| 1. |
- Goldstein, Larry B., et al.
(författare)
-
Relative effects of statin therapy on stroke and cardiovascular events in men and women : secondary analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) Study
- 2008
-
Ingår i: Stroke. - 0039-2499 .- 1524-4628. ; 39:9, s. 2444-8
-
Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND AND PURPOSE: In SPARCL, treatment with atorvastatin 80 mg daily reduced stroke risk in patients with recent stroke or TIA and no known coronary heart disease by 16% versus placebo over 4.9 years of follow-up. The purpose of this secondary analysis was to determine whether men and women similarly benefited from randomization to statin treatment. METHODS: The effect of sex on treatment-related reductions in stroke and other cardiovascular outcomes were analyzed with Cox regression modeling testing for sex by treatment interactions. RESULTS: Women (n=1908) constituted 40% of the SPARCL study population. At baseline, men (n=2823) were younger (62.0+/-0.21 versus 63.9+/-0.27 years), had lower systolic BPs (138.1+/-0.35 versus 139.5+/-0.47 mm Hg), higher diastolic BPs (82.2+/-0.20 versus 81.0+/-0.25 mm Hg), more frequently had a history of smoking (73% versus 38%), and had lower total cholesterol (207.0+/-0.54 versus 218.9+/-0.67 mg/dL) and LDL-C levels (132+/-0.45 versus 134+/-0.57 mg/dL) than women. Use of antithrombotics and antihypertensives were similar. After prespecified adjustment for region, entry event, time since event, and age, there were no sex by treatment interactions for the combined risk of nonfatal and fatal stroke (treatment Hazard Ratio, HR=0.84, 95% CI 0.68, 1.02 in men versus HR=0.84, 95% CI 0.63, 1.11 in women; treatment x sex interaction P=0.99), major cardiac events (HR=0.61, 95% CI 0.42, 0.87 in men versus HR=0.76, 95% CI 0.48, 1.21 in women; P=0.45), major cardiovascular events (HR=0.78, 95% CI 0.65, 0.93 in men versus HR=0.84, 95% CI 0.65, 1.07 in women; P=0.63), revascularization procedures (HR=0.50, 95% CI 0.37, 0.67 in men versus HR=0.76, 95% CI 0.46, 1.24 in women; P=0.17), or any CHD event (HR=0.54, 95% CI 0.41, 0.72 in men versus 0.67 95% CI 0.46, 0.98 in women; P=0.40). CONCLUSIONS: Stroke and other cardiovascular events are similarly reduced with atorvastatin 80 mg/d in men and women with recent stroke or TIA.
|
|
| 2. |
- Jimenez, Camilo, et al.
(författare)
-
Follow-up of pituitary tumor volume in patients with acromegaly treated with pegvisomant in clinical trials
- 2008
-
Ingår i: European Journal of Endocrinology. - 1479-683X. ; 159:5, s. 517-523
-
Tidskriftsartikel (refereegranskat)abstract
- Objective: We examined pituitary tumor volumes in patients treated with pegvisomant for 18 months or longer and in whom the tumors were monitored for at least 3 years. We present details on 9 of 304 patients in clinical trials with pegvisomant who experienced tumor growth within the first year of treatment. Method: Magnetic reonance images prior to start of pegvisomant and at last follow-up were examined in 43 patients (14% of participating patients). Twenty-nine had received prior radiation therapy (18% of irradiated patients and all but live received somatostatin analogs between periods of pegvisomant treatment. Results: At follow-up, the received tumor volume was 0.6 cc (range 0.0-19.7 ccl. in comparison with 1.6 cc (0.0-19.7 cc) at baseline (P<0.001). Twenty-five patients, of which 23 received radiation therapy, had tumor volume reduction therapy, had an increase in tumor volume from 1.61 to 1.93 cc. Of the nine patients with tumor growth, six had progressive growth before initiating pegvisomant. Two patients with stable tumors while on octreotide experienced enlargement after octreotide discontinuation but remained stable on long-term pegvisomant therapy. Conclusion: The present data indicate that pegvisomant does not promote tumor growth and suggest that the nine observed cases of tumor progression. which occured within 8 months after commencing pegvisomant, are likely rebound expansions after discontinuation of somatostatin analogs and/or the natural history of aggressively growing pituitary tumors. Continued long-term surveillance of tumor volume, particularly in non-irradiated patients is recommended.
|
|
| 3. |
- Parkinson, Craig, et al.
(författare)
-
Gender, body weight, disease activity, and previous radiotherapy influence the response to pegvisomant
- 2007
-
Ingår i: Journal of Clinical Endocrinology and Metabolism. - : The Endocrine Society. - 1945-7197 .- 0021-972X. ; 92:1, s. 190-195
-
Tidskriftsartikel (refereegranskat)abstract
- Context/Objective: To effectively normalize IGF-I in patients with acromegaly, various covariates may affect dosing and plasma concentrations of pegvisomant. We assessed whether sex, age, weight, and previous radiotherapy influence dosing of pegvisomant in patients with active disease. Design: Data from 69 men and 49 women participating in multicenter, open-label trials of pegvisomant were retrospectively evaluated using multiple regression techniques. Sixty-nine subjects ( 39 men, 30 women) had undergone external beam pituitary radiotherapy. Serum IGF- I was at least 30% above age- related upper limit of normal in all patients at study entry. After a loading dose of pegvisomant ( 80 mg), patients were commenced on 10 mg/d. Pegvisomant dose was adjusted by 5 mg every eighth week until serum IGF- I was normalized. Results: At baseline, men had significantly higher mean serum IGF- I levels than women despite similar GH levels. After treatment with pegvisomant, IGF- I levels were similar in men and women. A significant correlation between baseline GH, IGF- I, body weight, and the dose of pegvisomant required to normalize serum IGF- I was observed ( all P < 0.001). Women required an average of 0.04 mg/ kg more pegvisomant than men and a mean weight- corrected dose of 19.2 mg/ d to normalize serum IGF-I [14.5 mg/d ( men); P < 0.001]. Patients treated with radiotherapy required less pegvisomant to normalize serum IGF- I despite similar baseline GH/ IGF-I levels ( 15.2 vs. 18.5 mg/ d for no previous radiotherapy; P < 0.002). Conclusions: Sex, body weight, previous radiotherapy, and baseline GH/ IGF- I influence the dose of pegvisomant required to normalize serum IGF- I in patients with active acromegaly.
|
|
