovascular mortality was 8.9 percent in the hormone therapy group vs. 9.0 percent in the placebo group (HR, 1.00), with no differences between trials. Total cancer mortality was 8.3 percent for the CEE plus MPA group vs. 7.9 percent for the placebo group (HR, 1.06). Additionally, cancer mortality was 8.0 percent for the CEE group vs. 8.1 percent for the placebo group (HR, 0.99). Mortality from other causes also did not differ significantly between the hormone therapy group (10 percent) and the placebo group (10.7 percent).

When examined by 10-year age groups (50-59 years vs. 70-79 years) in the pooled cohort, the ratios of nominal HRs for all-cause mortality were 0.61 during the intervention phase and 0.87 during cumulative 18-year follow-up, without significant heterogeneity between trials. The trend by age group was significant during the intervention phase but not during the cumulative follow-up period.

In an accompanying editorial comment, Melissa McNeil, MD, MPH, notes, “This information will be helpful in counseling women considering whether to start hormone therapy and hopefully will alleviate concerns that many patients and physicians have about the initiation of hormone therapy.” She adds, “For women with troubling vasomotor symptoms, premature menopause, or early-onset osteoporosis, hormone therapy appears to be both safe and efficacious.”

Manson JE, Aragaki AK, Rossouw JE, et al. JAMA 2017;318:927-938.

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