Alternative Treatments?

Phosphodiesterase type 5 inhibitors — In patients who have obtained some but inadequate benefit from a CCB and who tolerate that therapy, we suggest the addition of a PDE type 5 inhibitor and continue the CCB. In patients who do not benefit from the CCB, we either add a PDE inhibitor or try the PDE inhibitor as an alternative, depending upon the ability to tolerate the medications, if critical ischemia is not present. (See 'Severe symptoms despite oral and topical agents' below.)

Based upon the available evidence and our clinical experience, we initiate therapy at a low dose (eg, sildenafil 20 mg once or twice daily) and increase the dose to 20 mg three times daily if no benefit is achieved. This dose is similar to that used in patients with pulmonary hypertension. A four- to six-week trial should be adequate to determine whether the combination is of benefit. (See "Pulmonary vascular disease in systemic sclerosis (scleroderma): Treatment", section on 'Phosphodiesterase type 5 inhibitors'.)

Care must be taken to fully assess cardiopulmonary status (eg, for pulmonary hypertension) before starting combined vasodilation therapy. Systemic blood pressure measurements should be followed serially. When possible, we advise patients to obtain a blood pressure (BP) cuff and to monitor their BP daily at first until dosing is stable and then weekly thereafter, as well as when symptoms of hypotension occur.

A PDE inhibitor should not be used together with topical nitrates due to the increased risk of hypotension. Other adverse effects that may occur include peripheral edema, palpitations, tachycardia, hearing loss, and visual disturbances.

The increasing use of these medications in efforts to improve peripheral and pulmonary circulation in several disorders is discussed in separately. (See "Pulmonary vascular disease in systemic sclerosis (scleroderma): Treatment", section on 'Phosphodiesterase type 5 inhibitors' and "Treatment of idiopathic pulmonary fibrosis", section on 'Phosphodiesterase inhibitors'.)

Efficacy of PDE inhibition — The efficacy of sildenafil, tadalafil, and vardenafil was best examined in a meta-analysis of six randomized controlled trials that included 244 patients with secondary RP [1]. There was a modest but significant benefit of PDE inhibitors on Raynaud’s Condition Score (RCS), as well as on the frequency and duration of RP attacks [1]. PDE inhibitors reduced the frequency of RP attacks by approximately 0.5/day compared with placebo, which is comparable to the reduction reported in another meta-analysis assessing the efficacy of CCBs in systemic sclerosis (SSc)-related RP (0.6/day) [2]. The RCS represents the level of difficulty experienced by the patient each day that is attributed to RP, and is assessed using a visual analog scale. Although the improvement in the RCS was significant, it was not a clinically meaningful difference [3] (see "Initial treatment of the Raynaud phenomenon", section on 'Assessment of the response to therapy') Additional well-designed trials involving more patients are needed to better assess the role and optimal dosing of sildenafil, tadalafil, vardenafil, and other PDE inhibitors in primary and secondary RP.

sorry it is so long, and technical

gary

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Mary Alice 07882