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Heart failure in patients with diabetes mellitus
The American Journal of Geriatric Pharmacotherapy
Updates
percutaneous transluminal coronary angioplasty, and ischemic stroke, they were 24% and 13%. All of these reductions were statistically significant (P values not provided). Don't forget to consider both approaches to the secondary prevention of CVD. Reference Hennekens CH, Sacks FM, Tonkin A, et al. Additive benefits of pravastatin and aspirin to decrease risks of cardiovascular disease: Randomized and observational comparisons of secondary prevention trials and their meta-analyses. Arch Intern Med. 2004;164: 40-44. HEART FAILURE IN PATIENTS WITH DIABETES MELLITUS Results of a recent case-control study support the hypothesis that the thiazolidinediones (TZDs) rosiglitazone and pioglitazone may increase the risk of heart failure in patients with type 2 diabetes mellitus. In an analysis of the Pharmetrics Integrated Outcomes Database (35 health plans, 17 million lives) between January 1995 and March 2001, TZD recipients (N = 5441) were younger than control subjects (N = 28,103) (mean [SD] age, 57.2 [12.2] vs 58.8 [12.9] years, respectively; P < 0.001) but were more likely to have coronary artery disease or diabetes complications; to have received angiotensin-converfing enzyme inhibitors, beta-blockers, metformin, or insulin; to have undergone glycosylated hemoglobin testing or eye examination; and to have more comorbidities and higher management costs (all, P < 0.05). Even after controlling for these differences, TZD use remained predictive of heart failure (hazard ratio = 1.76; P < 0.001). The adjusted incidence of heart failure at 40 months was 8.2% for TZD recipients and 5.3% for control subjects. Practitioners should use caution when prescribing TZDs for patients with heart failure and be vigilant for worsening or new heart failure. Therapy should be changed if signs and symptoms consistent with heart failure emerge during TZD therapy. Reference Delea TE, Edelsberg JS, Hagiwara M, et al. Use of thiazolidinediones and risk of heart failure in people with type 2 diabetes: A retrospective cohort study. Diabetes Care. 2003;26:2983-2989. DOES LOWERING PLASMA HOMOCYSTEINE LEVELS REDUCE RATES OF CARDIOVASCULAR ADVERSE EVENTS? Among newly proposed cardiovascular risk factors is an elevated plasma total homocysteine concentration. Will
152
lowering levels of this substance with vitamin therapy reduce rates of cardiovascular adverse events? In 3680 adults with nondisabling stroke, patients were randomized to receive either a low-dose vitamin regimen (pyridoxine 200 ~g, cobalamin 6 ~g, folic acid 20 ~g) or a high-dose vitamin regimen (pyridoxine 25 mg, cobalamin 0.4 mg, folic acid 2.5 mg). The primary outcome measure was the rate of recurrent stroke, and secondary measures were rates of GriD and death. Although the mean reduction in plasma total homocysteine levels was 2 p m o l / L greater in the high- versus low-dose group, the chance of any event within 2 years was statistically equivalent in the 2 groups (18.0% and 18.6%, respectivdy). The risk of recurrent stroke within 2 years also was statistically equivalent (9.2% and 8.8%). However, there was a graded association between baseline plasma total homocysteine level and outcomes--a 3 - p m o l / L lower plasma total homocysteine level at baseline was associated with a 10% lower risk of stroke (P = 0.05), a 26% lower risk of C H D events (P < 0.001), and a 16% lower risk of death (P = 0.001) in the low-dose group, and corresponding 2%, 7%, and 7% lower risks in the high-dose group (P = NS). What does this mean? Probably that elevated plasma total homocysteine levels have different effects on cerebral and coronary arteries (the treatment effect on coronary events has been much larger to date). Certainly, longer trials are warranted in other patient populations with elevated plasma total homocysteine levels. If the effects are positive, such an inexpensive therapy for atherosclerosis would be very helpful in our elderly population. Reference Toole JF, Malinow MR, Chambless LE, et al. Lowering homocysteine in patients with ischemic stroke to prevent recurrent myocardial infarction, and death: The Vitamin Intervention for Stroke Prevention (VISP) randomized controlled trial. JAMA. 2004;291:565575. NEW DRUG Abarelix Abarelix is a new gonadotropin-releasing hormone (GnKH) antagonist approved for use in advanced prostate cancer for which there is no alternative therapy (ie, the cancer has not responded to other hormonal therapies and the patient refuses surgical castration). Due to an increased risk of serious and potentially life-threatening allergic reactions, distribution of this agent will be limited to physicians and hospital pharmacies enrolled in a risk-management program sponsored by the manufacturer. The agent is injected IM into the buttocks every 2 weeks for 2 doses and -
-
Updates
percutaneous transluminal coronary angioplasty, and ischemic stroke, they were 24% and 13%. All of these reductions were statistically significant (P values not provided). Don't forget to consider both approaches to the secondary prevention of CVD. Reference Hennekens CH, Sacks FM, Tonkin A, et al. Additive benefits of pravastatin and aspirin to decrease risks of cardiovascular disease: Randomized and observational comparisons of secondary prevention trials and their meta-analyses. Arch Intern Med. 2004;164: 40-44. HEART FAILURE IN PATIENTS WITH DIABETES MELLITUS Results of a recent case-control study support the hypothesis that the thiazolidinediones (TZDs) rosiglitazone and pioglitazone may increase the risk of heart failure in patients with type 2 diabetes mellitus. In an analysis of the Pharmetrics Integrated Outcomes Database (35 health plans, 17 million lives) between January 1995 and March 2001, TZD recipients (N = 5441) were younger than control subjects (N = 28,103) (mean [SD] age, 57.2 [12.2] vs 58.8 [12.9] years, respectively; P < 0.001) but were more likely to have coronary artery disease or diabetes complications; to have received angiotensin-converfing enzyme inhibitors, beta-blockers, metformin, or insulin; to have undergone glycosylated hemoglobin testing or eye examination; and to have more comorbidities and higher management costs (all, P < 0.05). Even after controlling for these differences, TZD use remained predictive of heart failure (hazard ratio = 1.76; P < 0.001). The adjusted incidence of heart failure at 40 months was 8.2% for TZD recipients and 5.3% for control subjects. Practitioners should use caution when prescribing TZDs for patients with heart failure and be vigilant for worsening or new heart failure. Therapy should be changed if signs and symptoms consistent with heart failure emerge during TZD therapy. Reference Delea TE, Edelsberg JS, Hagiwara M, et al. Use of thiazolidinediones and risk of heart failure in people with type 2 diabetes: A retrospective cohort study. Diabetes Care. 2003;26:2983-2989. DOES LOWERING PLASMA HOMOCYSTEINE LEVELS REDUCE RATES OF CARDIOVASCULAR ADVERSE EVENTS? Among newly proposed cardiovascular risk factors is an elevated plasma total homocysteine concentration. Will
152
lowering levels of this substance with vitamin therapy reduce rates of cardiovascular adverse events? In 3680 adults with nondisabling stroke, patients were randomized to receive either a low-dose vitamin regimen (pyridoxine 200 ~g, cobalamin 6 ~g, folic acid 20 ~g) or a high-dose vitamin regimen (pyridoxine 25 mg, cobalamin 0.4 mg, folic acid 2.5 mg). The primary outcome measure was the rate of recurrent stroke, and secondary measures were rates of GriD and death. Although the mean reduction in plasma total homocysteine levels was 2 p m o l / L greater in the high- versus low-dose group, the chance of any event within 2 years was statistically equivalent in the 2 groups (18.0% and 18.6%, respectivdy). The risk of recurrent stroke within 2 years also was statistically equivalent (9.2% and 8.8%). However, there was a graded association between baseline plasma total homocysteine level and outcomes--a 3 - p m o l / L lower plasma total homocysteine level at baseline was associated with a 10% lower risk of stroke (P = 0.05), a 26% lower risk of C H D events (P < 0.001), and a 16% lower risk of death (P = 0.001) in the low-dose group, and corresponding 2%, 7%, and 7% lower risks in the high-dose group (P = NS). What does this mean? Probably that elevated plasma total homocysteine levels have different effects on cerebral and coronary arteries (the treatment effect on coronary events has been much larger to date). Certainly, longer trials are warranted in other patient populations with elevated plasma total homocysteine levels. If the effects are positive, such an inexpensive therapy for atherosclerosis would be very helpful in our elderly population. Reference Toole JF, Malinow MR, Chambless LE, et al. Lowering homocysteine in patients with ischemic stroke to prevent recurrent myocardial infarction, and death: The Vitamin Intervention for Stroke Prevention (VISP) randomized controlled trial. JAMA. 2004;291:565575. NEW DRUG Abarelix Abarelix is a new gonadotropin-releasing hormone (GnKH) antagonist approved for use in advanced prostate cancer for which there is no alternative therapy (ie, the cancer has not responded to other hormonal therapies and the patient refuses surgical castration). Due to an increased risk of serious and potentially life-threatening allergic reactions, distribution of this agent will be limited to physicians and hospital pharmacies enrolled in a risk-management program sponsored by the manufacturer. The agent is injected IM into the buttocks every 2 weeks for 2 doses and -
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